Supreme Court Denies Cert. In Lilly V. Sun

Posted on May 17, 2011 by Warren Woessner

In my post of May 6, 2011, I discussed the facts in some detail in this controversial Fed. Cir. decision and concluded that the majority of the Fed. Cir. got this one wrong – the court voted 5-4 to deny rehearing en banc. Although Lilly had prosecution strategies available that would have avoided invalidation of their patent on a newly discovered use of gemcitabine, Lilly picked the wrong one. All practitioners should re-read this decision so as to not fall into the same trap. Ironically, this is an appeal in which Supreme Court review likely would have helped the patent system.

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John L. White Dies – Authored Chemical Patent Practice

Posted on May 11, 2011 by Warren Woessner

I was saddened to hear of the recent passing of John L. White, a founder of the Arlington firm of Millen, White, Zelano & Branigan. Although I did not know him well, he will be remembered for a long, long time as the editor of “Chemical Patent Practice,” a very practical guide that helped me (and countless other practitioners) learn to cite case law effectively to the PTO as we learned patent prosecution. “My associates” soon learned that I referred to this spiral bound volume as “The Bible.” All the answers we needed were in there somewhere. I am not sure when it was first published, though Amazon references as 1972 edition. I still use my heavily annotated 1993 edition (published by the Patent Resources Group) and I have a 1996 edition that was updated and published by his firm. Paragraphs from the 1993 edition recall sections of the Myriad debate, almost verbatim:

“The extracted product adrenalin was held patentable notwithstanding the fact it existed in the tissue gland from which it was extracted because in extracted form it became, for all practical purposes, a new thing commercially and therapeutically. Parke-Davis v. Mulford (2d Cir. 1912) 196 F. 496. Same, the substantially pure compound primarily responsible for the flavor of strawberries one of the 33 volatile acids thereof not  identified in the prior art. In re Kratz (CCPA 1979) 592 F2d 1169, 201 USPQ 71.”

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Chisum Patent Academy Open for Business – Patent Law 401

Posted on May 11, 2011 by Warren Woessner

I wasn’t sure what number would emphasize “advanced,” but this seminar series is definitely well above “101.” I don’t think any scholar is quoted more by the Federal Circuit than Don Chisum, and articles by Professor Janice Mueller have been widely recognized as authoritative (though we both got it “wrong” on the need for a separate written description requirement).

Disclaimer: Janice is my former law clerk, before she clerked for Judge Rich, worked  at Justice and entered academia. Get back on top of patent law – which has been bucking off practitioners lately like a mechanical bull.

Chisum Patent Academy

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What Were They Thinking? A Second Look at Lilly v. Sun

Posted on May 6, 2011 by Warren Woessner

As we all learned years ago, when trying to make sense of Lilly v. Barr, if a Fed. Cir. decision wrestles with obviousness-type double patenting, it will be a labor of Hercules to reason it out. But the majority of the Fed. Cir. really blew it in Eli Lilly v. Sun Pharma. Ind., 611 F.3d 1381 (Fed. Cir. 2010), both in the original decision and in denying en banc review. Newman, Rader, Lurie and Linn made up the minority in that vote, and when those four agree on something, attention must be paid.

But I  don’t feel that much attention was paid. Maybe the decision was too close to the holidays. Maybe folks just thought, “Just another case of Lilly trying to evergreen the patent protection on a blockbuster drug [gemcitabine].” I got re-interested in the decision when I read the amicus brief filed by the Washington Legal Foundation in support of Lilly’s petition to the Supreme Court to grant cert. Although I have dipped my toe in the sometimes murky waters of this right-wing think tank in the past- I summarized the Supreme Court’s decision in Pioneer Hi-Bred v. JEM –  they are usually more interested in supporting suits to reverse “Obamacare” or to i.d. illegal immigrants. Whatever your political leanings, its amicus brief was well-written (even if it never used the term “obviousness-type double patenting” and framed the question too broadly). In any case, it got me to re-consider just how bad the panel decision was.

It is a little hard to follow the timeline of the filings of the two patents in question without a timeline, but I will try. To begin with, both patents issued out of pre-GATT filings and so got 17 years from their issue dates. The “oldest patent application” was filed in 1983 claiming gemcitabine (“gem”) and its use as an anti-viral (Of course this was at the beginning of the AIDS epidemic). Lilly subsequently discovered that gem was an effective anti-cancer drug (now Gemzar) but, instead of just filing a CIP of its pending application disclosing, and perhaps claiming, the new use, they ALSO filed an original application on the same day (Dec. 4, 1984) claimed the new use. The “oldest patent application” claiming gem issued as the ‘614 patent on Feb. 28, 1989 and Lilly got PTE, so that it did not expire until May 15, 2010. Lilly did not file a divisional on the use of gem to treat cancer, although this would have been a pre-GATT filing and given Lilly a lot of extra patent term.

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