Biotech/Pharma Docket

    By Suresh Pillai --

Capricorn Keeps Zicam® IP Suit Active, But Loses Bid for Inventorship Change

The U.S. District Court for the District of Delaware has ruled that Capricorn Pharma, Inc. can proceed with its suit against Matrixx Initiatives Inc. for allegedly infringing Capricorn's patent covering Zicam®, a cold medication.  The patent-in-suit, U.S. Patent No. 6,375,982, covers rapid semi-solid compositions and methods of making such compositions.  In its complaint, Capricon alleges that Matrixx infringed the '982 patent following the expiration of a manufacturing agreement between the two companies, under which Capricorn had used its proprietary technology to manufacture RapidMelt® disintegrating tablets that would be sold under the Zicam® brand by Matrixx.  At the time, Matrixx had knowledge of the technology, and Capricorn has alleged that Matrixx was bound by non-disclosure terms in the agreement not to disclose this technology.  However, after the agreement was executed, Matrixx, through Zicam® LLC, filed two provisional patent applications which, according to Capricorn, contained its proprietary and confidential information.

In the latest action, Matrixx attempted to dismiss Capricorn's claims of breach of contract, specific performance, misappropriation of trade secrets, fraud, and negligent misrepresentation under the reasoning that such claims were time barred under a three-year statute of limitations.  Capricorn countered Matrixx's arguments by stating that Matrixx had fraudulently concealed its misappropriation of trade secrets and breach of the manufacturing agreement, thereby negating the application of the statute of limitations.  Capricorn also sought to correct inventorship on a pending patent application related to the '982 patent.

Though the District Court sided with Capricorn on the statute of limitations issue, the Court refused to correct inventorship, holding that such changes were under the exclusive control of the U.S. Patent and Trademark Office.

Bayer Suit over Nexavar® Dismissed

The Delhi (India) High Court has dismissed Bayer HealthCare AG's lawsuit challenging Cipla Ltd.'s application with the Drugs Controller General of India to market and manufacture Nexavar® in India.  Currently, Bayer holds Indian patent protection for Nexavar® until 2020; the patent was granted in 2008, and Cipla filed its opposition to that patent this past April.  In spite of Bayer's patent, the Indian Court held that Bayer was "attempting to tweak public policy" and that Bayer's lawsuit was "vexatious" in nature.  Nexavar is an oral anti-cancer therapy that has been approved in numerous countries for the treatment of liver cancer and advanced kidney cancer.

Bayer's attempt was viewed by the Indian Court as a means to link the patent process with that of regulatory approval by preventing generic companies from utilizing the drugs for efficacy tests in anticipation of generic production, thereby lengthening the amount of time required to get the generics on the market.

Mylan Appeals Federal Court Validation of Benicar® Patent

Mylan Pharmaceuticals Inc. has filed a notice of appeal in the U.S. District Court for the District of New Jersey, formally objecting to the Court's ruling that Mylan had infringed on Daiichi Sankyo Co. Ltd.'s patent covering Benicar® and Azor®, two drugs for the treatment of hypertension (see "Biotech/Pharma Docket," August 11, 2009).  The patent-in-suit, U.S. Patent No. 5,616,599, covers the active ingredient in both drugs.  Sankyo Co. Ltd., the owner of the patent, and Daiichi Sankyo Inc., its American licensee, originally filed suit in 2007 following Mylan's filing of an ANDA seeking FDA approval to make and market a generic version of Benicar® prior to the expiration date of the patent (see "Court Report," July 9, 2007).  A second suit was filed in 2008 following Matrix Laboratories Inc.'s submission of an ANDA seeking FDA regulatory approval to market a generic version of Azor®.

At trial, the District Court held the patents to be valid, and dismissed Mylan's counterclaims of noninfringement and invalidity.  The Court enjoined Mylan from producing generic versions of both drugs until after the patent expires in April 2016.

Comments

[Keep It Real]

http://www.nytimes.com/2009/09/03/business/03health.html?_r=1&hp

WASHINGTON — Top aides in the Obama administration announced a $2.3 billion settlement on Wednesday with the pharmaceutical giant Pfizer Inc. over the company’s illegal promotion of its now-withdrawn painkiller, Bextra.

It is the largest fine ever levied for fraud in the Medicare and Medicaid programs, and Obama administration officials — criticized by Republicans on Capitol Hill for failing to crack down on fraud in the government’s health programs — sought to highlight the case by having Kathleen Sebelius, secretary of health and human services, make the announcement. The agreement also includes some promotional practices involving other Pfizer drugs — Zyvox, Geodon and Lyrica.

The settlement had been expected. Pfizer, which is acquiring a rival, Wyeth, had reported in January that it had taken a $2.3 billion charge to resolve claims involving Bextra and other drugs. Pfizer shares were down about one percent at mid-day.

Marketing fraud cases against pharmaceutical companies have become almost routine, with almost every major drug maker having been accused of giving kickbacks to doctors or shortchanging the Medicaid program on prices. Prosecutors said that they had become so alarmed by the growing criminality in the industry that they had begun increasing fines into the billions of dollars and would soon start charging doctors individually as well.
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Just a friendly reminder.

[Kevin E. Noonan]

Dear Keep:

1) these fines were for marketing practices, not drug discovery
2) it's good that this administration takes oversight seriously, unlike the last one
3) no one ever said pharmaceutical companies walked with the angels, just that if you want new drugs, don't look to generics - that's not their market niche.

But thanks for the reminder.

[Keep It Real]

"no one ever said pharmaceutical companies walked with the angels, just that if you want new drugs, don't look to generics"

Was Bextra a new drug?

[Kevin E. Noonan]

Dear Keep:

Did we say fining Pfizer was somehow inappropriate?