Apotex USA, Inc. v. Merck & Co., Inc.
254 F.3d 1031 (Fed. Cir. 2001)

  • Merck invented a very popular blood pressure drug and patented it in both the US and Canada. After receiving the patents, they started manufacturing the drug and disclosed the ingredients of the drug to the scientific community.
  • At a scientific conference in Canada, an employee of Apotex listened to a Merck scientist's presentation about the drug, and figured out how to manufacture the drug. He ran back home and filed a patent on the manufacturing process.
    • Note that Merck had patented the drug, but had never bothered to patent the process for how to manufacture the drug, even though they were obviously using the process to manufacture the drug.
    • Merck filed a patent for the process after Apotex had filed.
  • Apotex started manufacturing the drug using their process, Merck sued Apotex for infringing on their drug patent. Apotex sued Merck for infringing on their process, and Merck counter-sued arguing that Apotex's patent was invalid because Merck had already invented the process.
    • Merck argued that since they were manufacturing the drug before Apotex filed, Merck had proof that they had both conceived of the invention and had reduced it to practice prior to Apotex's filing.
      • Under 35 U.S.C. 102(g), if a second filer can show conception and reduction to practice before the first filer filed, then the second filer gets the patent.
    • Apotex argued that Merck had forfeited their right to patent the manufacturing process because they had suppressed or concealed the invention.
      • Under 35 U.S.C. 102(g)(2) an inventor loses the right to patent an invention if they have "abandoned, suppressed, or concealed" the invention.
      • Basically, Apotex was arguing that Merck was keeping the process as a trade secret, and trade secrets can't be used as evidence of prior art.
  • The Trial Court found for Merck. Apotex appealed.
    • Apotex argued that Merck intentionally hid the manufacturing process by not disclosing the specifics to the public and not attempting to file a patent on the process.
    • Merck argued that they didn't conceal anything, and that the manufacturing process would be obvious to someone who knew the ingredients of the drug.
  • The Appellate Court affirmed.
    • The Appellate Court noted that the burden on proof for suppression or concealment lay on Apotex.
    • The Court found that the fact Merck hadn't filed for a patent was evidence of suppression.
    • However, the Court then found that, looking at the facts, the information Merck had released to the public did satisfactorily meet the burden of disclosure. In addition, the Court found that since the Apotex scientist immediately figured out the process after hearing Merck's presentation at the scientific conference, the process was 'obvious' to someone skilled in the art.
      • Basically, an inventor can be said to have disclosed an invention as long as they give enough information to let someone skilled in the art reproduce it. They don't have to give step my step details.
      • Apotex argued that since Merck disclosed the process in Canada, that shouldn't count, since the wording of 102(g)(2) does say that the disclosure "in this country." However, the Court looked at the legislative history and decided that disclosures that break the trade secret can occur abroad.
  • Merck probably didn't patent the process because they knew that their patent on the drug would eventually expire (and then generic drug companies like Apotex could make it). But keeping the process as a trade secret, Merck might have been hoping that they'd be able to keep generic manufactures out.