Apotex Corp. v. Merck

Case: Apotex Corp. v. Merck & Co., Inc., 2007 U.S. App. LEXIS 26562 (Fed. Cir. 2007)

Facts: The patent holder claimed that the pharmaceutical company infringed patents it held on a process for producing tablets of the compound enalapril, which was used to treat high blood pressure. The district court found that the patents were invalid under 35 U.S.C.S. § 102(g) because the pharmaceutical company invented and used the process before the patent holder made the invention set forth in its patents. In reaching its decision, the district court rejected the patent holder's argument that it was entitled to patent the process because the pharmaceutical company practiced the invention in secret. After the court of appeals affirmed the district court's judgment, the patent holder filed a motion in the district court, pursuant to Fed. R. Civ. P. 60(b), arguing that the court's judgment had to be set aside because the pharmaceutical company committed fraud on the court. The district court denied the motion, and the patent holder appealed. The court of appeals found that the patent holder had not shown that the pharmaceutical company committed fraud on the court. Statements the company's attorneys made to the court were argument about inferences that could be drawn from the evidence.

Holding- The court of appeals affirmed the district court's judgment

Reasoning- In considering Apotex's motion, the district court divided into three groups the allegedly fraudulent statements that Merck was accused of having made in the previous litigation. The first group consisted of Merck's statements that it had publicly disclosed its entire process before the Apotex invention; the second group consisted of Merck's statements that its process could be reverse-engineered from the details that were disclosed; the third group consisted of Merck's statements that it did not suppress or conceal the process. The district court analyzed the statements of each group, and found that they did not constitute fraud. The court observed that if some aspect of Merck's witness presentation or attorney argument at the trial had been defective or over-stated, then Apotex should have challenged it with contrary evidence and argument at the trial. It is apparent that Apotex had the opportunity to challenge Merck's position in the previous litigation, and indeed did so.
The court found no error shown in the district court's analysis and conclusions. As the court observed, during discovery and trial in Apotex I Merck presented evidence that it was wet-granulating enalapril maleate with sodium bicarbonate and at least one excipient in the early 1980s. These ingredients were published in the Dictionnaire Vidal since at least 1985, as well as in promotional materials provided to pharmacists and doctors in Canada. The district court found, and it was not disputed, that this process had been used continuously in Merck's plants in the United States, since before Apotex's asserted date of conception of the same process. The Merck process was discussed in open court during the Canadian Litigation, and the district court's finding that it was not abandoned, suppressed, or concealed was not shown to be in error.
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