Friday, 23 July, 2010

Pantoprazole Sodium (Protonix) patent issues Part II: Court Found Innovator's Key Patent Valid & Infringed by generic players

Refer to my earlier blog post on Pantoprazole Jury decision (

Now, the pharma giant Teva Pharma announced that the U.S. District Court for the District of New Jersey denied Teva's motion to overturn key patent US4758579 (Expiry: Jan 19, 2011) w.r.t jury verdict finding the patent in suit not invalid.

As per press release from innovator Nycomed, Judge Jose L. Linares of the U.S. District Court for the District of New Jersey has confirmed the jury verdict in favor of Nycomed and Pfizer Inc. The decision upholds the jury verdict issued on April 23, 2010, confirming that the patent is valid and rejecting allegations by the defendants that the patent was invalid as obvious and invalid for double patenting

The Court also denied Wyeth and Nycomed's request for FDA to reset the date of Teva's final approval to January 2011, based on the fact that Teva has patent inequitable conduct defenses remaining at the District Court, including patent misuse. Accordingly, Teva is not prohibited from making further sales prior to January 2011, the date when the pediatric exclusivity expires. The Court has not yet issued its underlying reasoning for today's decisions. Teva continues to believe the patent is invalid and unenforceable and intends to pursue all available legal remedies including appeals.

As per Nycomed press release, Nycomed now will continue to vigorously pursue its damage claims in this case, resulting from the launch of generic versions of Pantoprazole tablets at-risk by generic players Teva and Sun. The generic version by Teva was launched in Nov, 2007 and by Sun in Jan, 2008. The said launch was at risk launch.

Source: Press Releases By

1) Teva (

2) Nycomed (

3) Sun (

Minocycline Hydrochloride Extended Release Tablets (Minocycline ER), 45 mg, 90 mg and 135 mg Tablets: Announces Settlement Agreement with innovator

Generic player Mylan announced that its subsidiary Matrix Laboratories Limited received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Minocycline Hydrochloride Extended Release Tablets (Minocycline ER), 45 mg, 90 mg and 135 mg, the generic version of Solodyn(R) ER, a treatment for acne, sold by Medicis Pharmaceuticals Corporation (Medicis). Further, Mylan has obtained approval on this important product on on July 20, 2010

Mylan also announced that it reached settlement and license agreements with Medicis resolving patent litigation relating to Minocycline ER, and the company has ceased additional distribution. Pursuant to the terms of the agreements, Medicis will release Mylan from any liability related to the prior sales of this product, and Mylan will have the right to market Minocycline ER in the U.S. beginning in November, 2011 or earlier under certain circumstances. Additional terms of the agreement were not disclosed.

Earlier, innovator has settled the patent litigation with generic player Teva, as reported earlier by this blog

Minocycline ER had U.S. sales of approximately $496 million for the 12 months ending March 31, 2010, according to IMS Health.

to Memantine hydrochloride (Namenda) 5 mg and 10 mg tablets: Mylan announced settlement with innovator

After settlement with generic player Lupin and others, the innovator Forest and Merz Pharma have settled the patent litigation w.r.t method of use patent U.S. Patent No. 5,061,703 (scheduled to expire in April, 2015) with generic player Mylan. Mylan has confirmed in a press release that that it has entered into settlement and license agreements with Forest Laboratories and Merz Pharmaceuticals related to Memantine hydrochloride (Namenda) 5 mg and 10 mg tablets

As per agreement, Mylan will have the right to market Memantine HCl in the U.S. on Jan. 11, 2015, or earlier, under certain circumstances. Additional details of the agreement remain confidential and remain subject to review by the U.S. Department of Justice and the Federal Trade Commission (FTC).

Earlier, the various generic players like Barr Lab, Cobalt Lab, Lupin, Orchid, Teva Pharma, Upsher-Smith Lab, Genpharm, Sun, Ranbaxy and Wockhardt filed ANDA with Paragraph patent IV certification against ‘703 patent. Subsequently, innovator sued various generic players for the infringement of ‘703 patent in U.S. District Court for the District of Delaware.

Importantly, most of the generic players have settled the patent litigation with innovator. The some of generic players like Lupin, Mylan and others will enter almost 3 months prior to patent expiry.

Namenda had U.S. sales of $1.2 billion for the twelve months ending March 31, 2010, according to IMS Health.

Refer to my earlier posts on Namenda

Source: Press release of Mylan (

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Disclaimer: "IP Pharma Doc" blog is published for information purpose only. "IP Pharma Doc" blog contains no legal advice. I assume no legal responsibility for the views/information expressed here. “IP Pharma Doc” blog is my personal website and not edited by my employer, accordingly, no part of my blog should be attributed to my employer. All information on the present blog should be double checked for its accuracy and applicability. © Dr. Sarwal (2007)
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