Philip Brooks' Patent Infringement Updates

Cast Vote Today for Medical Research - Halfway to March 18 Goal!

The following is excerpted from an article posted at The Wistar Institute:

My name is Scott Hensley, Ph.D., and I’m an assistant professor here at The Wistar Institute. Like most academic biomedical researchers, I rely on grants from the National Institutes of Health and other agencies to fund my work. I would like to ask for your help in continuing to move our research forward.

For decades, government funding has propelled biomedical research, fostering new discoveries and creating real improvements in the lives of all Americans. Every vaccine we give our children, every lifesaving medical procedure, and every new drug that comes to the market, owes its origins to the fundamental science done in places like Wistar.

Recently, the White House has released a proposed budget for the 2013 fiscal year, which essentially flattens the NIH. This year’s budget is the same as last year’s, which effectively means a 3.5 percent cut due to inflation. This cut means that a potential cancer treatment could go untested, or that researchers might not be able to explore new avenues of research. It means a loss of jobs and impairs our ability to train young scientists.

We can all understand that these are difficult times and budgetary sacrifices must be made, but I believe we can do so without sacrificing our future in the process.

I ask you to urge President Obama to increase the NIH budget for FY2013. One of our colleagues in the research community has posted a petition on the official White House website. This petition must get 25,000 signatures by March 18 if the White House is to review it.

While a single petition does not mean much by itself, it gives impetus and ammunition to the many advocacy networks that are trying to convince the President and Congress to increase funding for the NIH on behalf of all Americans.

So I ask you to do two easy things: sign this petition, and ask your friends and family to join sign it too. It won’t take more than a few minutes of your time and it can make a real difference.

Europe's Landmark Decision on Stem Cell Patents

The following is excerpted from an October 27, 2011 Jones Day Commentary by Niklas Piening, Christian Paul and Martin Weber:

In a landmark decision on October 18, 2011, the highest court of the European Union—the Court of Justice—decided on the patentability of stem-cell-related inventions (case number C-34/10). The dispute arose around the definition of the term "human embryo" in the European Biotechnology Directive. Based upon this decision, the Court will now apply a very broad definition, which will result in nonpatentability and invalidity of many stem-cell-related inventions in Europe. The impact on biotechnology and life sciences innovator companies will be significant.

According to the Court, the definition shall include the fertilized human ovum. Reaching even further, the term shall also include artificial cell types including the ones obtained by cell nucleus transfer from a mature human cell into a nonfertilized human ovum. This technology was used to obtain the clone sheep "Dolly," for instance.

The Court of Justice further ruled that not only is any such—broadly defined—human embryo unpatentable, but also that every invention that requires the prior destruction of a human embryo shall not be the subject of a patent. This also applies to inventions using stem cell lines that resulted from the destruction of a human embryo long before the cell line was employed for the invention.

Read the full commentary here.

Boy Scouts Add Invention Merit Badge

The following is excerpted from a July 7, 2010 article by Addy Dugdale appearing at Fast Company:

The Boy Scouts of America do good, we all know that. And now they do invention. The 100-year-old organization--it celebrated its centenary on Feb 8 of this year--has teamed up with MIT's Lemelson program, founded by the father of modern invention in America, Jerome H. Lemelson, to provide a new merit badge: that of invention.

Aside from defining what patent infringement and intellectual property is, there's the practical aspect to the test, where scouts are expected to build a clay model and then a working prototype of their invention.

Read the full article here.

ACLU's Chris Hansen Discusses Biotech Patent Ruling

The following is excerpted from a November 11, 2009 post at the Bulletproof Blog drawn from a recent interview with Chris Hansen, staff attorney with the ACLU First Amendment Working Group. In the interview, Mr. Hansen discusses the impact of the recent U.S. District Court ruling that a lawsuit challenging patents on human genes can move forward, as well as what this means for the biotech industry.  The suit is centered around the idea that patents on human genes violate the First Amendment and patent law because genes are “products of nature.”:

...the ACLU First Amendment Working Group,...scored a major victory on November 2 when the United States District Court for the Southern District of New York ruled that its lawsuit challenging patents on human genes can go forward.

Association for Molecular Pathology, et al. v. U.S. Patent and Trademark Office, et al., originally filed on May 12, charges that two patents on genes associated with hereditary breast and ovarian cancer are illegal. The patents, owned by the University of Utah Research Center, are licensed to Salt Lake City-based Myriad Genetics. Along with claims that the patents restrict scientific research and patient access to medical care, the suit contends that patents on human genes violate First Amendment and patent law because genes are "products of nature."

The American Civil Liberties Union was joined in the suit by the Public Patent Foundation, a not-for-profit affiliated with the Benjamin N. Cardozo School of Law.

What will be the impact of this case?

Chris Hansen: That depends on whether we win it or lose it. The next step is to try it in the U.S. District Court for the Southern District of New York. After that I would expect appeals all the way to the Supreme Court, which might well agree to hear a case of this magnitude.

The issue of whether human genes can be patented has been around a long time and it seemed the Patent Office had concluded the debate was resolved in favor of patent-holders. At the very least, Judge [Robert] Sweet’s decision not to dismiss should disabuse them of that notion.

If we succeed, the potential impact can best be measured by the fact that 20% of the genes in the human body are now patented. Among them are genes associated with Alzheimer's disease, muscular dystrophy, colon cancer, asthma, and many other illnesses

Read the full post here.

Noted Scientist Urges More Flexibility in Technology Transfer

The following is excerpted from a September 29, 2009 IP Advocate press release:

Speaking of the then-divided Berlin, former President Reagan famously admonished Soviet leader Gorbachev to “tear down this wall.”  In a similar spirit, IP Advocate founder Dr. Renee Kaswan is calling on the university technology transfer system to remove the barriers that keep innovations from moving swiftly into the marketplace.

IP Advocate today announced that Dr. Kaswan has been invited to speak at the 2009 Technology Transfer Society (T2S) Annual Conference, to discuss the dilemma that faculty inventors face in the process of commercializing their inventions.  

Dr. Kaswan joins speakers from Harvard Business School, Stanford, MIT, Duke, NASA and many other global institutions, to discuss the latest issues concerning the process of university technology transfer and the social consequences of entrepreneurial activity in society.

The conference, titled “The Entrepreneurial Enterprise,” will be held October 2 at the University of North Carolina Greensboro.  Dr. Kaswan is participating in the Issues in Technology Transfer Roundtable session.

“It’s important to include the inventor’s perspective when examining how to improve the university technology transfer system – and I’m honored to give that unique perspective a voice, among such prestigious colleagues,” said Dr. Kaswan.  “What our nation needs is an efficient way to move an idea from an inventor’s mind to an entrepreneur’s office to a consumer’s bedside table as quickly as possible.  But our current system creates bottlenecks at that first stage, by essentially taking all inventions across an entire campus teeming with curious minds and forcing them through one – often very small – porthole.  If inventors had the freedom to choose with whom to partner, the entire technology transfer program would benefit.”

The original licensing deal Dr. Kaswan structured for the University of Georgia with pharmaceutical giant Allergan for Restasis would have netted the university about $300 million.  But when the University of Georgia Research Foundation (UGARF) negotiated a secret new deal, without Dr. Kaswan’s participation, it made a miscalculation that ultimately cost the university, its inventor and Georgia taxpayers at least $220 million in royalties.  Dr. Kaswan also contends that the pivotal response on the Invention Disclosure Form she filed with the university was changed without her knowledge – a change that the university relied upon to support its right to assignment, control and licensure of her patents to Allergan.

IP Advocate Adds New Expert Opinions Section

On July 14, 2009, IP Advocate issued a press release (see excerpt below):

Adding new functionality and resources to its award-winning online community, IP Advocate has launched “Expert Opinions,” a new section in the IPAO Forum on IPAdvocate.org designed to offer academic researchers insight and information on current intellectual property issues.

Participating experts will address topics such as technology transfer, commercialization, patent reform, IP legislation, university litigation and related subjects.  IPAdvocate.org is an online community founded to help safeguard the interests of faculty inventors and assist them in preserving their rights in their work.

“Expert Opinions” currently features a Q&A with Galen Suppes, Ph.D., Professor of Chemical Engineering at the University of Missouri-Columbia. Dr. Suppes discovered an environmentally friendly use of glycerin, the co-product of biodiesel production, and is currently fighting the University for the rights to several of his inventions. The Q&A with Dr. Suppes titled “Critical Issues in University Intellectual Property,” covers job scope issues and best practices in provisional patent applications in a university setting. "Under no instances should an employee be required to assign an invention to a university or corporation until due diligence has been performed to determine whether the invention was truly within the scope of his/her job,” Dr. Suppes notes.

Another “Expert Opinions” contributor, Fred Mermelstein, PhD., Executive Director of Javelin Pharmaceuticals, Inc., discusses how NIH-sponsored research could be advanced and more efficiently leveraged. “A few simple modifications…..would likely generate significant outcomes,” Dr. Mermelstein writes. “These include dedicating a minimal amount of grant funds to cover costs associated with filing a U.S. patent application to increase interaction between funded laboratories and their technology transfer offices and corporations interested in commercial development of research.”

Take a look here.

Inventor Fights for Ownership Rights To His Own Patents

           ATLANTA (July 8, 2009) – IP Advocate today announced that it has published a new case study on its website – www.IPAdvocate.org – presenting the story of an academic researcher honored by the EPA who is now battling his university for the ownership rights to discoveries made prior to his faculty appointment.

 

            IP Advocate is a non-profit organization dedicated to helping academic researchers preserve their rights in their work. The new case study is one of many featured at this online community for academic researchers and students.  

 

            Dr. Galen J. Suppes, a professor in the Chemical Engineering Department of the University of Missouri (MU), received the EPA’s highest honor in 2006 – The Presidential Green Chemistry Challenge Award – for his discovery of an eco-friendly use for glycerin, a co-product of biodiesel production. His process converts the excess glycerin into a “green” antifreeze.

 

            The Suppes case is the latest in a series of examples of universities litigating with faculty researchers over intellectual property rights. IP Advocate’s website features similar accounts involving Dr. David Townsend, co-inventor the PET/CT scanner; Petr Táborský, who made a discovery in wastewater treatment while he was a graduate student; Dr. Stephen Badylak, a pioneer in tissue re-growth; and IP Advocate founder, Dr. Renee Kaswan, inventor of Optimmune® and Restasis®, which treat dry eye in animals and humans.  The website also features compelling examples of positive results when universities stand by their inventors, such as the success of Emory University and its faculty researchers, Drs. Liotta, Schinazi and Choi, who co-developed two of the major drugs in the HIV/AIDS arsenal: 3TC and FTC.

 

Turning on an Asset

            A frequent contributor to professional journals and oft-cited author, Dr. Suppes had been regularly recognized by the University of Missouri (MU) as an asset.  His research has resulted in numerous awards and patents, but the University of Missouri accused its professor of not giving the college its due.  For more details, see the case study here:  http://www.ipadvocate.org/studies/suppes/.

 

            The University of Missouri has claimed ownership over patents for research conducted and completed before Suppes was employed by the school. The patents in question were based on provisional patent applications filed before he began working at MU. The university is also challenging Suppes’ efforts to pursue patents and licensing for his innovations that the school has abandon or ignored.

 

            The federal case filed against Dr. Suppes was dismissed, citing lack of jurisdiction. However, the same day that case was set aside, attorneys for the university filed in the Boone County court system. Dr. Suppes is fighting the charges against him, and is filing a counter-suit against the university in the county court.

 

            Dr. Suppes said he has been the victim of “incredible neglect” by the MU tech transfer program, which he said is “totally broken and basically beyond repair.” The university’s president, Gary Forsee, told the St. Louis Business Journal in March: “Our university has not done a great job in putting the processes and systems and resources in place to do that [commercialization].  We are trying to cobble together some incremental funding so we can do tech transfer.”

 

            “This story raises the fundamental questions of whether a university has the right to force a professor to assign all their inventions to the institution, and what recourse an inventor has if the university isn’t a good steward of that intellectual property,” said Dr. Kaswan, founder of IP Advocate, former research professor at the University of Georgia and inventor of the billion-dollar drug Restasis®.  “The Bayh-Dole Act gives universities the right to claim patent assignment of some employee inventions.  But it’s not a bulldozer – it does not give universities the right to seize the intellectual property of an individual inventor.”

 

            “It’s important to tell the stories of researchers like Suppes, alongside positive stories of universities and inventors working collaboratively,” said Rhaz Zeisler, IP Advocate executive director.  “Our online community is motivated to publicize both the best and worst in technology transfer practices at our universities today. We’ve built an extensive library of resources for academic researchers, so they can avoid the frustrations and potential litigation that Dr. Suppes and many others have endured.”

 

About IP Advocate

IP Advocate (www.IPAdvocate.org) is a non-profit organization that educates and empowers faculty researchers on patent rights and the process of commercialization – helping inventors protect their rights during the complex process of getting their invention from the lab to the people who need it. IP Advocate is a rich resource of information and best practices related to the commercialization of intellectual property. The organization was founded by Dr. Renee Kaswan, inventor of the billion-dollar drug Restasis® and a former research professor at the University of Georgia; and is led by executive director Rhaz Zeisler, a recognized international interactive media brand strategist, and former Walt Disney producer and IBM creative executive. IP Advocate is a 501(c)(3) organization, based in Atlanta.

Patent Infringement Advice for University Researchers

Robert S. MacWright, Ph.D., Esq., University of Virginia (UVA) Patent Foundation Executive Director; John Breen, Ph.D., Esq., UVA Patent Foundation Senior Patent Counsel; and Rick Kast, Esq., UVA Associate General Counsel and Special Assistant Attorney General offer a presentation titled, "Can Patents Block My Research?."  They offer advice on steps university researchers should take in considering the potential impact patents may have on their investigations.

They conclude, in response to the question posed in their presentation title, that "the highest U.S. patent court has ruled that university research is NOT exempt from liability for patent infringement." Some highlights from the presentation:

Implications of Madey v. Duke

• There is no safe haven for academic research!
• It is risky business to ignore patents. You need to actively steer clear of of them,  license them, or buy from licensed vendors.
• If you discover a patent issue, you need to bring it to the University’s attention.

The Risks If You Infringe

• A patent owner could sue UVA for patent infringement; They could also sue you personally
• Defending an infringement suit can cost well over $1,000,000!
• The patent owner might seek and obtain a preliminary injunction to stop your research almost immediately
• Your research program may have to be completely re-designed
• Your valuable research time and energy could be consumed by legal matters

See the full presentation here.