Guest Commentary

Eric J. Fues, Finnegan, Henderson, Farabow, Garrett & Dunner, LLP*

The United States has a “first to invent” patent system.  This principle is embodied, among other places, in section 102(g)(2) of the Patent Code, which states that a person is not entitled to a patent if “before such person’s invention thereof, the invention was made in this country by another inventor who had not abandoned, suppressed, or concealed it.”  35 U.S.C. § 102(g)(2).  Relying on this provision, the U.S. District Court for the District of Pennsylvania (the “EDPA”) recently invalidated a drug formulation patent, U.S. Patent No. RE39,502 (“the ’502 patent”), due to AstraZeneca’s prior invention.  See Teva Pharm. Indus. v. AstraZeneca Pharms. (E.D. Pa. Oct. 20, 2010) (D.I. 92).

In October 2008, Teva Pharmaceutical Industries Ltd. (“Teva”) sued several AstraZeneca companies for alleged infringement of the ’502 patent.  Teva asserted that its patent covered AstraZeneca’s blockbuster drug product, CRESTOR®.  Teva filed the lawsuit in the EDPA, near the headquarters of its U.S. subsidiary, Teva Pharmaceuticals USA, Inc.  (“Teva USA”).  At the time Teva filed suit, Teva USA was a defendant in a consolidated ANDA case in the U.S. District Court for the District of Delaware for infringement of a patent covering the active ingredient of CRESTOR®.

In the EDPA case, AstraZeneca moved for summary judgment of patent invalidity under § 102(g)(2).  AstraZeneca argued that it had made batches of tablets containing the same ingredients, in the same amounts, as the CRESTOR® tablets accused of infringement by Teva before the earliest invention date claimed by Teva for its ’502 patent formulation—December 1, 1999.  For the purposes of summary judgment only, AstraZeneca also conceded infringement of the asserted ’502 patent claims, meaning that identity of invention was established.  AstraZeneca then invoked “[a] century-old axiom of patent law [holding] that a product ‘which would literally infringe if later in time anticipates if earlier.’” Upsher-SmithLabs., Inc. v. Pamlab, L.L.C. (Fed. Cir. 2005) (citations omitted); accord Peters v. Active Mfg. Co. (1889) (“That which infringes, if later, would anticipate, if earlier.”).

Teva did not dispute that AstraZeneca made batches of CRESTOR® tablets before December 1, 1999.  Instead, Teva argued that even if AstraZeneca had earlier created the exact commercial formulations, AstraZeneca still could not prove conception or reduction to practice of the invention claimed by the ’502 patent because there was no evidence that AstraZeneca appreciated that crospovidone, the amido-group containing polymeric compound included in CRESTOR®, contributed to the stability of the formulation.  According to Teva, AstraZeneca’s failure to appreciate this was “fatal to its claim of prior invention.”  D.I. 92 at 15.

The EDPA Court explained in a 30-page opinion that to establish prior invention, prior conception and reduction to practice must have occurred.  It also noted that “conception and reduction to practice require ‘contemporaneous recognition and appreciation of the invention represented by [the asserted patent claims].’” D.I. 92 at 21 (emphasis in original) (citations omitted).  But as the court explained:

[T]the inventor need not ‘establish that he recognized the invention in the same terms as those recited in the [claims]’ as ‘[t]he invention is not the language of the claims but the subject matter thereby defined.’.  .  . Rather, the inventor must establish that he recognized and appreciated ‘a compound corresponding to the compound defined by the [claims].’

D.I. 92 at 21 (citations omitted).  And because AstraZeneca recognized that it had created a new formulation, a specific appreciation of the role of one of the ingredient in that formulation was not necessary:

Accordingly, the court concludes as a matter of law that an appreciation of the stabilizing effect of crospovidone by AstraZeneca, as opposed to its appreciation of the stabilization of its overall pharmaceutical composition that contained crospovidone, was not required.

D.I. 92 at 26-27.  The Court added that “The discovery of this inherent property does not make the pharmaceutical compositions claimed by Teva—which AstraZeneca undisputedly made first—new.”  D.I. 92 at 26.  Because Teva had, at most, discovered an inherent property of a prior art composition, its asserted ’502 patent claims were invalid.

*Mr. Fues and several of his colleagues represented Astra Zeneca in its defense of the case discussed in this post.