Posts Tagged ‘Ariad v. Lilly’

Update, Partner and Innovate — AUTM Eastern Regional Meeting

Thursday, April 14th, 2011

I will be on a panel entitled “Kicking the Hornet’s Nest – Patenting Early Stage Technology” at the AUTM Eastern Regional Meeting in Baltimore (May 24th). I will be joined by Esther Kepplinger, Director of Patent Operations at Wilson Sonsini and Dr. Kathryn R. Doyle of the Riverside Law Group. We will cover new developments in patenting DNA, claiming diagnostic methods and what the full-term written description requirement of Ariad v. Lilly means to your patenting strategy. How is isolated DNA different than a gold nugget? How is a diagnostic method like Murphy’s Law? Can you still get a mechanism-of-action claim? Your panel of experts will answer these questions and more.  Y’all come!

Happy Birthday Patents4Life – We Are 2!

Thursday, March 3rd, 2011

Well almost. The first posts on Patents4Life were dated March 24, 2009. One was on a fairly obscure decision, SRI International (the prior art effect of internet postings), but the other two were on the Fed. Cir.’s summary affirmance of the district court’s finding of invalidity in Classen (applying Bilski as they saw it) and on the Board’s decision ex parte Kubin (that went on to invalidate a DNA patent as obvious to try in the wake of KSR). These decisions were just the first ripples of the tidal wave of judicial decisions at all levels that have limited the scope of patent protection. While the Supreme Court in Festo facially rejected the absolute bar to the application of the doctrine of equivalents endorsed by the Fed. Cir., no one would have picked it as the high water mark of pro-patent case law in our time. The presumptive surrender of access to the DOE has proven daunting to the use of the DOE in practice. But compared to most of the later decisions on central issues of patent law, Festo looks like a beacon of hope.  If you have been reading this blog (or any number of others) over the last two years, the number of “anti-patent” decisions that have been handed down is simply overwhelming.

Now some of them are not yet carved in judicial stone, being at various stages of appeal, but the sum of KSR,  Bilski (well, I guess it was more pro-patent than the strict M or T test it replaced with a test yet-to-be-determined), Ariad v. Lilly (WDR grows up), Lilly v. Sun,(broadened base for obviousness-type double patenting), Centocor v. Abbott (WDR rules),  Microsoft v. i4i (lower evidentiary bar to patent invalidation), Janssen v. Teva (no utility for hypothetical bioactivity), Stanford v. Roche (weakens Bayh-Dole Act), Myriad (DNA and diagnostics are natural phenomena), Therasense v Becton Dickinson (more ways than ever to show inequitable conduct), and the WARF stem cell reexamination (WARF lost at the Board) do not bode well for the system Jefferson hoped would help modernize the young republic.  The only bright spot on this judicial trial of tears was the Fed. Cir.’s affirmance in Prometheus v. Mayo in December that methods of medical treatment and monitoring past muster under Bilski.  And yet, even this modest decision may be reconsidered by the Supreme Court.

Still, the last time the full court addressed the issue of patentable subject matter was in 2001 in Pioneer v. JEM Ag Supply, in which the patent eligibility of plants was affirmed, and the Court refused to back down from Chakrabarty.  The issuance of the Chakrabarty patent was 30 years ago this month and most would agree that granting biotech patents has done our society a lot more good than it has rained evil upon us. Except, perhaps for the folks who are trying to block Obama’s order permitting funding for stem cell research. Or the Myriad plaintiffs. But they are in the minority. Aren’t they?

Director Kappos Comments on Ariad v. Lilly

Thursday, May 6th, 2010

USPTO David Kappos recently posted a comment on the Fed. Cir. decision in Ariad v. Lilly in which he noted that the Fed. Cir. held that broad functional claims (presumably mechanism-of-action claims) must be supported by sufficient species (read “working examples”). While Director Kappos clearly approves of this holding, he does no more to provide guidance to Examiners attempting to decide how many examples will support such claims and, more importantly, are there generic claims for which no number of working examples would provide sufficient support (like the Ariad claims at issue)?

Ariad v. Lilly Comes Down (On Us) – Judge Lourie Rules!

Tuesday, March 23rd, 2010

In a majority opinion authored by Judge Lourie for the Federal Circuit sitting en banc (Appeal No. 2008-1248 (Fed. Cir. March 22, 2010)) (a PDF of which is attached to the end of this post), the court held that there is indeed a written description requirement (WDR) in section 112 that is separate from the enablement requirement and that the claims-in-suit in U.S. Pat. No. 6,410,516, broadly directed to reducing NF-kB activity in cells, are invalid for failure to meet the written description requirement. This decision, though lengthy, amounted to an affirmance of the earlier panel’s decision and, of course, of the “possession” test first articulated (by Judge Lourie) in UC v. Lilly in 1996. Judge Lourie spends about 20 pages writing and re-writing his opinion in UC v. Lilly (which he essentially concedes would be decided differently today). The problem the majority feels they are addressing has not, however, changed in the almost 20 years since UC v. Lilly was decided. It is to reign in overly-broad claims based on discoveries that are not fully realized:

 “The problem is especially acute with genus claims that use functional language to define the boundaries of a claimed genus. In such a case, the functional claim may simply claim a desired result, and may do so without describing species that achieve that result. But the specification must demonstrate that the applicant has made a generic invention that achieves the claimed result and do so by showing that the applicant has invented species sufficient to support a claim to the functionally defined genus”

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