Posts Tagged: "biotechnology"

Review Not Warranted: SG Tells SCOTUS to Scrap Amgen’s Case on Enablement Test for Biotech Patents

The United States Solicitor General (SG) on Wednesday accepted the U.S. Supreme Court’s invitation to file an amicus brief regarding Amgen’s petition for certiorari in its case against Sanofi. Amgen is seeking review of the U.S. Court of Appeals for the Federal Circuit’s (CAFC’s) decision invalidating antibody patent claims based on a lack of enablement for genus claims. The High Court invited the SG to file a brief in April and, on September 21, the SG recommended that the Court deny the petition and said Amgen’s argument that the CAFC “erred by treating enablement as a question of law and by examining the full scope of the claims in assessing whether they are fully enabled…. lack merit.”

Waiving IP Rights During Times of COVID: A ‘False Good Idea’

Over the course of four months, close to 850 million doses of COVID-19 vaccines have been administered in over 100 countries. To the extent the unprecedented pace of research, development and manufacturing to combat the ongoing pandemic is a success, it has many fathers. But it would not have been possible without the participation of the U.S. biopharmaceutical industry and its collaboration with global partners. To ensure that developed and developing countries around the globe maintain and expand access to safe and effective COVID-19 vaccines, therapeutics and diagnostics, it is critical that the U.S. government support ongoing industry collaboration and oppose well-intentioned but counterproductive efforts to waive intellectual property (IP) rights.

Future Visioning the Role of CRISPR Gene Editing: Navigating Law and Ethics to Regenerate Health and Cure Disease

As society adjusts to a new world of social distance and remote everything, rapid advancements in the digital, physical, and biological spheres are accelerating fundamental changes to the way we live, work, and relate to one another. What Klaus Schwab prophesized in his 2015 book, The Fourth Industrial Revolution, is playing out before our very eyes. Quantum computing power, a network architecture that is moving function closer to the edge of our interconnected devices, bandwidth speeds of 5G and beyond, natural language processing, artificial intelligence, and machine learning are all working together to accelerate innovation in fundamental ways. Given the global pandemic, in the biological sphere, government industrial policy drives the public sector to work hand-in-glove with private industry and academia to develop new therapies and vaccines to treat and prevent COVID-19 and other lethal diseases. This post will envision the future of gene editing technologies and the legal and ethical challenges that could imperil their mission of saving lives.

Regeneron, Pfizer and BioNTech Accused of Infringing Allele Patent in Connection with COVID-19 Technologies

Allele Biotechnology and Pharmaceuticals, Inc. (Allele) has accused Regeneron Pharmaceuticals, Inc. (Regeneron); Pfizer, Inc. (Pfizer); and BioNTech SE and BioNTech US, Inc. (collectively BioNTech) for allegedly infringing U.S. Patent No. 10,221,221 (the ’221 patent), which is directed to an artificial flourescent, i.e. mNeonGreen, used for testing COVID-19 assays against vaccine candidates.  Allele argues that Regeneron, Pfizer and BioNTech have been infringing the ‘221 patent by taking mNeonGreen “for their own unauthorized commercial testing and development.” Regeneron has been in the news lately for famously providing the “antibody cocktail” given to President Donald Trump shortly after he tested positive for COVID-19 last week. The cocktail is name in the complaint as one of the allegedly infringing technologies.

The Future of Patents on Genetically Modified Organisms in India

Earlier this year, the Supreme Court of India set aside an order of the division bench of the Delhi High Court that revoked a patent granted on genetically modified cotton, holding that the single bench of the High Court should assess the patentability of the invention after hearing arguments from both sides. The Indian Patent Office granted Patent No. 214436 to Monsanto Technology LLP on genetically modified cotton. In 2016, Monsanto filed a suit before the single judge bench of the Delhi High Court [Civil Suit (Comm) No. 132 of 2016] alleging infringement by Nuziveedu Seeds Ltd., which responded with a counterclaim for invalidity of the patent, among other claims. The single judge ruled in favor of the petitioner and granted an injunction. On appeal, the division bench of the Delhi High Court vacated the injunction and invalidated the patent. That decision was set aside by the Supreme Court, which held that the matter at hand was the injunction and that patentability issues must be dealt with separately by the High Court. This suggests a changing mindset by the Indian courts regarding patentability of genetically modified living organisms. India may now be set to join the league of various other nations that respect biotechnological inventions.