Friday, January 28, 2005

Merck loses Fosamax case to Teva

A judgment of Judge Farnan of D. Delaware was vacated/reversed by the CAFC in the case Merck v. Teva concerning Fosamax. Merck patent claims in US 5,994,329 went from valid and infringed to invalid and not infringed.

According to the CAFC [opinion by Judge Gajarsa], the district court had interpreted claim terms "about 35 mg" and "about 70 mg" to mean "exactly 35 mg" and "exactly 70 mg." That perhaps oversimplifies the problem, which arises from unusual (and perhaps questionable) claim drafting.

The weight [mass] element of the claims in question was written in an odd way:

"about 70 mg of alendronate monosodium trihydrate, on an alendronic acid basis..."

"about 35 mg of alendronate monosodium trihydrate, on an alendronic acid basis..."

WHAT DOES THIS MEAN? Is is 70 mg [or 35 mg in the other claim] of alendronate monosodium trihydrate or of alendronic acid? What does "about" modify? Intelligent minds differed, and Merck ended up losing.

Dissenting Judge Rader characterized the issue as Teva arguing that the word "about" could be analyzed separately, with "about" meaning approximately, and as Merck arguing that "about" should be analyzed in the context of the entire phrase, with "about" referring to the variable amounts of salt needed to correspond to 70 mg [or 35 mg in the other claim] of alendronic acid. Of course, in the context of the disputed claims, there was ONLY ONE salt mentioned, so the use of "about" became somewhat strange (ie, there is exactly ONE PRECISE AMOUNT of alendronate monosodium trihydrate THAT CORRESPONDS to 70 mg of alendronic acid [or 35 mg in the other claim]; the use of "about" in the context of the phrase only makes sense for situations where there is MORE THAN ONE salt)

Prior art at issue included articles in the Lunar News in April and July 1996.

The July 1996 reference referred to "oral alendronate" at 40 or 80 mg.

It is interesting to note that the district court discounted the Lunar News articles because they were NOT peer reviewed journals, 288 F. Supp. 2d at 628-629. The district court also discounted the statements of a Dr. Mazess, based in part on his academic training. The CAFC rejected both approaches.

The CAFC also dealt with secondary considerations, citing to among others McNeil, 337 F3d 1362. Here, Merck had ANOTHER patent, US 4,621,077, which excluded others from using alendronate sodium for treating osteoporosis. Thus, Merck's commercial success arose by its exclusionary right from a different patent, and was not a proper secondary consideration to rebut a prima facie case of obviousness.

Footnote 4 attempted to deal with some issues with possibly varying (chemical) forms of alendronic acid.

In his dissent, Judge Rader discussed the lexicographer rule, citing among others Boehringer, 320 F3d 1339. This is presumably a prelude to the upcoming battle in Phillips v. AWH, 376 F3d 1382. Judge Rader may have a good point about the application of the lexicographer rule to the Merck case. However, I notice that he did not comment on the legally separate (but not unrelated) issue that the majority vacated the determination that the '329 was not invalid through obviousness and held that there was obviousness. The judgment of infringement was REVERSED by the majority (result: patent claims invalid; Teva does NOT infringe). Most importantly, Judge Rader did not respond to the challenge set forth by the majority in footnote 10 (page 14 of the pdf file) that the claims were obvious under either the majority's or Rader's claim construction. Thus, the dispute about the lexicographer rule may not affect the outcome (Merck loses).

I [LBE] note in the claim text, "about 70 mg [or 35 mg in the other claim] of alendronate monosodium trihydrate, on an alendronic acid basis..." BOTH alendronate monosodium trihydrate AND alendronic acid are compounds of well-defined molecular weight. Talking about "variability" arising from the use of "a salt" is irrelevant, because the claim talks about ONE salt and ONE acid. If Judge Rader's reference to the specification is correct ['329 patent, column 10, line 65ff], the claim elements refer to a specific amount of a specific compound [alendronate monosodium trihydrate] which is equal to 70 mg of alendronic acid. Further, even if Judge Rader's interpretation of the claim term is correct, the claims are still likely going to be obvious.

As to the drafting, the USPTO database for the '329 lists
Attorney, Agent or Firm: Sabatelli; Anthony D., Winokur; Melvin

As to litigation, John F. Lynch of Howrey Simon represented Merck.

Under related applications: This application is a continuation of PCT/US98/14796, filed Jul. 17, 1998, and also claims priority to U.S. provisional applications Serial Nos. 60/053,535, filed Jul. 23, 1997, and 60/053,351, filed Jul. 22, 1997, both now abandoned, the contents of all of the foregoing of which are hereby incorporated by reference in their entirety.

This would appear to be an example of a continuation application from a PCT, an example of a continuation which is NOT a repeated attempt to obtain the same claims [that is, another counterexample to the approach of Quillen/Webster] Whether it is proper to say provisional applications become "abandoned" may be contemplated.

The '329 patent is itself cited by seven US patents, most recently by US 6,670,343.

from the AP on January 29, 2005:

A federal court invalidated the patent on Jan. 28 for Merck & Co.'s second-largest selling drug, the blockbuster osteoporosis treatment Fosamax, in a decision that offers millions of patients hope for a cheaper version sooner, but darkens the company's already clouded outlook.

Fosamax is the No. 2 drug for Whitehouse Station, N.J.-based Merck. It reported sales of $3.16 billion for Fosamax last year, more than 90 percent of which were for the 35 mg and 70 mg once-a-week versions, according to company spokesman Tony Plohoros.

Zocor, for high cholesterol, is Merck's biggest drug, with $5.2 billion in sales last year.

Although AP didn't address the issue, what happens if Ranbaxy beats Pfizer on Lipitor, which goes generic, and the market for Zocor bottoms out?

Teva won a similar legal battle in a British appeals court in November 2003, when the court unanimously affirmed the decision of a patents court and ruled in favor of Teva and two other companies, saying two Merck patents relating to Fosamax were invalid. (The two patents referred to the pharmaceuticals containing the active ingredient of Fosamax, and the once weekly administration). However, sales of Fosamax in Britain reach only $110 million a year, a far cry from the potential in the U.S. that Friday's court ruling has opened for the company.


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