UNeBlog a Technology Transfer Blog by UNeMed

Dr. Dixon to present Thursday night at Cornstalks

September 26, 2012 Comments Off on Dr. Dixon to present Thursday night at Cornstalks News Like

by Michael Stacy, Silicon Prairie News

OMAHA, Neb. (Sept. 25, 2012)—Representatives from Pipeline, a Kansas City, Kan.-based regional entrepreneurial fellowship, are scheduled to present Thursday night at Cornstalks, a monthly forum hosted by the Greater Omaha Chamber of Commerce for people interested in high-growth entrepreneurship.

Thursday’s event gets underway with networking at 6:30 p.m. and features a Pipeline presentation at 7:30. Cornstalks takes place at the Silicon Prairie News office (1111 North 13th St., Suite 208) and is free and open to the public.

Joni Cobb, the founding president and CEO of Pipeline, will talk Thursday. Others tentatively scheduled to present include Pipeline partners Dr. Michael Dixon (UNeMed) and Karen Linder (Nebraska Angels) and current Pipeline innovators Ben Pankonin (Social Assurance) and Blake Lawrence (Hurrdat Social Media).

Pipeline is a year-long program highlighted by intensive, three-day modules each quarter and an Innovator of The Year event in January. The program takes applicants from from Kansas, Missouri and Nebraska and seeks to fill its classes with entrepreneurs that hail from a variety of industries.

Pipeline is accepting applications for its 2013 class until Oct. 29. Thursday’s event is designed to help entrepreneurs interested in applying learn more about the program. People interested in attending Thursday are encouraged to RSVP to Nora Freyman at nfreyman@pipelineentrepreneurs.com.

For more on Pipeline and applications for its 2013 class, see our previous story: “Pipeline opens application process for 2013 entrepreneurial fellowship“.

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How to determine who is an inventor on a patent: Unraveling inventorship vs. authorship

September 26, 2012 Comments Off on How to determine who is an inventor on a patent: Unraveling inventorship vs. authorship Blog Like

by Bill Hadley, UNeMed | Sept. 26, 2012

Not all authors are necessarily inventors

I recently had a meeting with a faculty member, whom I will call Dr. A, to review an invention disclosure Dr. A had recently made. Shortly after the meeting started, however, Dr. A received a phone call from a colleague (the creatively-named Dr. B) at another university. As I waited for the call to end, I couldn’t help but hear a bit of the discussion. As it turns out, Dr. B was negotiating with Dr. A to have Dr. B’s name appear on a publication coming out of Dr. A’s lab. Aware that discussions of this nature are common in academia, I didn’t pay this much mind, until, at the end of the conversation, the talk turned to intellectual property. In return for Dr. A’s agreeing to put Dr. B’s name on a publication coming out of his lab, Dr. A requested that Dr. B include Dr. A on a patent application that was coming out of Dr. B’s work – at which point, I promptly reacted like this. This is a big no-no from a patent perspective and here’s why.

Authorship on a publication is determined by custom; Inventorship on a Patent is determined by law

Authorship attribution can even vary between labs.

“Authorship” on a publication is attributed differently among the various academic disciplines and can even vary from institution to institution. In large part, authorship is determined by custom: for an academic publication, a variety of people may be legitimately considered for authorship, including those persons involved in the experimental design, those who performed lab work, wrote or edited the manuscripts, or even contributed their general expertise. Authorship may also be bestowed for financial reasons or professional courtesy to collaborators and mentors.

The rules for inventorship, on the other hand, are determined by law, and violation of these rules can have severe impacts on a resulting patent. In order to show how inventorship of a patent differs from authorship of a publication, let’s take a few minutes to explore the patent law on this oft-overlooked issue.

Inventors are the Original Owners of a Patent

When it comes to patents, inventorship is vitally important. This is because, under Article I, § 8 of the Constitution, patents are originally owned by their inventors:

The Congress shall have power…to promote the progress of science and the useful arts, by securing for limited times to authors and inventorsthe exclusive rights to their respective writings and discoveries.

This mandate is codified in 35 USC § 101, which limits the persons who can receive a patent to the inventor. (“whosoever invents… may obtain a patent”). Note that § 101 does not prohibit the inventor from subsequently assigning their rights in the patent away (such as in an employment agreement, see e.g. UNMC Board of Regents Policy Nos. 3.10 and 4.4.1). As a procedural step, however, the identified inventors of a patent must be named the original owners of the patent.

Legal Definition of “Inventor”

Because inventors are the original owners of their patents, it is imperative to define who, exactly, the inventor of a patent is.

In legal terms, the invention in a patent is defined by its claims – you might expect, then, that the inventor of a patent is defined by the claims as well. This turns out be true, as, to be an inventor of a patented invention, an inventor must have contributed to the conception of the invention and to at least one claim on the issued patent (see e.g. Ethicon Inc. v. United States Surgical Corp., 135 F.3d 1456 (Fed. Cir 1998)).

Moreover, under 35 USC § 116, there may be more than one (i.e. a joint) inventor of a single patent, so long as each joint inventor individually meets the legal requirement for inventorship described above, and there was at least some concerted effort between the inventors (see e.g. §116; Eli Lilly v. Aradigm Corp., 376 F.3d 1352 (Fed. Cir 2004). Note that there are many problems that can arise in a patent with joint inventors, some of which we have previously noted in our discussion regarding collaborations and their impact on inventions and patents.

Ramifications of Mis-Identified Inventors

If the inventors on a patent are mis-identified, the end-result is that the patent can be invalidated – often costing the inventors thousands of dollars and years of hard work. Fortunately, if the error in identifying the proper parties was made in good faith, these defects can be remedied under either §116 or 35 USC §256. For an excellent summary of actions that can be taken to correct inventorship on a patent, check out this article from Campbell Chiang at Duke University.

The take-home message here is: don’t use inventorship on a patent application as a commodity, as is sometimes done with authorship on a publication.

This is for two reasons. First, the “agreement” between the collaborators will be found to be invalid if it is ever discovered (which it will be for any valuable patent) – rendering such an “agreement” worthless. Second, if inventorship is found to be invalid due to an intentional act by one valid inventor, courts may construe the bargain as an intentional attempt to defraud the USPTO, thus nullifying the good-faith exceptions to remedying inventorship errors described above. This could invalidate the patent in its entirety.

From my perspective, full disclosure with your attorney or patent agent is the best policy. When disclosing an invention to your technology transfer office (or patent attorney), do not simply list the authors of a related publication as inventors. Although all authors may be considered inventors in some circumstances, the inventors of a patent are not necessarily all of the authors of a related publication.

When in doubt, provide your counsel with the names of all the individuals who contributed to the invented work, and let the attorneys decide who fits the bill as inventors. This may be more work for the attorneys in the short term, but it can pay dividends to the inventors (and investors!) down the road if the patent is ever challenged in court.

If you have any questions or comments, please do not hesitate to contact the author or leave a comment below.

Join us next week when we discuss Trademarks.

About the Author

Bill Picture
Bill Hadley, JD

Bill is a licensing associate at UNeMed, where he handles evaluation, development, marketing, and licensing for medical device, software, and telemedicine-based invention disclosures. He received a B.S. in Chemistry from the Colorado School of Mines and a J.D. from the Creighton University School of Law. Bill is currently in training for next fall’s intramural volleyball league, where he has personally guaranteed at least one victory for the mighty UNeMed Volley Llamas.

Contact Bill: Bill.Hadley@unemed.com

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Five important aspects of copyrights that you should know

September 17, 2012 Comments (2) Blog Like

by Bill Hadley, UNeMed | Sept. 17, 2012

In 2009, Fredrik Colting attempted to publish 60 Years Later: Coming Through the Rye, a thinly-veiled sequel to The Catcher in the Rye, by J.D. Salinger.

In 2009, Swedish author Fredrik Colting (under the pen name J.D. California) attempted to publish a book titled 60 Years Later: Coming Through the Rye. Unfortunately, Coming Through the Rye, was a thinly-veiled sequel to the 1951 classic, The Catcher in the Rye, by J.D. Salinger. Both novels are set in New York, feature the same characters (though identified differently – Holden Caulfield is called “Mr. C”, for example), and feature similar events. Salinger sought to prevent Colting from publishing the sequel and sued him for copyright infringement. Salinger eventually won, but Through the Rye illustrates complex issues about the scope of our copyright system.

1. Copyrights promote the progress of science and the useful arts

How far, exactly, does Salinger’s copyright in The Catcher in the Rye extend? Does it allow Salinger to prohibit others from using similar story arcs, characters, or themes? Conversely, Through the Rye can easily be viewed as a simple cash grab – that Colting simply sought to take advantage of the popularity of Catcher in order to “take the easy way out” in writing his own novel. Should this be permitted? Where do courts draw the line in determining whether Colting was merely “inspired by” Salinger, commenting on Salinger, or whether he was flat-out copying him? Don’t all stories, to some extent, build on their predecessors?

These are not easy questions to answer, and they strike at the heart of the copyright system. Copyrights, along with patents, are explicitly implemented by the Constitution to promote the “progress of science and the useful arts”. But is that really happening here? Some would argue that Salinger’s copyright is inhibiting creative progress by sabotaging Colting’s ability to publish his own work. Others would argue that it is functioning perfectly because Colting’s work is not creative at all: it simply exploits the creativity of Salinger. Copyrights are necessary, this latter group would argue, to protect the original author’s interest in his creation and to maintain the sanctity of the creative work.

Be under no illusions – I don’t have the space to faithfully examine these (extremely controversial) issues here. But, by providing the framework for how the copyright system operates, I can hopefully provide a basis for you to reach your own educated conclusion.

2. Works that may be copyrighted

Under 17 USC § 102(a), a copyright may be granted to:

Any original work of authorship fixed in a tangible medium of expression, now known or later developed, from which [the original work of authorship] can be perceived, reproduced, or otherwise communicated, either directly or with the aid of a machine or device.

Using this definition, 17 USC § 102(a) illustrates the types of work that are eligible for copyright protection:

Literary works
Musical Works
Dramatic Works
Pantomimes and choreographic works
Pictorial, graphic, and structural works
Motion pictures
Sound recordings
Architectural works

Pointedly, 17 USC § 102(b) explicitly disclaims ideas, procedures, processes, systems, methods of operation, concepts, principles, or discoveries from copyright protection. In other words, a copyright only extends to the expression of an idea, not to the idea itself. Thus, an author may have a copyright on a novel exploring teenage angst, but the copyright only extends to the expression of teenage angst provided in that novel, not to all novels displaying teenage angst.

3. Exclusive rights are granted by a copyright

Under 17 USC § 106, the owner of a copyright has the exclusive right to do the following with the copyrighted work for the life of the author, plus an additional 70 years:

To reproduce the copyrighted works
To prepare derivative works
To distribute copies of the work
To perform the copyrighted work publicly
To display the copyrighted work publicly
To perform the copyrighted work publicly by means of a digital audio transmission.

Unfortunately, the way these exclusive rights work in practice is not at all obvious. In fact, there are far too many nuances to these rights to describe in detail here. For a more in-depth explanation, check out this article.

4. Unauthorized use leads to copyright infringement

Ronnie Mack sued George Harrison for copyright infringement over Harrison’s 1970 hit “My Sweet Lord”. Compare the works here.

Simply put, a copyright is infringed when there is an unauthorized use of one of the exclusive rights from 17 USC § 106. Sometimes this determination is easy – often it is clear if an unauthorized party is distributing or displaying a copyrighted work. On the other hand, it is much more difficult, in many cases, to determine whether someone is actually reproducing a copyrighted work.

To resolve this issue, courts generally apply some form of the “substantial similarity” test. Determining whether the reproduction right of a copyright has been infringed, however, is actually quite complex, and application of the substantial similarity test is not a settled issue among the circuits. Therefore, for now, suffice to say that infringement of the reproduction right occurs when there has been an unauthorized copying of the material portion of a creative work.

For a comparison of a number of fascinating cases alleging infringement of a musical copyright, I highly recommend checking out the UCLA /Columbia University Music Copyright Infringement Resource.

5. Obtaining a copyright is a piece of cake

A copyright automatically vests in the author upon creation of a copyrighted work in a tangible medium of expression. So, in effect, all that is necessary to obtain a copyright is to complete work that is eligible for a copyright. It is also possible to formally register a copyright. To do so, all that is required is to complete an application form and submit a nominal 35$ fee along with a copy of the copyrighted work to be stored at the Library of Congress. Registering a copyright definitely has a number of important benefits for copyrights with commercial value.

Conclusion

In early 2012, the Congress attempted to pass the “Stop Online Piracy Act” (SOPA) in a desire to curb internet-based copyright infringement. Due to outcry from sources like Wikipedia (shown above), the House Judiciary Committee has postponed consideration of the bill.

Copyright protection extends to original works of authorship which are fixed in a tangible medium of expression. Furthermore, the copyright only extends to the expression of the idea behind that work of authorship – not the idea itself. Simple, right? Sort of – but unfortunately things become much more complex when applying concepts like Fair Use, Works for Hire, and the First Sale or Merger Doctrines. Moreover, copyrights as applied to software can be even more troublesome, especially when placed in the context of the internet.

The fact of the matter is that copyrights (usually) make a great deal of sense when discussing tangible items like books, artwork, or sheet music (i.e. things that were around when the copyright laws were drafted). They become much more complicated when applied to the newer digital mediums. The Digital Millennium Copyright Act seeks to address some of these issues, but in many cases only makes things more complicated. Hopefully we can discuss this in a subsequent post, but for today I hope this brief summary was useful in providing an overview of this commonly muddled area of the law.

If you have any questions or comments, please do not hesitate to contact the author or leave a comment below.

Join us next week when we discuss inventorship and naming co-inventors.

About the Author

Bill Picture
Bill Hadley, JD

Bill is a licensing associate at UNeMed, where he handles evaluation, development, marketing, and licensing for medical device, software, and telemedicine-based invention disclosures. He received a B.S. in Chemistry from the Colorado School of Mines and a J.D. from the Creighton University School of Law. Bill is currently in training for next fall’s intramural volleyball league, where he has personally guaranteed at least one victory for the mighty UNeMed Volley Llamas.

Contact Bill: Bill.Hadley@unemed.com

Nothing in this post should be construed as legal advice. It has been developed by the UNeMed staff as an educational resource for faculty, staff, students, and other personnel associated with the University of Nebraska Medical Center. While all information contained herein has been thoroughly fact-checked, this site is provided on an “as is” and “as available” basis. Neither UNeMed nor the University of Nebraska Medical Center make any representations or warranties of any kind, express or implied, as to the site’s operation or the information, content or materials included on this site. To the full extent permissible by applicable law, UNeMed and the University of Nebraska Medical Center hereby disclaim all warranties, express or implied, including but not limited to implied warranties of merchantability and fitness for any particular purpose. Neither UNeMed nor the University of Nebraska Medical Center will be liable for any damages of any kind arising from the use of or inability to use this site. You expressly agree that you use this site solely at your own risk.

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What everyone ought to know about using patents versus trade secrets

September 10, 2012 Comments Off on What everyone ought to know about using patents versus trade secrets Blog Like

by Bill Hadley, UNeMed | Sept. 20, 2012

Why do we have patents?

According to the U.S. Constitution, the patent system exists to “promote the progress of science and the useful arts.” We can (and should!) argue how effectively the patent system accomplishes this, but the important message here is that, at the end of the day, the patent system is in place to encourage innovation – but innovation by (and for) whom?

The simple answer is the inventor – after all, the inventor is personally incentivized to innovate via the exclusive rights bestowed upon them by virtue of a patent. This is correct, in a sense – but it is not the entire answer. Sure, in the short-run, inventors may be rewarded for their innovation by an issued patent. It is important to remember, however, that the real aim of the patent system is to promote the long-term innovation necessary to advance society as a whole. Rewarding individual inventors is just the short-term means to that long-term end.

The key consideration here is disclosure: a patent rewards the inventor for developing his patented gizmo by prohibiting others from making, using, selling, offering to sell, or importing the patented invention. In addition, patents also reward inventors for disclosing the invention. This is important, because, by disclosing the nature of the invention in the patent, the inventor has provided the basis for a future inventor to improve upon the invention. In turn, the future inventor will hopefully disclose their improvement in a patent, which someone else will improve upon and disclose in a patent, and so forth.

The thought behind this innovation loop is that, by promoting inventors to disclose their innovations to the public, we foster greater overall innovation, which, in the aggregate, benefits society.

As you may recall, trade secrets operate in a manner very similar to patents. That is, in certain circumstances, a trade secret gives its holder the exclusive right to use the trade secret information. Apart from that basic principle, trade secrets and patents are very different because trade secrets don’t require disclosure – in fact, they prohibit it. In other words, trade secrets are not intended to promote societal advancement, they are intended further only the interests of the trade secret holder.

So is it better to have a trade secret or a patent for an invention?
Society – as reflected by Congress and the USPTO – would certainly prefer that inventors patent their inventions. This is demonstrated by the strong rights given to patent holders and the restrictions in place on trade secrets (e.g. maintenance of secrecy and the possibility of reverse-engineering). In many ways, patents are designed to incentivize innovators not to use trade secrets. Nevertheless, in some circumstances, a trade secret is a perfectly viable option for an inventor.

To illustrate the competing nature of patents and trade secrets, consider the following hypothetical invention

The Hadley Widget

Let’s say, for example, that I have just invented a promising new invention which we will call, somewhat uncreatively, the Widget. (Note that it does not matter what the Widget is, only that it is subject-matter which is eligible for patent protection under 35 U.S.C. § 101.) The Widget is quite valuable and I have decided to build a company around it and make my fortune. Before doing anything else, however, it behooves me to consider the best way to protect the Widget from a competing firm – either by applying for a patent or keeping it a trade secret.

If I elect to pursue a patent, I will have to disclose the innovative concepts of the Widget to the public and pay substantial filing and attorney’s fees in order to obtain the patent. In return, in approximately 2-4 years – if a patent is eventually issued – I will have (relatively) dependable exclusive rights to the Widget for a period of 20 years from the date of my application. Thereafter, competitors will be free to use the widget to compete with my company.

On the other hand, if I elect to maintain the Widget as a trade secret, I will not need to pay any fees nor will I need to file any documents. Moreover, so long as the innovations of the Widget remain secret, my exclusive rights will exist in perpetuity. In return, I will have to implement policies within my company that are “reasonable” (whatever that is in my jurisdiction) to maintain the secrecy of the Widget. I will also have to accept that if anyone ever legitimately reverse-engineers or otherwise uncovers the innovative aspects of the Widget, I will immediately lose my exclusive rights to it.

With that in mind, here are a few considerations I need to take into account before determining which scheme is more beneficial to me:

How easy is the Widget to reverse-engineer? If the Widget is something easily reproduced or understood by a consumer (e.g. a paperclip or thumbtack), I should probably elect to get a patent. Conversely, if the Widget is something which, even if widely used, is difficult to precisely gain knowledge of (e.g. WD-40 composition, software source code), a trade secret may be in order.

How much have I invested in the Widget? Depending on the amount of funding I’ve received (or am attempting to get), it may be wiser to pursue a patent due to the relative certitude of patent enforceability (unlike that of the trade secret). Conversely, if the invested amount is significant, I may feel that I need 20+ years to recoup my investment. In that case, I might be willing to risk a trade secret (and I should probably review my business model!).

What is my market window? If the widget is only likely to be valuable for a few years or less, it might be smarter to go with a trade secret due to the delay and costs inherent to the patent application process. Moreover, the odds of the Widget being reverse-engineered or otherwise legitimately revealed in such a short window are dramatically smaller.

How confident am I in the Widget’s patentability? If I apply for a patent and it is subsequently rejected by the USPTO, the patent application will still be published to the public – thereby destroying any ability I have to keep the Widget a secret (note: this is why recipes are usually protected by trade secret).

How confident am I that I can build a brand around the trade secret information? Imagine if, by some miracle, the Google search algorithm was uncovered by Microsoft and was subsequently implemented in Bing, such that Google and Bing search results displayed identical results. Does anyone believe Bing would become a legitimate competitor to Google in that circumstance? Likely not, based on the strength of Google’s brand, its existing market share, and the functionality of its peripheral components.
In this case, the Google search algorithm’s secrecy bought Google the time it needed to establish a strong brand, customer loyalty, and market share without the necessary investment or delay incumbent in a patent application. If I think that I can build a brand around the Widget which can sustain a company outside the market advantage gained by a patent or trade secret, due to the lower entry costs of obtaining a trade secret, it might be an attractive option.

Do patents really foster innovation for society as a whole? This is a difficult question, and rational minds can certainly differ as to the answer. Nevertheless, it can be fun to play the “what if…” game to try and wrestle with complex issues like this.

So, what if, for example, Coca-Cola had elected to patent their recipe for a soft drink instead of keeping it as a trade secret?

It is entirely possible that, today, the soft drink industry would be quite different. For example, instead of a variety of different flavors/brands of soft drinks (e.g. Mountain Dew, Dr. Pepper, Root Beer, Grape Soda), we might have been stuck with four or five firms producing a cola which tastes identical to a Coke. Once the Coke patent had elapsed, what would have been the incentive to innovate or invest away from a formula which is proven to be the most popular in the market?

This is an example of an industry where a trade secret didn’t hinder innovation – instead of many firms trying to emulate the “Coke experience,” rival firms have been forced to innovate in ways to differentiate themselves from the secret coke formula. This has resulted in more competition and greater variety for the consumer. Or, stated another way, a societal improvement in the soft drink industry.

On the other hand, had the Twinkie recipe had been patented, we might even now find ourselves in a world where multiple Twinkie manufacturers were engaged in a price war to produce the most cost-effective Twinkies. I don’t think any of us would have a problem with that.

If you have any questions or comments, please do not hesitate to contact the author at bill.hadley@unmc.edu or by leaving a comment.

Join us next week when we discuss the key elements of a Copyright.

Nothing in this post should be construed as legal advice. It has been developed by the UNeMed staff as an educational resource for faculty, staff, students, and other personnel associated with the University of Nebraska Medical Center. While all information contained herein has been thoroughly fact-checked, this site is provided on an “as is” and “as available” basis. Neither UNeMed nor the University of Nebraska Medical Center make any representations or warranties of any kind, express or implied, as to the site’s operation or the information, content or materials included on this site. To the full extent permissible by applicable law, UNeMed and the University of Nebraska Medical Center hereby disclaim all warranties, express or implied, including but not limited to implied warranties of merchantability and fitness for any particular purpose. Neither UNeMed nor the University of Nebraska Medical Center will be liable for any damages of any kind arising from the use of or inability to use this site. You expressly agree that you use this site solely at your own risk.

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UNeMed to host research commercialization introductory course

September 5, 2012 Comments Off on UNeMed to host research commercialization introductory course News Like

OMAHA, Neb. (Sept. 5, 2012)—UNeMed Corporation, the technology transfer leader for UNMC, will once again sponsor a free Webinar series for all researchers, post docs,and graduates studentsevery Wednesday beginning on September 19 through November 14 from 2:30 to 4:00 p.m.

UNeMed first hosted the series, presented by the National Council of Entrepreneurial Tech Transfer, in 2009 and certificates of completion were presented by UNeMed to 22 participants. The course focused on the successful commercialization of research and the practical steps required to protect and market intellectual property.

Beginning on Wednesday September 19, the 8-week course will help researchers better understand how research commercialization works. Research commercialization involves taking intellectual property generated during research activities and bringing it to users and patients to address significant medical and clinical needs.

Areas covered in the course include intellectual property, patents, copyrights, trade secrets, trademarks, licensing agreements, employment agreements, consulting agreements, tech transfer, creating and funding companies, and federally funded Small Business Innovation Research (SBIR) programs.

The first lecture will be Wednesday, September 19 in the DRC 1004 from 2:30 – 4:00 pm.Each lecture is a live 90-minute online class with Q&A and all sessions are from 2:30 to 4:00 p.m. Class schedule is shown below.

Participants are encouraged to pre-register for the courseby e-mailing Val Gunderson at vgunders@unmc.edu, by September 14.Snacks will be served to all registered participants. Upon completion of the course, UNeMed will award a Certificate of Completion for the course.

If you are interested in the free course, but unable to attend in person, you may sign up to view the session from any computer by registering at the Researcher Commercialization Course website.

Also refer to the announcement on the UNMC Today

CLASS SCHEDULE

Lecture 1: The Importance of Commercializing Research
Wednesday, September 19, 2012 at 2:30 p.m.

Lecture 2: Patents
Wednesday, September 26, 2012 at 2:30 p.m.

Lecture 3: Copyright, Trademarks and Trade Secrets
Wednesday, October 3, 2012 at 2:30 p.m.

Lecture 4: Employment and Consulting Agreements
Wednesday, October 10, 2012 at 2:30 p.m.

Lecture 5: Tech Transfer and Licensing Agreements
Wednesday, October 17, 2012 at 2:30 p.m.

Lecture 6: Small Business Innovation Research (SBIR) Grants
Wednesday, October 24, 2012 at 2:30 p.m.

Lecture 7: Introduction to Early Stage Funding
Wednesday, October 31, 2012 at 2:30 p.m.

Lecture 8: Introduction to Structuring and Leading the Research-Intensive Company
Wednesday, November 7, 2012 at 2:30 p.m.

Lecture 9: Moving from R&D to Manufacturing
Wednesday, November 14, 2012 at 2:30 p.m.

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Safeguarded in the vault: How trade secrets work

August 28, 2012 Comments (1) Blog Like

by Bill Hadley, UNeMed | Aug. 28, 2012

Secrets lie behind the closed gate

Believe it or not, for most of us, the classic 1971 movie Willy Wonka and the Chocolate Factory was our first experience with intellectual property. For those who haven’t seen it (SPOILERS!) the plot can be reduced to this: a reclusive candy mogul (Willy Wonka) wishes to pass on his secret recipe for chocolate to a worthy heir and, to do so, distributes 5 golden tickets to the public by way of his candy bars. The lucky recipients of these tickets are rewarded with a tour through Wonka’s mysterious factory where, at the end, one person (the incorruptible Charlie Bucket) is identified as the heir to the Wonka chocolate recipe.

As silly as it seems, the Wonka chocolate recipe is a perfect example of the little brother of intellectual property protection mechanisms: the trade secret. While patents, copyrights, and trademarks are the most well-known IP protection schemes, the importance of trade secrets should not be undersold. In fact, many interesting innovations are still protected by trade secret today, including the composition of WD-40, the recipe for Twinkies, Google’s search algorithm, and, of course, the inestimable Coca-Cola recipe.

Image by trexfiles23

Because trade secrets are dependent on the – surprise! – secrecy of their innovations, trade secrets are anathema to university culture. Nevertheless, over the course of their careers, many UNMC faculty, students, and staff will work with industrial partners who have valuable trade secrets. Moreover, understanding the relationship between trade secrets and patents is crucial to understanding the patent system as a whole. So, without further ado, let’s look at the law surrounding trade secrets.

The Basics of Trade Secrets

Trade Secrets are interesting in that they are generally considered matters of state law; consequently, the definition of a trade secret can be subtly different in different states. Fortunately, the Uniform Trade Secrets Act (UTSA; a model act published by the Uniform Law Commission) has been adopted in some form in 46 states (including Nebraska). Under the UTSA, a trade secret is defined as:

Any information, including a formula, pattern, compilation, program, device, method, technique, or process that:

(i) Derives independent economic value, actual or potential, from not being generally known to, and not being readily ascertainable by proper means by, other persons who can obtain economic value from its disclosure or use, and
(ii) Is the subject of efforts that are reasonable under the circumstances to maintain its secrecy.

So, in more general terms, a trade secret is any information which falls into the stated categories which is valuable, at least in part, due to its secrecy (read: exclusivity to the owner) and which the owner maintains at least reasonable efforts to keep secret.

Rights Given by a Trade Secret

In general, trade secrets protect their holder from competitors who seek to use the protected innovation, if that competitor has obtained the protected information by an improper means or through misappropriation. That is to say, if, for example, Microsoft was able to (illegally) hack in Google’s internal network and retrieve Google’s search engine algorithm, Google could sue Microsoft for infringing their trade secret rights.

The UTSA provides a number of remedies to parties whose trade secret rights have been infringed, including:
1. An infringed party may enjoin (stop) the alleged infringer from using the trade secret information.
2. The infringed party may recover damages from the misappropriating party (lost profits, etc.)

Remember, as a model act, the UTSA is not necessarily implemented uniformly throughout its adopting jurisdictions. Therefore, when considering a trade secret issue, it is prudent to consult your state laws to investigate how the UTSA is applied in your jurisdiction (if at all).

Additionally, the Economic Espionage Act of 1996 has trade secret- related provisions which make theft or misappropriation of a trade secret a federal crime. 18 U.S.C. §1831 criminalizes theft of a trade secret to benefit a foreign power while 18 U.S.C. §1832 criminalizes theft of a trade secret for economic purposes.

Misappropriation of Trade Secrets

It is important to note that a trade secret does not protect its owner from a rival who legitimately reverse-engineers or discovers the secret information. Borrowing from my earlier example, if, instead of hacking into Google’s network, Microsoft had been able to chart trillions of normal Google searches, and was able to deduce the exact mechanisms by which the search results are produced from this body of information, the Google algorithm would be considered “ascertained by proper means” under the UTSA, and trade secret law would not protect Google from Microsoft from using the same search algorithm within its own search engine, Bing.

It is very important, then, to understand when a trade secret has been discovered by improper means or when it has been inequitably misappropriated. Under the UTSA, trade secrets are obtained via “improper means” when they are uncovered by theft, bribery, misrepresentation, breach (or inducement to breach) of a duty to maintain secrecy, or espionage (electronic or otherwise). “Misappropriation”, essentially, is acquisition of a trade secret by one person from another, when the first person knows, or has reason to believe, that the other has acquired the trade secret through improper means, or if the first person acquires the secret information through certain other inequitable conduct.

Trade Secrets at UNMC

As I mentioned earlier, it is anathema for an institution of higher learning such as UNMC not to disclose to the public information discovered by its faculty and students. Therefore, only in the most extreme circumstances will UNeMed elect to protect an invention by trade secret. In fact, as of today, neither UNeMed nor any of its spin-out companies has ever held a trade secret. That being said, many UNMC faculty members work with outside companies, and many of our students and post-docs will also transition to industry after they graduate. Because private industry frequently utilizes trade secrets, it behooves us to help our readers gain at least an overview of trade secret law. Ironically enough, a familiarity with trade secret law is one compilation which does not derive any value from its secrecy.

If you have any questions or comments, please do not hesitate to contact the author at bill.hadley@unmc.edu or by leaving a comment.

Join us next week when we discuss the essential differences between Patents and Trade Secrets.

Nothing in this post should be construed as legal advice. It has been developed by the UNeMed staff as an educational resource for faculty, staff, students, and other personnel associated with the University of Nebraska Medical Center. While all information contained herein has been thoroughly fact-checked, this site is provided on an “as is” and “as available” basis. Neither UNeMed nor the University of Nebraska Medical Center make any representations or warranties of any kind, express or implied, as to the site’s operation or the information, content or materials included on this site. To the full extent permissible by applicable law, UNeMed and the University of Nebraska Medical Center hereby disclaim all warranties, express or implied, including but not limited to implied warranties of merchantability and fitness for any particular purpose. Neither UNeMed nor the University of Nebraska Medical Center will be liable for any damages of any kind arising from the use of or inability to use this site. You expressly agree that you use this site solely at your own risk.

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UNeMed blog aims to keep inventors in the tech transfer loop

August 20, 2012 Comments Off on UNeMed blog aims to keep inventors in the tech transfer loop News Like

UNeMed was featured on the UNMC Today on August 20, 2012

UNeMed blog aims to keep inventors in the tech transfer loop

UNeMed has started a weekly blog called UNeBlog that focuses on technology transfer and related topics.

The blog aims to educate researchers about technology transfer and also inspire them to work with UNeMed on the commercialization of their inventions.

The blog also will feature interviews with active members of local/regional technology transfer community as well as news and announcements from the field of technology transfer.

View the original UNMC Today article here

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Collaborations and Their Impact on Inventions and Patents

July 31, 2012 Comments (1) Blog Like

by Bill Hadley, UNeMed | July 31, 2012

Collaborations are an essential part of the research process.

An essential part of the research process is collaboration. As the reader is well aware, today’s most important solutions often involve complex systems which require the expertise of multiple parties to fully address. Take, for example, the sequencing of the human genome, completed (mostly) in 2003. The story of the Human Genome Project (HGP) is well-described elsewhere, but those familiar with the history of the HGP will recognize that it was supported by a long line of luminaries – both in academia and in industry – specializing in fields such as chemistry, biology, physics, engineering, computer science, and mathematics.

Many research projects, even if less ambitious in scope than the HGP, are not so different. At UNeMed, for example, we regularly foster collaboration between faculty at UNMC and engineers at UNL to develop innovative medical devices and software packages. Collaborations need not merely be an exchange of expertise, however. They can also involve an exchange of resources or tools. A researcher located here at UNMC, for example, may have identified a potential therapeutic target for a drug, but lacks the compound library necessary to identify a drug candidate. It is perfectly reasonable for that researcher to collaborate with an outside partner who has a compound library ready to be screened for potential hits.

While collaborations of this type occur on a regular basis, they do have interesting implications for the commercialization process. In this blog entry, I would like to take a few minutes to describe how collaborative research impacts the intellectual property rights to an invention that comes out of the collaboration. Furthermore I will discuss how UNMC – by way of UNeMed – handles the commercialization of collaborative technologies, both in the cases of academic-academic and academic-industry pairings.

Co-Ownership of Patents derived from Research Collaborations

Under 35 U.S.C. § 116, a patent is co-owned by each inventor of the invention claimed in the patent. Thus, if the claimed invention was invented in collaboration with multiple parties, the resulting patent will be co-owned by each party. This can lead to a number of issues which, if not addressed ab initio, can fester into more serious complications down the road.

First, a key point to consider is that, to be an inventor (and thus co-owner) on a patent, a party must have contributed to the conception of a claim found in the patent. Because the scope and nature of patent claims are often modified during the course of patent prosecution, it is common that collaborators – who may have initially been considered inventors at the time of the patent application – are subsequently eliminated from the inventor/ownership pool by the time the patent is issued. The problems this can cause within the collaboration are obvious.

The second problem with co-ownership of a patent is that, similar to personal property interests, a co-owner of a patent has a “50% undivided share” (if two co-owners) of the property rights. Co-owners to property have a number of rights in the property, but the most important for our purposes is an unrestricted right of access to it. This can make commercializing the patent difficult, because the value of a patent is greatly diminished if it does not provide exclusivity.

Take, for example, the following situation: a UNMC researcher co-invents a patentable invention with a collaborator. A few years later, the patent is subsequently issued with UNMC and the collaborator as co-owners. Nevertheless, the invention still requires significant investment (e.g. 510(k), IND, etc.) to develop it to the point where it can be sold as a product or otherwise be utilized in the public interest. UNeMed wants to license UNMC’s rights in the patent to an industrial partner to further develop the invention, but the collaborator does not wish to license the patent. Instead, the collaborator wants to hold on to the patent and build a company around it himself (UNeMed is not keen on this idea, as – for purposes of this hypothetical – the collaborator is a wildly inexperienced businessman).

In this situation, UNeMed will have difficulty finding an industrial licensee who is willing to invest in the patented technology because the collaborators equal right of access to it – by virtue of the collaborator’s status as a co-inventor/owner – provides an immediate competitor to the licensee. Why would UNeMed’s licensee want to invest the money to develop the technology when the collaborator (or the collaborator’s licensee) can come in later and cut into their market share with no investment at all? By a similar token, the collaborator will have a difficult time finding venture or other funding to build his company due to UNeMed’s outstanding rights.

This is clearly a worst-case scenario, but it is illustrative of the problems that can occur when co-ownership rights in a patent are not addressed ahead of time. So how are these issues resolved? Generally, most research collaborations by UNMC faculty are of two types: academic-academic (including other non-profits) and academic-industry. Based on the interests and commercialization capabilities of the collaborating entity, the nature of the solution may change based on which type of collaboration has occurred.

Academic-Academic Collaborations

When the collaborating party is another academic institution, it is typical for the institutions to put in place an Inter-Institutional Agreement (“IIA”) once an invention is generated. The IIA contractually outlines each party’s rights in the co-owned intellectual property. For example, the common IIA will consolidate patent rights and establish which entity is responsible for marketing and prosecuting the patent. It will also determine what the distribution of proceeds will be if a licensee is found (typically the institution which is taking the lead takes a higher percentage of proceeds). In circumstances where UNeMed does not take the lead on patent prosecution, provisions are included in the agreement giving UNeMed rights to oversee the prosecution of the patent such that UNMC’s rights in the patent are not inequitably terminated in the course of prosecution.

Academic-Industry Collaborations

This agreement is different when a UNMC researcher has collaborated with an industry researcher. Generally, in these circumstances, the company is interested in pursuing the invention – why else would their researcher be working on it – and therefore it is simply a matter of licensing (or giving an option to) UNeMed’s rights in the co-owned patent. Conversely to an IIA, in an academic-industry collaboration contractual agreements overseeing the patent rights are put in place before the intellectual property is generated. Moreover, in these circumstances, UNeMed generally retains control, subject to the company’s input, of patent prosecution as well.

UNeMed is here to help

If not handled properly, collaborations have the potential to be painful experiences for researchers interested in commercializing their intellectual property. Fortunately, with a little foresight, nearly every major hurdle to the commercialization process can be anticipated and addressed with the help of UNeMed. If you are currently engaged in (or are contemplating in engaging in) a research collaboration with an outside entity that may produce commercializable intellectual property, please do not hesitate to give us a call – we’re happy to help in any way we can. Here, of all places, we should realize that an ounce of prevention is worth a pound of cure.

Please leave any questions or suggestions you may have in the comment section below.

You can also shoot me an email at bill.hadley@unmc.edu

Nothing in this post should be construed as legal advice. It has been developed by the UNeMed staff as an educational resource for faculty, staff, students, and other personnel associated with the University of Nebraska Medical Center. While all information contained herein has been thoroughly fact-checked, this site is provided on an “as is” and “as available” basis. Neither UNeMed nor the University of Nebraska Medical Center make any representations or warranties of any kind, express or implied, as to the site’s operation or the information, content or materials included on this site. To the full extent permissible by applicable law, UNeMed and the University of Nebraska Medical Center hereby disclaim all warranties, express or implied, including but not limited to implied warranties of merchantability and fitness for any particular purpose. Neither UNeMed nor the University of Nebraska Medical Center will be liable for any damages of any kind arising from the use of or inability to use this site. You expressly agree that you use this site solely at your own risk.

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The Need for Material Transfer Agreements

July 25, 2012 Comments Off on The Need for Material Transfer Agreements Blog Like

by Bill Hadley, UNeMed | July 25, 2012

The University of Nebraska has many of the nation’s brightest minds conducting research at its facilities. These innovators often work with other organizations to solve some of the world’s most difficult problems through various research projects. In order to complete a given project, it is often necessary for a University of Nebraska Medical Center (UNMC) researcher to provide or borrow materials from other entities. To protect their contribution to the research (which may include commercializable intellectual property), universities use various contractual instruments, such as a material transfer agreement (MTA), to protect their interests.

Although an MTA itself does not generate revenue, it sets the stage for future licensing contracts. UNMC’s total revenue for 2011-2012 was $602.5 million, portions of which were due to revenue generated from intellectual property. An MTA outlines which party to the agreement owns intellectual property developed from use of the materials. If UNMC retains ownership to this intellectual property, it is often able to license these rights to an industrial partner and garner royalties, thereby both increasing research funds available to UNMC generally and providing additional financial compensation to the researcher.

Each party to an MTA has a slightly different form that it prefers. If the parties are universities, the exact terms and conditions for each MTA are typically negotiated by the technology transfer offices of the two institutions. This process is generally not too time consuming, as most universities have similar interests.

MTAs may become more complicated when one party is a for-profit entity. This is for obvious reasons: universities are interested in disseminating research results, whereas for-profit corporations focus primarily on generating profits from their materials. Nevertheless, industry-university MTAs are quite common, though the terms of the agreements may require more negotiation.

While it is simple enough to contact UNeMed and ask us to get an MTA in place, researchers also play an important role in MTA formation. By providing descriptions of research plans and descriptions of the materials transferred, the researcher delivers key elements used to draft the MTA and to outline the permitted use of the materials. Since researchers are also responsible for providing or accepting the materials transferred, they read, review, and sign the final MTA to acknowledge awareness of any special conditions that must be observed.

Although MTAs may require some advanced planning to avoid delays in research, they serve an important purpose. MTAs lay the foundation for individual and institutional financial gain, and protect the materials and intellectual property in which universities have rights. These agreements also protect future intellectual property and the researchers’ rights to publish research results. Protections like these are necessary for the existence and mission fulfillment of federally-funded universities. With these protections in place, the brilliant minds employed by UNMC can focus on their research with peace of mind that their contributions will be protected and properly attributed.

Steps for receiving materials from organizations:

Obtain organization’s contact information (“Provider”).
Prepare a brief description of materials to be received.
Write a brief (2-3 sentences) project plan or description, outlining the intended use of the materials.
Contact UNeMed Contracts Manager, Jeff Andersen, at jeff.andersen@unmc.edu or 402-559-3274. Provide project and material descriptions and a copy of any MTA that Provider may have forwarded to you. If you have not already obtained a copy of Provider’s standard MTA, UNeMed will do so in order to review the terms of the MTA.
UNeMed and Provider will enter into negotiations until a finalized MTA is agreed upon.
UNeMed will supply the finalized MTA for you to read, review, and sign.
Send signed MTA to UNeMed, who will then review and sign.
MTA is executed by Provider. UNeMed provides a copy of the fully-executed MTA to the researcher, and materials soon follow.

Steps for transferring materials to organizations:

Obtain organization’s contact information (“Recipient”).
Prepare a brief description of materials to be transferred.
Obtain from the Recipient’s principal investigator a brief paragraph of project plan or description, for which materials will be used.
Contact UNeMed Contracts Manager, Jeff Andersen, at jeff.andersen@unmc.edu or 402-559-3274.. Provide project and material descriptions. UNeMed then sends a copy of UNMC’s standard MTA to Recipient to begin negotiations.
UNeMed and Recipient will enter into negotiations until a finalized MTA is agreed upon.
UNeMed will supply the finalized MTA for you to read, review, and sign.
Send signed MTA to UNeMed, who will then review, sign, and return it to the Recipient.
MTA is executed by Recipient. UNeMed provides a copy of the fully-executed MTA to the researcher, who can then transfer the materials to the Recipient.

For questions regarding MTAs contact Jeff Andersen at jeff.andersen@unmc.edu or 402-559-3274.

For additional information regarding MTAs, we recommend the following:

Material Transfer Agreements: A University Perspective by Wendy D. Streitz and Alan B Bennett.
Material Transfer Agreement information from the University of Chicago
Material Transfer Agreements information from UNeMed

Join us next week for a discussion about collaborations

Nothing in this post should be construed as legal advice. It has been developed by the UNeMed staff as an educational resource for faculty, staff, students, and other personnel associated with the University of Nebraska Medical Center. While all information contained herein has been thoroughly fact-checked, this site is provided on an “as is” and “as available” basis. Neither UNeMed nor the University of Nebraska Medical Center make any representations or warranties of any kind, express or implied, as to the site’s operation or the information, content or materials included on this site. To the full extent permissible by applicable law, UNeMed and the University of Nebraska Medical Center hereby disclaim all warranties, express or implied, including but not limited to implied warranties of merchantability and fitness for any particular purpose. Neither UNeMed nor the University of Nebraska Medical Center will be liable for any damages of any kind arising from the use of or inability to use this site. You expressly agree that you use this site solely at your own risk.

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Case Study: Dr. Gaymalov and NeuroNano Pharma

July 18, 2012 Comments Off on Case Study: Dr. Gaymalov and NeuroNano Pharma Blog Like

by Agnes Lenagh, UNeMed | July 18, 2012

Many researchers are drawn to the biomedical field by the dream of improving people’s lives. While biomedical research alone may be a career path of choice for some, others take their findings to a whole new level.

Zagit Gaymalov, PhD, clearly falls into the latter group. “When I was a graduate student, I often wasn’t satisfied with the answers my research provided. [Many times] there’s a big gap between experimental outcome and clinical efficacy of [new] drugs. I imagined research we did in the Center For Drug Delivery and Nanomedicine (CNND) [could] become a real product.”

Fortunately, his PhD advisor at the time, UNMC faculty member Dr. Alexander “Sasha” Kabanov shared Zagit’s passion for translational research. Together they decided to select technologies that showed best the translational potential and work on taking them to the market through a newly-created start-up company,NeuroNano Pharma. NeuroNano’s leading technology, PluroMAC, is the basis of a drug LeptiPOL formulated for intranasal administration to treat obesity. Several other technologies are also in development to address diseases like Alzheimer’s and Parkinson’s, as well as stroke.

UNeMed has also played an important role in NeuroNano’s formation. Drs. Gaymalov and Kabanov approached UNeMed with the idea for the biotech startup and the parties have recently entered into negotiations for licensing agreement including the PluroMAC technology. This is important, because, although Dr. Kabanov was an inventor in all the technologies that the NeuroNano selected for development, the Board of Regents of the University of Nebraska is assigned all patent rights for technologies developed by UNMC faculty. Thus, NeuroNano had to license the rights to make, use, sell, offer for sale, and import patented technologies from the university.

Today, Dr. Gaymalov is a recent graduate of the College of Pharmacy Department of Pharmaceutical Sciences and the chief executive officer (CEO) of this new startup company called NeuroNano Pharma (As a side note, we recommend reading a post by Tara Hunt to better understand what a CEO of a start-up company really does.

While LeptiPOL is still in early preclinical trials to test its potential to lower food intakeand body fat, Dr. Gaymalov is raising funds and spreading the word about his company. His participation in competitions such as the LES Business Plan Competition, which NeuroNano attended earlier this spring, helps with both.

Early stage fund raising is always a great challenge for startups (we will be covering the challenges of early-stage fundraising, often referred to as “valley of death”, in a later post). NeuroNano is currently seeking up to $13M to advance LeptiPOL to Phase II clinical trials. Partnership with a large pharmaceutical company will then be necessary to further continue and complete development of the drug candidate. Patience will also be needed, as the time required to complete drug development is currently expected to be around 15 years.

None of this would be possible without the continued passion and dedication of the founders and management team. Drs. Kabanov and Gaymalov understand that the path to success will not be easy, but the fact that over 30% of people in the US are obese is what fuels their passion – this is their opportunity to make people’s lives better.

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Research Tools

July 10, 2012 Comments Off on Research Tools Blog Like

by Agnes Lenagh, UNeMed | July 10, 2012

Many of you have probably seen some of our posters asking investigators to submit their research tools to our office, so we can commercialize them. However, you may be asking yourself, “what exactly is a research tool and why would they be valuable?”

Research tools are items that you created in your lab and use to perform day-to-day experiments. Common examples of research tools include antibodies, cell lines, mouse models, small molecules, chemical reagents, growth media, and many other types of materials. These research materials are usually created by a researcher to help complete experiments or research projects so that they can obtain data for publications and grants. Sometimes, however, these research tools can have much broader value and utility.

Many research tools can become integral parts in drug discovery and drug development. Pharmaceutical companies often require research materials, such as cell lines or mouse models, to help in various aspects of drug development. Instead of using their time and money to develop these research tools internally, companies often seek to obtain them from outside sources including universities.

Furthermore, research tools like antibodies and small molecules, assuming they do not have any direct therapeutic applications, are items that can be developed rather quickly into products for the research market. There are numerous companies, many of which you are probably familiar with, that sell antibodies, chemicals, culture media, etc. What may surprise you is that many of these products were originally created in universities like UNMC.

UNeMed uses license agreements to transfer research tools to companies (a licensee) and to restrict or limit what they can do with the research tools. Typically, these licenses can be broken up into two types: a license that allows for the sale of the research tool by the licensee or a license that only allows the licensee to use the research material for internal research projects.

So, what’s in it for you?

When UNeMed licenses a research tool we generally seek upfront license fees and royalties, assuming the research material is going to be sold by the licensee. Money that is generated through the license agreement is then shared with the researcher and can help fund additional work in their laboratory.

So, who knows? Maybe you have a key research material sitting in your freezer and it could be a valuable tool for drug discovery or could be the next big seller in the research tools market.

If you have any questions about research tools or think you have a research tool that may have potential value outside of your laboratory, please contact Matt Boehm and he would be happy to discuss the possibility of commercializing your research material.

Next week we will be discussing Material Transfer Agreements and how these can be used to share research tools while protecting their intellectual property.

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UNMC pair’s malaria drug hailed as ‘major milestone’

July 6, 2012 Comments Off on UNMC pair’s malaria drug hailed as ‘major milestone’ News, Success Stories Like

by Rick Ruggles, Omaha World-Herald

OMAHA, Neb. (July 6, 2012)—A drug created at the University of Nebraska Medical Center has been deployed to fight malaria in India.

The drug, called Synriam, uses the findings of Jonathan Vennerstrom and Yuxiang Dong, scientists in UNMC’s College of Pharmacy.

It’s the first approved drug invented at UNMC in at least 10 years, said Michael Dixon, CEO of UNeMed Corp. UNeMed commercializes research for UNMC scientists.

UNeMed gave the compound’s rights to Medicines for Malaria Venture, an international group that battles malaria with the help of the Bill & Melinda Gates Foundation and other organizations. There is little profit in malaria medications in industrialized nations such as the United States, Dixon said, because malaria has been virtually defeated in them.

The countries where malaria continues to cause havoc, such as sub-Saharan African nations, can’t afford to pay much for the drugs.

The World Health Organization estimates that 216 million malaria cases occur worldwide each year, killing about 655,000 people. Most deaths occur in Africa, the WHO says.

Vennerstrom, a UNMC scientist since 1987, spent much of his childhood in Ethiopia, where his parents were missionaries. He saw people sickened by malaria, which is caused by a parasite carried by mosquitoes. Symptoms include fever, chills, body aches, lethargy and nausea.

As a scientist, Vennerstrom knew the chemical makeup of a natural Chinese product called artemisinin, which is used in some anti-malaria drugs. He said a considerable amount of the plant material must be harvested to produce a small quantity of anti-malarial medicine.

Vennerstrom also knew, from scientific literature, that a German laboratory had identified a new chemical reaction using ozone that might produce chemicals similar to the natural product. The German lab wasn’t working on a malaria drug, however.

Vennerstrom asked the head of the German lab whether he had a scientist who could come to Omaha to work with him on a malaria medication. Dong, a postdoctoral scientist, joined Vennerstrom in 1997.

“Timing is everything,” Dong said.

Dong, 49, grew up on a farm in China and had suffered malaria as a boy 44 years ago. “I remember my mom carried me to the small clinic,” Dong said.

He was shivering and lethargic. He suspects that clinicians gave him a medicine made with artemisinin.

Vennerstrom and Dong developed a synthetic compound with similarities to the natural Chinese anti-malarial substance.

It took about three years and many starts and stops.

“Drug discovery’s unpredictable,” Vennerstrom said. “You don’t design a drug like you design a house.”

They had hit upon a promising prototype by about 2000. Then they partnered with scientists in Switzerland, Australia and Great Britain for, among other steps, testing on animals and humans.

Vennerstrom said Medicines for Malaria Venture turned the compound over to Ranbaxy Laboratories, India’s top drugmaker, which launched the drug for adults in India this year.

MMV’s chief scientific officer, Tim Wells, said via email that the drug is “a major milestone.”

“We look forward to more data from patients in Africa and from studies with children, since this is where the vast majority of the disease is,” Wells said.

Synriam requires three doses to knock out malaria, and another compound discovered by Vennerstrom and Dong offers the potential for a single-dose cure. The same international team has worked to bring that drug to the finish line. It’s currently in human trials.

So far, the Omahans have celebrated with typical Midwestern modesty. “I guess we went out to the China Buffet one day,” Vennerstrom said.

Contact the writer:

402-444-1123, rick.ruggles@owh.com

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Maintaining Confidentiality: Confidential Disclosure Agreements

July 3, 2012 Comments Off on Maintaining Confidentiality: Confidential Disclosure Agreements Blog Like

by Bill Hadley, UNeMed | July 3, 2012

On December 12, 1980, Congress enacted legislature commonly known as the Bayh-Dole Act. This legislature contributed to a major change in university facilitated research and development. Under the Bayh-Dole Act, universities may now retain title to inventions created under federally-funded research programs. Based on this policy, the act has helped generate a significant increase in the amount of patents and licenses owned by U.S. research universities. (See, McCowery, David C., et al. The Effects of the Bayh-Dole Act on U.S. University Research…, pp25-29).

Accordingly, after the passing of the Bayh-Dole Act, universities’ policies regarding intellectual property began to change. For example, universities began requiring researchers to report inventions created through university research programs in order to protect valuable intellectual property (See, UNMC Policy No: 8000(7)(H)). Moreover, with the increase in the number of patents held by universities, many institutions were forced to update their procedures for protecting their intellectual property rights.

One method of protecting intellectual property is the confidential disclosure agreement (CDA), also known as a nondisclosure agreement (NDA) or secrecy agreement. The CDA protects the exchange of confidential information that is not yet ready for patenting or publication. This protection is invaluable since unprotected disclosure may result in a loss of U.S. and foreign patent rights.

As discussed previously, unprotected disclosure of university research and development may bar patentability under United States Patent Law. To help protect U.S. and foreign intellectual property rights, researchers should be careful about discussing the details of their research.

When discussing research that is not publicly known, researchers should consult with UNeMed and use the CDA to help protect against disclosures that may bar patentability. By using a CDA researchers can show that any disclosure that was made to a party to the agreement was not meant to be public, but was, in fact, confidential.

How can you, as a researcher, benefit from a CDA?

CDAs can be very useful in furthering research and development. The confidentiality provided by CDAs allows the parties to the agreement to openly share information concerning the research project, even if the information is not yet published or patented.

This open exchange increases the progression of the research project. While the project progresses, the possibility for finding scientific breakthroughs and marketable intellectual property also increases.

The progression of research and development can mean not only an increase in knowledge, but also an increase in University revenue. This is because with more marketable intellectual property discovered, more licensing agreements will be formed. From those licensing agreements, royalties will be paid and UNMC researchers generally receive a portion of the net royalties. Royalty distributions and licensing agreements will be the topic of discussion in future posts.

Steps for entering into a CDA

There are usually three different scenarios when a CDA will be used. First, when another organization wants to receive confidential information from UNMC; second, when UNMC wants to receive confidential information from another organization; and third, when UNMC and another organization collectively want to share confidential information with each other. The following generally outlines the steps for each scenario:

A UNMC researcher plans to enter into discussions about research being conducted at UNMC with another organization (because that organization needs information from UNMC, UNMC needs information from that organization, or they both need information from the other).
The UNMC researcher should not disclose any confidential information, but should obtain that organization’s contact information as well as a description of the information to be discussed (if the need for information lies with UNMC alone, the researcher can request the organization’s standard CDA as well).
The UNMC researcher should contact Jack Mayfield, Contract Specialist at UNeMed, jack.mayfield@unmc.edu, and provide the organization’s contact information and the description of information to be discussed (and the organization’s standard CDA, if applicable. See steps 2 &4).
UNeMed will then send our standard CDA for the organization’s review (unless it is the case that UNMC unilaterally needs information from the other organization; in that case, the other organization usually provides their standard CDA).
The UNMC and the organization accept the terms as they are, or they enter into negotiations to reach mutually agreeable terms.
UNeMed sends the CDA to the UNMC researcher to read and review for acknowledgment of special conditions. The UNMC researcher should sign the CDA and return a signed copy to UNeMed (via email or campus mail).
UNeMed then signs the CDA and sends a copy of the fully executed agreement to both the researcher and the other organization. The UNMC researcher may then discuss the confidential research information, as outlined in the CDA, with the other organization.

For questions regarding CDAs or any of the above procedures, contact: Jack Mayfield, Contract Specialist at UNeMed, jack.mayfield@unmc.edu.

Nothing in this post should be construed as legal advice. It has been developed by the UNeMed staff as an educational resource for faculty, staff, students, and other personnel associated with the University of Nebraska Medical Center. While all information contained herein has been thoroughly fact-checked, this site is provided on an “as is” and “as available” basis. Neither UNeMed nor the University of Nebraska Medical Center make any representations or warranties of any kind, express or implied, as to the site’s operation or the information, content or materials included on this site. To the full extent permissible by applicable law, UNeMed and the University of Nebraska Medical Center hereby disclaim all warranties, express or implied, including but not limited to implied warranties of merchantability and fitness for any particular purpose. Neither UNeMed nor the University of Nebraska Medical Center will be liable for any damages of any kind arising from the use of or inability to use this site. You expressly agree that you use this site solely at your own risk.

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UNeMed welcomes aboard Dr. Madsen, our Entrepreneur in Residence

June 29, 2012 Comments (3) News Like

OMAHA, Neb. (June 29, 2012)—UNeMed, the technology transfer office for the University of Nebraska Medical Center (UNMC), is pleased to announce the addition of Gary Madsen, PhD to the position of Entrepreneur in Residence.

In this role, Dr. Madsen will help identify promising UNMC technologies that have the potential to form the basis of a new startup company. He will be responsible for establishing partnerships between industry, faculty, clinicians and funding sources in order to develop new business ventures based on novel technologies.

Dr. Madsen holds a PhD in Medical Microbiology from Creighton University School of Medicine in Omaha, NE. “I’m very pleased to be back in Nebraska and look forward to helping UNeMed commercialize the exciting biotechnology discoveries coming out of the Medical Center. I truly believe that there is great potential for dramatic expansion of the vibrant biotech community in the Cornhusker State.”

He joins the UNeMed team following a successful career in biotechnology product and business development. Dr. Madsen comes to us from Madison, Wisconsin where he recently formed a consulting firm, Biotech Resolutions. Previously, he worked in several biotech companies in Madison, such as Gilson, Third Wave Technologies (Hologic), Promega and EraGen Biosciences. Dr. Madsen started his biotechnology career at Abbott Laboratories diagnostics division in suburban Chicago and then served as Vice President of R&D at IDEXX Labs in Westbrook, Maine.

Dr. Madsen comes to UNeMed with over 30 years of experience in building new technologies into real diagnostic and life science products. He will provide UNeMed with his knowledge and support on licensing, product development, manufacturing, and new technology commercialization.

Dr. James Linder, President of the University Technology Development Corporation states, “The Entrepreneur in Residence program was funded by the University of Nebraska to enable UNMC, and other campuses to bring unique skills to the process of technology development and commercialization. Dr. Madsen has a wealth of industry experience that will help UNeMed staff, and the faculty bring our inventions into clinical use.”

About UNeMed:

UNeMed is dedicated to working with the faculty and staff of UNMC to commercialize innovative ideas that have the potential to improve public health for Nebraska residents and beyond. Through collaborations with established industrial partners or through the creation of new companies, UNeMed’s focus is on the transfer of new and improved products and processes from the research bench to the market place.

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Oops, I did it again: Public Disclosure

June 26, 2012 Comments (1) Blog Like

by Bill Hadley, UNeMed | June 26, 2012

Part of our work at UNeMed includes reading through the published research from UNMC. When we identify a possible invention we immediately contact the researcher so we can begin evaluating the invention. We recognize that the primary concern of our faculty is their ability to publish on their research. As an institution of higher learning, the dissemination of knowledge from its faculty is clearly – and rightfully – UNMC’s highest priority. On the other hand, the patent law discourages inventors from disclosing their innovations to the public prior to filing an application for a patent – often with strict penalties. Managing this conflict is one of UNeMed’s most important functions.

As you might imagine then, due to these conflicting paradigms, we are constantly balancing the desires of our faculty to publish with the university’s desire to commercialize upon the value of their research. When there is an unavoidable conflict between the ability to publish and the ability to patent, the publication rights must come first. When looking at disclosures that come out of the university – in terms of publications, presentations, or posters, to name a few – we are primarily concerned with eliminating “enabling public disclosures” of patentable subject-matter. If a given disclosure is both ‘public’ and ‘enabling’, it can have severe ramifications on the patentability prospects of an invention contained therein. That being said, a researcher armed with a prior knowledge of the patent law – and some foresight – can navigate these oft-confusing waters and successfully publish their work and preserve their patent rights at the same time.

With that in mind, let’s look at what, exactly, constitutes an enabling public disclosure, what the effect of such a disclosure is, and how you can take steps to prevent an inadvertent disclosure of your invention.

A disclosure is “public” if interested members of the public could obtain access to the disclosure of the invention if they so desired (Constant v. Advanced Micro-Devices Inc. , 848 F.2d 1560 (1988)). Note that under this standard there is no requirement that members of the public actually accessed the information and all that is required is that they could have. Thus, a single copy of a graduate thesis, which sat on a library shelf for a number of years in a university library without being checked out, was found to be a public disclosure because the university had a catalog system which would have allowed a member of the public to find the thesis, were they so inclined (In re Hall , 781 F.2d 897 (1986)).

A disclosure is “enabling” if it teaches someone of ordinary skill in the art how to devise the invention without undue experimentation (Struthers Scientific & Intern. Corp. v. Rappl & Hoenig Co., 453 F.2d 250 (1972)). Examples of enabling disclosures that commonly take place in an academic setting are research presentations, journal submissions, federal grant applications (which may or may not be considered “public” based on the application’s availability under a Freedom of Information Act request), postings on individual lab websites, a thesis or dissertation, and meetings with companies or colleagues outside of UNMC where there is no confidentiality agreement in place.

The relevant statute when one looks at public disclosures of an invention is 35 U.S.C. § 102(b). Assuming, for the moment, that the claimed invention meets the threshold criteria of novelty, usefulness, and non-obviousness, 35 U.S.C. § 102(b) provides another restriction relating to the inventor’s use of the patented invention prior to their application for a patent.

There is a lot packed into §102(b), but the take-home message is this: to be eligible to receive a patent in the U.S., the claimed invention must not have been previously publicly disclosed (by the inventor or anyone else) more than one year prior to the date of application. Thus, for a U.S. patent, a public disclosure starts a clock: an inventor has one year from the date of the enabling public disclosure to file for patent protection – whether the invention is ready or not. (This rule will be subtly changed under the America Invents Act. When the relevant provision comes into effect, we will update this post accordingly. For now, however, this is the applicable rule.)

For patents filed in a foreign country, the Patent Cooperation Treaty (“PCT”) specifies, among other things, rules relating to patent eligibility. Rule 64 of the PCT is even less forgiving than §102(b); under Rule 64.1(a) , for patents filed internationally, there is no one-year grace period. Any written disclosure of the claimed invention prior to the filing date automatically removes eligibility to receive a patent. This means that as soon as you publicly disclose your invention, you lose the international patent rights and your work will no longer be protected in the international market.

If these rules seem rather vague, you are clearly reading them properly. Fortunately, there are a number of steps that can be taken to prevent an enabling public disclosure of a potentially patentable invention. While there is a grace period for a U.S. patent, given the strict rules internationally, we always strive to protect patentability prior to any enabling public disclosure.

The easiest way to protect your rights (and UNMC’s) is to work with us. If you believe your research may contain potentially patentable subject-matter, please contact UNeMed. We are always interested to hear about your research and we deal with this issue on a daily basis. Odds are, we can provide guidance in a matter of minutes. If, after discussing your research, we think that a patent is possible, we can look at the type of disclosure that you would like to make and take steps designed to preserve future patent rights (such as filing a provisional patent application or putting in place a confidentiality agreement).

Finally, here are some other things you may want to keep in mind in order to prevent an inadvertent enabling public disclosure of your patentable invention:

Consider sending UNeMed journal manuscripts, speech notes, or poster images prior to submission or public display. Often we can review these in a matter of hours and provide feedback or file a provisional patent application.

Let us know if industry contacts you about your research or to contract for your services. A simple CDA can protect against an accidental slip of the tongue without hindering your relationship with the company.

When submitting a state or federal grant application, list as confidential the pages of the application which contain a description of potentially patentable subject-matter and write “CONFIDENTIAL” on each identified page.

To preserve confidentiality of a thesis, request that the thesis be kept in a secure section of the library and not be made available to the public until patent protection is in place.

Oral disclosures such as departmental seminars or thesis defenses may also be public disclosures, based on the ability of a member of the public to attend. If a potentially patentable invention will be discussed in one of these meetings, you may want to contact UNeMed.

UNeMed strongly supports the UNMC community’s interests in public dissemination of knowledge, academic freedom, and open collaboration. Fortunately, with a little foresight, it is possible to fulfill all of these prerogatives while preserving patent rights in the results of that work. If you are contemplating a public disclosure of your research and feel that there may be patentable subject-matter discussed therein, please don’t hesitate to contact us. Rest assured, we share the same goals you do and will be happy to discuss all avenues available to satisfy both your and UNMC’s interests.

Please leave any questions or suggestions you may have in the comment section below. You can also shoot me an email at bill.hadley@unmc.edu. I will be happy to address any thoughts you may have.

Nothing in this post should be construed as legal advice. It has been developed by the UNeMed staff as an educational resource for faculty, staff, students, and other personnel associated with the University of Nebraska Medical Center. While all information contained herein has been thoroughly fact-checked, this site is provided on an “as is” and “as available” basis. Neither UNeMed nor the University of Nebraska Medical Center make any representations or warranties of any kind, express or implied, as to the site’s operation or the information, content or materials included on this site. To the full extent permissible by applicable law, UNeMed and the University of Nebraska Medical Center hereby disclaim all warranties, express or implied, including but not limited to implied warranties of merchantability and fitness for any particular purpose. Neither UNeMed nor the University of Nebraska Medical Center will be liable for any damages of any kind arising from the use of or inability to use this site. You expressly agree that you use this site solely at your own risk.

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UNeMed at BIO2012 convention

June 20, 2012 Comments Off on UNeMed at BIO2012 convention Blog Like

UNeMed is looking forward to the BIO2012 convention in Boston next week.

Come visit us at booth 2722! We have prepared new materials that highlight our diverse portfolio of intellectual property. In addition to printed materials, this year we will be handing out flash drives containing information about UNeMed and key technology that represents significant advances in biomedical and clinical technology being developed at UNMC.

We will also be participating in the BIO Partnering Business Forum. If you’re looking for some 1 on 1 time with us, this is the perfect opportunity to meet up with us.

Don’t forget to follow us on Twitter @UNeMed so you can stay up-to-date with the latest happening at the convention. We will be using #bio2012 to connect with everyone at BIO2012.

Hope to see you there!

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Authorship on a publication is determined by custom; Inventorship on a Patent is determined by law

Inventors are the Original Owners of a Patent

Legal Definition of “Inventor”

Ramifications of Mis-Identified Inventors

1. Copyrights promote the progress of science and the useful arts

2. Works that may be copyrighted

3. Exclusive rights are granted by a copyright

4. Unauthorized use leads to copyright infringement

5. Obtaining a copyright is a piece of cake

Conclusion

Why do we have patents?

The Hadley Widget

The Basics of Trade Secrets

Rights Given by a Trade Secret

Misappropriation of Trade Secrets

Trade Secrets at UNMC

UNeMed blog aims to keep inventors in the tech transfer loop

Co-Ownership of Patents derived from Research Collaborations

Academic-Academic Collaborations

Academic-Industry Collaborations

UNeMed is here to help

Join us next week for a discussion about collaborations

So, what’s in it for you?

Technologies

Photos on flickr