Friday, January 26, 2007

BMS Plavix sales hurt by activity before preliminary injunction

In August 2006, generic drug maker Apotex Inc. began selling a cheaper version of Plavix, a blood thinner Bristol-Myers co-markets with Sanofi-Aventis SA, after an agreement to settle a patent dispute fell apart. A judge issued a preliminary injunction requiring Apotex to stop selling the generic drug but Apotex wasn’t required to recall what was already in the market. Plavix sales sank 53 percent to $496 million from $1.06 billion. Overall revenue for the period fell to $4.2 billion from $5.02 billion. [from AP through Bridgewater Courier-News.]

Some analysts have suggested that the issuance of a PI suggests that BMS will prevail on the merits at trial. They overlook the deal BMS tried to make, and some of the possible legal complexities associated with the "chiral switch." Recall that got a PI against Barnes & Noble.

There is a very lengthy post at PatentBaristas discussing the Plavix matter (Is it Worth it for Generics to Challenge Branded Drugs? )

Within the post is the text: While it is true that basic active ingredient patents are challenged more and more frequently, no generic drug has been legally permitted to enter the US market before a branded drug’s initial active ingredient patent’s expiration

Among others, it might seem that Plavix itself is a counterexample to the assertion on PatentBaristas. PatentBaristas notes: In the Apotex case, the disputed patent, U.S. Patent No. 4,847,265, covers Plavix’s main ingredient and does not expire until 2011. As explicitly noted earlier in this IPBiz post: Apotex wasn’t required to recall the generic Plavix that was already in the market and branded Plavix sales sank 53 percent. Thus generic Plavix was legally permitted to enter the US market before the 2011 date of the expiration of the patent on the (+)-enantiomer of clopidogrel bisulfate. There may be some other counterexamples.

PatentBaristas also has a post: More On Ariad v. Lilly re Evista, Xigris. The post contains a discussion of a Lilly inequitable conduct defense based on failure to disclose references which were inherently anticipating:

Ariad asserted that, during the ‘516 prosecution, the Manual of Patent Examination Procedure instructed examiners that inherency required “contemporaneous recognition” (i.e., that the missing descriptive matter is not only necessarily present, but also that it would be recognized by those of ordinary skill). Ariad argued that there was no contemporaneous recognition here, that no one recognized that any of the various compounds cited reduced NF-kB activity.

The inherent anticipation argument is complicated because two separate lines of cases conflict on the issue of “contemporaneous recognition,” with each side citing cases that favor its interpretation.

IPBiz thought that "contemporaneous recognition" is NOT required.


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