Liveblog of 4/2 panel on Hot Topics in European Bio-Patent Law, Part IV

By Nicholson Price

Finishing up the event today is Tom Kowalski from Vedder Price, giving a US perspective on section 101 on patentable subject matter.  This post will encompass his presentation and general questions afterward.

Kowalski starts with a brief review of patentable subject matter, and states his view that after Prometheus and Myriad, “the fabric of the patent system has been torn.”  His view is that isolated DNA is a separate chemical entity, and that the Supreme Court simply got it wrong. 

He turns to thinking about workarounds for avoiding the Myriad holding that isolated DNA is unpatentable, though cDNA is.  Notably, the court declined to opine on the validity of cDNA claims under sections 102, 103, and 112, and also declined to opine on method claims, altered genes, or other natural products.

For methods claims, looking at Prometheus, Kowalski notes that the diagnostic industry is hurt by the decision, and that the Supreme Court addressed this concern to Congress.

Dovetailing the two is a real challenge – application of a new law of nature is not patent if relying on elements already known in the art to add (seeBowman, discussed here).

But the PTO’s recent guidance (pdf) on this is a big deal, and takes Myriad to the limits.  Combinations of naturally found elements are going to face a tough barrier to patentability.  And–Kowalski thinks–methods of treatment covering human organisms may even fall under the combination of Myriad, Mayo, and the AIA’s prohibition on patents covering human organisms.  (This strikes me as a little unlikely)

But a more immediate question Kowalski raises is the trade-secret monopoly created by Myriad when it diagnosed huge numbers of women when its patents were in force.

Questions

Glenn Cohen, Professor of Law here, asks if embryos used for deriving stem cells are eligible for implantation, and about the science of whether stem cells derived nondestructively are as good as those derived from destruction.

Dr. Nichogiannopoulou replies that, at least in her view, it’s a waste of scientific and technical resources to try to scientifically work around moral issues – politicians should be brave and face the issues head-on.  Here, the EPO has no idea how many of the embryos used for derivation are eventually implanted–and considers that irrelevant to patentability.

On the second question, Dr. Nichogiannopoulou replies that there’s no scientific answer yet.

Ben Roin asks, as he admits is a bit out of left field, asks aboutCLS Bank v. Alice, a case about software patenting which the Supreme Court heard 2 days ago.  Is the EPO thinking about the interaction of software patents and diagnostics?

Dr. Nichogiannopoulou replies that software isn’t patentable, though carriers of software are – that is, if the software is in a machine and has a technical effect, that’s enough.  There’s a whole field of bioinformatics, which is increasing.  If the combination is smart enough to escape the exception of software patents and the hurdles in diagnostics, that’s clever of them, and not a problem.  Algorithms themselves aren’t patentable.

An audience questions the expressed institutional view that all patents are good, and follows up by noting that it looks like a natural experiment on divergence of EU and US law – are people monitoring the economics of that divergence?

Dr. Nichogiannopoulou replies that there’s quite a bit of international collaboration, cooperation, and monitoring.  Issues are certainly different–for instance, patent trolls aren’t an issue in Europe (for a few reasons, including [currently] non-unified enforcement, cost-shifting, and the lack of punitive damages)–and those differences may suggest inter-systemic lessons.

Tom Kowalski jumps in to mention different evolution in the EU versus the US; some workarounds will exist, but there’s a real difference in patentability.  Will industries move to the US, as a safe-haven/patent-free zone?

Finally, an audience member asks about the presence of moral judgment in the Edinburgh decision on human embryonic stem cells.  Dr. Nichogiannopoulou answers no – the decision was totally on technical grounds.

And that’s our panel!  Quite a lively discussion, and an overall very interesting look into the EPO’s practice on big issues of today.

Read posts on the other presentations:

Part I: Dr. Aliki Nichogiannopoulou, EPO

Part II: Dr. Anja Schmitt, EPO

Part III: Dr. Maaike van der Kooij, EPO

W. Nicholson Price

W. Nicholson Price

Nicholson Price is an Assistant Professor of Law at the University of Michigan Law School. Previously, he taught law at the University of New Hampshire. He holds a PhD in Biological Sciences and a JD, both from Columbia, and an AB from Harvard. He clerked for Judge Carlos T. Bea on the Ninth Circuit, and was then appointed as an Academic Fellow at the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard. Nicholson teaches patents and health law and studies life science innovation, including big data and artificial intelligence in medicine. He recommends reading Bujold, Jemisin, and Older. His work has appeared in Nature, Science, Nature Biotechnology, the Michigan Law Review, and elsewhere. Nicholson is cofounder of Regulation and Innovation in the Biosciences, co-chair of the Junior IP Scholars Association, and a Core Partner at the University of Copenhagen’s Center for Advanced Studies in Biomedical Innovation Law.

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