Patent Law Weblog
recent posts
- Why the Alice Test is Stupid, Part IV: The Usefulness Paradox
- Teva Capitulates to Federal Trade Commission Coercion
- USPTO Issues Memoranda on Subject Matter Eligibility
- USPTO Revokes Guidance on AI-Assisted Inventorship, But Rules Remain Basically the Same
- Why the Alice Test is Stupid, Part III: Eligible Independent Claims Can Have Ineligible Dependent Claims
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Category: Written Description
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By Kevin E. Noonan — Last week, the Federal Circuit affirmed a District Court decision (by Circuit Judge Bryson, sitting by designation) in an ANDA litigation, finding obvious claims asserted for treating patients having mild to moderate hepatic impairment with extended release opioid formulations, in Persion Pharmaceuticals LLC v. Alvogen Malta Operations Ltd. In reaching…
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By Kevin E. Noonan — Last week, the Federal Circuit reversed findings of non-obviousness and affirmed (over Chief Judge Prost's dissent) a finding that claims asserted in ANDA litigation were not invalid for failure to satisfy the written description requirement in Nalproprion Pharmaceuticals, Inc. v. Actavis Laboratories FL, Inc. ANDA litigation arose over Nalproprion Pharma's…
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By Joshua Rich — Every patent must include a written description of the invention sufficient to enable a person of ordinary skill in the art to make and use the invention. A broadening reissue under 35 U.S.C. § 251 must meet a more exacting standard: the claimed invention must be clearly and unequivocally disclosed in…
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By Kevin E. Noonan — There are provisions and interpretations of U.S. patent law that can be in tension depending on the circumstances under which they are argued, whether before an Examiner or during litigation. One of these is the dichotomy between arguing that the prior art would provide insufficient expectation of success to render…
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By Kevin E. Noonan — The Supreme Court denied certiorari last week in Amgen Inc. v. Sanofi, in a case that asked the Court to review the Federal Circuit's jurisprudence related to the written description requirement of 35 U.S.C. § 112(a). To recap, the Federal Circuit overturned the "newly characterized antigen test" set forth in…
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By Donald Zuhn — Today, in In re Tropp, the Federal Circuit vacated and remanded a decision by the U.S. Patent and Trademark Office's Patent Trial and Appeal Board affirming the Examiner's rejection of claims 29-53 of U.S. Application No. 13/412,233 for lack of sufficient written description under 35 U.S.C. § 112. In vacating the…
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By Donald Zuhn –- Last month, in FWP IP ApS v. Biogen MA, Inc., the Federal Circuit affirmed a decision by the U.S. Patent and Trademark Office's Patent Trial and Appeal Board granting Biogen's motion that FWP's U.S. Application No. 11/576,871 did not provide an adequate written description under 35 U.S.C. § 112 for claims…
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By John E. Conour — Even with billions of dollars of funding and the cumulative knowledge and experience of over a hundred years of experimental pharmacology, de novo discovery of effective and safe therapeutics remains a costly and risky endeavor. The number of unsuccessful attempts to obtain Food and Drug Administration (FDA) approval of drugs…
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By Kevin E. Noonan — The application of the written description requirement under 35 U.S.C. § 112(a) with regard to disclosed ranges is not always entirely straightforward or intuitively obvious, and this can particularly be the case when the question is involved with another notoriously arcane species of patent law, interferences. (Interference practice was abolished,…
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By Donald Zuhn –- In a memorandum distributed last week to the U.S. Patent and Trademark Office patent examining corps, Robert Bahr, the Deputy Commissioner for Patent Examination Policy, sought to clarify the Office's guidance regarding the written description requirement of 35 U.S.C. § 112(a), and in particular, the examination of claims directed to antibodies…
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