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** 35 U.S.C. § 312(A)(2) DOES NOT CREATE AN INFORMATIONAL RIGHT
Dolby Labs. Licensing Corp. v. Unified Pats., LLC, 23-2110 — Yesterday in an opinion by Chief Judge MOORE, the Federal Circuit dismissed an inter partes review (IPR) decision in which the USPTO refused to adjudicate whether there were real parties in interest (RPI) not named in the IPR. Dolby argued that the USPTO violated its informational right to know the identities of all RPI in IPR proceedings under 35 U.S.C. § 312(a)(2).
The Federal Circuit disagreed. The U.S. Supreme Court had found an informational right existed in cases where the express purpose of the legislation at issue was to allow public access to information. The America Invents Act (AIA) did not include such a purpose and barred judicial review of IPR institution decisions. Because the right to have RPI disputes adjudicated would only arise in the context of an IPR proceeding, the AIA did not create an informational right, and Dolby did not suffer an injury-in-fact sufficient to confer standing.
(1 to 4 stars rate impact of opinion on patent & trademark law)
EUROPEAN COUNCIL REACHES AGREEMENT ON PROPOSED “EU PHARMA PACKAGE”
The European Council has reached an agreement on its position regarding the proposed “EU Pharma Package,” paving the way for negotiations with the European Parliament. This package, which aims to consolidate in one regulation and one directive all current EU pharmaceutical legislation, was proposed on April 26, 2023, and represents the most significant reform of EU medicine laws in over 20 years.
The primary goal of this reform is to ensure that patients across the EU have equitable access to safe, effective, and affordable medicines, regardless of their location. Additionally, it is aimed at enhancing the competitiveness of the EU’s pharmaceutical industry by reducing regulatory burdens and simplifying the regulatory framework.
The “EU Pharma Package” has garnered attention for several reasons, including its initial proposal to decrease regulatory data protection and the broadening of the so-called “bolar exemption” (Article 85). The Council now proposes that Article 85 of the new directive explicitly state that the exemption from intellectual property rights protection will also apply to submissions for procurement tenders, expanding its previous scope, which included only health technology assessments and pricing and reimbursement procedures.
With this agreement in place, the Council is ready to begin negotiations with the European Parliament. Once a package is finalized, the new rules will undergo legal-linguistic revision before being officially adopted.
Thanks to DANIELA GILL-CAREY (Astellas), co-chair of IPO’s Pharmaceutical & Biotechnology Issues Committee, for this update.
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COMMENTS FROM THE READERS
Formal Logic Rules: A friendly reader commented, “This stuff does not play well in my linear mind.” Granted, logic rules aren’t silver bullets. You can make winning arguments without knowing logic rules if you support your conclusions with common-sense reasoning.
Federal Circuit v. CAFC: Why do people persist in using “CAFC”? One reader thinks it might be because the court’s internet address is cafc.uscourts.gov. Another reader, STEVE MURRAY, wonders whether CAFC is being used to reduce the word count in patent briefs.
Unneeded Parentheticals: BRYAN GARNER isn’t a reader, but he knows of this column. In a recent article he said many judges and lawyers write, “Petitioner Herman Grundy (hereinafter ‘Grundy’).” If there’s only one Grundy in a case, a parenthetical isn’t needed. After the first mention, just write “Grundy” and give your readers credit for having intelligence.
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