Sunday, August 13, 2006

Star-Ledger addresses Apotex launch of generic PLAVIX

George Jordan's article in the Newark Star-Ledger begins: Barry Sherman, the outspoken owner of the Canadian generic drug company Apotex, howled for years about Big Pharma's dirty tricks in battling the generics industry.

[Sherman's] latest maneuver -- flooding the American market last week with a copycat version of the top-selling blood thinner Plavix -- may rewrite the rules of the tug-of-war between generic drugmakers and the big, brand-name pharmaceutical companies.

[I]f a court later finds the brand-name's patent has been violated, the generics company faces triple the damages. Only a half-dozen times in the past two decades have drugmakers launched a copy-cat drug "at risk."

Sherman told The Star-Ledger in an interview that he planned all along for a product launch because he didn't expect U.S. regulators to sign off on the "reverse payment" deal.

In a line that could have come right out of Stalk and Lachenhauer's "Hardball:"

"This is a bold strike and consistent with his business strategy," Jim Keon, president of the Canadian Drug Manufacturers Association, said of Sherman. "You don't get to be No. 1 by sitting back and being conservative. Barry built his company from scratch."


Apotex has earned a reputation for being combative and litigious; during the 1990s the company was involved in 100 different court cases. It also has a long history of challenging big drugmakers before their patents expire.

In 2001, Apotex made copies of Bayer's antibiotic Cipro, and in 2004 Sherman sold a low-cost version of the antidepressant Paxil before GlaxoSmithKline's patent expired. In both cases, he avoided punitive legal judgments.

The article also states:

Several published reports have noted the central character in John Le Carre's novel "The Constant Gardener," which was made into a major motion picture in 2005, bears a striking resemblance to Nancy Olivieri, a renowned Canadian hematologist at the center of a whistler-blower dispute with Apotex.

Jordan's article did not get into the underlying legal and technical issues of the PLAVIX (S-clopidogrel) matter. PLAVIX is an example of the chiral switch, as is NEXIUM.

Of the Newark Star-Ledger's allusion to triple damages for intentional infringement, note that the "In the Pipeline" blog as a different story:

The ceiling tiles really began to rain down at that point. There was a clause in the agreement that if the deal didn't go through, Apotex could start selling its generic version with five days notice, and that's exactly what they've started doing as of earlier this week. The generic isn't all that much cheaper, but it's enough to torpedo the branded version.

What's more, it appears that BMS and Sanofi-Aventis limited their potential recourse. Under the usual rules, they'd be able to sue and obtain triple damages if they won, but they seem to have waived that right, along with several others. This would seem to be an indicator of just how much they wanted to keep the generic off the market, and how hard a bargain Apotex drove. It's enough to make you wonder if Apotex factored in, up front, the chance of the whole thing being rejected and decided to give their rivals enough rope with which to hang themselves.

It would seem that if Pipeline got the story right, then the Newark Star-Ledger got that part of the story wrong.

Pipeline also said:

It's difficult to see how this could have worked out more horribly for the two big companies here: their best-selling drug is under attack five years early, they've signed away their rights to do much about it, the analysts are downgrading their stock and the financial rating agencies are looking at lowering their credit ratings, and the criminal investigation is rolling right along. Short of a meteor strike or a plague of frogs, I'm not sure what else could go wrong. And the worst part is, they brought it on themselves. Their patent position should have been stronger in the first place to protect a compound of this importance, and they shouldn't have pushed the envelope so much with their go-away payments to Apotex. It didn't have to be this way. Did it?

One commenter on Pipeline got to the potential issue:

The original patent, which claimed the racemic form and explicitly both enantiomers of clopidogrel, expired in July 2003, while BMS and Sanofi have relied on the validity of a patent, US 4,847,265, filed in July 1989 but valid until 2011, which only claims the marketed enantiomer.

Although the Star-Ledger praised BMS CEO Dolan, one Pipeline commenter wrote:

The CEO of BMS is Peter Dolan, who hasn't made a major value-enhancing move for BMS since he became CEO six years ago. Why should he break his streak now?

And another wrote:

and the french taking on a business in Jersey? sanofi-aventis US headquarters is in NJ (Bridgewater) AND they just moved to the old AT&T complex at 55 Corporate Drive. They also have approval to build 3 new buildings there, in addition to the 3 already there. Mark my words, Sanofi will make a play for BMS.

IPBiz notes US 4,847,265 issued July 11, 1989 based on US app 07/155,550 filed Feb. 12, 1988. There are claims of foreign priority, but the '550 is not a continuation application.

The '265 patent cites to US 4,529,596, the abstract for which states: The invention also relates to the preparation process of new thieno [3,2-c] pyridine derivatives and to their therapeutic application as blood-platelet aggregation inhibiting agents and antithrombotics.


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