FDA Approves Biogen’s Tofidence®, a Biosimilar Competitor to Genentech’s Actemra®

On September 29, the U.S. Food and Drug Administration granted approval for Tofidence®, a biosimilar produced by Biogen, for Genentech’s Actemra®. As reported, this marks a significant step for Biogen in the biosimilar sector. Actemra®, originally developed and marketed by Genentech, is a widely used medication designed to treat a variety of severe medical conditions….

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Advancements in Ophthalmic Anti-VEGF Therapeutics: A Glimpse into Promising Clinical Trials

In the rapidly changing drug development world, there has been a significant progress in the field of ophthalmic anti-VEGF therapeutics, as noted by a recent article published on JD Supra. The article points out several significant developments in ophthalmic anti-VEGF therapeutics that are currently under clinical trials. Anti-VEGF (Vascular Endothelial Growth Factor) therapeutics aim to…

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European Commission’s SEP Licensing Proposal Sparks Intellectual Property Debate

As law professionals abroad are aware, the conversation surrounding the European Commission’s proposed regulation of Standard Essential Patent (SEP) Licensing has sparked a significant debate. This proposal, which began surfacing this summer, garnered the attention of an array of individuals and entities, soliciting approximately 150 comments for consideration. Evidence of these discussions can be found…

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Secrecy Orders: Concealing Extraterrestrial Innovations in Patent Law

The topic of secrecy orders as a shield for alien innovations is attracting ever-increasing curiosity. This was recently explored in a post on JDSupra, where the intriguing question was raised: Could patent applications indicate knowledge of extraterrestrial spacecraft?JDSupra The inherent dilemma that governments and organizations face is whether to open such advanced technology for patenting,…

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Fragmentation and Thin Slices: The Shifting Landscape of 5G Standard Essential Patents

In recent times, the business of 5G standard essential patents (SEPs) has seen considerable shifts. As delineated by IPlytics in a recent report, the ownership landscape of these innovatively transformative patents is undergoing significant fragmentations. A situation being widely presumed, it is now confirmed that as more patent holders seek to collect royalties on their…

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Canada’s PMPRB Adopts Amended Interim Guidance: Implications for Pharmaceutical Industry

The Patented Medicine Prices Review Board (PMPRB) has approved amendments to its Interim Guidance, colloquially known as the “Amended Interim Guidance”. These changes, which were proposed in June 2023, will affect the review of prices for patented medicines and were designed with the forthcoming release of new guidelines in mind. Notably, these guidelines pertain to…

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Decade After Actavis Ruling: Lasting Impacts on Pharmaceutical Antitrust Law and Patent Strategies

Reflecting on a decade subsequent to the consequential Supreme Court decision in Federal Trade Commission v. Actavis, it’s clear that this ruling fundamentally reshaped pharmaceutical antitrust law, by simultaneously defining “reverse payment settlements” and affirming that antitrust liability can apply to these settlements. Initially aiming to steer clear of instant condemnation of such settlements, the…

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GSK v Teva Fallout: Induced Infringement, Skinny Labels, and Implications for Pharma Litigation

Last year, the Supreme Court made its decision to refuse the petition for certification in the landmark case GlaxoSmithKline v Teva Pharmaceuticals USA, widely known as GSK v Teva. The ripple effects of this denial have continued making waves within the legal community, particularly in the context of induced infringement claims and litigation strategies against…

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USPTO Director Vacates PTAB Decision, Reigniting Debate on Patent Interpretation and Limitations

In a recent development that could reshape legal precedents, USPTO Director Kathi Vidal vacated a PTAB decision on August 24, 2023. The case under scrutiny was Keysight Technologies, Inc. v. Centripetal Networks, Inc. The matter was then remanded for further proceedings. This case which is currently attracting the attention of legal experts across the globe…

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USPTO Ruling Challenges Doctrine of Foreign Equivalents in Trademark Cases

In a recent decision reached by the US Patent and Trademark Office’s (USPTO’S) Trademark Trial and Appeal Board, it was established that the application of the “doctrine of foreign equivalents” to trademarks is not an absolute rule. This could set a significant precedent for corporations nationwide dealing with patent and trademark issues. Specific cases involving…

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Purdue Pharma vs. Accord Healthcare: The Impact on Pharmaceutical Patent Battles and Industry Precedent

In the world of pharmaceutical law, new cases with intriguing developments and possible generational ramifications pop up quite frequently. One such instance is the ongoing Purdue Pharma L.P. v. Accord Healthcare Inc., a case that draws attention to the highly sensitive matter of patents related to OxyContin® (oxycodone HCl). Here is a closer look at…

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Judge Ellis Balances Rigorous Case Management and Patent Suit Venue Transfers: Implications for Future Lawsuits

In an interesting legal development, U.S. District Judge Thomas S. Ellis III recently denied a motion to strike new evidence from a reply brief; notably, he further granted a motion to transfer venue of the related patent suit from the Eastern District of Virginia (EDVA) to California. This specific case, Monarch Networking Solutions LLC v….

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