CRESTOR® is a prescription drug belonging to a group of drugs called statins that are used to treat high cholesterol. AstraZeneca began selling the drug after the FDA approved a New Drug Application in August 2003. However, in early 1999, the researchers developed the formulations for all dosage strengths of the drug and began development of the commercial products (referred to internally as rosuvastatin sales formulations). In mid 1999, AstraZeneca manufactured numerous batches of 2.5 mg and 5.0 mg sales formulation tablets, which contained the same ingredients as the commercial CRESTOR® tablet cores. In the late summer of 1999, a researcher gave a presentation on the sales formulation tablet cores, which consisted then of the same ingredients and amounts that exist in the current commercial products. In the fall of 1999, AstraZeneca manufactured a batch of coated tablets and later submitted the records from the batch to the FDA as part of the New Drug Application. On January 26, 2000, a patent application was filed in Great Britain on behalf of AstraZeneca, but eventually the application was terminated. On August 4, 2000, AstraZeneca filed a patent application in the United States, which issued as U.S. Patent No. 6,316,460 (“the ‘460 Patent”).
Prior to December 1, 1999, Teva began researching certain stabilizing formulations that contained a certain statin drug called pravastatin. On December 1, 1999, Teva performed stability tests on a pharmaceutical formulation containing pravastatin and confirmed that the formulation was exceptionally stable despite other traditional stabilizers being used in the formulation. On April 10, 2000, Teva filed a provisional patent application disclosing the invention. On April 9, 2001, Teva filed a patent application regarding this invention, which issued as U.S. Patent No. 6,558,659 (“the ‘659 Patent”) on May 6, 2003. Teva filed an application for reissue of the ‘659 Patent on March 17, 2005, which reissued as the ‘502 Patent on March 6, 2007.
Pursuant to 35 U.S.C. § 102(g)(2), 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. The courts have held that conception is the formation, in the mind of the inventor, of a definite and permanent idea of the complete and operative invention and must encompass all limitations of the claimed invention, and is complete only when the idea is so clearly defined in the inventor’s mind that only ordinary skill would be necessary to reduce the invention to practice without extensive research or experimentation. Furthermore, the courts have held that an actual reduction to practice is established when the inventor demonstrates that s/he constructed an embodiment or performed a process that met all the limitations of the allegedly infringed patent, and s/he determined that the invention would work for its intended purpose.
AstraZeneca argued that, if the accused products infringe as alleged by Teva, then the asserted claims of the ‘502 Patent were invalid because AstraZeneca conceived of and reduced to practice the accused products prior to when Teva invented its subject matter covered by the ‘502 Patent. As a threshold matter, the court determined that there was no genuine issue of material fact that AstraZeneca arrived at and manufactured the product formulations before Teva conceived of and reduced to practice the subject matter of the ‘502 Patent. Also, the court agreed that AstraZeneca was able to concede Teva’s allegations of infringement, for purposes of summary judgment, in order to satisfy its burden that its earlier-made CRESTOR® products met all the limitations of the asserted claims of the ‘502 Patent.
Teva challenged AstraZeneca’s argument by claiming that AstraZeneca failed to show prior invention of the subject matter because there was no evidence that AstraZeneca appreciated that a certain compound in CRESTOR® contributed to the overall stability of the formulation. Teva’s expert stated that the use of certain compounds to stabilize the overall formulations was not disclosed in the patent application filed in Great Britain, the ’460 Patent or the New Drug Application; however, he acknowledged that the compounds were disclosed in these documents for uses other than stabilization. AstraZeneca argued that it was not necessary to appreciate how exactly the allegedly infringing formulations achieved stability in order to establish priority of invention under 35 U.S.C. § 102(g)(2) and relied on Federal Circuit cases that have held that a reference may anticipate even when the relevant properties of the thing disclosed were not appreciated at the time. The court concluded that the contribution of the compound to the stability of the formulations as discovered by Teva was an inherent property and that such an appreciation was not required by AstraZeneca.
Finally, the court concluded that AstraZeneca did not abandon, suppress or conceal its earlier-developed CRESTOR® formulations. AstraZeneca avoided the disqualifying effects of § 102(g) by filing the patent applications, submitting the New Drug Application and marketing CRESTOR® commercially in the United States after receiving FDA approval all in a timely manner.