Greenblum & Bernstein, P.L.C.

PHARMACEUTICAL

PRACTICE GROUP NEWSLETTER

Recent News in Intellectual Property

 

                                                                                                     April 2012   

In This Issue

·    Federal Circuit Affirms Finding Of Inequitable Conduct In Taxotere® Patent Litigation

·    Federal Circuit Clarifies Orange Book “Indications” In Infringement Context And Affirms Dismissal Of Inducement To Infringe Claims In Yasmin® Patent Litigation

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Federal Circuit Affirms Finding Of Inequitable Conduct In Taxotere® Patent Litigation 

In one of the first inequitable conduct decisions post-Therasense, the Federal Circuit recently affirmed the holding by the U.S. District Court for the District of Delaware, in Aventis Pharma S.A. v. Hospira, Inc., that two Sanofi/Aventis Taxotere® (docetaxel) patents, i.e., U.S. Patent Nos. 5,750,561 and 5,714,512, were unenforceable for inequitable conduct as well as the limited holding of obviousness and non-infringement of certain patent claims.  By way of background, the Federal Circuit’s ruling in Therasense enunciated a new more stringent test for inequitable conduct by requiring, inter alia, that the intent to deceive element be proved "by clear and convincing evidence that the applicant knew of the reference, knew that it was material, and made a deliberate decision to withhold it."  Previously, intent to deceive could be inferred on a sliding scale depending upon the level of materiality of the prior art reference in-question; that is, the more the reference is material to patentability, the less that needed to be shown to satisfy the intent to deceive element.     

The Federal Circuit rejected Sanofi/Aventis’ claim construction arguments, and based upon the District Court’s claim construction, the Federal Circuit affirmed the Delaware District Court’s holding that the prior art references in-question, i.e., the Vidal and GV references, were material to patentability and that inventor Fabre intentionally withheld the references from the Examiner with intent to deceive.  In so doing, the Federal Circuit rejected Sanofi/Aventis’ arguments that the references were cumulative, i.e., not material to patentability, and that there was no intent to deceive and thus no inequitable conduct.  Sanofi/Aventis specifically argued with respect to intent to deceive that, because the inventor explained the failure to disclose the references, the single most reasonable inference that could be drawn from the evidence was not that the inventor acted with the requisite intent to deceive the Examiner. 

The Federal Circuit began its analysis quoting Therasense in its discussion of materiality observing that "when a 'claim is properly invalidated in district court based on the deliberately withheld reference, then that reference is necessarily material' for purposes of the inequitable conduct inquiry;" and then opining that “we have affirmed the district court's finding that the '561 and '512 patents were invalid based on, inter alia, the withheld GV and Vidal references.  Because such references are necessarily material to patentability, the district court did not err in finding that the materiality requirement was established.”

Turning to the intent to deceive element, the Federal Circuit noted that, although the Delaware District Court’s decision pre-dated Therasence, "based on the district court's thorough discussion of its factual findings and its well-reasoned analysis that is consistent with Therasense, this determination was not an abuse of discretion."   

Federal Circuit Clarifies Orange Book “Indications” In Infringement Context And Affirms Dismissal Of Inducement To Infringe Claims In Yasmin® Patent Litigation

The Federal Circuit ruling in Bayer Schering Pharma v. Lupin affirmed the U.S. District Court for the Southern District of New York’s dismissal of Bayer's assertions that Watson, Sandoz and Lupin infringed Bayer's U.S. Patent No. 5,569,652 (the ‘652 patent) because the respective ANDAs did not seek approval for the claimed uses.  In so doing, the Federal Circuit clarified that certain uses or effects, although identified on the drug label, were not FDA approved Orange Book “Indications and Usages” identified on the drug label that could properly support an infringement claim.  

By way of explanation, the ‘652 patent is a method-of-use patent that is listed in the Orange Book for Yasmin®, which, as is relevant to the instant analysis, is approved by the FDA "for the prevention of pregnancy in women who elect to use an oral contraceptive."  The '652 patent however claims more than a contraceptive use or effect; the patent claims a method of simultaneously achieving: (1) a contraceptive effect; (2) an anti-androgenic effect; and (3) an anti-mineralocorticoid effect. 

Bayer filed suit in response to submission of respective ANDAs containing paragraph IV certifications by Watson, Sandoz and Lupin asserting that the respective generic versions of Yasmin® would not induce infringement of the '652 patent.  Watson and Sandoz thereafter moved for judgment of non-infringement on the pleadings on the grounds that the respective ANDAs sought approval for using the generic versions of Yasmin® as a contraceptive alone, and not the other claimed uses.  The New York District Court accordingly dismissed Bayer’s infringement actions "because the FDA had not given approval for the use of the drug that was claimed in the '652 patent, Bayer could not state a claim for patent infringement."

On appeal, Bayer argued that the FDA did approve Yasmin® for all three uses or effects because the “Clinical Pharmacology” section of the drug label contained information relating all three uses.   The Federal Circuit rejected this argument holding that, although the drug label did identify the other claimed uses, merely including this information on the label did not establish that the FDA had approved Yasmin® for all three claimed uses.

The Federal Circuit, in so holding, noted that FDA approved uses are listed in the “Indications and Usage” section of the drug label and cannot "be implied or suggested” whether or not such uses appear in other sections of the label, such as the Clinical Pharmacology section, because 21 C.F.R. § 201.57, “makes clear that the FDA has not approved the use of Yasmin® to produce the pharmacological effects that are listed in the Clinical Pharmacology section of the label."   

The Federal Circuit further remarked that:

 the fact that certain of the effects of a drug are described in the Clinical Pharmacology section of the label does not mean that the FDA has approved the use of the drug to produce those effects; it only ensures that physicians are aware of the full range of the drug's pharmacological effects (especially those that might be considered adverse effects) when prescribing the drug for a purpose set forth in the Indications and Usage section and under the conditions described in other parts of the label.

As such, the Federal Circuit held that the FDA had not approved Yasmin® for any uses other than as a contraceptive because the FDA did not study or find Yasmin® to be safe and effective to be used for the other claimed effects or uses, and that accordingly the ANDAs in-question that sought to market the generic versions of Yasmin® solely for use a contraceptive could not induce infringement of the '652 patent.

The GREENBLUM & BERNSTEIN NEWSLETTER is issued by GREENBLUM & BERNSTEIN, P.L.C., an intellectual property firm, to provide timely news in the field of intellectual property.  The NEWSLETTER provides monthly updates on recent issues of general interest in this field.  The views and/or opinions expressed herein do not necessarily reflect those of GREENBLUM & BERNSTEIN, P.LC.  Information regarding the contents of the Newsletter can be obtained by contacting P. Branko Pejic at GREENBLUM & BERNSTEIN, P.L.C., 1950 Roland Clarke Place, Reston, VA 20191.  Copyright 2012 GREENBLUM & BERNSTEIN, P.L.C. [01300582.DOC