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Sanofi wins over Apotex in PLAVIX battle in Canada

By Lawrence B. Ebert, Esq.

In a 7-0 judgment on 6 Nov 08, the Canadien Supreme Court rejected a request from Apotex Inc. to invalidate Sanofi's patent for an anti-coagulant drug (Plavix) used to combat cardiovascular degeneration.

Coverage by Kirk Makin in the Globe and Mail did NOT get to the heart of this court battle involving patenting of racemates vs. patenting of enantiomers:

Judge Rothstein said that in case of Sanofi's anti-coagulant drug - marketed under the name, Plavix - the company showed a clear willingness to expend time and energy on investigative blind alleys.

This diligence proved that Sanofi did not simply leap toward an obvious development leading from its original discovery in hopes of doubling its period of patent protection, Judge Rothstein said.

He noted that Sanofi's original patent pertained to a large family of compounds (also known as a ?genus,') that contained more than 250,000 individual, compounds which had potential to help inhibit platelet aggregation activity in the blood.

After considerable searching, it narrowed them down to a particular compound which proved through testing to be both effective and non-toxic - Plavix.

For a more thorough discussion of the patent/technical issues, see

Enantiomers, racemates, and the chiral switch

For some of the interesting business plotting going on in the Plavix wars, see

http://ipbiz.blogspot.com/2006/08/star-ledger-addresses-apotex-launch-of.html

http://ipbiz.blogspot.com/2007/01/newark-star-ledger-on-plavix-trial.html

***
Canada.com also did not get into the racemate business, but did discuss the issue of "selection patents"
and evergreening, in an article SCOC upholds blood-thinning drug patent :

In a 7-0 decision, the court ruled that Paris-based drugmaker Sanofi-Synthelabo put a lot of effort and money into refining Plavix, which is taken to combat potential strokes and heart attacks, to make it less toxic and deserved the benefit of its secondary patent - called a "selection patent."

Justice Marshall Rothstein concluded that selection patents "encourage improvements" and are therefore legitimate in their own right.

In Sanofi's case, the company identified 250,000 possible chemical compounds in its original patent and later developed one into a better drug. The selection patent allowed the company to secure a second 17-year window to sell its drug without competition from generic companies.

IMS Health Canada, a health data group, ranked Plavix 21st on its list of 50 best-selling drugs in Canada last year.
Apotex unsuccessfully argued that selection patents amount to double patenting and a form of "evergreening" - seeking to extend patents indefinitely by making minor changes to a product rather than coming up with a new invention.

Full post as published by IPBiz on November 07, 2008 (boomark / email).