December 19, 2023
IAM
In 2023, we saw cases with the potential to alter how life sciences companies big and small approach patent protection for their most important assets. It is not every year that the US Supreme Court hears a patent case and even more rare for it to decide an issue as critical for the life sciences as enablement.
Some have debated whether the Amgen v Sanofi decision materially changed the law or just reiterated a standard that has always applied, but either way the law has continued to develop with lower courts applying the Amgen test. The past year also saw the US Court of Appeals for the Federal Circuit address the obviousness-type double patenting doctrine, for the first time, providing guidance on how it may affect related patents with patent-term adjustment.
Subject matter eligibility, on the other hand, saw little development, despite the desire of many to see change in the patentability of diagnostic innovations.
In Amgen v Sanofi, the Supreme Court considered the enablement requirement. The claims at issue covered a class of antibodies defined by their function, and the fundamental question was whether Amgen’s patent description, which disclosed examples of antibodies performing the claimed function and methods for generating such antibodies, entitled Amgen to patent claims covering all antibodies having that function. The court found that it did not, commenting that “if a patent claims an entire class of processes, machines, manufactures, or compositions of matter, the patent’s specification must enable a person skilled in the art to make and use the entire class”.
In the wake of Amgen, defendants have raised enablement challenges for a variety of different types of claims. In Baxalta Inc v Genentech Inc, the Federal Circuit considered claims directed to an antibody that increases procoagulant activity. The court found the facts were “materially indistinguishable from those in Amgen” and invalidated the claims. On the other hand, Orexo v Sun involved an enablement challenge to a claim for a pharmaceutical composition with certain characteristics. There, the US District Court for the District of New Jersey found Amgen inapposite, noting that “Orexo does not seek to ‘monopolize an entire class of things defined by their function,’ rather Orexo’s invention is a narrow composition covering a sublingual tablet.”
Going forward, defendants can be expected to rely on the Amgen decision to challenge asserted patents, especially broadly drafted functional claims. Those seeking to protect inventions in the life sciences should monitor how the Amgen test is applied and employ prosecution strategies that account for the risk enablement challenges may pose.
Obviousness-type double patenting is a judicially created doctrine that may prevent a patentee “from obtaining an extension of the right to exclude through claims in a later patent that are not patentably distinct from claims in a commonly owned earlier patent”, ruled the Federal Circuit in 2001’s Eli Lilly & Co v Barr Laboratories Inc. This doctrine can have a significant impact on inventions in the life sciences, where the most valuable years of patent exclusivity may be at the end of the patent term.
In 2014, the Federal Circuit found in Gilead Sciences Inc v Natco Pharma that a later-issued but earlier-expiring patent from one patent family could qualify as an obviousness-type double patenting reference for an earlier issued, later-expiring patent in a second patent family, where the claims were nonobvious variants. In 2018 in Novartis AG v Ezra Ventures, the Federal Circuit declined to find that a statutorily authorised patent term extension would render a patent invalid under obviousness-type double patenting if the patent would otherwise be valid without the patent term extension.
But none of the previous Federal Circuit cases had addressed how obviousness-type double patenting would apply to patents of the same family that expired on different dates because of a patent term adjustment. That question was addressed in 2023 by In re Cellect.
In re Cellect involved a family of patents directed to devices with image sensors. Some of the patents in the family had over 700 days of patent term adjustment, whereas other patents in the family had no patent term adjustment at all. The Federal Circuit held: “While the expiration date used for an obviousness-type double patenting analysis where a patent has received patent term extension is the expiration date before the [patent term extension] has been added, the expiration date used for an obviousness-type double patenting analysis where a patent has received [patent term adjustment] is the expiration date after the [patent term adjustment] has been added.”
The Cellect patents with patent term adjustment were deemed invalid. Cellect has filed a petition for rehearing en banc. Recently, the District of Delaware applying Cellect found obviousness-type double patenting applied even where the patent receiving patent term adjustment was the first-filed and first-issued patent in the family, according to Allergan USA Inc v MSN Laboratories.
The Cellect decision’s impact on patents in the life sciences is potentially significant. It is important for those prosecuting such patents to be mindful of the potential impact of obviousness-type double patenting. Patent applicants should be careful when drafting claims that may be considered obvious variants of claims that have already issued, especially if the issued claims received patent term adjustment. Terminal disclaimers can be used in appropriate circumstances to address an obviousness-type double patenting issue, but doing so may result in shorter overall patent term.
Ever since the Supreme Court’s decisions in Alice and Mayo, lower courts have been grappling with subject matter eligibility. The Federal Circuit has commented that in some instances the Mayo test has the effect of excluding from patentability inventions that some would consider worthy of a patent. For example, see Ariosa Diagnostics Inc v Sequenom Inc. Not much changed for diagnostic patents in 2023.
In CareDx v Natera in 2022, the Federal Circuit applied its precedent in finding that three patents related to diagnosing or predicting organ transplant status were directed to ineligible subject matter because they were “directed to a natural law together with conventional steps to detect or quantify the manifestation of that law”. CareDx filed a petition for a writ of certiorari asking the Supreme Court to address the question of “whether a new and useful method for measuring a natural phenomenon, that improves upon prior methods for measuring that very same phenomenon, is eligible for patent protection under Section 101”.
The cert petition was denied in October, but with an indication that Justice Brett Kavanaugh would have granted it, perhaps giving hope to some that the justices might be willing to consider the issue in a future case. For now, those patenting inventions in the life sciences must deal with the law that has developed under the Alice and Mayo framework, which makes patenting certain types of inventions challenging.
Originally printed in IAM on December 19, 2023. This article is for informational purposes, is not intended to constitute legal advice, and may be considered advertising under applicable state laws. This article is only the opinion of the authors and is not attributable to Finnegan, Henderson, Farabow, Garrett & Dunner, LLP, or the firm’s clients.
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