Caraco – The Little Counterclaim That Could?

Posted on June 16, 2011 by Warren Woessner

I normally try to steer clear of issues raised in Hatch-Waxman litigation between the “innovators” and the “generics,” unless it raises specific points of patent law of general interest – there is just so much of it, and other blogs that are dedicated to following its often double-jointed trail. However, the Supreme Court may well grant cert. within the next few weeks in  Caraco Pharm. Labs, Ltd. V. Novo Nordisk, Supreme Ct. 10-844, opinion below, Novo Nordisk A/S v. Caraco Pharm. Labs. Ltd, 601 F.3d 1359 (Fed. Cir. 2010), reh’g den. 615 F.3d. 1374 (2010), evidenced both by the fact that the Solicitor General filed an amicus brief requested by the Court that supported cert., and the Fed. Cir. decision below drew a strong dissent.

There is almost no way to do a short course on the laws, regulations, and strategies employed by holders of NDA-approved drugs (the innovators’ or branded’s drugs) to keep generic competitors out of the market, but I will try to summarize the relevant facts. An innovator will list an FDA approved drug in the “Orange Book” along with a list of patents certified to cover the drug or its method of use in treatment. The innovator also provides a use code for each patent (e.g., U-83 is treatment of seizures, but some use descriptions are very narrow, e.g., Use of drug x with drug y and drug z to  improve glycemic control in patients with condition w.) These “use codes” are important because they are supposed to be reflected in the labeling.

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Supreme Court: Evidence Of Invalidity Must Be “Clear And Convincing”

Posted on June 10, 2011 by Warren Woessner

On June 9, 2011, the Supreme Court rejected Microsoft’s contention that a preponderance of the evidence should be sufficient to establish patent invalidity in an 8-0 (Roberts abstained) opinion, which affirmed the Fed. Cir.’s opinion (for a change). (The decision can be found at the end of this post.) The Court interpreted Congress’ intent in 35 USC 282 to preserve the presumption of validity of a patent claim unless an attacker can meet the burden of presenting “clear and convincing” evidence of invalidity.

The Court also rejected the notion that some sort of “fluctuating standard of proof” should apply in situations in which the evidence relied upon was not considered by the PTO during prosecution. Even if the primary rationale behind the clear and convincing standard, that the PTO applied its expertise correctly, “seems much diminished’ (citing KSR 550 US 398), the Court held that Congress “codified the common-law presumption of patent validity and, implicitly the heightened standard of proof attached to it” and that standard of proof must still be met. The Court suggested that, in such cases, the jury could be instructed that it could give weight to the fact that the evidence before it is “materially new” when determining if clear and convincing evidence of invalidity had been presented.

See my post of March 25 on this case

10-290_supremecourt_microsoft

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Nonanalogous Art Lives! In Re Klein

Posted on June 9, 2011 by Warren Woessner

Yesterday, the CAFC decided IN RE ARNOLD G. KLEIN 2010-1411, finding error in the USPTO’s rejection of patent claims based on obviousness, using non-analogous art.  You may find the following useful in your prosecution efforts. (A link to the decision can be found at the end of this post.)

The law is …

“A reference qualifies as prior art for an obviousness determination under § 103 only when it is analogous to the claimed invention. Innovention Toys, LLC, v. MGA Entertainment, Inc., No. 2010-1290, slip op. at 12 (Fed. Cir. Mar. 21, 2011); In re Bigio, 381 F.3d 1320, 1325 (Fed. Cir. 2004); In re Clay, 966 F.2d 656, 658 (Fed. Cir. 1992). “Two separate tests define the scope of analogous prior art: (1) whether the art is from the same field of endeavor, regardless of the problem addressed and, (2) if the reference is not within the field of the inventor’s endeavor, whether the reference still is reasonably pertinent to the particular problem with which the inventor is involved.” Bigio, at 1325. Here, the Board focused exclusively on the “reasonably pertinent to the particular problem” test. “A reference is reasonably pertinent if, even though it may be in a different field from that of the inventor’s endeavor, it is one which, because of the matter with which it deals, logically would have commended itself to an inventor’s attention in considering his problem.” Clay, 966 F.2d at 659. “If a reference disclosure has the same purpose as the claimed invention, the reference relates to the same  problem, and that fact supports use of that reference in an obviousness rejection.” Id.

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Supreme Courts decides Stanford v. Roche – Clarifies Scope of Bayh-Dole Act

Posted on June 8, 2011 by Warren Woessner

On June 6, 2011, the Supreme Court rejected Stanford’s arguments that provisions of the Bayh-Dole Act created university ownership rights to inventions made by university employees with federal funding. (A copy of the decision is found at the end of this post.) In effect, the Court held that an assignment in hand is worth (more than) two rights to elect under the Act. Stanford was trying to read the provisions of the Act that give universities the right to elect to retain title to inventions made with government funding to, in fact, vest title in the universities at the time the invention was made; essentially Stanford wanted the Court to read “retain” to mean “acquire or receive.” The Court rejected this interpretation, finding that “You cannot retain something unless you already have it” and, without an assignment from the inventor in hand, Stanford had nothing to retain. Any language in the Act relating to its superiority over other acts disposing of rights, the Court held, does not displace the basic principle that, in the first instance, an inventor owns the rights to his/her invention.

The Court felt that this disposition of rights was only fair since, otherwise, a university could assert rights to inventions conceived prior to the inventor’s employment, so long as reduction of practice used any amount of federal funding while the inventor was an employee. Also, a very small amount of federal funding, combined with funding from other sources, would permit the university to claim title to the entirety of the invention.

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