CAFC Rules “Secret Prior Art” Requires Only Appreciation that Invention Made in Teva Pharmaceutical*
|Written by Eric W. Guttag
Eric W. Guttag IP Law Office
Posted: December 4, 2011 @ 11:46 am
The novelty bar under 35 U.S.C. § 102(g)(2) has been characterized (accurately) as involving “secret prior art.” By “secret,” I mean that the patent applicant likely won’t even be aware of that “prior art” because it hasn’t been published (or is otherwise not publicly available to see). In fact, since the 1973 CCPA case of In re Bass, 474 F.2c 1276, 35 U.S.C. § 102(g)(2) (and its predecessor) has also been an annoying source of “prior art” for the purposes of obviousness under 35 U.S.C. § 103(a).
While having “secret prior art” undercut an effort to patent an invention may be frustrating for many patent applicants, yet another source of irritation is the doctrine of “inherency.” For example, the prior efforts of others can be invalidating “prior art” whether or not those “others” recognize the significance or relevance of the properties of that “prior” invention. (This frequently happens in the technical field of chemical compounds, and especially, drugs.) In fact, all that is required is that the “others” creating that “prior” invention appreciate that, in fact, they made it.
The doctrines of “secret prior art” and “inherency” both merged in the case Teva Pharmaceutical Industries Ltd. v. AstraZeneca Pharmaceuticals LP to surprise, and unpleasantly upend the patentee. In Teva Pharmaceutical, the claimed invention covered by Reissued U.S. Pat. No. 39,502 (the “’502 patent”) was stabilized pharmaceutical formulations for treating dyslipidemia (i.e., an abnormal amount of lipids in the blood). The active in these pharmaceutical formulations was a statin drug. But the critical aspect of the claimed invention was the use of an amido-group containing polymeric compound (“AGCP compound”) as the only component to stabilize the statin drug (i.e., no other stabilizers are used other than the claimed AGCP compound). Also important to know (as will shortly become apparent) is that the ‘502 patent claimed the priority benefit of a provisional application filed on April 10, 2000.
In October 2008, Teva Pharmaceutical sued AstraZeneca for infringing the ’502 patent based on the manufacture and sale of AstraZeneca’s well-known CRESTOR® drug for treating high cholesterol. CRESTOR® is a stabilized statin (rosuvastatin calcium) formulation which may also be used to treat dyslipidemia. The designed for CRESTOR® was tribasic calcium phosphate, which is not an AGCP compound. But CRESTOR® additionally contained crospovidone, which was an AGCP compound, and would “inherently” act as a stabilizer for the statin active. AstraZeneca included crospovidone in CRESTOR® expressly as a disintegrant, but did not understand that crospovidone also had the stabilizing effect for the statin active.
AstraZeneca moved for summary judgment of invalidity under 35 U.S.C. § 102(g)(2), alleging that it had conceived and reduced to practice its CRESTOR® drug to practice prior to Teva Pharmaceutical’s first conception of the claimed AGCP compound stabilized statin formulation. One of these earlier conception/reduction to practices was based on the “undisputed showing that, in mid-1999, [AstraZeneca] manufactured a 10,000-unit batch of a rosuvastatin calcium formulation containing the same ingredients in the same amounts as its commercial [CRESTOR®] drug.” (Interestingly and certainly tactically, AstraZeneca also conceded infringement of the asserted claims of the ‘502 patent for purposes of this summary judgment motion, even though the inclusion of tribasic calcium phosphate, a non-AGCP-compound, as the stabilizer in its CRESTOR® drug might have also been a strong noninfringement defense.) The district court granted AstraZeneca’s summary judgment motion, and held that the asserted claims in the ‘502 patent were invalid under 35 U.S.C. § 102(g)(2) in view of AstraZeneca’s prior conception/reduction to practice of its mid-1999 rosuvastatin calcium formulation (and potentially other prior conception/reduction to practices of these 1999 formulations as will be mentioned later).
On appeal, Teva Pharmaceuticals primary argument was that the district court misapplied 35 § 102(g)(2) by “failing to require AstraZeneca to prove that it appreciated the stabilizing effect of crospovidone in its drug formulation.” That argument went nowhere with the Federal Circuit panel (Judge Linn writing the opinion, with Chief Judge Rader and Judge Dyk joining). While it was undisputed that AstraZeneca “did not understand that crospovidone acted as a stabilizer in its drug prior to Teva [Pharmaceutical]’s conception, if at all,” that did not end the applicability of 35 § 102(g)(2).
Instead, citing first the 1972 CCPA decision of Parker v. Frilette, Judge Linn’s opinion ruled that “[a]n inventor need not understand precisely why his invention works in order to achieve an actual reduction to practice.” Even more on point was the 2001 Federal Circuit decision in Dow Chemical Co. v. Astro-Valcour, Inc. (“undisputed, clear and convincing evidence in the record that [the alleged prior inventor’s] employees immediately appreciated what they had made, and indeed its significance, when they made [the claimed] isobutane-blown foam”) which held that the first to invent need not be “the first to appreciate the [patentable aspect] of the invention.”
Judge Linn’s opinion for the Federal Circuit panel also cited the 2001 Federal Circuit decision in Mycogen Plant Science v. Monsanto Co., and the 2005 Federal Circuit decision in Invitrogen Corp. v. Clontech Labs., Inc. which, like Dow Chemical, held the prior inventor need only “prove that it appreciated what it had made,” and not “everything about how or why its invention worked.” Relying upon the collective holdings in Dow Chemical, Mycogen Plant Science, and Invitrogen, the Federal Circuit panel then concluded that “it is apparent that the district court correctly entered summary judgment” of invalidity of the asserted claims in the ‘502 patent under 35 § 102(g)(2).
Others have taken the view that, with the change to “first to file” regime which will come into effect on March 16, 2013 under the “new” § 102 provision of the America Invents Act (AIA), “prior art” assertions like those made by AstraZeneca under 35 § 102(g)(2) in the Teva Pharmaceutical’s case will be “eliminated.” Au contraire, “old” § 102(g)(2) “prior art” may still be alive and well, even in view of the AIA (or as I call it, the Abominable Inane Act). As of March 16, 2013, the “new” § 102 of the AIA bars patenting if the claimed invention was “in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.” AstraZeneca might still be able to assert some other “prior art” evidence, namely, it’s late summer-1999 CRESTOR formulation (which were characterized in the Federal Circuit panel opinion as being “disclosed”) under the ““new” § 102 as either a “public use” or at least “otherwise available to the public.” This other evidence would be still prior to Teva Pharmaceuticals earliest effective filing date (i.e., the provisional filing date of April 10, 2000).
Please also note that the “new” § 103 of the AIA still says “prior art” without saying that “prior art” has to be one of the barring acts described in the “new” § 102. That “prior art” in the “new” § 103 could still be prior inventions by others prior to the effective filing date of the patent/patent application, even if supposedly “secret.” Put differently, those reports of the supposed “demise” of “old” § 102(g)(2) in view of the AIA may be greatly exaggerated.
*© 2011 Eric W. Guttag.
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