Biotechnology & Life Sciences

Eye on Biotech

Through the rise of biosimilars, the evolution of patent eligibility (Section 101), and the advent of hedge-fund challenges to pharma patents, Marshall Gerstein keeps a watchful eye on PTAB developments in the world of biotechnology and life sciences. Follow this industry-focused section of our blog to stay informed on post-grant proceedings and the related issues that matter most to your business.

Recent Blog Posts

• Patent Interferences May Not Involve Pure AIA Patent The Patent Office is not supposed to issue separate patents for the same invention to competing inventors. Several statutory provisions empower the Office to reject pre-AIA patent application claims of the later inventor. But sometimes it’s not clear who is the later inventor. Those provisions are therefore unhelpful. So, the Patent Trial and Appeal Board administers an increasingly rare proceeding called an “interference” to assesses which inventor was the last to invent. Through this proceeding, the Office cancels as unpatentable... More
• The Headaches in Claiming Antibody-based Inventions Broadly Recent Federal Circuit decisions call into question the value of patents broadly claiming inventions on antibodies and their function in treating debilitating diseases. The decisions in these cases originated in district courts and arguably swept aside the merits of scientific breakthroughs because the inventions claimed were not enabled or were otherwise insufficiently described to justify their broad breadth.* In Teva Pharmaceuticals Int’l GmbH v. Eli Lilly and Company, Appeals 2020-1747, -1748, and -1750 (Fed. Cir. Aug. 16, 2021), the Federal... More
• Section 101 Challenges are Out of Bounds in IPR Appeals Neptune Generics v. Eli Lilly & Company, Case No. 2018-1257, 2018-1258 (Fed. Cir. April, 2019), concerns an Eli Lilly & Co. patent protecting method of administering folic acid and a methylmalonic acid (MMA) lowering agent, e.g., vitamin B12. Specifically, the method concerns the administration of these products before administering pemetrexed disodium, an anti-folate chemotherapeutic, to reduce toxic effects of the anti-folate. Pemetrexed disrupts metabolic pathways for vital enzymes for making components of DNA and RNA, thereby resulting in cell growth... More
• What Qualifies As Prior Art? This blog has previously reported on several PTAB and Federal Circuit decisions concerning what does and does not qualify as prior art: See here for an example of where the PTAB concluded that a product catalog was not publicly accessible because the relevant tradeshow was not announced to the public, but where the CAFC found that the catalog was prior art; See here for an example of where the PTAB concluded that a tradeshow catalog qualified as prior art because the catalog... More
• Play the Claim Monsanto Technology LLC v. E.I. DuPont de Nemours & Co. Appeal 2017-1032 (Fed. Cir. Jan. 5, 2018), illustrates “[t]he life of a patent solicitor has always been a hard one.” [1] The case concerns an inter partes reexamination of a Monsanto patent in which the Patent Office concluded the claimed subject matter was inherently described in an earlier DuPont patent. The Patent Office reached this conclusion because DuPont presented during the reexamination its unpublished data regarding experiments described in its earlier patent.... More
• Rituxan Patent Spared by Failure to Establish Product Label as “Printed Publication” A patent relating to a method of treating rheumatoid arthritis using rituximab recently survived its fourth IPR challenge. Celltrion, Inc. v. Biogen, Inc., IPR2016-01614 (PTAB Feb. 21, 2018). The PTAB determined that the Petitioners failed to establish that the challenged claims of the patent were obvious over prior art, in part, because of the Petitioners’ failure to establish the prior art status of the product label for RITUXIN®, which contains rituximab. Petitioners bears the burden of establishing that a printed... More
• Petitioner Failed to Show That Patent Owner’s Drug Product Package Insert Was a Printed Publication On February 9, 2018, the PTAB denied Sandoz Inc.’s petition for inter partes review of U.S. Patent No. 9,512,216, a patent owned by AbbVie Biotechnology Ltd. The patent recites methods for treating moderate-to-severe chronic plaque psoriasis with adalimumab, a human anti-tumor necrosis factor α (TNFα) antibody.  The methods of the claimed invention involve subcutaneously administering to a patient an initial dose of 80 mg of adalimumab, followed by 40 mg of adalimumab every other week starting one week after the... More
• CAFC Hears IPR Appeal From Parties That Were Time-Barred From Filing Petition Research Corporation Technologies, Inc. (RCT) sued Mylan Pharmaceuticals, Inc. (Mylan), Breckenridge Pharmaceutical, Inc. (Breckinridge), and Alembic Pharmaceuticals Ltd. (Alembic), in federal district court, accusing them of infringing United States Reissued Patent No. RE38,551. The patent claims pharmaceutical compositions useful in the treatment of epilepsy and other central nervous system disorders. Within one year of being served with the infringement complaint, Breckenridge alone petitioned the PTAB to institute inter partes review of the patent, but the PTAB denied the petition on... More
• PTAB Not Always Bound By Previous Court Decisions Regarding Patent Validity In Novartis AG v. Noven Pharm. Inc., Appeal 2016-1678-1679 (April 2017), Novartis appealed two PTAB decisions holding claims of two patents obvious over cited prior art (IPR2014-00549 and IPR2014-00550), arguing that previous judicial holdings of non-obviousness should control the PTAB’s factual findings and that the claims should have been held non-obvious. The two Novartis patents at issue (U.S. Patent Nos. 6,316,023 and 6,335,031) were from the same patent family and are directed to a pharmaceutical composition comprising rivastigmine (Exelon®) and an... More
• Eli Lilly’s Pemetrexed Therapy Claims Survive Challenge At PTAB The Federal Circuit’s decision in Eli Lilly & Co. v. Teva Parenteral Medicines, Inc., 845 F.3d 1357 (Fed. Cir. 2017) attracted much attention for applying the theory of divided infringement in the context of pharmaceutical therapeutic regimen claims.  Before the Federal Circuit decision, a scrum of petitioners successfully petitioned for IPR of the Lilly patent, alleging that the claims were obvious in view of a combination of references that included prior art considered by the court in the litigation. Our... More