Patent Law

Donna Young, Washington Editor, writes on April 8, 2009 for BioWorld Today:

A ruling last Friday by a three-judge panel from the U.S. Court of Appeals for the Federal Circuit, which affirmed the government's rejection of a patent application filed by two Amgen Inc. scientists, could not only impede gene patenting, but could make all medical-related patents more difficult to obtain.

The case, known as In re Kubin, involved claims directed to the cDNA encoding the human natural killer cell activation inducing ligand (NAIL) protein.

For the cells to become active, they need to be triggered. The inventors involved in the patent application, Marek Kubin and Raymond Goodwin, discovered the trigger and cloned the gene that codes for the trigger protein.

Prior to the filing of the Kubin patent, which is owned by Thousand Oaks, Calif.-based Amgen, other scientists also had been working on the killer cells and had identified the receptor protein but had not fully characterized it.

While an earlier scientist had partially characterized the protein and had created an antibody against it, he did not know the amino acid sequence or the gene that was later claimed by Kubin in the Amgen patent application.

When the U.S. Patent and Trademark Office (PTO) examiner evaluated the Kubin patent application, the examiner determined that because the protein was already known and there were reliable methods in place for working on such a discovery, that any scientist in that area could have identified the amino acid sequence and conducted all of the same experiments as Kubin to arrive at the same conclusion with the cloned gene.

Therefore, the PTO examiner determined that Kubin did not do anything that other scientists could or would have inevitably done in due course. And so the PTO rejected Kubin's patent on the grounds of obviousness.

Amgen appealed the PTO's decision to the Court of Appeals for the Federal Circuit.

Hans Sauer, associate general counsel for intellectual property at the Biotechnology Industry Organization, said the patent office's decision, as well as the Federal Court's decision, were wrong because they failed to follow controlling legal authority in the court's 1995 ruling in a patent rejection case known as In re Deuel.

...the Federal Circuit determined that a 2007 ruling by the Supreme Court in KSR International v. Teleflex Inc. voided the Deuel decision.

If taken to its logical conclusion, the Federal Circuit's decision "is quite disconcerting because it would make many biotech inventions that we now think are legitimate inventions obvious and make it much harder to get a patent for what today are legitimate discoveries of patentable inventions."

Read the full article here.