WASHINGTON -- Genetics Institute Inc. petitioned the U.S.Supreme Court on Monday in its effort to recover a patent forerythropoietin (EPO). GI's attorneys said their appeal, ifsuccessful, could have wider implications for thebiotechnology industry.

If the petition is upheld, "some existing biotechnology patentswould be invalidated" and the level of disclosure required infuture biotechnology patents would be increased, LaurenceTribe, GI's counsel in the case, told BioWorld. GI retainedTribe, a renowned constitutional scholar at the Harvard LawSchool, to develop its appeal to the high court.

The petition will not be heard at least until October, when theSupreme Court resumes.

In March, a federal appeals court invalidated GI's EPO patent.The company took a one-time $11 million charge as a result ofthe decision, which left the U.S. EPO market in the hands ofAmgen Inc., whose patent was upheld by the appeals panel.

GI's petition turns on two legal concepts: "best mode" and"enablement." Under U.S. patent law, an inventor must disclosethe best mode for producing a patented invention, andinformation provided in the patent must be sufficient to enablesomeone skilled in the art to replicate the invention. GI'spetition claims that Amgen failed to meet these criteriabecause it did not deposit the type of host cells thatconstitute its best mode for producing EPO.

Although Amgen produces EPO using a transfected host cellline derived from a Chinese hamster ovary (CHO) cell strain, it"deposited ... a bacterial virus containing the human EPO gene,and an E. coli bacterial host cell transfected with a monkeyEPO gene," according to the petition.

The petition claims that the U.S. District Court and later theCourt of Appeals for the Federal Circuit erred when theyallowed Amgen to fulfill the best mode requirement bydescribing its best mode for producing EPO rather than depositan actual sample of the ultimate cell line.

"The Court of Appeals appeared to act on the curiousassumption that creating a new life form by means ofrecombinant DNA technology ... is a simple matter of followinga set of written instructions," the petition said. "No depositsof such revolutionary life forms need be made, we are told,because other scientists supposedly can just grow somethinglike them in their own labs. Thus the court ... held that agenetic engineer, unlike all other inventors, may keep his bestmode cell line as a proprietary trade secret." The petition callsthis a "perverse hypothesis" and says that the Federal Circuitoverstepped its authority in making this exception.

On the enablement issue, the petition said the appeals court"subverted" its role in overturning the district court's decisionto allow a GI patent on purified EPO hormone.

According to the petition, the district court "had held thatAmgen failed to prove that GI's purified hormone patent wasnot enabled." In reversing the lower court, the federal circuit"sidestepped (the) traditional appellate role by belatedlyshifting the burden of proof to GI, holding after the trial wasover that GI should have proved that its own patent wasenabled."

Iver Cooper, a patent attorney for the firm of Browdy &Niemark in Washington, D.C., told BioWorld that "if the SupremeCourt reverses the Federal Circuit Court, the pendulum willswing toward requiring more disclosure, and that might affectthe validity of a couple of patents where people were skatingtoo close to the edge. It is going to make anybody that hasdecided to dispense with deposit altogether and rely on thesequence information nervous. But they shouldn't worry unlessthey knew that particular host cells were preferred" and hidthat information.

Amgen said it considers it unlikely that the Supreme Courtwill grant the petition "and also very unlikely that GeneticsInstitute will prevail if the petition were granted."

In a separate legal action, Amgen filed a motion on Mondaywith the U.S. District Court in Boston requesting that apermanent injunction be reinstated preventing GeneticsInstitute from producing or selling EPO and reinstating theescrow account for GI's proceeds from its past sales of EPO inthe United States.

-- Steve Usdin BioWorld Washington Bureau

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