Posts Tagged: "eli lilly"

‘With the U.S. patent expiration of Cymbalta last December and that of Evista coming in March, we expect 2014 to be the most financially challenging year of Lilly’s current period of patent expirations,’ said Derica Rice, Lilly executive vice president, global services and chief financial officer. ‘We are prepared for this challenge and are positioned to return to growth and expand margins in 2015 and beyond.’

In a non-precedential opinion issued October 18, 2013, the Federal Circuit decision calls into question the overall utility of forum selection clauses in contractual relationships. In fact, Eli Lilly lost its bid to have its dispute with Genentech and City of Hope heard in the Northern District of California despite having a forum selection clause in the governing contract that stated the parties would litigate any dispute in the Northern District of California.

Not all of Eli Lilly and Company’s developments are strictly related to human health. Today’s featured patent application discusses a form of dietary additive for animals that can reduce the chances of insect populations thriving on manure. The new dietary additive formula is much safer to animals and the environment than previous additives. Other patent applications include a few inhibitor treatments to reduce the progression of cancer, as well as an application that discusses improvements to medication dose delivery devices. We also look at a few issued patents that improve the portfolio of Eli Lilly’s patent holdings. Three of these patents protect improved methods of treating various diseases, including diabetes, tumors and hyperlipidemias. Another patent protects a method of creating a vaccine for the infectious viral disease SARS. Finally, we look at a patent that discusses a method of healing wounds that utilizes naturally occurring, low-toxicity spinosyns.

Coming as no surprise, a majority of the en banc Federal Circuit just ruled in Ariad Pharmaceuticals v. Eli Lilly &Co. that there is there is a separate and distinct “written description” requirement in the first paragraph of 35 U.S.C. § 112. Also not surprisingly, there were multiple concurring (and dissenting) opinions. Judge Lourie (writing the majority opinion) has now won the on-going debate that has raged between him and Judge Rader (who has strenuously argued there is no written description requirement separate and distinct from the “enablement” requirement) since the 1997 case of Regents of the University of California v. Eli Lilly & Co.

In the opinion, the BPAI agreed with the reexamination Examiner that any one of four (out of five) prior art references that contained descriptions of oral administration of the herb Yin Yang Huo (also known, perhaps not too surprisingly, as horny goat weed) are anticipatory prior art for claim 24. There were other rejections (double patenting rejections) that the Examiner set forth and that BPAI upheld. The patent claims cover the first commercially (wildly) successful male impotence drug Viagra®.

In probably the most significant case since In re Bilski, the en banc Federal Circuit in Ariad Pharmaceuticals v. Eli Lilly is about to ponder two questions:  (1) is there a separate and distinct “written description” requirement in the first paragraph of 35 U.S.C. § 112?; and (2) if there is, what does it mean?  My answer to the first…