Tuesday, February 01, 2005

More on lexicographer issue in fosamax case

We had earlier discussed the "patentee as lexicographer" issues in the case Merck v. Teva over Fosamax. The 70mg referred to 70mg of the alendronic acid. The "about" referred to the amount of a different form (alendronate) such that "that" amount was equal to 70 mg of alendronic acid. The issue is a rather basic chemical concept; the claim drafting was not good; the specification did explain what the applicant meant.

The rather conclusory arguments below oversimplify what was going on.

from Patently O blog:

Professor Polk Wagner, for one, believes that "Rader is absolutely dead wrong on this argument."

The majority does exactly what it should do: any fair reading of the specification does not clearly convey to a PHOSITA an intent to use the term "about 70mg" to mean "exactly 70mg" [as found by the district court]; at best, the language is unclear and ambiguous.

Further, Rader's suggestion that this case means that patentees shouldn't use the lexicographer option is specious: the message of this case is that the court isn't going to infer a definitional statement where one doesn't exist, and -- more importantly -- that attorneys can't dress up the tired old arguments about how the specification limits the claims by inference in the guise of lexicography. Rader's approach would take us exactly the wrong direction: towards patent claims that have no meaning whatsoever until several years of litigation proceed, and no finality until a Federal Circuit panel divines a so-called 'contextual' meaning that varies according to the idiosyncratic senses of the judges involved.
Kudos to Gajarsa for getting this one right. Let's hope the majority in Phillips similarly holds back the tides of hysteria over clarifying the rules.

*****

Of Wagner's text: "any fair reading of the specification does not clearly convey to a PHOSITA an intent to use the term "about 70mg" to mean "exactly 70mg" [as found by the district court]; at best, the language is unclear and ambiguous," I actually took the time to run the relevant claims/specification by several chemists. They all understood what Merck was saying. Does Wagner have a degree in chemistry or any knowledge of what a PHOSITA would know about this?

Further, Wagner mischaracterizes what the district court found. As pointed out in footnote 4 of the majority's opinion:

--the disputed claim terms 'about 70/35' to mean the equivalent of 70/35 mg of alendronic acid acid when taking into account molecular weight variances for its derivatives that carry accessories. Merck, 288 F. Supp. 2d at 616.--

Wagner merely repeats the mischaracterization of the majority without analyzing what the district court said. The district court said that the 70 mg (or 35 mg in the other claim) referred to the amount of alendronic acid. The phrasing containing "about" referred to the weight of the alendronate that was equivalent to that 70mg amount. Although the claim drafting was clumsy, the specification did explain the patentee's useage, and Judge Rader was correct about the lexicographer point.

To illustrate the technical issue with a simpler example, consider the case of formic acid, which has the formula HCOOH, and a molecular weight of 46 [=(12 + 2*(16) +2*(1))]. Let's say the patent claim seeks to cover an amount of each of several chemical variants of formic acid which are equal to 70 mg of formic acid. By "equal," we mean the same number of molecules. Let's say one of the variants is the sodium salt of formic acid of molecular weight 68 [= (12 +2*16 +1 +23)]. Because the sodium salt of formic acid is heavier by a ratio of 68/46, one would need an amount (70 mg)(68/46) = 103 mg to be equivalent to 70 mg of formic acid itself. However, let's say we might also want the potassium salt of formic acid of molecular weight 84 [=(12 + 2*16 + 1 +39)]. Because the potassium salt of formic acid is heavier by a ratio of 84/46, one would need an amount (70 mg) (84/46)) = 128 mg to be equivalent to 70 mg of formic acid itself.

Judge Rader got the lexicographer argument right. Whether the claims are obvious independently of the claim construction is a different story. No kudos to Polk Wagner for a superficial repetition of the majority's misunderstanding of a basic chemical concept. Reminds one of the Osram case wherein the judge used atomic numbers instead of atomic weights to perform stoichiometric calculations. Here, the stoichiometric issue was ignored entirely.

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