The FDA’s Center for Biologics Evaluation and Research (CBER), a unit responsible for regulating cell and gene therapies in the ever-evolving biotech sector, is currently on the brink of significant transformation. This change is anticipated across several fronts – leadership, significant growth, and new measures to tackle complex scientific and regulatory issues. CBER maintains a…
In a recent Federal Circuit ruling, Baxalta Inc. v. Genentech, Inc., ongoing debates about patent rights and the ways U.S. patent law applies continue to evolve. This application is centered on preventing innovators from acquiring patent rights that extend beyond the bare minimum they may be entitled to. Let’s explore this further. The specifics of…
In the recent ruling of Baxalta Inc. v. Genentech, Inc, the Federal Circuit affirmed the District of Delaware’s grant of summary judgment regarding the lack of enablement for broad antibody claims. This judgement upheld the Supreme Court’s precedent set in Amgen Inc. v. Sanofi, maintaining that antibody claims that specify functionality rather than structure lack…
Recently, in a case involving Sandoz Inc. vs Acerta Pharma B.V. (IPR2023-00478), the Patent Trial and Appeal Board (“PTAB”) found itself denying IPR institution where the asserted prior art was labelled as cumulative of that considered during prosecution. This ruling is drawing attention from legal professionals and corporations alike, in light of its precedent-setting nature….
In a new development that may resonate with many legal professionals, the U.S. Court of Appeals for the Federal Circuit (“Federal Circuit”) has issued a precedential decision clarifying the law on comparison prior art in design patent cases. The decision emerged from the case of Columbia Sportswear North America, Inc. v. Seirus Innovative Accessories, Inc.,…
Professional dignity and judicial prestige establish the tone at the Bench and Bar Conferences, making them profoundly insightful experiences for attending litigators. The 2023 Bench and Bar Conference held by the Delaware Chapter of the Federal Bar Association was no exception. On the first day, I was privy to two panel discussions, including a resourceful…
In an ever-evolving field like Artificial Intelligence (AI) law, keeping up with the latest developments can feel like a titanic task. Enter a new article on JDSupra, highlighting some recent key points. This news marks another valuable addition to the discourse on AI patents and legislation. The pace at which AI technology is advancing demands…
In a recent shift in stance towards psychedelics, Western U.S. states, notably Hawaii and California, are leading the way. They are progressing towards expanding legal, or at the very least, decriminalizing the access to these substances, offering a striking contrast to their previous more conservative images. While the trend of decriminalization and legalization of psychedelics…
The Unified Patent Court’s (UPC) Local Division Munich has begun making its mark in the business sphere, having recently granted a preliminary injunction in favor of 10x Genomics. This decisive move stops NanoString Technologies, Inc. in its tracks — they are now prohibited from selling their CosMx Spatial Molecular Imager (SMI) instruments and CosMx reagents…
In a recent announcement, the director of the U.S. Patent and Trademark Office (USPTO) has suggested that federal administrative judges should avoid presiding over patent and trademark disputes where they or their family members have a financial interest in one of the parties involved in the case. Handling conflicts of interest such as these could…
In an unexpected decision, the Director of the U.S. Patent and Trademark Office (USPTO) has recently vacated a denial of institution from the Patent Trial and Appeal Board (PTAB), as the decision contradicted Federal Circuit precedent on anticipation and written description for a method of treatment patent. According to a report on JD Supra, a…
On June 1, 2023, a new chapter in European patent law began with the inauguration of the European Unified Patent Court (UPC). With a territory covering 17 member states, this novel framework allows enforcement of European patents in these states through one consolidated action. Providing a much-needed simplification and unification of the patent system, the…
One of the critical questions being deliberated in legal and technocratic circles pertains to the intriguing intersection of artificial intelligence and intellectual property rights. Consider for instance, who should be granted the patent when an AI is the inventor? The question assumes increased relevance today as AI’s footprint expands into diverse areas, such as pharmaceuticals….
In a recent case, Elekta Limited vs Zap Surgical Systems, Inc., a renewed emphasis was placed on the role that prosecution history plays in supporting motivation to combine. This case and its outcome provide valuable insight into the interplay between patent prosecution and litigation. Details of the case show that the Patentee’s failure during prosecution…
On September 18, in a pair of identical opinions against Google and Apple, Eastern Virginia District Judge Michael Nachmanoff ruled that four patents related to geolocation of mobile devices are invalid under 35 U.S.C. § 101. The defendant in each case was Geoscope Technologies PTE, LTD. The cases are listed as Geoscope Technologies PTE, LTD….
The Federal Trade Commission (FTC), with the endorsement of the Food and Drug Administration (FDA), recently took a significant action that reflects their collective intent to aggressively police the pharmaceutical industry. On September 14, the FTC announced its intent to “scrutinize improper Orange Book listings” as part of its strategy to identify possible infringements of…
In a recent ruling, the Court of Appeals for the Federal Circuit overturned a final written decision by the Patent Trial and Appeal Board (“PTAB”) that Apple Inc. had failed to meet its burden of proving unpatentability. The original judgment was due to an alleged error in Apple’s expert declaration in a case against Corephotonics,…
In a noteworthy verdict, the U.S. Court of Appeals for the District of Columbia Circuit confirmed the dismissal of an antitrust suit on August 25, 2023. The lawsuit, initially brought by the Federal Trade Commission (FTC), was against Endo Pharmaceuticals’ exclusive patent license for its drug, Opana ER – an extended-release version of oxymorphone –…
In a recent decision, the Federal Circuit emphasized the preliminary nature of guidance in patentability cases, asserting that the Patent Trial and Appeal Board (PTAB) retains the discretion to change its stance in its Final Written Decision (FWD). This is a stance that can significantly impact parties involved in PTAB proceedings, namely, those who adjusted…
In a recent case concerning the Patent Trial & Appeal Board’s application of the field of endeavor and reasonably pertinent tests for determining analogous art, the US Court of Appeals for the Federal Circuit provided valuable clarity The Court ruled that the Board should not have required a petitioner to precisely articulate the relevant field…
In the increasingly critical field of vaccine patent litigation, there have been significant developments between biopharmaceutical companies Alnylam and Moderna. This article serves as an update on these recent proceedings, central to which is the mRNA vaccine producer, Moderna, currently under the spotlight amidst the overarching global health crisis. As previously reported, this litigation is…
Recently, the Federal Circuit Court has significantly influenced the discourse surrounding patent infringement and design protection, particularly regarding the weight of analogous art used in infringement analysis. In a precedent setting opinion, Netflix, Inc. v. DIVX, LLC, the Court engaged in a critical review of the prior board’s findings, which has far-reaching implications for how…
Maintaining a robust patent estate is a critical task for many corporations, particularly those operating in innovative fields. In the biotech industry, this task becomes particularly paramount due to the highly competitive nature of the environment and the significant investments often required for research and development. Emerging biotech companies often face a myriad of challenges…
The advent of generative artificial intelligence (GenAI) has set the stage for fascinating debates surrounding patent law. GenAI has been in the limelight for the better part of 2023, highlighting the technology’s potential to reshape the economic landscape through its ability to introduce remarkable efficiencies in business operations and, concurrently, disrupt job markets. Interestingly, GenAI’s…
In a recent development, Voxer, a communication technology company, was awarded partial deposition costs by a judge in a patent infringement lawsuit against Meta, the parent company of Facebook. This follows the history-making judgement last September where an Austin, Texas jury awarded Voxer nearly $175 million in damages. The judgement was monumental, closing a chapter…