Five minutes with… Dmitry Karshtedt
Genus claims—or patent claims covering a family of related compounds—are commonplace in life sciences patent law. But following a rising trend of invalidity rulings, the future of the claim seems bleak.
The precedential decision in Idenix v Gilead in 2019 saw the scope of the genus claim narrowed to no longer encompass a large number of compounds, a move which some legal professionals argue renders the claim valueless outside of niche circumstances.
Among those is Dmitry Karshtedt, associate law professor at George Washington University Law, who, along with two other professors, co-authored a paper called “The Death of the Genus Claim”.
LSPN Connect will host a virtual panel on July 8, inviting Karshtedt and IP adviser Poliana Zorzal PhD to discuss the latest genus cases, how the genus claim stands up to the enablement challenge, and what the implications of recent case laws are for life sciences IP.
We sat down with Krashtedt ahead of the panel to ask a few key questions on the future of genus claims in life science litigation.
LSIPR: How has the decision in Idenix v Gilead changed life sciences IP litigation over the past five years?
Krashtedt “Idenix v Gilead crystallized just how difficult it is for genus claims to survive challenges under both enablement and written description requirements. Realising this, defendants are making ever more aggressive 112(a) arguments and succeeding in district courts as well as at the PTAB in PGR proceedings.
“Thus, we have seen successful 112(a) challenges against not only chemical-type claims and antibody claims as seen in Syngenta v. FMC and Amgen v. Sanofi, but also against formulation-type claims including Lipocine v. Clarus.”
In what niche situations can patentees argue genus claims effectively?
“As explained in my paper with Mark Lemley and Sean Seymore, patentees seem to stand a chance with claims directed to relatively small genuses and genuses not at the point of novelty (in other words, the genus is built around known technology).
“In addition, we have seen genus claims survive Section 112(a) challenges in interferences, where neither party usually has an incentive to argue overbreadth. Interferences, however, have gone away after the America Invents Act.”
What do these latest cases involving genus claims (particularly Amgen v Sanofi) tell us about genus claims going forward?
“Going forward, I think it will be really important for the patentees to include as many narrow species-type claims as possible in their claim sets because genus claims are unlikely to survive.
“In addition, given the Federal Circuit's guidance in Amgen v. Sanofi, patentees should include as many prophetic examples as possible in specifications - basically, they should list out every species they can think of - to increase the chances of survival of genus claims.
“The Federal Circuit panel in Amgen suggested that patentees should rely on the doctrine of equivalents. Of course, the specification and claim drafting strategies will not help those inventors who already obtained their patents before the change in the law, and the doctrine of equivalents is a notoriously unreliable tool in the plaintiff's arsenal.”
LSPN Connect is the membership programme for the Life Sciences—to watch this session and for more information on joining, visit www.lspnconnect.com
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