WASHINGTON -- The U.S. Supreme Court decision on Monday notto review Genetics Institute Inc.'s patent appeal forerythropoietin bolstered rival Amgen Inc.'s stock and leftuntested procedural issues related to deposition of cell linesin patent cases.
The decision leaves intact Amgen's monopoly over sales of theanti-anemia drug in the United States, where its orphan drugexclusivity is now bolstered by unchallenged patent rights.Amgen stock (NASDAQ:AMGN) closed Monday at $54.88, up $2.Genetics Institute (NASDAQ:GENI) dropped $1.38 to $38.13.
The amount of patent infringement damages that GI will haveto pay to Amgen will be determined by a U.S. District Courtnext spring, according to the companies. GI has taken an $11million charge against possible damages. The company'sEuropean partner, Boehringer Mannheim GmbH, has agreed toindemnify GI for any damages over $11 million.
Under U.S. patent law, an inventor must disclose the "bestmode" for producing a patented invention, and informationprovided in the patent must be sufficient to enable someoneskilled in the art to replicate the invention.
GI's petition claimed that Amgen failed to meet these criteriabecause it did not deposit the type of host cells thatconstitute its best mode for producing EPO.
GI's attorneys branded as a "perverse hypothesis" the lowerU.S. Appeals Court for the Federal Circuit ruling, whichallowed Amgen's patent to stand based upon a description ofits best mode for producing EPO rather than a deposit of theultimate cell line. GI warned that failure by the Supreme Courtto overturn the ruling would imperil the integrity of the patentprocess by allowing inventors to obtain patents whileretaining trade secrets.
However, according to Iver Cooper, an attorney with Browdy &Neimark in Washington and the author of "Biotechnology andthe Law," GI's position was "a deliberate exaggeration."
Cooper told BioWorld that the issue wasn't whether depositsof biological materials are required, but whether in caseswhere deposits are required, functional equivalents of the bestmode of the invention can be deposited.
"The issue in the Amgen case was whether using any oldChinese hamster ovary cells was good enough, or if you had touse the particular CHO cell line that had been used by Amgen,"said Cooper. "There were CHO lines in the public domain thatwere functionally equivalent to the CHO cell lines. The [lower]court said under those circumstances, functionally equivalentis good enough," he said.
Cooper said the ruling will slightly shift the balance awayfrom making deposits, but will not eliminate the need to makethem.
There is no hard-and-fast rule indicating when deposits arerequired, he said. The Patent and Trademark Office in essencesets policy on a case-by-case basis. In cases where thematerials used are publicly available and the methodology canbe replicated using techniques known to scientists in the field,the office has ruled that it is sufficient to describe themethods used and to provide a written description of theinvention -- for example, a gene sequence.
"The whole issue of best mode is one in which the FederalCircuit has spoken with a divided voice," Cooper said,predicting that the issue will be raised again.
-- Steve Usdin BioWorld Washington Bureau
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