Tuesday, December 26, 2006

Lilly's Zyprexa patent upheld at CAFC

Those who predicted Lilly's Zyprexa patent (US 5,229,382) would be upheld at the CAFC proved correct. Bloomberg reported:

The U.S. Court of Appeals for the Federal Circuit Dec. 26 affirmed a lower court decision that the patent is valid. The Ivax unit of Teva Pharmaceutical Industries Ltd. and Dr. Reddy's Laboratories Ltd. had claimed a U.S. judge was mistaken in ruling the drug was protected until Indianapolis-based Lilly's patent expires in 2011.

In addition, "Lilly did not fail to disclose information" to the patent office, as its rivals suggested, the judges said in their 21-page opinion released today.

The losing defendants were represented by Lerner, David; Kenyon & Kenyon; and Budd Larner.

The CAFC noted that the patentability of a compound does not depend only on structural similarity, citing Deutsche Gold and Silver, 397 F.2d 656. In re Lalu, 747 F.2d 703 was also cited. The CAFC analogized the case to Yamanouchi v. Danbury, 231 F.3d 1339.

Of relevance to the pending KSR v. Teleflex case on obviousness, the CAFC delves into motivation, and does cite In re Kahn, 441 F.3d 977, in turn citing In re Rouffet, 149 F.3d 1330. The CAFC also rejected the bracketing concept advanced by IVAX based on In re Payne, 606 F.2d 303.

The CAFC also got into the public use issue with olanzapine, based on FDA-required tests. The CAFC concluded that Lilly maintained confidentiality during the tests.

The CAFC rejected several different inequitable conduct arguments.

In summary, the CAFC affirmed the trial court on issues of anticipation, obviousness, and public use. The legal conclusions on inequitable conduct were affirmed. A complete victory for Lilly as to the '382 patent.

IPBiz notes that Judge Rader wrote this opinion. One thinks back to an earlier opinion, reviewing Judge Posner sitting by designation, that reached somewhat different conclusions as to public use and FDA testing.

A press release on the Lilly victory stated:

On April 14, 2005, in the case of Eli Lilly and Company v. Zenith Goldline Pharmaceuticals et al., the U.S. District Court for the Southern District of Indiana ruled in favor of Lilly on all of the generic companies' patent challenges, including obviousness, double patenting, inequitable conduct, anticipation, and public use.

"Today's appeals court ruling not only affirms the validity of our patent, but upholds patent law that helps enable the significant investments required to develop the next generation of revolutionary medicines for the patients who need them," said Sidney Taurel, Lilly chairman and chief executive officer.

The New York Times included other aspects of the Zyprexa saga:

Lilly is also defending its marketing of Zyprexa in lawsuits filed by the attorneys general of Mississippi, Louisiana, West Virginia and Alaska alleging the company promoted the drug for unapproved uses and hid the risks of weight gain and diabetes.

Sales of Zyprexa dropped 16 percent and fell behind AstraZeneca’s Seroquel as America’s best-selling antipsychotic in 2005, according to IMS Health, which provides data on drug sales.

Worldwide sales of Zyprexa dropped 4.9 percent to $4.2 billion last year and accounted for about 29 percent of Lilly’s revenue.


Blogger Danny Haszard said...

Eli Lilly makes billions on diabetes treatment and also gets $4.2 billion a year in sales of their biggest cash cow Zyprexa which has been scandalized as *causing* diabetes as a major side effect.
Not fair~Daniel Haszard

8:16 AM  

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