Festo v. Shoketsu Kinzoku Kogyo Kabushiki Co., No. 2005-1492 (Fed. Cir. 2007)
In a decision that appears to diminish the value of pharmaceutical formulation patents, today the Federal Circuit held that "[a]n equivalent is foreseeable if one skilled in the art would have known that the alternative existed in the field of art as defined by the original claim scope, even if the suitability of the alternative for the particular purposes defined by the amended claim scope were unknown." Judge Dyk wrote today's opinion; he was joined by Chief Judge Michel. Judge Newman wrote a strong dissent.
This litigation began in August 1988 when Festo sued the defendant for infringement of U.S. Patent No. 4,354,125. The '125 patent, entitled "Magnetically Coupled Arrangement for a Driving and a Driven Member," has nothing whatsoever to do with pharmaceuticals, but the ensuing litigation has had a dramatic effect on patent law. The case has made two round-trips from the district court to the Federal Circuit and Supreme Court and back--and then finally back up to the Federal Circuit, which is where today's decision was made.
The case concerns the scope of the Doctrine of Equivalents, a judicial doctrine stating that although an accused product might not be literally identical to a patented invention, it still may be held to infringe the patent if it is "equivalent". The doctrine is especially important with respect to pharmaceutical formulation patents, because generic drug companies often try to "design around" such patents by using excipients that are not identical to those used in the innovator product, but which serve the same function.
In 2002 (in "Festo VIII"), the Supreme Court held that a narrowing amendment to the claims of a patent application, made during prosecution, would preclude application of the doctrine of equivalents, with three exceptions: (1) the equivalent was "unforeseeable at the time of the application," (2) "the rationale underlying the amendment bears no more than a tangential relation to the equivalent in question," or (3) that "some other reason suggests that the patentee could not reasonably be expected to have described the insubstantial substitute in question."
Earlier this year, the Federal Circuit strictly limited the "tangential relation" exception (in Cross Medical); now the court has done something similar with the "unforeseeability" exception. By holding that whether a scientist in the field of the invention would have in fact recognized a substitute as usable is irrelevant to the legal question of foreseeability, the court has practically eliminated the exception.
As applied to pharmaceutical formulation patents, generic drug companies will certainly argue that the case stands for the proposition that if an excipient was known to exist at the time a claim amendment was made, then as a matter of law it was not unforeseeable--even if a formulation scientist would not have recognized that the excipient could have served as an acceptable substitute.
Given the Federal Circuit's pattern of rulings in Doctrine of Equivalents cases over the last 15 years or so, today's decision is not especially surprising. Nonetheless, it serves to remind patent owners that they should anticipate having to enforce patents by proving literal infringement.
Article is nice but there is one typographical error i.e. this case was started in August 1988
Posted by: ashutosh | July 05, 2007 at 11:29 PM