West Coast Editor

The winds of change are blowin' in the world of biotechnology patents, and those winds - having judicially shifted, at least for the moment - are no longer ill.

Last month, in a closely watched case that pitted Enzo Biochem Inc., of Farmingdale, N.Y., against San Diego-based Gen-Probe Inc. and four others over a patent related to gonorrhea detection, the U.S. Court of Appeals for the Federal Circuit reversed an earlier summary judgment by a federal court that had invalidated Enzo's patent.

This remands the case to trial court again, and that's a good thing for the industry, said Patrea Pabst, partner and patent lawyer in the Atlanta office of the law firm Holland & Knight LLP. At least, she noted, the facts will be heard.

"We have all these conflicting cases that have come down in the last 10 years, and it's not applicable to any other area, but it's bad for [biotechnology]," Pabst told BioWorld Today, adding that she works with many start-up firms.

"The patent may be thrown out, but not for the reasons given here," she added.

At issue was whether Enzo in its patent met the requirement for description of the technology it claims. Until the matter goes to trial, which Pabst guessed could happen within the year, the answer seems to be that the summary judgment's answer was wrong.

Under that judgment, a patent that fails to describe the nucleotide sequence of the claimed genetic material may be ruled invalid even if someone ordinarily skilled in "the art" (that is, the subject of the patent) would fully understand the invention.

The patent could be ruled invalid even if the description is supported by a deposit of the nucleic acid molecule at issue with the American Type Culture Collection, the main repository of cell lines in the U.S. (in accordance with a 1985 court ruling).

Named with Gen-Probe in the Enzo lawsuit are Chugai Pharmaceutical Co. (Gen-Probe's parent company), of Tokyo; Chugai Pharma U.S.A. Inc., a subsidiary; bioMerieux Inc., of Durham, N.C.; and Becton Dickinson and Co., of Franklin Lakes, N.J.

The original district court decision went against Enzo because the company's claimed nucleotide sequence was described only by its binding to N. gonorrhoeae by a ratio of "greater than about five" by comparison to N. meningitidis.

This was not specific enough, the court said, and the first federal ruling affirmed the district court's finding, refusing also to buy Enzo's insistence that the hybridization of the nucleotide sequences amounts to a "chemical property" that can be claimed in a patent.

"Enablement means enabling to make and use," Pabst said. "In written description, you've got to tell exactly what it is [under the first federal ruling]. That's never been the case before."

In the new decision, the federal court simply changed its mind.

With the summary judgment overturned, requirements for written patent descriptions are less stringent. Patents can't be declared worthless so easily, so biotechnology firms ought for the moment to feel relieved, Pabst said, because companies were otherwise put in a serious bind.

For example, "they clone the mouse gene and not the human, and the [U.S. Patent and Trademark Office] says, You didn't clone the human.' And the companies say it's routine to do it this way," she said.

Another scenario: "You have company X' who sits and watches what your nonprofit researchers do at the university. They say, Thank you for the research, we'll go and [clone] the human.' So they get around the patent if the researchers are limited to the mouse. That's what happened with insulin."

The way things stood before is simply "not good for he industry," she said.

"Patents are issued, and they are in full compliance with applicable law and rules and regulations, and then you're going to come along 10 years later and say, We don't care what the rules are?'" Pabst said.

Enzo was the second patent-related decision favorable to the industry this year, she added.

The other, handed down by the U.S. Supreme Court in May, matched Festo Corp., of Hauppauge, N.Y., against Shoketsu Kinzoku Kogyo Kabushiki Co., also known as SMC Corp., with offices in Tokyo and Indianapolis, in a patent case dating from 1988 over magnetic rodless piston cylinders and how widely patent holders might extend their claims. Issues in the case had critical ramifications for biotechnology.

Patent owners lose rights given up by narrowing their scope during the application process, the court agreed - and earlier rulings had said so - but the new decision also said the patent owner could recover for infringements not foreseen at the time of giving up any particular claims.

Festo was a welcome wising up, Pabst said, and Enzo was particularly disappointing, as it stood before.

"It makes no sense form a scientific standpoint, but it's created precedent that is bad," she said.

"We always have that problem," she added. "We have the litigators who like to destroy, and others who like to get patents and develop products. The lawyers didn't care what ramifications it would have. They were working for their clients. But they got a really bad decision, and they were proud of it."

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