House Passes Interagency R&D Bills; CAFC Affirms Induced Infringement Finding Against Mylan; and Several Drug Patent Bills Introduced into Congress

This week in Other Barks & Bites: three bills with bipartisan backing that would impact access to generics and pharmaceutical R&D are introduced into the U.S. Senate; the European Patent Office announces the first administration of Paper F on modern examination techniques as part of the EQE; Tencent will invest $1.25B USD into a new Ubisoft video gaming subsidiary; the Federal Circuit upholds findings from the District of New Jersey that an ANDA label proposed by Mylan will induce infringement of antipsychotic treatment patent claims; a Texas patent attorney is ordered to pay Google $124K in attorney’s fees for filing false patent infringement allegations; the House of Representatives passes several pieces of legislation aimed at improving interagency R&D and reducing malign interference in CHIPS Act foreign recruitment programs; and the USPTO announces a new PTAB workflow management framework under which Acting Director Coke Morgan Stewart will handle requests for discretionary denial at the pre-institution phase.

Bites

CAFC Says Mylan’s Proposed ANDA Label Will Induce Infringement of Antischizophrenia Drug – On Friday, March 28, the U.S. Court of Appeals for the Federal Circuit issued a nonprecedential decision in Janssen Pharmaceuticals, Inc. v. Mylan Laboratories Ltd. affirming the District of New Jersey’s ruling following bench trial that Mylan will induce health care providers to infringe Janssen’s patent claims covering treatments for antipsychotics in long-lasting injectable form. The Federal Circuit agreed that Mylan’s proposed generic label in its Abbreviated New Drug Application (ANDA), while it discouraged health care providers from missing dosages, established the specific intent necessary for induced infringement as the ANDA labels instructed providers to reinitiate patients who missed dosages onto the treatment using the asserted claims’ methodology.

Drug Patent Bills Introduced in Congress to End Pay-for-Delay, Improve Interagency Communication – On Wednesday, March 26, a trio of bills with bipartisan support that would impact patent rights to pharmaceutical innovations were introduced into the U.S. Senate. Senators Dick Durbin (D-IL), Thom Tillis (R-NC), Chuck Grassley (R-IA), Chris Coons (D-DE) and Peter Welch (D-VT) introduced the Interagency Patent Coordination and Improvement Act, which would create a task force to enhance coordination between the U.S. Patent and Trademark Office (USPTO) and the U.S. Food & Drug Administration (FDA) on actions involving drug patents. That same day, Senator Grassley joined with Senator Amy Klobuchar (D-MN) to introduce both the Preserve Access to Affordable Generics and Biosimilars Act, which would ban pay-for-delay deals that block access to generics drugs that are 80% cheaper than their branded counterparts, and the Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics (Stop STALLING) Act, which would give the Federal Trade Commission authority to act against pharmaceutical companies that file sham citizen petitions with the FDA to interfere with the approval of generic pharmaceuticals or biosimilars.

Acting USPTO Director Stewart Takes Over Requests for Discretionary Denial at PTAB – On Wednesday, March 26, the USPTO issued a memorandum announcing that the agency would be implementing an interim process for workload management at the Patent Trial and Appeal Board (PTAB) by which Coke Morgan Stewart, Acting Director of the USPTO, would handle requests for discretionary denial at the pre-institution phase for inter partes review (IPR) and post-grant review (PGR) proceedings to determine whether discretionary considerations support the denial of institution for those proceedings, while PTAB administrative patent judges (APJs) will continue to assess the merits of petitions and statutory considerations.

House Passes Several Bills on Interagency R&D, Malign Recruitment Under CHIPS Act – On Tuesday, March 25, the House Committee on Science, Space, and Technology announced that the full U.S. House of Representatives had passed several bills advanced to the House floor from the Science Committee, including the United States Research Protection Act, which updates the definition of “malign foreign talent recruitment programs” within the CHIPS and Science Act; the DOE and NSF Interagency Research Act, which authorizes R&D collaboration between the U.S. Department of Energy (DOE) and the National Science Foundation (NSF); the DOE and USDA Interagency Research Act, which authorizes R&D collaboration between the DOE and the U.S. Department of Agriculture (USDA); and the Innovative Mitigation Partnerships for Asphalt and Concrete Technologies (IMPACT) Act, which supports advanced R&D in asphalt and cement production.

EPO Patent Index 2024 Shows Unitary Patent Requests Outpacing Expectations – On Tuesday, March 25, the European Patent Office (EPO) published its Patent Index 2024 showing that patent application filings at the EU’s patent agency remained essentially unchanged from 2023’s recent highs. Among the reports key findings were higher than expected requests for patents with unitary effect, which was requested for 28,000 patents granted by the EPO in 2024, and significant increases in patent applications claiming inventions in the technical fields of computer technology and electrical machinery, apparatus and energy.

Dr. Filler Files Rebuttal to Special Committee Leading Inquest Against Judge Newman – On Monday, March 24, Dr. Aaron G. Filler, the unpaid expert who filed a report with the Special Committee of the Federal Circuit attesting to Circuit Judge Pauline Newman’s fitness to continue serving on the bench of the Federal Circuit, filed a rebuttal with the Special Committee pushing back against claims of bias and calling irrelevant the “major errors” identified by the Special Committee’s own medical experts. Dr. Filler’s rebuttal points out that the FDA does not regulate the use of neuropsychology to assess dementia, as the Special Committee’s experts claimed, and pointed out that those experts misunderstood the labeling used in his report.

Barks

USPTO Adds ID.me Identity Verification Process to Verify Patent Center Users– On Thursday, March 27, the USPTO announced that it would be introducing ID.me’s modern identity verification platform as part of the user application process for the agency’s Patent Center online platform, adding that the identity verification process through ID.me can typically be completed in less than 30 minutes.

Second Circuit Remands Lego Minifigure Case for Proper Analysis of Copyrightable Elements – On Wednesday, March 26, the U.S. Court of Appeals for the Second Circuit issued a summary order in Lego A/S v. Zuru Inc., remanding the copyright infringement case filed by Lego back to the District of Connecticut to reconsider its entry of a temporary restraining order enjoining Zuru from selling Third-Generation Figurines after holding that the district court did not properly explain its reasoning for entering injunctive relief. “ In particular, we instruct the district court on remand to apply the more discerning observer test in its assessment of substantial similarity,” the Second Circuit wrote, adding that the current record makes it impossible to determine whether injunctive relief was entered based on unprotectable elements of Lego’s own minifigures.

EPO Announces First Offering of Paper F in Transition to New EQE – On Tuesday, March 25, the EPO announced that its most recent administration of the European Qualifying Examination (EQE), which lawyers must pass in order to represent patent applicants in proceedings before the EPO, included Paper F, which tests prospective EPO patent attorneys on modern examination techniques, as the agency transitions to a fully reformed EQE that will be fully in place in 2027.

USPTO Seeking Nominations to Fill Vacated Membership of Public Advisory Committees – On Monday, March 24, the USPTO announced that it would be seeking nominations to fill 18 recently vacated positions on the Patent Public Advisory Committee (PPAC) and Trademark Public Advisory Committee (TPAC). New members would serve effective May 2025 and would serve out the remainder of existing vacancies that end in December of 2025, 2026 and 2027.

Seventh Circuit Says Northern Illinois Erred in Refusing Profits Award on Revenue Evidence – On Monday, March 24, the U.S. Court of Appeals for the Seventh Circuit issued a ruling in Dyson Technology Ltd. David 7 Store reversing the Northern District of Illinois’ refusal to award profits in a trademark infringement action brought by Dyson against several online retailers selling counterfeit hairstyling products. The Seventh Circuit found that, under either de novo or abuse of discretion standards of review, the district court erred under the plain language of the Lanham Act in failing to accept Dyson’s uncontested evidence of revenue, which the defaulting defendants failed to controvert with costs or deductions claimed.

TX Patent Attorney Ordered to Pay Google $124K in Attorney’s Fees for False Allegations – On Monday, March 24, U.S. Magistrate Judge Valerie Figueredo of the Southern District of New York entered an opinion and order finding that Houston, TX-based patent attorney Bill Ramey must pay Google $124,000 in attorney’s fees after failing to conduct an adequate pre-suit investigation that would have demonstrated that patent infringement claims filed by Ramey lacked merit.

This Week on Wall Street

Tencent Investing $1.25B Into Video Gaming Subsidiary Jointly Owned With Ubisoft – On Thursday, March 27, French video game publisher Ubisoft, well-known for such titles as Assassin’s Creed and Far Cry, announced that it was transferring ownership of its most popular games into a new subsidiary that will receive $1.25 billion USD in investment from Chinese multimedia conglomerate Tencent, with the deal expected to bring new multiplayer offerings and increased new content for those games.

Quarterly Earnings – The following firms identified among the IPO’s Top 300 Patent Recipients for 2024 are announcing quarterly earnings next week (2023 rank in parentheses):

• Monday: Mitsubishi Heavy Industries Ltd. (123rd)
• Tuesday: None
• Wednesday: None
• Thursday: Exxon Mobil Corp. (t-233rd)
• Friday: None