Ryan T. Babcock

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The Federal Circuit has issued a unanimous precedential decision holding that a patent whose term was extended through Patent Term Adjustment (“PTA”) can be invalidated for obviousness-type double patenting (“ODP”), affirming the PTAB’s Ex Parte Cellect decision that we discussed in a previous post. The Court agreed with the PTAB that ODP should be assessed after PTA is applied to a patent, meaning that PTA does not protect a patent from ODP.Continue Reading Federal Circuit Invalidates Patent Term Adjustments for Obviousness-Type Double Patenting

IP rights offer innovators the exclusive right to exploit their innovations while recovering their expenditures, by providing IP owners with the ability to stop others from commercializing infringing products. During a public health crisis such as the COVID-19 pandemic, where time is of the essence, these competing interests rose to the forefront, as the patent community grappled with the question: how do we effectively balance respecting an owner’s IP rights with promoting the research and commercialization of life-saving vaccines in an expedited way? In the rush to develop COVID-19 vaccines, the patent community balanced these competing interests via patent pledges. However, in the face of other public health challenges even well before the COVID-19 pandemic, several alternative approaches were also proposed by others, including the pooling of Standard Essential Patents (SEPs).Continue Reading During a Public Health Emergency Should Patents Covering Vaccine Development Be Treated as Standard Essential Patents? (Part 2 of 2)

More than two years into the COVID-19 pandemic, we have a clearer picture of how the patent community responded to the rush to develop COVID-19 vaccines: patent pledges.  Patent pledges are voluntary, public commitments that a patent holder makes to refrain from exercising some or all of its patent rights, including suing for patent infringement.  Prior examples of patent pledges can be found in the automotive industry (e.g., electric vehicle makers Tesla and Toyota), the software industry (e.g., IBM and Google relating to open-source code), and in the biotechnology industry (e.g., Monsanto relating to genetically modified seeds and Myriad’s pledge not to assert its DNA patents against academic researchers).  In the midst of the COVID-19 pandemic, many patent holders pledged not to enforce patents needed for vaccine development, the frontline immunotherapy for combating COVID-19.  By April 2020, the Open COVID Pledge platform had been formed, allowing for the large-scale pledging not to enforce COVID-19 vaccine-related patents until the end of the pandemic, as declared by WHO, or January 1, 2023 (likely to be extended).Continue Reading During a Public Health Emergency Should Patents Covering Vaccine Development Be Treated as Standard Essential Patents? (Part 1 of 2)

In a warning to patent owners, a patent whose term had been extended through Patent Term Adjustment (“PTA”) was recently found invalid for obviousness-type double patenting (“ODP”) by the U.S. Patent Trial and Appeal Board (“PTAB”). Ex Parte Cellect Patent Owner and Appellant, Appeal No. 2021-00503, 2021 WL 5755329 (PTAB, Dec. 1, 2021). This is particularly concerning for makers of biopharmaceuticals, especially immunotherapeutic proteins and other biologic drugs. The duration of the patents protecting these drugs is critical to their value, and the terms of these patents are often extended by PTA. Moreover, effective lifecycle management strategies for immunotherapeutics typically involve developing broad, independent patent portfolios (often covering new or extended medical indications), increasing the risk of generating potentially invalidating ODP art.

Previously, several district courts have split on whether a PTA-based extension of patent term is vulnerable to ODP. In 2021, two New Jersey district court decisions found
Continue Reading Does the PTAB’s Recent Ex Parte Cellect Decision Signal Concern for the Valuable Patent Terms of Biopharmaceuticals?