A Nickel’s Worth of Free Advice: Biotech and the Law

This year’s participants in Emerging Techniques in Protein and Genetic Engineering, a two-credit graduate course offered in partnership with the Department of Oncology, UW-Madison, held July 17-21, 2017.

Today’s author extends thanks to Heather Gerard, Intellectual Property Manager, Promega Corporation for contributing her expertise to this post.

Students most often come to the BTC Institute with the primary goal of learning about molecular biology technologies. Our mission is to help them update their experimental tool-box, facilitating more capable studies of DNA, RNA and proteins back in their home laboratories.

But what else do we do? Well, we’re glad you asked.

We are thankful to have a large number of friends and colleagues who are willing to augment the core material of our courses with information about how they use their scientific expertise in less conventional ways, often bringing the “real world” into our classroom.

One such invited guest is David Casimir, founding shareholder of Casimir Jones, S.C. and one of our most popular guest speakers of the summer. Contributing to our Emerging Techniques in Protein and Genetic Engineering course, he starts out plainly enough, with a talk presented in PowerPoint, using a layout that is part of the program package. The first slide simply says “Patents” – an inauspicious beginning to a wildly interactive and extremely useful hour and a half session of asking, considering and answering – and free advice.

I credit David, with his Biochemistry doctorate (UW-Madison) and Stanford Law degree for this entirely. He is an excellent speaker, and his free advice is certainly worth more than a nickel. So, I contacted David to get his opinion on the top developments in patent law in recent times as well as the best places to start for scientists curious about patent law.

In developments within the field, first – the Supreme Court:

According to David, “The Supreme Court has gotten very interested in patent law recently and has taken an unusual number of patent cases – with some dramatic changes made in the categories of technologies that can and cannot be patented in the software and life sciences fields.”  For example, in June 2013, the Supreme Court, in the Association for Molecular Pathology v. Myriad Genetics, Inc. case, ruled that isolated genomic DNA (gDNA) was not patent-eligible subject matter, yet maintained that cDNA was patent-eligible subject matter.

In addition, Congress passed the Leahy-Smith America Invents Act in 2011. It went into effect in March 2013. Ensuing drama has been related to two significant elements of this legislation:

  • A re-examination system was created to allow people to challenge the validity of patent in the patent office, rather than having to take patents to Federal Court. This part of the Act has been actively used, and a large number of patents have been wiped out – either completely or in part.
  • The US was changed to a first-to-file country rather than a first-to-invent country. The change to first-to-file affects the determination on who is issued a patent on an invention when different inventors file a patent application around the same time on the same invention thus making it much more important for people to file their patent applications early.The implications of the first-to-invent system, which still applies to applications filed before March 15, 2013, can be seen in the patent inference proceedings occurring in the U.S. patent office regarding the CRISPR-Cas9 technology.  Several key CRISPR-Cas9 technology patent applications were filed before the change to first-to-file, and now the University of California-Berkeley and the Broad Institute have asked the U.S. patent office to determine who owns the rights to these patents based on who invented the technology first.  Had the U.S. been under the first-to-file system, whoever filed an application on the technology first, would have the rights.

For the scientists out there (or to be fair, non-scientists as well) who are curious about what’s happening in the world of patent law, but maybe not ready to become lawyers themselves, here are some places to start and some resources you can use.:

  • You can take an IP class at your local law school. I checked with UW Madison’s Law School and current Graduate Students at UW Madison can enroll in Law courses after getting permission from both Law School administrators and the professor of the particular course. For folks who are not current students, you can still take Law courses through the UW Madison Division of Continuing Studies (DCS) and apply as a University Special Student on a per-credit basis. Once you are admitted as a special student and matriculate, you similarly need to be granted permission from administrative staff at the Law School and the instructor of the course prior to enrolling. So, taking a formal course is a little complicated, but these complications are not insurmountable.
  • More informally, you can follow on-line blogs – one suggested by Dr. Casimir is PatentlyO – “America’s leading patent law source” (https://patentlyo.com/). Blog authors are professors at schools of law in Iowa and Missouri and about 25,000 people subscribe to it. Recent posts appeal mostly to the law community, but as a non-lawyer, I did find it interesting to see what’s been in the courts lately.
  • If you are at a university, contact your technology transfer office. They often hold discussions or other events on campus to educate researchers on intellectual property, in particular patents and patent law.  I am sure they would also be more than happy to have a one-on-one discussion with one of their researchers about intellectual property and IP law.
  • Lastly, you could meet one-on-one for discussions with professionals in the field to learn about how they use patent law in their careers. This may not just be patent attorneys, but also patent agents (those who are admitted to the patent bar and can represent in U.S. patent office) or patent scientists/engineers.  Many companies and law firms employ patent agents and patent scientists/engineers who are well-versed in the science/technology as well as the patent law.

Thank you to David and to all of our Summer 2017 course instructors!

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Amy Prevost

Director, Scientific Courses at BioPharmaceutical Technology Center Institute
Amy Prevost received her doctorate from UW-Madison in 2012 in Educational Leadership and Policy Analysis. Amy is a program director at the BioPharmaceutical Technology Center Institute (BTC Institute), a non-profit located on the Promega campus in Fitchburg, Wis., where she coordinates scientific programs for adult learners. She is also a project manager on a grant aimed at understanding student success in advanced manufacturing programs at two-year colleges with the Center on Education Research at UW Madison. Amy’s primary areas of interest in educational research include understanding educational pathways in STEM programs, improving student outcomes at the post-secondary and graduate levels – including access to careers, and trying to map elements of doctoral programs that contribute to students’ abilities to transfer knowledge.

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