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Will the Supreme Court s Festo Decision Spur More Bioinformatics Patenting?

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The US Supreme Court ruled last week on a case that technology firms and patent attorneys alike have been closely following for a year and a half. In a unanimous decision, the high court partly overturned the US Court of Appeals for the Federal Circuit’s ruling in Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., effectively strengthening the protective power of patents.

This comes as good news for the biotechnology industry, which relies heavily on intellectual property protection and has lobbied to overturn the decision. In the bioinformatics sector, where patenting is just beginning to gain a foothold over copyright and trade secret protection, the repercussions are less certain, but all signs point to a more favorable patenting landscape ahead.

The Supreme Court decision reinstated the “doctrine of equivalents” in intellectual property enforcement, under which a patent holder can sue for infringement against a product or process that performs a function deemed “equivalent” to that of the patented technology. The appeals court decision, in an attempt to resolve the ambiguity that is bound to occur when defining equivalence, narrowed the scope of protection to a very literal interpretation of those claims. While supporters of this decision claimed it would cut down on litigation, opponents argued that it severely hampered their ability to sue infringers: A competitor could easily change a small component of a patented technology in cases where the claims were narrowed during the prosecution process and claim it as a new invention.

Technology giants have been split on the issue since the appeals court ruling in November 2000: Arguing that it would discourage frivolous patent suits, IBM, Intel, DuPont, Genentech, and Ford supported the ruling. However, companies such as Pfizer, Sun Microsystems, 3M, and Dow Chemical argued in favor of reversing the decision in order to protect the value of existing patents. Most experts agree that smaller companies who structure their businesses around only a few crucial patents stand to benefit from the reversal.

While Festo hasn’t been a significant barrier to bioinformatics patenting, the Supreme Court decision should make the process easier, said Nelson Capes, an intellectual property lawyer with Briggs and Morgan, a Minneapolis-based law firm that recently launched a bioinformatics practice. “The way the federal circuit had left Festo was very difficult for patent draftsmen in any field, but especially in bioinformatics, because if you didn’t use the exact right words you were effectively excluding your client from protection they had a right to get,” he said.

The language used to describe any technology is often difficult to agree on, but bioinformatics, which draws its rapidly evolving vocabulary from the equally dynamic lexicons of computer science and biology, was particularly affected by the standing ruling, according to Capes. “The history of Festo is a battle to define language,” he explained. Because bioinformatics uses “a whole new vocabulary that’s perhaps never been used before,” the literal interpretation of claims required under the federal circuit’s Festo ruling made the process especially difficult.

Qin Shi, an attorney with Heller Ehrman in Washington, DC, who specializes in life science informatics, noted that the Supreme Court decision is “pro-inventor and pro-patenting … for any kind of invention, whether pharmaceutical, computer science, or bioinformatics.” The decision is particularly important for software patenting, she noted, because it would be very easy to change a single module in a software system in order to get around the literal interpretation of claims required under the federal circuit ruling. “Software patents without the benefit of equivalency are really nothing,” she said. Before the Supreme Court’s decision, software patent protection was essentially “reduced to copyright protection,” which covers only the code itself, not the underlying methodology.

The decision will benefit those bioinformatics firms who have already been issued patents, Shi said, because the broader interpretation of their claims will give them a stronger position relative to latecomers. “Copycat” inventions that simply modify the technology of an incumbent will no longer be patentable, a situation that Shi said encourages true innovation in the field.

Capes and Shi agreed that it was too soon to tell what direct impact the Supreme Court’s decision would have on bioinformatics patenting, though they agreed it’s unlikely the ruling will lead to an immediate rush on the patent office within the sector.

With only a relatively few number of bioinformatics patents issued to date, the decision will have the greatest impact on those companies filing now. “We’ll have to wait and see,” said Capes. “Now that it’s out there, we won’t know what the impact is until a couple of lawsuits appear.”

— BT

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