Solicitor General Recommends that Supreme Court Deny Certiorari in SKB v. Apotex, Arguing that Federal Circuit's Inherent Anticipation Finding was Correct
Responding to the Supreme Court's invitation, the Solicitor General has filed an amicus brief in SmithKline Beecham v. Apotex. The Solicitor General recommends that the Supreme Court deny SKB's petition for certiorari.
Previously, SKB lost its patent infringement suit against Apotex both in the district court and at the Federal Circuit. In the suit, SKB alleges that Apotex's ANDA for a generic version of Paxil infringes SKB's patent on the hemihydrate form of paroxetine hydrochloride (PHC), the active ingredient in Paxil. Paxil is a leading anti-depressant drug, with annual sales of over $3 billion.
This case has a long, somewhat convoluted history, which has been closely tracked by Patently-O. In 2003, Judge Posner, sitting by designation, found SKB's patent not infringed. In 2004, a Federal Circuit panel affirmed the decision, but on different grounds: the patent was invalid because the invention had been in public use during clinical trials. In 2005, the full Federal Circuit vacated the panel decision and simultaneously the original panel issued a new opinion, holding that SKB's patent was invalid as inherently anticipated.
The Federal Circuit held that a prior art patent inherently anticipated PHC hemihydrate because "the manufacture of PHC anhydrate according to the [prior art] patent necessarily results in the production of PHC hemihydrate." Further, according to the Federal Circuit, although no one recognized the creation of PHC hemihydrate in the prior art, "inherent anticipation does not require a person of ordinary skill in the art to recognize the inherent disclosure in the art at the time the prior art is created."
In its petition for certiorari, SKB presented the issue for review as follows:
Whether the Federal Circuit erred in holding, in conflict with this Court's decision in Tilghman v. Proctor, 102 U.S. 707 (1881), and its progeny, that the "unwitting" and "unappreciated" prior creation of a product renders a subsequent patent of that product invalid as "inherently anticipated," and thus not novel under Section 102 of the Patent Act.
The Solicitor General's brief argues that the Supreme Court has "squarely rejected" the contention that inherent anticipation occurs only if persons skilled in the art recognize the inherent matter at the time the prior art was created; to the contrary, the Court has held that "a characteristic of a pre-existing product is not patentable even if no one had previously recognized that characteristic." The Solicitor General argues that PHC hemihydrate is a characteristic of PHC because producing PHC inevitably results in PHC hemihydrate.
Moreover, according to the Solicitor General, the cases cited by SKB "are distinguishable for three reasons: they did not involve attempts to patent pre-existing products; they did not involve patents that would prevent the public from practicing the prior art; and it was not clear in those cases that the prior art had in fact inevitably produced the allegedly inherent result."
The following briefs have been filed in the Supreme Court:
Thanks to an alert reader for bringing the Solicitor General's brief to my attention!
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