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Article Excerpt
Contents
Specification Comprising Summaries of Papers and No Experimental Data Does Not Enable Treatment Claims
Inequitable Conduct Is Not Easily Shown
Patent Infringement Claims for Acts Done "for the United States " Exclusively Reside Before the Court of Federal Claims
Manuscript with Title Searchable in Database Is Printed Publication Under 35 U.S.C. s.102
Claim Differentiation Does Not Trump the Clear Import of Specification
The ''Entire Market Value'' Rule--Not So Appealing
Standing on Shaky Ground
Pricing Information Disclosed Without Restriction Is Not a Trade Secret
Intrinsic Record Key to Claim Construction, Trumps Expert Testimony
Ninth Circuit Affirms No Infringement by Bratz Dolls
Quick, Tasty and Possibly Infringing Pizza
Advocate General Provides Opinion in Google AdWords Case
Description of Invention in Specification May Overcome Broad Interpretation Underlying Assertion of Ineligibility
USPTO Abandons Pursuit of Controversial Changes to Rules; Proposes Changes to Examiner Productivity System
Specification Comprising Summaries of Papers and No Experimental Data Does Not Enable Treatment Claims By Christopher L. May
The U.S. Court of Appeals for the Federal Circuit invalidated claims for a method of treating Alzheimer's disease because the specification comprised a summary of six scientific papers and reported no data on the use of the compound at issue in humans. In re '318 Patent Infringement Litigation (Fed. Cir., Sept. 25, 2009) (Dyk, J.; Gajarsa, J., dissenting)
The patent-in-suit claimed a method of using the compound galantamine for the treatment of Alzheimer's disease. The specification of the patent was a little over one page long, and consisted in its entirety of six scientific papers in which galantamine had been administered to either animals or humans not suffering from Alzheimer's. During prosecution, the applicant had stated that experiments using animal models were in process and expected to show that treatment with galantamine did result in improvement. The U.S. Patent and Trademark Office (USPTO) allowed the claims without this data, but the data did not become available until after the patent issued. The district court found the patent not enabled for two reasons: because the relevant animal tests were the only evidence of utility and these were not complete at the time the patent was allowed and because the application only surmised how the claimed method could be used without providing sufficient galantamine
dosing information.
A majority panel of the Federal Circuit affirmed. First, the Court found that none of the experiments in the specification involved galantamine and Alzheimer's disease, as well as that the post-issuance data could not be used to show enablement. The Court further found that while tests were not necessarily required for enablement, the plaintiff's argument that utility could be "established by analytic reasoning" did not have any support in the case law. The Court noted that, even if support existed for such reasoning in USPTO procedure, the reasoning put forward by the plaintiff, i.e., that galantamine affected the ability of acetylcholine to bind nicotinic and muscarinic receptors to the brain, was not described in the specification. Finally, the Court pointed to the testimony of the patentee herself, who testified that when she submitted the patent, she was not sure that cholinesterase inhibitors (which included galantamine) would work for the purpose intended in the patent.
Judge Gajarsa dissented from the Court's decision, stating that the Court should remand for additional fact-finding by the district court based on its failure to determine if the patent's written description would have credibly revealed to a person of ordinary skill the compound's utility.
Inequitable Conduct Is Not Easily Shown By Tianxin (Cynthia) Chen, Ph.D.
The U.S. Court of Appeals for the Federal Circuit recently reaffirmed the principle that inequitable conduct based on a patentee's failure to submit material information during prosecution must be supported by evidence of deceptive intent. AstraZeneca Pharmaceuticals LP v. Teva Pharmaceuticals USA, Inc., Case Nos. 08-1480, -1481 (Fed. Cir., Sept. 25, 2009) (Newman, J.).
AstraZeneca sued Teva and Sandoz alleging infringement of its patent covering quetiapine, the generic name for AstraZeneca's Seroquel', an atypical antipsychotic agent. The district court granted summary judgment for AstraZeneca, finding no inequitable conduct in obtaining the patent-in-suit.
The material information asserted by defendants Teva and Sandoz related to certain quetiapine analogs. During prosecution, AstraZeneca filed a declaration after the examiner specifically requested that AstraZeneca overcome the structural obviousness rejection "by a side-to-side comparison with the closest prior art compound(s)," including a compound termed "Schmutz X." The declaration presented the antipsychotic activity not of "Schmutz X," but of a related compound termed "Schmutz B." The reason for this substitution was that data for Schmutz X did not exist and "would be very expensive to generate" at the time. The declaration showed that the antipsychotic behavior of certain prior art compounds was "typical."
The defendants argued both at trial and before the Federal Circuit that AstraZeneca did not disclose to the Patent Office internal data showing "atypical" antipsychotic behavior for perlapine, fluperlapine, Compound 21076 and Compound 24028, and that withholding the data was "deliberately misleading." In essence, "AstraZeneca presented internal test data about similar compounds that were typical while omitting internal test data about similar compounds that were potentially atypical."
The Federal Circuit first noted that AstraZeneca did not withhold any relevant references, noting that AstraZeneca had cited references disclosing atypical antipsychotics, including fluperlapine. Pointing to a lack of evidentiary support, the Court then rejected the defendants' allegations that AstraZeneca made material misrepresentations during prosecution, such as it being "too expensive" to provide data for the Schmutz X compound. AstraZeneca's reason for substituting Schmutz X data with Schmutz B data was deemed plausible and not a material misrepresentation. Finally, although AstraZeneca withheld its internal data for those "atypical" antipsychotic compounds whose structures were "equally close" to quetiapine, the Court nonetheless found that AstraZeneca's submission was "directed to the closest prior art compounds" (as asserted by the examiner) and was not an implied misrepresentation. Therefore, the Court concluded, the evidence did not support that AstraZeneca misrepresented or omitted material information.
Similarly, the Court found that the defendants did not establish deceptive intent by clear and convincing evidence. The Court rejected the argument that "lesser showing of intent to deceive" was needed due to "high degree of materiality" and held that "[e]vidence of mistake or negligence, even gross negligence, is not sufficient to support inequitable conduct."
Patent Infringement Claims for Acts Done "for the United States " Exclusively Reside Before the Court of Federal Claims By Kenneth L. Cage
The U.S. Court of Appeals for the Federal Circuit interpreted 28 U.S.C. s.1498(a) to mandate that the exclusive jurisdiction to assert patent infringement for acts done "for the United States" is before the Court of Federal Claims. Advanced Software Design et al. v. Federal Reserve Bank of St. Louis et al., Case No. 08-1152, (Fed. Cir. Sept. 30, 2009) (Newman, J.).
Advanced Software (Advanced) asserted that Federal Reserve Banks in St. Louis , Philadelphia and Atlanta infringed three of its patents directed to software methods referred to as "seal encoding" technology, which is used to detect fraudulent checks. On a preliminary motion, the district court dismissed the infringement claims that were based on U.S. Treasury checks, ruling that the alleged acts of infringement were "for the United States" and could be litigated only in the Court of Federal Claims pursuant to 28 U.S.C. s.1498(a). Section 1498(a) provides that the Court of Federal Claims is the forum to redress unauthorized use of a patent "by...
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