The generic player Teva (announced in a press release here ) about ongoing patent litigation and jury’s decision on Pantoprazole Sodium (Protonix) formulation.
The Jury appointed by US district Court for the district of New Jersey has opined on April 23, 2010 that innovator Nycomed’s ( who licensed the molecule’s patents to wyeth, now part of Pfizer) compound patent US4758579 (Expiry: Jan 19, 2011), which covers Pantoprazole as product is valid and infringed by generic players. Now, the court's final verdict is keenly awaited by pharma experts.
As per Teva’s press release, the Court has reserved decision on the issue of what, if any, effect to give to the jury's determinations in connection with the obviousness-type double patenting defenses, which Teva has argued is to be decided by the Court. A decision by the District Court judge independent of today's jury verdict would be sufficient to invalidate the patent.
The Jury appointed by US district Court for the district of New Jersey has opined on April 23, 2010 that innovator Nycomed’s ( who licensed the molecule’s patents to wyeth, now part of Pfizer) compound patent US4758579 (Expiry: Jan 19, 2011), which covers Pantoprazole as product is valid and infringed by generic players. Now, the court's final verdict is keenly awaited by pharma experts.
As per Teva’s press release, the Court has reserved decision on the issue of what, if any, effect to give to the jury's determinations in connection with the obviousness-type double patenting defenses, which Teva has argued is to be decided by the Court. A decision by the District Court judge independent of today's jury verdict would be sufficient to invalidate the patent.
As per USFDA database, 3 generic players have final approval for this formulation:
1) Teva: ANDA approved on Aug 2, 2007
2) Sun Pharma: ANDA approved on Sep 10, 2007
3) Kudco Ireland: ANDA approved on Mar 17, 2009
Background of the case
The generic players Teva filed ANDA on this product in April, 2004, the other generic players like Sun filed ANDA with invalidation grounds against product patent in March 1, 2005 and June 25, 2005, respectively. Subsequently, innovator applied for preliminary injunction to stop generic players from marketing generic version in New Jersey District Court. As per preliminary injunction opinion of the district court, court opined that patent is vunerable to invalidation based on strong prior art documents produced by generic players.
Generic player Teva launched Pantoprazole in 2007 and Sun launched in 2008. Further, to affect sale of generic players, innovator launched authorized generic version through Prasco in 2007.
Generic player Teva launched Pantoprazole in 2007 and Sun launched in 2008. Further, to affect sale of generic players, innovator launched authorized generic version through Prasco in 2007.
Also, innovator appealed against district court's decision in U.S. Court of Appeals for the Federal Circuit (CAFC). During appeal, the U.S. Court of Appeals for the Federal Circuit (CAFC) unanimously affirmed the ruling by US district Court for the district of New Jersey
The district court and CAFC denied innovator Altana preliminary injunction based on strong invalidity argument in the light of following prior art:
1) US4255431: product patent on Omeprazole which discloses various structural features for optimal Proton pump inhibitory (PPI) activity
2) US4555518 : Disclosed 18 Proton Pump Inhibitors (PPI) compounds and compund number 12 exhibit structural similarity with Pantoprazole. Further, compound 12 differ from pantoprazole in terms of difference in substituents at 3 position of pyridine ring. Pantoprazole has methoxy group while compound 12 of ‘518 patent contains methyl group.
3) Article by Sachs, Brysnon and ‘431 patent on PPI which shows various structural features for optimal PPI activity like Benzimidazole ring, pyridine ring, methyl sulfinyl groups. Also, these articles describe that methoxy group at pyridine ring lowers Pka value (to about 4) of PPI and exhibit optimal PPI activity.Based on above elements district court opined the vulnerability of ‘579 on obviousness standards and denied preliminary injunction. Subsequently, Altana appealed in CAFC based on following points:
1. District court’s failure to take into account an accused infringer’s clear and convincing burden to prove invalidity
2. District Court’s selection of compound 12 (US4555518) as lead compound
3. District court’s interpretation of Sachs (George Sachs, Pump Blockers and Ulcer disease, 310 New Eng J. Med. 785 (1984), which discloses that substitution of methyl substituent with methoxy substituent in pyridine ring enhances proton pump inhibitory actions.
3. District court’s interpretation of Brysnon articles (Dr A Bryson, The ionization constants of 3-substituted pyridines, substituted quinolines and 4-substituted isoquinolines J. Am. Chem. Soc. 82, 4871 (1960), which discloses the effect of various substituents at 3 position of pyridine ring.
3. District court’s interpretation of Brysnon articles (Dr A Bryson, The ionization constants of 3-substituted pyridines, substituted quinolines and 4-substituted isoquinolines J. Am. Chem. Soc. 82, 4871 (1960), which discloses the effect of various substituents at 3 position of pyridine ring.
Further, the CAFC upheld (in May, 2009) District court’s decision and opined that elements considered by lower court while denying preliminary injunction were correct.
During ongoing full trial in New Jersey District Court, the jury found patent valid and infringed. Importantly, court’s final decision is pending which will provide more clarity w.r.t techno-legal arguments held during trial.
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