Sanofi-Aventis requested Canada's Supreme court to upheld existing Canadian patent laws and protect its blood-thinner Plavix (Clopidogrel) from generic competition from Apotex.
Clopidogrel (+)-(S)-methyl 2-(2-chlorophenyl)-2-(6,7-dihydrothieno[3,2-c]pyridin-5(4H)-yl)acetate) is a potent oral antiplatelet agent often used in the treatment of coronary artery disease, peripheral vascular disease, and cerebrovascular disease. It is marketed by Bristol-Myers Squibb and Sanofi-Aventis under the trade name Plavix. It acts by blocking a receptor called P2Y12. Clopidogrel is marketed as clopidogrel bisulfate (clopidogrel hydrogen sulfate), most commonly under the trade names Plavix, as 75 mg oral tablets. In 2006, generic clopidogrel was briefly marketed by Apotex, a Canadian generic pharmaceutical company before a court order halted further production until resolution of a patent infringement case brought by Bristol-Myers Squibb.The court ruled that Bristol-Myers Squibb's patent was valid and has patent protection until November 2011. In 2007, the production was halted to many retail pharmacies and will be changing back to Plavix. In 2005 it was reported that Plavix was the world's second highest selling pharmaceutical with sales of US$5.9 billion
Sanofi Aventis attorney stressed that it took lot of effort to develop New chemical moiety like Clopidogrel. Sanofi spent millions of dollars and even abandoned the project before discovering the compound that led to the development of Plavix, he said.
However, Apotex claims that Sanofi's following patent
CA1336777(equivalent to US4847265) (Expiry:2012) - Which covers Dextro-rotatory isomer of methyl alpha-5(4,5,6,7-tetrahydro(3,2-c)thieno pyridyl) (2-chlorophenyl)-acetate substantially separated from the levo-rotatory isomer and its pharmaceutically acceptable salts.
Is obvious as per earlier expired patent, which covers Clopidogrel genrically . Apotex attorney said Sanofi scientists used known research methods on a large group of compounds the company had patented earlier to come up with the key ingredient in Clopidogrel as per doctrine of selection.
Apotex argued that the doctrine of selection is contradictory to established principles of patent law and urged the court to abolish the practice that allows innovator companies to patent a large group of generic structures and then obtain new patents with enhanced life on individual components that prove useful.
Plavix last year regained its title as the world's second best-selling drug, behind Pfizer Inc.'s Lipitor, with $8.1 billion in global sales.
Apotex claims that clopidogrel bisulfate, the active ingredient, was covered by a US4529596 (Expired in 2003). Innovator Sanofi maintains that the earlier patent covered a whole class of generic compounds (Genus) and the discovery of clopidogrel bisulfate was serendipity.
Researchers separated the racemic compound into individual enatiomenrs. Sanofi further stressed that resolution of enatiomer resulted into therapeutically active enatiomer.
The expert during testimony stressed that abolishing the principle of the doctrine of selection would stifle research and innovation. Supreme court panel announced it would reserve a decision.
Clopidogrel (+)-(S)-methyl 2-(2-chlorophenyl)-2-(6,7-dihydrothieno[3,2-c]pyridin-5(4H)-yl)acetate) is a potent oral antiplatelet agent often used in the treatment of coronary artery disease, peripheral vascular disease, and cerebrovascular disease. It is marketed by Bristol-Myers Squibb and Sanofi-Aventis under the trade name Plavix. It acts by blocking a receptor called P2Y12. Clopidogrel is marketed as clopidogrel bisulfate (clopidogrel hydrogen sulfate), most commonly under the trade names Plavix, as 75 mg oral tablets. In 2006, generic clopidogrel was briefly marketed by Apotex, a Canadian generic pharmaceutical company before a court order halted further production until resolution of a patent infringement case brought by Bristol-Myers Squibb.The court ruled that Bristol-Myers Squibb's patent was valid and has patent protection until November 2011. In 2007, the production was halted to many retail pharmacies and will be changing back to Plavix. In 2005 it was reported that Plavix was the world's second highest selling pharmaceutical with sales of US$5.9 billion
Sanofi Aventis attorney stressed that it took lot of effort to develop New chemical moiety like Clopidogrel. Sanofi spent millions of dollars and even abandoned the project before discovering the compound that led to the development of Plavix, he said.
However, Apotex claims that Sanofi's following patent
CA1336777(equivalent to US4847265) (Expiry:2012) - Which covers Dextro-rotatory isomer of methyl alpha-5(4,5,6,7-tetrahydro(3,2-c)thieno pyridyl) (2-chlorophenyl)-acetate substantially separated from the levo-rotatory isomer and its pharmaceutically acceptable salts.
Is obvious as per earlier expired patent, which covers Clopidogrel genrically . Apotex attorney said Sanofi scientists used known research methods on a large group of compounds the company had patented earlier to come up with the key ingredient in Clopidogrel as per doctrine of selection.
Apotex argued that the doctrine of selection is contradictory to established principles of patent law and urged the court to abolish the practice that allows innovator companies to patent a large group of generic structures and then obtain new patents with enhanced life on individual components that prove useful.
Plavix last year regained its title as the world's second best-selling drug, behind Pfizer Inc.'s Lipitor, with $8.1 billion in global sales.
Apotex claims that clopidogrel bisulfate, the active ingredient, was covered by a US4529596 (Expired in 2003). Innovator Sanofi maintains that the earlier patent covered a whole class of generic compounds (Genus) and the discovery of clopidogrel bisulfate was serendipity.
Researchers separated the racemic compound into individual enatiomenrs. Sanofi further stressed that resolution of enatiomer resulted into therapeutically active enatiomer.
The expert during testimony stressed that abolishing the principle of the doctrine of selection would stifle research and innovation. Supreme court panel announced it would reserve a decision.
The European and U.S. laws make it more difficult to patent specific compounds taken from a larger group of genus, however Canadian laws are not strict on this aspect. The U.S. Supreme Court gives companies challenging patents more latitude to argue that something is simply an obvious variation of earlier inventions.
