Judges: Rader (author), Linn, Prost

[Appealed from S.D. Ind., Judge Barker]

In Eli Lilly & Co. v. Teva Pharmaceuticals USA, Inc., Nos. 10-1005, -1033 (Fed. Cir. Sept. 1, 2010), the Federal Circuit affirmed the district court’s findings that the principal patents underlying Eli Lilly and Company’s (“Lilly”) blockbuster osteoporosis drug, Evista®, were valid and infringed. Specifically, U.S. Patent Nos. 6,906,086; RE39,049; RE38,968 (collectively “the Bone Loss Patents”); and RE39,050 (“the Low Dose Patent”) were held nonobvious and enabled. The Court therefore affirmed the district court’s permanent injunction preventing any manufacture or distribution of a generic version of Evista® until these patents expire in 2014. The Federal Circuit also affirmed the district court’s ruling that certain claims of other patents directed to particle size, U.S. Patent Nos. 6,458,811 and 6,894,064 (“the Particle Size Patents”) were invalid for lack of written description. Teva Pharmaceuticals USA, Inc. (“Teva”) filed an ANDA with the FDA for raloxifene hydrochloride for the prevention of postmenopausal osteoporosis and included a Paragraph IV certification to Lilly’s patents for Evista®. Lilly timely filed its infringement suit on the Bone Loss Patents, the Low Dose Patent, and the Particle Size Patents. After trial, the district court held that Lilly’s Bone Loss Patents and its Low Dose Patent were not invalid for obviousness under 35 U.S.C. § 103. The district court held that the Bone Loss Patents and Low Dose Patent are not invalid for failure to satisfy the enablement requirement of 35 U.S.C. § 112. The district court, however, held that the Particle Size Patents lacked an adequate written description to satisfy 35 U.S.C. § 112.

The Federal Circuit affirmed the district court on all counts. The Court held that raloxifene’s long history of bioavailability problems, specifically the rapid metabolism and excretion of the compound, foreclosed a reasonable expectation of successfully treating postmenopausal osteoporosis with raloxifene. Because of this widely known deficiency, the Court noted that Teva pointed to no evidence that “would teach, suggest, or motivate or supply any common sense reason for a person of ordinary skill in the art to reject the bioavailability concerns and routinely, simply, or easily arrive” at Lilly’s invention in the Bone Loss Patents and Low Dose Patent. Slip op. at 12, 21-22. Moreover, the Court rejected Teva’s argument that the Low Dose Patent claims were invalid for nonstatutory double patenting over the Bone Loss Patents. Teva acknowledged that it did not raise the issue before the district court, and the Court concluded that the record was insufficiently clear for it to conclude that the proper resolution was beyond any doubt. The Court therefore “decline[d] to excuse Teva for failing to raise the nonstatutory double patenting issue at trial.” Id. at 23.

Teva further argued that if the Bone Loss Patents and the Low Dose Patent were nonobvious due to concerns about raloxifene’s bioavailability, then the patents could not be enabled under § 112, first paragraph, because of the prevailing view that raloxifene would not work in humans. But the Federal Circuit affirmed that those skilled in the art could make and use the claimed invention, and that the specification disclosed the results of previously unpublished Lilly experiments. The Court also cited the PTO’s policy that FDA approval of a clinical trial, the blueprint of which was described in the Bone Loss Patents and which was ongoing at the time the application was filed, presumptively establishes “that the subject matter of that trial is reasonably predictive of having the asserted therapeutic utility.” Id. at 26 (emphasis omitted) (quoting MPEP § 2107.03(IV) (8th ed., rev. 6, Sept. 2007)).

Lastly, the Federal Circuit upheld the district court’s invalidation of the Particle Size Patents under written description. The Court noted that the proper test for written description was “whether the disclosure of the application . . . reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date.” Id. at 29 (alteration in original) (quoting Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc)). While the Federal Circuit agreed that the district court may have improperly focused on “whether the patent includes a description of the steps that may be used to prove infringement,” the result nevertheless could be affirmed. Id. at 29, 30. Because the specification only disclosed measurements of bulk raloxifene, and because the record was conflicting as to whether persons of ordinary skill would determine that the inventor possessed the invention of formulated raloxifene falling within the claimed size range, the Court could not hold that the district court made a clearly erroneous factual finding as to the Particle Size Patents. Id. at 30.