The federal Appeals Court in Washington hears arguments today in acase that could have a broad impact on how genes are patented in theU.S.

The case involves an appeal by St. Louis Jewish Hospital researchersof the 1993 rejection of their patent for a DNA sequence encoding aheparin-binding growth factor. The U.S. Patent and TrademarkOffice (PTO) denied the patent based on a general finding thatcloning DNA sequences is routine and that makes them obvious.Non-obviousness is one of three major requirements in getting apatent. (For more background on the case, see BioWorld Today,June 20 1994, p. 1.)

The PTO's approach to biotechnology-related patents has been thefocus of a heated dispute between industry and the governmentoffice.

In a prior case, which is similar to the Jewish Hospital appeal,Emeryville, Calif.-based Chiron Corp. successfully challenged aPTO patent denial in 1993 for its DNA sequences encoding humaninsulin-like growth factors I and II.

However, the PTO apparently has ignored that ruling. The JewishHospital case, which is being argued by St. Louis attorney G. HarleyBlosser, is the first appeal to reach the court since the Chirondecision.

"This could be a very important case depending on whether the courtdecides to do a lengthy discussion of obviousness," said DebraShetka, a lawyer in Palo Alto, Calif., who filed an amicus brief forthe Biotechnology Industry Organization and the Bay AreaBioscience Center in support of the Jewish Hospital researchers.

Shetka said the PTO looks at the method for getting topolynucleotides and rejects patent claims by saying that becausemethods of cloning are routine, the gene discovered is obvious,especially when a partial amino acid sequence is known.

Compare What Is Known, To What Is Discovered

The standard for obviousness, she said, should be based on astructural analysis, comparing what is known to what is discoveredin the patent claim.

Said Blosser, "The big issue is whether or not discovery of a partialDNA sequence by one researcher prevents another researcher fromgetting a patent for the gene that encodes that protein."

Blosser said the biotechnology industry believed that issue wasdecided by the 1993 Chiron decision in which the court ruled thatdisclosure of a DNA sequence did not make a subsequent patentclaim obvious.

Another issue, he added, involves "a long-standing line of cases thatsay you don't look at the method of making a chemical composition,you look at the composition itself in deciding whether it's obvious."

Blosser said if the court sides with the patent office in the JewishHospital appeal "it will be difficult to get a patent on a gene even if afraction of the sequence is disclosed." And other areas ofbiotechnology could be affected, he said, such as protein purificationand antibody development.

The appeals court could take up to a year to decide the case. n

-- Charles Craig

(c) 1997 American Health Consultants. All rights reserved.