Posts Tagged ‘Lilly v. Barr’

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

Friday, May 6th, 2011

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.