CHAU BUI UC BERKELEY NOVEMBER 3, 2008 IEOR 190G Sanofi-Aventis vs. Apotex Plavix® Patent Case.
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Transcript of CHAU BUI UC BERKELEY NOVEMBER 3, 2008 IEOR 190G Sanofi-Aventis vs. Apotex Plavix® Patent Case.
CHAU BUIUC BERKELEY
NOVEMBER 3, 2008IEOR 190G
Sanofi-Aventis vs. ApotexPlavix® Patent Case
Plavix® Patent CaseOutline
1. Introduction2. Plavix® Patent3. Patent litigations4. Court decision5. Opinion6. Questions
1. Introduction
Plavix® a prescription medication for heart attacks, stroke,
peripheral vascular disease the second highest selling pharmaceutical the largest market share In 2005, $5.9 billion was sold
Cloridrogel Active ingredient for Plavix The dextro-rotatory enatiomer of methyl alpha
tetrahydro thiano pyradyl chlorophenyl acetate (MATTPCA)
The enantiomer is bisulfate salt The patent of producing cloridrogel is held by Bristol in
the US, and Sanofi-Aventis in the other countries Sanofi-Aventis
A multinational pharmaceutical company The fourth largest pharmaceutical company Research, develop, manufacture and market
pharmaceutical products , including Plavix® Apotex
Founded in 1974 The largest producer of generic drugs in Canada Produces over 300 generic pharmaceuticals Market generic clopidogrel in 2006
2. Plavix® Patent
2. Plavix® Patent (cont’)
2. Plavix® Patent (cont’)
What are enantiomers?Enantiomers are molecules that have the same
molecular formula and sequence of bonded atom, but different spatial arrangements.
Enantiomers are capable of rotating plane-polarized light. Dextro-rotatory enantiomers rotate polarized light to
the right. Levo-rotatory enantiomers rotate polarized light to the
left
Racemate is mixture of equal amount of dextro and levo enanatiomers, exhibiting no optical activity.
2. Plavix® Patent (cont’)
Process of preparation of dextro-rotatory enantiomer from the
racemate
Racemate Solution salt Crystalline Salt
acetone Recrystallisation
acetone Alkaline With
AqueousNaHCO3
Dextro-rotatory
enatiomer
PrecipitateHydrogen SulfateOf
Dextro-rotatoryenantiomer
3. Patent litigation
Timeline Racemate of was first identified prior US patent was filed in 1983 Dextro-rotatory enantiomer of was carried forward US patent was filed in 1988 In 2006, generic cloridogrel was marketed by Apotex In 2006, Bristol-Myers Squibb filed a suit to Apotex for
patent infrigement.
3. Patent litigation (cont’)
Apotex’s position Anticipation
The bisulfate salt was invalid over the previous patent. The patent ‘596 disclosed the method of producing
MATTPC where bisulfate salt was stated as preference. F.3d at 1376.
Obviousness A person of ordinary skill in the art is able to separate
dextro-rotatory MATTPC based on the patent ‘596. 470 F.3d at 1378.
3. Patent litigation (cont’)
Sanofi’s claims Influence of levo-rotatory enantiomer Influence of bisulfate of enantiomer
There are over 50 salts to choose from Experiment is needed to determine the suitable salt
Influence of salt form crystalline form
The difference in solubility of enantiomer
4. Court decision
In 2006, Federal Circuit affirmed Apotex’s generic clopidogrel bisulfate product infringes the ‘265 patent
In 2007, generic cloridogrel was halted in retail pharmaceuticals in the U.S.
In 2008, Sanofi wins protection for Plavix patent in Canada.
5. Opinion
“Intellectual property rights are essential for
the research-based pharmaceutical and
biotech industry to continue to develop
innovative medicines to treat serious
diseases.”
6. Questions ??
? ?
???
?
Bibliography
US patent 4,847,265US patent 4,529,596http://www.fr.com/news/2007/July/
Sanofivapotex.pdfhttp://patentdocs.typepad.com/patent_docs/
2006/12/sanofisynthelab.htmlhttp://www.google.com/patents?
id=Vbk4AAAAEBAJ&dq=4,847,265http://www.google.com/patents?
id=zeA7AAAAEBAJhttp://www.pubs.acs.org/cen/news/84/i37/8437plavix.html