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

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?

Companies have been exploring the potential to use combinations of various checkpoint inhibitors to enhance the treatment of patients with various cancers. The recent approval by the U.S. Food and Drug Administration of Bristol Myers Squibb’s Opdualag™ for the treatment of patients with unresectable or metastatic melanoma shows that such combinations offer new avenues for patients suffering from cancer. Opdualag™, a fixed-dose combination of the antibodies nivolumab (a programmed death-1 inhibitor) and relatlimab (a lymphocyte activation gene-3 inhibitor) formulated as a single intravenous injection, showed improved results compared to nivolumab monotherapy.

These results are good news from a clinical perspective. They also provide good news from a patent protection perspective because
Continue Reading Antibody Combinations in Immunotherapy Offer New Opportunities for Innovators to Strengthen IP Protections

The CRISPR-Cas9 gene editing system has revolutionized genetic engineering. Over the last decade, this technology has exploded at a breathtaking pace due to its simplicity, scalability, affordability and adaptability. Currently, the CRISPR-Cas9 system is employed in molecular biology laboratories all around the world and has been used to edit the genomes of a myriad of organisms from bacteria to yeasts to plants to mammals. This is particularly true in the cancer immunotherapy sphere, where the CRISPR-Cas9 system has been successfully used to genetically enhance different cancer-killing properties of human immune cells. Pickar-Oliver and Gersbach, 2019, Nature Reviews Molecular Cell Biology 20(8), 490-507.

Considering the potential application of the CRISPR-Cas9 system in the immunotherapy space, it is helpful to stay abreast of developments concerning the patenting of this technology. While there are a plethora of patents and patent applications relating to CRISPR,
Continue Reading Talk in the Biotech Industry has Focused on the Broad Institute’s Big Win—But Will Continued Scientific Development Minimize Its Impact?

March 23, 2020 marked the tenth anniversary of the enactment of the Biologics Price Competition and Innovation Act (BPCIA), which provided the approval pathway for biosimilar products. While it was five years before the first biosimilar—Sandoz’s Zarxio—was introduced in the United States, we now have twenty-six approvals and seventeen biosimilars on the market. With the steep increase in biologic drugs, presently accounting for 50% of sales within the pharmaceutical market, the pace of biosimilar development and approvals is increasing. Indeed, we now have multiple biosimilars competing in the same categories (e.g., five biosimilars of cancer immunotherapy drug Herceptin and six of autoimmune treatment Humira) and this occurrence will certainly reoccur.

Since BPCIA enactment, there have been numerous litigations and post-grant reviews relating to the patent portfolios of reference product sponsors (RPS). These disputes have served to clarify
Continue Reading Ten Years Into the BPCIA—How Will Immunotherapy Biologics Fare?