Archive for September, 2012

Federal Circuit Knocks Outside the Box’s Inequitable Conduct Charges Out of the Box

Tuesday, September 25th, 2012

The following is a guest post from Schwegman Lundberg & Woessner’s associate Ricardo Moran.

The issues on appeal were whether Travel Caddy, Inc. had committed inequitable conduct for: (i) not disclosing the existence of the litigation on U.S. Patent No. 6,823,992 (“the ‘992 patent”) during the prosecution of the application that matured into U.S. Patent No. 6,991,104 (“the ‘104 patent”; the ‘104 patent is a CON of the ‘992 patent; the ‘104 patent was filed shortly before the ‘992 patent issued); and paying small entity fees, even though Travel Caddy was not entitled to claim small entity status. (PDFs of both patents are available at the end of this post.)

Non-disclosure of the ‘992 patent litigation

To establish unenforceability based on inequitable conduct in the U.S. Patent and Trademark Office (PTO), it must be shown that (i) information material to patentability was withheld from the PTO, or material misinformation was provided to the PTO, with (ii) the intent to deceive or mislead the patent examiner into granting the patent. Therasense, Inc. v. Becton, Dickinson & Co., 649 F.3d 1276, 1290-92 (Fed. Cir. 2011) (en banc). Withholding of material information and intent to deceive or mislead must be established by clear and convincing evidence. Id. at 1287 (citing Star Scientific, Inc. v. R.J. Reynolds Tobacco Co., 537 F.3d 1357, 1365 (Fed. Cir. 2008)).

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PERSONALIZED MEDICINE TAKES OFF WHILE DIAGNOSTIC ASSAYS ARE GROUNDED

Tuesday, September 25th, 2012

A front-page article yesterday in the New York Times and other major newspapers reminded me that drug development and methods of medical treatment will be driven by the genomics of increasingly sub-divided patient populations. As reported by GenomeWeb, summarizing an article in Nature (Sept. 23, 2012), “members of the Cancer Genome Atlas presented a multifaceted genetic analysis of breast cancer, characterizing four main subtypes of the disease and uncovering shared molecular features between one of these subtypes and tumors from another part of the body.”

I won’t try to go into detail about their findings, but they were able to connect one particularly nasty form of “triple negative” breast cancer to ovarian cancer. Ironically, post-Myriad, “triple negative” basal-like breast cancer and ovarian cancers shared mutations and other alterations in genes such as BRCA1/2. This suggests that drugs like the platins that are useful to treat ovarian cancer, but are not generally used for breast cancer, might be efficacious to treat this new “subclass” of tumor.

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1st Media, LLC v. Electronic Arts, Inc. – Specific Intent Means Specific Intent

Monday, September 17th, 2012

On September 13th, the Fed. Cir. reversed a district court ruling that the inventor and the attorney who prosecuted a chain of applications claimed multi-media entertainment systems had committed inequitable conduct by failing to disclose three “relevant” references at various times. This was a pre-Therasense decision, and the judge had held the IC part of the trial prior to the case-in-chief. Thus, Therasense, “but-for materiality” had not been considered – the district court appears to have used the “reasonable examiner” standard.

The panel distinguished Aventis v. Hospira, 675 F.3d 1324 (Fed. Cir. 2012) as based on an “affirmative conduct by the applicants showing not only specific awareness of materiality [but-for materiality had been established at trial], but careful and selective manipulation of where, when and how much of the most material information to disclose…. Evidence of such selective disclosure is not present here.” Slip op. at 13-14.

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Akami/McKesson Decision Re-defines Induced Infringement

Monday, September 10th, 2012

In a 6-5 decision, the Fed. Cir., sitting en banc, decided two appeals which presented questions closely related to when an actor is liable for inducing infringement under 271(b); Akami Technologies, Inc. v. Limelight Networks, Inc. and McKesson Tech’s., Inc. v. Epic Systems Corp., App. No. 2010-1291 (Fed. Cir. August 31, 2012).

The claims at issue were both multi-step method claims.  McKesson’s patent claimed a software application that it argued Epic indirectly infringed when it caused patients to initiate communications providing “My Chart” healthcare information to which the providers would respond. Epic did not perform any of the claimed steps. I won’t discuss the Akami facts, since they are less closely related to life sciences.

The court framed the question as limited to the type of infringing acts that would impart liability for induced infringement under 271 (b) and did not purport to redefine direct infringement under 271(a). The court framed the questions to be resolved as:

“[W]hether a defendant may be held liable for induced infringement if the defendant has performed some of the steps of the claimed method and has induced other parties to commit the remaining steps [as in Akami], or if the defendant has induced other parties to collectively perform all of the steps of the claimed method, but no single party has performed all of the steps itself [as in McKesson].”

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