Tuesday, November 30, 2004

Posner to sit by designation over Pinpoint v. Amazon in ND Ill

Judge Richard A. Posner of the Court of Appeals for the Seventh Circuit will be sitting by designation as the district court judge presiding over the jury trial concerning infringement asserted by Pinpoint against Amazon.com's over claims of Pinpoint's U.S. Patent Nos. 5,758,257 and 6,088,722.

Judge Posner sat by designation in an earlier patent case, SKB v. Apotex. I had written in the May 2003 issue of Intellectual Property Today ("There's Always Something There to Remind You"):

-->In the case SmithKline Beecham v. Apotex, 2003 U.S. Dist. LEXIS 2902, the district court addressed the issue of de minimis infringement and concluded that a composition of matter claim can be read as if it excludes any [measureable] amount so small as to lack any commercial significance. Although this interpretation is helpful to generic companies seeking to design around proprietary drugs, it is not clear that it will stand up to text in Embrex v. Service Engineering, 216 F.3d 1343, 1352-1353; 55 USPQ2d 1161 (Fed. Cir. 2000)[J. Rader concurring: "no room remains in the law for a de minimis excuse," the patent statute gives no leeway to excuse infringement because the infringer only infringed a little and that questions of degree go to damages, not to liability]; Madey v. Duke University, 307 F.3d 1351 as quoted in Semitool v. Ebara, 2002 U.S. Dist. LEXIS 21939 ["Similarly, our precedent does not immunize any conduct that is in keeping with the alleged infringer's legitimate business, regardless of commercial implications."]. Provided that the patent holder did meet the requirements of the patent law, the patent holder is given the right to exclude a competitor from making, using, selling, or offering to sell his claimed invention, without reference to the "amount" of the claimed invention to be used. The concept that there can be a "de minimis" level of infringement will likely be rejected by the Federal Circuit.


The Glaxo decision has many interesting aspects. The claim at issue simply recites crystalline paroxetine hydrochloride hemihydrate. The words “paroxetine hydrochloride hemihydrate” describe chemical composition. One of ordinary skill knows what paroxetine is, what hydrochloride is, and what hemihydrate means. The word “crystalline” establishes a requirement of a degree of translational periodicity of the chemical entities; in practical terms, it means relatively narrow lines in x-ray diffraction. If this claim is indefinite, there are many, many claims which are indefinite. The opinion repeatedly talks about “single crystals,” although it does not mean “single crystals” as a scientist would understand them (a phase consisting of one crystal manifesting narrow diffraction lines corresponding to long coherence lengths through the Scherrer equation, as distinct from a polycrystalline material having crystallites of different orientations). In the context of the opinion, a single crystal means a single particle of the claimed material. There is much discussing of the “disappearing polymorph” phenomenon, which is more in the realm of anecdotal stories than well-researched evidence. If SARS were as contagious as the alleged seed contamination were pervasive, there would be no one left to read this article. The bigger problem in the case, however, is the adoption of a “de minimis” infringement exception in light of Federal Circuit cases to the contrary.<--

In the end, the Federal Circuit did not adopt Judge Posner's claim construction or the proposed "de minimis" level of infringement. Further, Posner's new defense was not accepted.

The CAFC affirmed Posner's decision on grounds Posner rejected: public use. It is interesting to note here that SKB began US testing in May 1985, just two months after the (British) lab discovery in March 1985. (However, there seemed to be a natural conversion in December 1984.) As a result of the decision, foreign drug companies will need to accelerate the timetable on US filings.

The judges in the case seemed to have an (unjustified) fear that the modification in question bore some similarity to prions and ice-nine. Ironically, the fear was instilled by SKB. [As a separate matter, as discussed in IPL&B, SKB's lawyers never really got on board with the way Judge Posner was running the case.]

For another pair of eyes on the Apotex case, here is text from the Orrick website:

-->In revising the claim construction, the Federal Circuit admonished the district court for its policy-driven narrowing of the unambiguous language of claim 1 of the '723. The Federal Circuit held the claim to be broad enough to cover even a single crystal of the hemihydrate, as SKB had argued. The court went to hold that because the record showed that Apotex's proposed drug would contain trace amounts of the hemihydrate, Apotex's proposed drug would infringe claim one of the '723 patent. More importantly, the record also showed that more than one year before filing the '723 patent SKB had conducted public clinical trials to test the efficacy of the hemihydrate as an antidepressant. It was on this basis that the court held that the claim at issue was invalid as barred by a prior public use under § 102(b).

Rejecting SKB's argument that the clinical trials constituted an experimental use which would negate the application of the public use bar, the court pointed out that "an experimental use only negates a statutory bar when the inventor was testing claimed features of the invention." Thus, because the asserted claim of the '723 patent claims only the hemihydrate regardless of its use as an antidepressant, clinical trials testing the drug's efficacy as an antidepressant were not an experimental use that negated the public use bar. Holding claim 1 of the '723 patent invalid for public use under § 102(b) as a matter of law, the court warned that: "a patentee should understand that testing the properties, uses, and commercial significance of a compound claimed solely in structural terms may start the clock under § 102(b) for filing a claim that is not limited by any property, commercially significant amount, or other use of the compound." SmithKline Beecham Corp. v. Apotex Corp., 2004 WL 868425 (Fed. Cir. (Ill.))<--

In the present matter, Pinpoint is represented by Phil Beck and Peter Bensinger, Jr.


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