Thursday, December 02, 2004

GlaxoSmithKline settles RELAFEN case

from Reuters

-->GlaxoSmithKline Plc, Europe's biggest drug maker, on Wednesday said it will pay $75 million to consumers and health insurers to settle a lawsuit alleging that the company blocked generic competition for arthritis drug Relafen.
Glaxo said the proposed settlement was given preliminary approval last week by a Massachusetts U.S. District Court judge.

The suit alleged that Relafen's distributors unlawfully obtained a patent which allowed them to enforce a monopoly over the drug and prevent generic competition, which resulted in exorbitant prices for Relafen.

Under the terms, third-party payors will receive $50 million of the settlement fund, while individual class members will receive $25 million for damages and fees. <--

Beecham's '639 patent on nabumetone (RELAFEN) was found invalid over prior art that had been examined by the PTO. There were separate issues of unenforceability (inequitable conduct). Curiously, in a parallel application to that leading to the '639 patent, Beecham told the PTO that the prior art did not even disclose the compound nabumetone.

I had written in Intellectual Property Today in July 2001 ("A Tale of Conflicting Models - The Coming Skirmish on the IP Frontier"):


In the case Biotec Biologische v. Biocorp, 2001 WL 503260 (Fed. Cir., May 14, 2001), the court observed, on the topic of a mistake made in prosecution:

An error in the prosecution record must be viewed as are errors in documents in general; that is, would it have been apparent to the interested reader that an error was made, such that it would be unfair to enforce the error. The defendants do not argue that this statement led them to believe that it clearly limited the invention that was claimed. A person of reasonable intelligence would not be misled into relying on the erroneous statement, for it is contrary not only to the plain language of the claims and the specification, but also to other statements in the same prosecution document. In Intervet America, Inc. v. Kee-Vet Labs., Inc., 887 F.2d 1050, 1054, 12 USPQ2d 1474, 1477 (Fed. Cir. 1989) the court dealt with an erroneous statement during prosecution and held: "When it comes to the question of which should control, an erroneous remark by an attorney in the course of prosecution of an application or the claims of the patent as finally worded and issued by the Patent and Trademark Office as an official grant, we think the law allows for no choice. The claims themselves control."

The policy rationale of Biotec (although not the facts) has relevance to issues in the case In re ‘639 Patent Litigation, 2000 U.S. Dist. LEXIS 20166, concerning the patent (US 4,420,639) to the drug nabumetone, marketed as RELAFEN. The case has facts which defy conventional wisdom. Although there are issues that certain countries, such as India, derivatize certain U.S. work, in the ‘639 case, the first disclosure of the formula of nabumetone was in the Indian Journal of Chemistry, 1973, 11, 213-218. The compound was later patented in the United States. For one of the steps in a multi-step synthesis, the Indian workers relied on a 1948 paper, written by researchers at a well-known U.S. drug company, which was published in the Journal of the American Chemical Society, generally considered to be the premier chemistry journal in the world. It happened that the 1948 paper had a serious mistake, which apparently had been overlooked by the 1948 authors and by the referees of the 1948 paper. It was a mistake that could be recognized by a first year student of organic chemistry, who would know that aliphatic ethers (specifically here a methyl, aryl ether) cleave in boiling concentrated hydrochloric acid. The mistake was in fact corrected in 1955, although not in the Journal of the American Chemical Society.10


Endnote 10 of the IPT stated:

-->The Journal of the American Chemical Society has a policy of not allowing mistake correction by third parties, and the present author has direct experience with this policy. This author wrote a paper on the calculation of the second moment of the fluorine nuclear magnetic resonance (NMR) of solid poly (carbon monofluoride), which led to the conclusion that the structure contained an infinite array of cyclohexane boats, rather than the expected chairs, J. Am. Chem. Soc., 1974, 96, 7841, which boat structure was reproduced in the Cotton and Wilkinson, 4th edition. Five years later, different workers, who also published in JACS, criticized the calculation, on the basis that it involved a single integration, rather than a double integration. Although the allegation had no basis in the text of the 1974 paper, and was untrue, the journal (which did not dispute the truth of what this author said) would not allow a comment to be published. Five years later, this author did publish a comment, which appeared in the Proceedings of the Workshop on Electrochemistry of Carbon, pp. 595-607, Electrochemical Society Proceedings Series, Volume 84 No. 5 (1984). (Poly(carbon monofluoride) is a useful cathode for high energy density lithium batteries.)<--

Somewhat ironically, exactly the same problem presented in the nabumetone case (eg, citing the earlier wrong article when a later correction exists) has now come up in the poly (carbon monofluoride) case. This later incident also implicates some important flaws in the way works.


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