Bio/Pharma IPRs: Will Institution Rates Rise in Response to USPTO Initiatives?

Attorneys: Richard D. Kelly and Elissa Sanford
August 12, 2022

When it comes to IPR petitions filed in the Bio/Pharma space, USPTO data tells us that while Bio/Pharma petitions make up only 8% of the total petitions filed for the fiscal year of 2022 (through June 30, 2022), there is a high intuition rate for those Bio/Pharma petitions. According to USPTO statistics, 80% of the Bio/Pharma cases have been instituted so far this year.  Put differently, 59 of the 74 petitions reviewed were subsequently granted.<... Read more

FDA Stays Juul Ban, Announces Plan To Implement New Policies

Attorney: Elissa Sanford
July 7, 2022

On June 23, 2022, the FDA banned the sale of Juul’s tobacco-and menthol-flavored products. The agency’s reasoning was that Juul’s applications did not have sufficient toxicological evidence to support the marketing of the products as appropriate for protecting public health.  Juul has long since been on the FDA’s radar for past marketing practices including the marketing of their now-discontinued fruit or candy-like flavors, which were viewed as appealing to minors.  The company secured an emergency stay on June 24, asserting that the FDA did not fully consider its 125,000 page application which purportedly contained studies showing how the products expose users to lower levels of harmful toxins as compared to conventional cigarettes.  Juul also cited political pressure as the FDA’s motivation due to an “inappropriate” level of interference from Congress.<... Read more

ModernaTx, Inc. v. Arbutus Biopharma Corp.: Sublicense Not Enough to Show Standing

Attorney: Elissa Sanford
December 13, 2021

On Dec. 1, 2021, the Federal Circuit held that Moderna lacked standing in an appeal from a Patent Trial and Appeal Board (“PTAB”) decision against rival Arbutus where the PTAB determined U.S. Patent No. 9,364,435 (“the ’435 patent”) was not unpatentable as obvious.[1] The ’435 patent concerns vaccine delivery technology, particularly a lipid nanoparticle delivery system used to protect nucleic acids delivered to cells as utilized in vaccines including Moderna’s COVID-19 vaccine.<... Read more

New Legislation Supports Biosimilar Drugs, Clarifies Qualifications for Obtaining FDA Exclusivity

Attorney: Elissa Sanford
May 20, 2021

Recent litigation, including the Federal Circuit decision in Amgen v. Sanofi, has created concern among biologics manufacturers with regard to whether their existing intellectual property will remain protected, and whether they will be able to secure patents for future drugs. The uncertainty surrounding the patentability of biologics has led the industry to search for potential alternatives to patent protection. One such alternative could lead to pharmaceutical companies leaning on the exclusivity granted by the U.S. Food and Drug Administration ("FDA") as a way to avoid the patent route entirely. Where patents are a property right granted by the United States any time during the development of a drug, FDA exclusivity attaches upon approval of the drug and grants certain delays and prohibitions on the approval of competitor drugs. Biologics are covered by a considerably longer exclusivity period than other drug types, usually with 12 years total of market protection, as delineated by the Biologics Price Competition and Innovation Act ("BPCIA").... Read more