Sunday, June 1, 2014

Pfizer, Torrent End Patent Dispute

Case Filed: Mar 17, 2014

Case Closed: May 27, 2014

Court: New Jersey District Court

Judge: Joel A. Pisano

Case Summary:
New York-based Pfizer Inc. filed a patent infringement lawsuit against India-based pharmaceuticals company Torrent to block sales of a generic version of erectile-dysfunction drug Viagra. The lawsuit concerned the filing of ANDA by Torrent, seeking approval from the U.S. Food and Drug Administration for generic Viagra, also known as sildenafil citrate.

Patent-in-suit:
The patent at issue was: US6469012 entitled ‘Pyrazolopyrimidinones for the treatment of impotence,’ issued on Oct 22, 2002 and expired[i] on Jun 09, 2013. Pfizer was the last assignee[ii] of the patent (source: MaxVal’ Assignment Database.) The patent at suit covers methods of treating erectile dysfunction by administering sildenafil.

As in Complaint:
Torrent notified Pfizer that it had filed abbreviated new drug application ANDA No. 091448 with the FDA, seeking approval to market and sell, prior to the expiration of the ’012 patent, 25 mg, 50 mg, and 100 mg tablets of sildenafil citrate, generic copies of Viagra®.  It further alleged that the ’012 patent is not valid, unenforceable, or will not be infringed.

The complaint sought an order permanently barring Ahmedabad, India-based Torrent, its officers, agents and employees from “making, using, selling, selling, marketing, distributing or importing” the allegedly infringing drug. Only the claims 25 and 26 were asserted in the case.

NDA Holder:
Pfizer currently holds[iii] the approved new drug application (NDA) for treating erectile dysfunction with sildenafil citrate, which Pfizer sells under the registered name Viagra® (source: MaxVal’s Patent Marker). Treatment of erectile dysfunction with Viagra® is covered by the ’012 patent.

The drug was approved by the FDA on Mar 27, 1998 and offered for sale in US later that year. In 2008, annual sales of Viagra peaked at $1,934 million. In 2013, Viagra delivered over $1 billion in revenue, which met only half the revenue made in 2012. The drug lost its exclusivity in most major EU markets in 2013 while in the US it will expire in 2019.

Pfizer’s Voluntary Dismissal:
Pfizer filed a notice of voluntary dismissal, accordingly the court granted and ordered the case be dismissed without prejudice with no costs imposed on the parties.
Others Cases by Pfizer:
Pfizer has filed nearly a dozen cases asserting the same patent covering the drug against Bayer, Actavis, Teva, Hetero Drugs, etc.

See 3:14-cv-01704 for more details. To get alerts on cases filed/closed, subscribe to our Litigation Alerts.

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[i] Expected expiration date. Patent Term Estimator is a free web-based tool that automatically calculates patent terms and expiration dates for U.S. utility patents.
[ii] MaxVal offers Patent Assignment Alert service where subscribers receive email alerts when assignments relating to target applications, patents or entities of interest are recorded.
[iii] Patent Marker provides an online environment where patentees can virtually mark products and search products for patent-related information.

1 comment:

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