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By Salvatore Salamone

June 15, 2002 | The Supreme Court, in a unanimous decision, rejected a narrowing of patent protection that would have made it easier for companies to copy patented products by making small changes to the patented design.

By preserving the status quo, the court helped life science companies with strong patent portfolios and potentially made it more difficult to develop alternative generic drugs and technology, say attorneys. At issue was whether patent protection should be restricted to the literal wording in final patent claims or be interpreted more broadly, as has been done historically.

The ruling effectively ended the Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co. (also called SMC Corp.) patent case that started in 1988 and was argued in front of the Supreme Court last January (see sidebar in Patent Protection Under Pressure, April Bio-IT World, page 23). Festo had sued SMC claiming it infringed on Festo’s patent for magnetic pneumatic tubes. SMC argued its design was sufficiently different than the literal wording in the Festo patent.

In the end, the Supreme Court agreed with Festo and overturned a lower court ruling for SMC in 2000. The lower court ruling established an absolute bar limiting patent protection to the literal wording in the patent claim, undermining the doctrine of equivalents that historically gave companies maneuvering room beyond the literal filing.

“The Supreme Court rejected the complete bar in favor of a flexible approach,” says Beth Arnold, an intellectual property attorney with Foley, Hoag LLP.

“Biotech patents have lots of amendments to satisfy the [US Code, Title 35,] Section 112,” says Ron Cahill, a partner in the intellectual property group at Nutter McClennen & Fish. Section 112 requires a patent to spell out the details of the item to be patented, including a description of the invention and the process used to make it. Satisfying this requirement typically involves producing many amendments to narrow the scope of the patent claim.

Consider the example of a patent filed by the University of Rochester for a method of treating inflammation with a non-steroidal prostaglandin inhibitor, which could, according to Palmer & Dodge attorney Kathleen Madden Williams, have provided a basis for infringement actions against two anti-inflammatory drugs—Celecoxib, sold by Pharmacia, and Vioxx, produced by Merck & Co.

Celecoxib—also known as Celebrex—and Vioxx were brought to market before the Rochester patent was issued, but subsequently could be seen to infringe on the patent. Had the Supreme Court upheld the lower court’s Festo ruling (and thereby holding Rochester to the literal wording of its patent), the university would have had great difficulty in attempting to obtain royalties from the two pharmaceutical companies.

Specifically, the university’s final patent was for “a method for selectively inhibiting PGHS-2 [or Cox-2] activity in a human host, comprising administering a non-steroidal compound that selectively inhibits activity of the PGHS-2 gene product to a human host in need of such treatment.” Several amendments preceded patent approval, and the phrase “selectively inhibiting” was not introduced until the final process. This change in language, without regard to technical issues, would have dramatically restricted the scope of Rochester’s patent protection if Festo had been upheld.

The Supreme Court ruling brings a “fairness to patentees,” says Cahill. “We have the doctrine of equivalents so people won’t cheat on a patent.”

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