Teva Pharmecutical v. AstraZeneca Pharmecutical (CAFC 2011-1091) precedential; Judges Rader, Linn (author), Dyk

AstraZeneca moved for summary judgment of invalidity under 35 U.S.C. § 102(g)(2) alleging that it had conceived and reduced its drug to practice prior to Teva's first conception of the claimed subject matter. AstraZeneca made an undisputed showing that, in mid-1999, it manufactured a 10,000-unit batch of a rosuvastatin calcium formulation containing the same ingredients in the same amounts as its commercial drug.  AstraZeneca made additional batches of rosuvastatin calcium in the summer and fall of 1999, also with the same ingredients in substantially the same amounts as the commercial drug.  By late summer 1999, AstraZeneca had disclosed the ingredients and quantities for its rosuvastatin formulation matching those of all commercial drug dosage strengths.  On the basis of these undisputed facts, the district court found that "there is no genuine issue of material fact as to whether AstraZeneca arrived at the same [AstraZeneca drug] product formulations that Teva accuses of infringement--and made batches of those formulations--before Teva conceived of or reduced to practice the subject matter of the '502 patent." Teva Pharm. Indus. Ltd. v. Astra-Zeneca Pharm. LP, 748 F. Supp. 2d. 453, 464 (E.D. Pa. 2010). 

The case hinges on whether an invalidating inventor has to understand exactly how a later claimed invention works. The answer is no.

Because AstraZeneca conceded infringement for the limited purpose of its summary judgment motion, and because Teva maintains the allegation of infringement upon which its suit is based, it is undisputed for the purpose of this appeal that AstraZeneca's drug is an embodiment within the scope of the asserted claims.  See Evans Cooling Sys., Inc. v. Gen. Motors Corp., 125 F.3d 1448, 1451 (Fed. Cir. 1997) ("Although [defendant] bore the burden of proving that the [asserted prior art/accused product] embodied the patented invention or rendered it obvious for purposes of the summary judgment motion, this burden is met by [plaintiff's] allegation, forming the sole basis for the complaint, that the [asserted prior art/accused product] infringes.").  It is undisputed that AstraZeneca conceived and reduced its drug to practice before Teva's first conception of the claimed subject matter.  It is also undisputed that AstraZeneca did not understand that crospovidone acted as a stabilizer in its drug prior to Teva's conception, if at all.  Therefore, this appeal does not involve a dispute of fact.  Thus, this court need only determine, as a matter of law, whether AstraZeneca had to understand that crospovidone stabilized its drug in order to win a priority dispute under § 102(g)(2).  For the reasons discussed below, it did not.

35 U.S.C. § 102(g)(2) provides:

A person shall be entitled to a patent unless . . . before such person's invention thereof, the invention was made in this country by another inventor who had not abandoned, suppressed, or concealed it.  In determining priority of invention under this subsection, there shall be considered not only the respective dates of conception and reduction to practice of the invention, but also the reasonable diligence of one who was first to conceive and last to reduce to practice, from a time prior to conception by the other. 

AstraZeneca could establish prior invention by showing that "(1) it reduced its invention to practice first . . . or (2) it was the first party to conceive of the invention and then exercised reasonable diligence in reducing that invention to practice." Mycogen Plant Sci. v. Monsanto Co., 243 F.3d 1316, 1332 (Fed. Cir. 2001).  Conception occurs "when the inventor has a specific, settled idea, a particular solution to the problem at hand . . . ." Creative Compounds, LLC v. Starmark Labs., No. 2010-1445, Slip Op. 13 (Fed. Cir. Jun. 24, 2011) quoting Burroughs Wellcome Co. v. Barr Labs., Inc., 40 F.3d 1223, 1228 (Fed. Cir. 1994).  But "[a]n inventor need not understand precisely why his invention works in order to achieve an actual reduction to practice." Parker v. Frilette, 462 F.2d 544, 547 (CCPA 1972).  In order to establish reduction to practice, the prior inventor must have (1) constructed an embodiment or performed a process that met all the claim limitations and (2) determined that the invention would work for its intended purpose.  Mycogen Plant Sci., 243 F.3d at 1332.

In deciding that a prior inventor need not be "the first to appreciate the patentability of the invention," this court explained that "the date of conception of a prior inventor's invention is the date the inventor first appreci- ated the fact of what he made." Id.  In Dow [Dow Chemical Co. v. Astro-Valcour, Inc., 267 F.3d 1334 (Fed. Cir. 2001)], this court reaffirmed its predecessor court's holding that "a party who first reduced to practice, but who 'fail[ed] to recognize that he had produced a new form [of matter] . . . is indicative that he never conceived the invention.'" Id. (quoting Heard v. Burton, 333 F.2d 239, 243 (CCPA 1964)). The court likewise reaffirmed that § 102(g) "does not require that [a prior inventor] establish that he recognized the invention in the same terms as those recited in the count [because t]he invention is not the language of the count but the subject matter thereby defined." Id. (quoting Silvestri v. Grant, 496 F.2d 593, 597, 599 (CCPA 1974)).  As Silvestri had explained, "the language of the count is but one way to define the new form and certainly not a unique definition [. . . and a]ny claim they might have written, based on this or other information specific to [the new form] would still define the same subject matter as the count even though in different terms." 496 F.2d at 601.  See also In re Kao, 639 F.3d 1057, 1066 (Fed. Cir. 2011) ("The claimed subject matter is not presumed to change as a function of how one elects to measure it."); William Shakespeare, Romeo and Juliette act 2, sc. 2 ("[T]hat which we call a rose [b]y any other name would smell as sweet.").

Affirmed.