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Michael Muczynski advises clients on all issues relating to patent strategy and portfolio management, with particular emphasis in patent prosecution and opinions in pharmaceutical and other chemical fields. His clients benefit from his previous litigation experience involving generic pharmaceuticals, in anticipating potential issues and strengthening patents through prosecution. Read full bio here.

Business people standing in line under a magnifying glass, as a metaphor for employee performance evaluation, EPS 8 vector illustration, no transparencies The House of Representatives recently sent to the Senate its bill (H.R.5) that combines six previous regulatory reform bills, including, as Title II of the bill, the “Separation of Powers Restoration Act.”  Section 202 of the bill effectively removes the option for courts to apply Chevron deference to agency rulemaking and interpretations.  Thus, rather than deciding whether a regulation is permissible as reasonably related to the purposes of the enabling legislation, by amending 5 U.S.C. § 706, the bill will require a reviewing court to “decide de novo all relevant questions of law, including the interpretation of constitutional and statutory provisions, and rules made by agencies.”  To eliminate any doubt about its intent, the amendment specifically states that the court shall not interpret any gap or ambiguity in a statue or regulatory provision as an implicit delegation of legislative rulemaking authority to an agency, and the court shall not defer to an agency’s interpretation on a question of law.  As a result, rather than simply deciding whether an agency’s construction of silent or ambiguous statutory provisions are permissible as a matter of statutory interpretation, the reviewing court must make its own, independent interpretation.  The change in the statute would mean that prior court approvals of agency rules, applying Chevron deference, will not dictate the outcome of future challenges under the doctrine of stare decisis.
Continue Reading Pending Bill Would Deliver More Judicial Scrutiny to USPTO and FDA Rules

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In considering a novel issue of Post-Grant Review (PGR) eligibility, the Patent Trial and Appeal Board followed the straightforward language of the America Invents Act (“AIA”), and longstanding precedent, holding that post-filing amendments to a pre-AIA patent application do not change its effective filing date and, thus, do not make it eligible for PGR.  David O.B.A. Adebimpe v. Doang-Trang T. Vu & The Johns Hopkins Univ., Case PGR2016-00020, Paper No. 14 (P.T.A.B. July 25, 2016).
Continue Reading Post-Filing Claim Amendments Don’t Change the Effective Filing Date for Post Grant Review

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The PTAB recently addressed the limits on strategies to patent drug labeling, canceling claims directed to a method of supplying a pharmaceutical product where the method includes a step of providing certain “information” to the medical provider. According to the PTAB, the claimed step of providing the information is entitled to no patentable weight under the “printed matter” doctrine where it is not functionally related to other elements of the claimed method.  Specifically, even if the claim says that the information is “sufficient to” cause some effect (e.g., for a medical provider to avoid treating a patient) there is no functional relationship with the claim if the claim doesn’t recite that effect.   Praxair Distribution Inc. v. Mallinckrodt Hospital Prods. IP Ltd., IPR2015-00529.
Continue Reading “Providing . . . information” Step Given No Patentable Weight