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
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
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
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.