In response to concerns about eroded public confidence in scientists and the alleged misuse of scientific information by federal agencies to justify political ends, President Trump’s “Restoring Gold Standard Science”...more
On January 27th, the Trump administration issued an order (the January 27th order) freezing all federal grants and loans, which would have cut billions of dollars of federal funding, largely to research universities....more
As an essential component of the drug development process, human clinical trials assist in determining whether a given drug will serve its intended purpose, but patent applicants should consider disclosure of such trials in...more
The Situation: The National Institutes of Health ("NIH") proposed a new policy requiring entities that receive licenses from the NIH to certain taxpayer-funded inventions to submit Access Plans for ensuring broader patient...more
Key Points - GLP-1 agonists have ushered in a new era in anti-obesity medication policy considerations against the backdrop of a continued focus by policymakers on both drug access and pricing. CMS has taken steps to clarify...more
In response to Biden Administration goals regarding increasing pharmaceutical competition and lowering drug prices, the USPTO recently released training provided to the USPTO examining corps on utilizing publicly available...more
In an appeal from the US Court of Federal Claims, the US Court of Appeals for the Federal Circuit affirmed a determination that 35 U.S.C. § 202(c)(4), a provision of the Bayh-Dole Act, operates to provide a license to the...more
The US Court of Appeals for the First Circuit affirmed the exclusion of a drug patent in a medical malpractice case, finding that the highly technical language of the patent would more likely confuse a lay jury than be...more
This week, the U.S. National Science Foundation (NSF) alongside public and private sector collaborators launched the National Artificial Intelligence Research Resource (NAIRR) pilot program. NAIRR seeks to advance AI...more
Under the University and Small Business Patent Procedures Act of 1980 (35 U.S.C. §§ 200-212), commonly referred to as the Bayh-Dole Act, the federal government can exercise “march-in” authority in certain circumstances to...more
In an attempt to rein in rising drug prices, the Biden administration unveiled a proposed framework of factors that federal agencies should consider when choosing whether to exercise so-called “march-in rights.” March-in...more
As retailers or distributors that are not manufacturers of a product, companies may believe they cannot infringe a patent claiming how the product is made. After all, the retailers or distributors are not performing any steps...more
In April of 2021, we provided a three-part series relating to the IP and Competitive Landscape for the mRNA market. In this post we provide a 2021 year in review update on mRNA pioneers and key players and offer additional...more
On August 4, 2020, a bipartisan coalition of over 30 attorneys general led by California Attorney General Xavier Becerra and Louisiana Attorney General Jeff Landry sent a letter request to United States Health and Human...more
As the COVID-19 pandemic spreads throughout the United States and Americans anxiously await the arrival of a vaccine, biotech companies are grappling with the uncertainty of patent protection for COVID related biomedical...more
Report on Research Compliance 17, no. 6 (June 2020) - A former assistant veterinary medicine professor at the University of Maryland will retract or correct seven papers published from 2013 to 2016 that contained reused or...more
A new infertility technique, mitochondrial replacement therapy (MRT), has been used to create so called “three-parent” babies. MRT is used in cases when mothers carry genes for mitochondrial diseases. Similar to in vitro...more
The U.S. Department of Justice (DOJ) filed six petitions for inter partes review (IPR) of three patents assigned to Discovery Patents, LLC. The patents cover security alarm systems and methods for providing secure real-time...more
In This Issue: - E&C continues to push for bipartisan efforts to improve drug pipeline - Implementation of the Affordable Care Act - Other Federal Regulatory Initiatives - Other Health Care News ...more
Last week, the National Institutes of Health denied a petition from a coalition of "public interest" groups who petitioned the agency to exercise so-called "march-in rights" under provisions of the Bayh-Dole Act against...more
In a July 12, 2013 letter to Dr. Francis S. Collins of the National Institutes of Health (“NIH”), Senator Patrick J. Leahy urged the NIH to exercise its march-in rights under the Bayh-Dole Act to directly license the genetic...more
On Friday, Sen. Patrick Leahy (D-VT) sent a letter to Dr. Francis Collins, the Director of the National Institutes of Health (NIH), "to urge [the Director] to consider using march-in rights under the Bayh-Dole Act to ensure...more
Good news for patients and stem cell researchers alike. On August 24th, the United States Courts of Appeals for the District of Columbia Circuit affirmed the District of Columbia court decision granting the government’s...more
Interested parties that can successfully navigate the evolving regulation of stem cell research stand to gain significant scientific and commercial advantage. Given that in the fall of 2011 the Court of Justice of the...more