Thursday, October 15, 2009

My Amicus Brief Has Been Filed in Ariad v. Lilly

I have filed an amicus brief in Ariad v. Lilly in support of neither party but arguing against the Lilly Written Description Requirement (LWD), available here.

My brief essentially argues that LWD has been applied by the courts and PTO in an arbitrary and inconsistent manner that lacks any rational basis in law, science, or policy, and in a manner that can effectively preclude some biotechnological inventors from obtaining adequate patent protection for their inventions, particularly inventions relating to proteins and DNA. My arguments dovetail in large part with those made by Novozymes in the brief they filed a couple days ago.

My colleagues Mark Janis (Indiana University) and Tim Holbrook (Emory University) have filed their own amici brief, arguing that there is no independent written description requirement, and that enablement is the proper and only doctrinal tool for policing claim scope and for determining whether a disclosure supports later added claims.

Wednesday, October 14, 2009

Law Professor's Debate Impact of Supreme Court's Quanta Decison on Patent Exhaustion and Licensing

Richard Epstein (Univ of Chicago), Scott Kieff (George Washington Univ, Mark Lemley (Stanford) and Fred von Lohmann (Electronic Frontier Foundation) vigorously debate Quanta. Available here.

Tuesday, October 13, 2009

Novozymes Files Amicus Brief in Ariad v. Lilly Arguing Against Lilly Written Description

The brief is attached here. I'll have some commentary and hopefully some more briefs in the next few days.

Tuesday, October 6, 2009

Ariad v. Lilly Appellant's Brief and Follow-On Biologics

Ariad's brief in this important Federal Circuit en banc rehearing of Araid v. Lilly, which asks the court to consider revising or perhaps completely eliminating written description as a separate requirement of patentability is available here. I have not had a chance to read it yet, but will post some commentary once I do.

Also, for those interested in the follow-on biologics legislation currently being considered by Congress, here is a short version of the article I posted last week which focuses specifically on the patent provisions of the bills.

Thursday, October 1, 2009

A Response to the FTC's Report on Follow-On Biologics

Congress is considering legislation that would create an abbreviated FDA approval process for follow-on biologics (FOBs), which proponents anticipate will promote competition and lower prices in the market for biologic drugs. In June of 2009 the FTC published a report on FOBs (“the FTC Report”), which attempts to forecast the nature of competition between innovator biologics and FOBs, and offers a number of substantive recommendations regarding specific provisions of the various FOB bills. In particular, the FTC Report concludes that there is essentially no justification for the inclusion of a substantial data exclusivity period (“DEP”) for innovators in pending FOB legislation, and that Congress should not include a pre-approval patent (dispute) resolution process (“PPRP”). The FTC Report bases its conclusion that a substantial DEP is unnecessary to adequately incentivize innovation in biologics in part on a misapplication of the results of a study I conducted in 2007 on the written description doctrine of patent law.

I have written a manuscript that responds to some of the conclusions and recommendations set forth in the FTC Report. In particular, I think it is important to clarify the scope and implications of my study on the written description doctrine, and explain why I believe that the FTC over-interpreted the results of the study to arrive at a conclusion that is unsupported by the data. In my view an extended DEP for innovators is justified and should be included in FOB legislation enacted by Congress.

I also disagree with the FTC's conclusion that a PPRP is unnecessary and unwarranted for biologic drugs; such a process is appropriate and would be important to maintain adequate incentives for innovation. Some of the proposed FOB legislation would discriminate against the developers of innovative biologic drugs, not only with respect to FOB producers, but also in comparison to the treatment currently afforded conventional drug innovators. These discriminatory provisions should be removed or rectified to provide a more balanced approach to promoting competition while maintaining adequate incentives for investment in biotechnology.

The full length manuscript is available as a Working Paper on SSRN (click here for link)

[Added Oct. 6 2009] A short version of the manuscript focusing on the patent provisions is available here.