Sunday, May 27, 2007

Newark Star-Ledger on KSR impact on pharma

On Sunday, May 27, 2007, the Newark Star-Ledger got around to observing that KSR v. Teleflex may not be good for drug companies:

Nowhere will the effect of the ruling be felt more than in New Jersey, home to some of the world's biggest drugmakers, which depend on patents to protect their enormous investments in research and development.

Sanofi-Aventis, for example, whose U.S. operations are based in Bridgewater, this year launched Ambien CR, an extended-release version of the popular sleep pill, in advance of Teva Pharmaceutical Industries selling a generic version of the original tablet, Ambien MR, which had $1billion in sales last year. Now, Barr Laboratories, based in Woodcliff Lake, is seek ing to invalidate Ambien CR's patent as obvious.

Calvert Crary, a Connecticut lawyer who published a paper on the case, said the ruling means the patents on medicines based on standard laboratory formulation techniques, or "tweaks," may be vulnerable to challenge.

"...spokesmen [for BIO] declined to comment for this [Star-Ledger] story.'

In terms of impact, the Star-Ledger identified the following issues:

# Barr's Seasonale, the extended-cycle birth-control pill, faces generic competition from Watson Pharmaceuticals. Seasonale had about $35 million in annual sales last year.

# Johnson & Johnson's epilepsy drug Topamax, which had $2 billion in 2006 sales, is being challenged by Mylan Laboratories. Johnson & Johnson, based in New Brunswick, was granted a federal court injunction two months ago blocking Mylan from selling copycat versions until the patent expires in 2008.

# Wyeth's Effexor XR, which rang up $3.5 billion in 2006 sales, is being challenged by Alza, a J&J company. Alza sued Madison- based Wyeth last year, saying the tablet infringes a patent covering a technology that allows a drug to be slowly released into the bloodstream.

# AstraZeneca's Seroquel for acute mania associated with bipolar disorder is being challenged by Teva Pharmaceutical Indus tries. The case has been pending in U.S. District Court in Newark since 2005.

Still unclear is what effect the Supreme Court's ruling could have on the validity of the patent covering the blood-thinner Pla vix. Bristol-Myers Squibb and Sa nofi-Aventis, which co-market the widely used drug, defended the patent from a challenge by Canadian generic drugmaker Apotex, which briefly flooded the market with copycat Plavix tablets last summer. U.S. District Judge Sid ney Stein in Manhattan could make a decision any day.

Spokesmen for Bristol-Myers, Sanofi and Apotex all declined to comment.

Relevant IPBiz posts:

As Vai Sikahema said in "Rutgers is Wrong": Well, it's New Jersey.

And, from a comment on civilwarcavalry: As to Mr. Ebert, great stuff, and something I thought about as well when reading descriptions of the books. Then again we are both from NJ, and we tend to think alike on stuff such as this. :) Crap and NJ…perfect together..:)


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