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Apotex Corp. v. Merck & Co.

June 29, 2005


The opinion of the court was delivered by: Matthew F. Kennelly, District Judge


Apotex Corp. has sued Merck & Co., alleging that Merck committed fraud on this Court in obtaining judgment in its favor in an earlier case in which Apotex had sued Merck for patent infringement. Before the Court are motions by Apotex seeking to compel Merck to respond to certain interrogatories and document requests that Merck has resisted on various grounds. For the reasons stated below, the Court grants the motions in part and denies them in part.


In an earlier case that was assigned to this Court's docket, Apotex sued Merck for infringing U.S. Patents No. 5,573,780 and 5,690,962. Apotex Corp. v. Merck & Co., No. 96 C 7375 (N.D. Ill.). Both patents cover a process for making a pharmaceutical compound used to treat high blood pressure. As the Court described the process in that case, it involves mixing the active ingredient, enalapril maleate, with an alkaline sodium compound and at least one other inactive ingredient, adding water to the mix, drying it, and processing it into tablets. The claimed novelty of the invention was that it produced a stable compound without requiring the steps of suspending the enalapril maleate in water, adding the alkaline sodium compound, and mixing until the reaction is complete and a clear solution is formed. See Apotex Corp. v. Merck & Co., No. 96 C 7375, 2000 WL 97582, *1 (N.D. Ill. Jan. 25, 2000). In the suit, Apotex alleged that Merck had infringed the patents in its process for making Vasotec, Merck's trade name for an enalapril maleate tablet.

The Court ruled that Merck had infringed the patents but that the patents were invalid under 35 U.S.C. § 102(g). Section 102(g) provides that a person is not entitled to a patent if "before the applicant's invention thereof the invention was made in this country by another who had not abandoned, suppressed, or concealed it." Merck contended that it had invented the process for Vasotec in this country prior to March 30, 1994, the earliest date on which the patent applicant, Dr. Bernard Sherman, claimed to have conceived the process, and that it had neither abandoned, suppressed, nor concealed the process. Apotex conceded that Merck had made the invention in the United States, had reduced it to practice here, and had not abandoned the invention. It contended, however, that Merck had suppressed and/or concealed the invention as of the time that Dr. Sherman had conceived of the process.

The Court concluded that Merck had shown by clear and convincing evidence that it had not suppressed or concealed the invention. Id., *7-8. In this regard, the Court relied on the fact that Merck had prepared and widely distributed a monograph listing the ingredients used to make Vasotec; had described its product in the Dictionnaire Vidal, a French-language pharmaceutical dictionary; and had publicly disclosed the process for making Vasotec at the trial of a patent infringement suit brought by Merck in Canada, during which Brian McLeod, Merck's vice president of marketing, displayed and narrated a video recording demonstrating the process. Id., *7. Merck's motion for summary judgment included as supporting material an affidavit by Dr. Gerald Brenner, the company's retired former director of research, who stated that McLeod's Canadian testimony regarding the manufacturing process "provides an accurate summary explanation of the steps of mixing enalapril maleate, a carrier, a stabilizer, and a disintegrant; adding water to a mixture of the milled ingredients to create a damp mass in a wet granulation step; drying the damp mass; and ultimately tableting the dried ingredients after they are blended with the lubricant magnesium stearate," and that the product monograph "contains an accurate identification of the ingredients used in that process." Brenner Affid. (Case No. 96 C 7375), ¶ 5. The Court rejected Apotex's argument that Merck's disclosures were insufficient to show a person of ordinary skill in the art how to duplicate the process. Id. *8.

The Federal Circuit affirmed this Court's judgment. In its ruling, the Federal Circuit relied on the same disclosures that had led this Court to rule in Merck's favor and, like this Court, rejected Apotex's argument that those disclosures did not adequately describe the process for manufacturing Vasotec. Apotex USA, Inc. v. Merck & Co., 254 F.3d 1031, 1040 (Fed. Cir. 2001).

In the May 2004 trial of a later lawsuit, held in federal court in New Jersey, Dr. Brenner gave the following testimony:

Q: ... Dr. Brenner, following the introduction of Vasotec in the market place, did Merck decided to maintain the role of sodium bicarbonate in its process as a trade secret?

A: Yes, it did.

Q: How long did Merck maintain its Vasotec process in [sic] the role of sodium bicarbonate in that process as a trade secret?

A: I would say at least to the late eighties or early nineties.


Q: Was there any consensus at Merck at that time period regarding whether people in the field could discern Merck's process for the role of sodium bicarbonate in that process from this reference?

A: The consensus within Merck was that knowing the ingredients themselves, the typical work [sic] in the field could not discern the process by ...

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