Posts Tagged: "life sciences"

Regulatory Law in the Life Sciences and Agribusiness sector plays an essential role in balancing scientific innovation and the protection of public interests. In Brazil, a country recognized for its vast biodiversity and potential for scientific research, regulation in this field is crucial to ensuring responsible access to genetic resources and to address emerging issues, such as cannabis regulation. Before commercializing products in the Brazilian market, a company must be able to navigate a vast array of laws and regulations, especially in cases involving pharmaceuticals, seeds, pesticides, food or feed, cosmetics and medical devices. On top of that, when it comes to biotechnology related products involving genetically modified organisms (GMOs), or products derived from access to genetic resources or where traditional knowledge is associated, another layer of rules is applicable.

One of the panels at last year’s IPWatchdog’s Life Sciences MastersTM Series addressed the thorny problem of patent eligibility.  I moderated the panel, titled Patent Eligibility and the Life Sciences Industry–What Next?, where the speakers, with input from passionate audience members, discussed the impact of section 101 jurisprudence on innovation in the life sciences industry. Do the limits on what is patent-eligible subject matter created by the courts strike the proper balance or do unpredictable court decisions harm investment and research in the life sciences? While the majority view appeared to be that patent-eligibility reform is necessary, both to provide clarity and to incentivize certain type of inventions, the panel also expressed the idea that some form of section 101 jurisprudence is necessary to prevent “discoveries” from being monopolized, which could also harm innovation.

In our previous blog post, we covered claim construction, Markush Groups, and dependent claim invalidation. As stated previously, while it is impossible to cover all of the various issues related to claim drafting for biotech, chemical and pharma patent applications, in Part II we will highlight some more of the most common issues that may come up, including changes to the law around indefiniteness; product-by-process and means plus function claims; and negative claim limitations.

The fields of patent prosecution and patent litigation are ever-evolving, and with every new court decision there are lessons for patent practitioners. While it is impossible to cover all of the various issues related to claim drafting for biotech, chemical and pharma patent applications, here, and in future blog posts, we will cover a range of claim drafting topics of interest.

During IPWatchdog’s Life Sciences Masters 2022 today, Retired Chief Judge of the U.S. Court of Appeals for the Federal Circuit (CAFC) Paul Michel said a lot could be fixed by the CAFC itself with respect to patent eligibility law if it would just go en banc more often. “By my recollection the Federal Circuit hasn’t gone en banc on a major patent case in a decade,” Michel said. “And yet, all CAFC judges are on record saying that 101 law is a total mess and needs to be fixed.” Michel was speaking on a panel moderated by Laura Smalley of program sponsor, Harris Beach, and including Mike Cottler of biosimilars company Alvotech and Tom Stoll of Genentech. The panelists were discussing the effect of U.S. patent eligibility law on the life sciences industry, including the potential impact of current efforts to reform patent eligibility law, such as Senator Thom Tillis’ (R-NC) Patent Eligibility Restoration Act. While Michel said he believes it’s ultimately Congress’ job to make the kind of policy judgments the Supreme Court and Federal Circuit have been making in this sphere, there is still a lot more the Federal Circuit could be doing to help the situation

The Federal Circuit’s denial of en banc rehearing and the Supreme Court’s denial of certiorari review mean the decision in American Axle & Manufacturing, Inc. v. Neapco Holdings LLC, 967 F.3d 1285 (Fed. Cir. 2020), is the latest word on subject-matter eligibility under 35 U.S.C. § 101. In American Axle, the Federal Circuit applied the Supreme Court’s two-part Alice/Mayo test to hold a method for manufacturing driveline propeller shafts with liners designed to attenuate vibrations invalid as directed to a use of a natural law. The Federal Circuit characterized the claims as simply “[c]laiming a result” without “limiting the claim to particular methods of achieving the result. . . .”  Id. at 1295. The method claims were directed to nonpatentable subject matter because, even though neither the claims nor the specification explicitly referenced a natural law, the method steps required the application of a natural law, “and nothing more.”  Id. at 1297. Although the panel in American Axle stressed its decision was consistent with Supreme Court and Federal Circuit precedent, see 967 F.3d 1295, 1296 (“Our cases as well have consistently rejected such claims as unpatentable.”), its rationale, literally applied, jeopardizes broad categories of patent claims that have traditionally been considered patent-eligible subject matter.

Patent claims define the boundaries of an invention and are meant to state with clarity what the patent protects. Having clearly constructed claims also proves valuable during infringement assertions. These well-known guidelines should be at the forefront of the patent practitioner’s mind when drafting solid-form claims. Patent attorneys practicing in the chemical arts use two primary methods of claiming chemical compounds. The first method relies on chemical nomenclature to describe a claimed chemical compound. Take for example, the drug Wakix® (U.S. Patent No. 7,169,928), in which the active ingredient, pitolisant, is claimed to reference its chemical name without drawing a corresponding structure. The second method claims the drawn chemical structure of a compound. Of course, there are intermediate ways to claim chemical compounds where both names and structure are used to define the scope — especially with genus and sub-genus claims.

The written description requirement is really the backbone of the quid pro quo between the public and the patent applicant. In exchange for information about an invention, society is willing to grant the applicant a patent, which conveys exclusive rights for a limited period of time to what is claimed, not described. But the description provided in the specification must demonstration that the applicant really has an invention in the first place and what the boundaries of that invention are—this is the written description requirement in lay terms.

Moderna has sued Pfizer and BioNTech over the mRNA vaccine patents behind the COVID-19 vaccines. Moderna is not seeking to remove Comirnaty® from the market and is not asking for an injunction to prevent future sale, nor damages related to Pfizer’s sales for any COVID-19 vaccine used in 92 low- and middle-income countries. Moderna is represented by Wilmer Cutler Pickering Hale and Dorr. The patents asserted in the complaint filed in the District of Massachusetts are: U.S. Patent Nos. 10,898,574 (the “’574 patent”), 10,702,600 (the “’600 patent”), and 10,933,127 (the “’127 patent”).

The life sciences are currently facing at least two major plagues in our patent world. The first is that many life science innovations have been deemed ineligible in terms of patentable subject matter. In other words, the courts and the patent office believe that the patent laws are not meant to protect these innovations. The second plague is that the courts believe that many life science patents are not enabled. In other words, they are not described in sufficient detail to enable one of skill in the art to make and use the invention.

On the final day of IPWatchdog LIVE last week, a panel titled “Jurassic Patents: Genetic Engineering and the Future of Life Science Innovation,” moderated by president and CEO of the PCT learning center and founding partner of Berenato & White, John White, examined the challenges of patenting discoveries in the life sciences in light of recent legal developments. The panel included patent litigator and partner at Akin Gump, Dr. Rachel Elsby, patent prosecutor and shareholder with Volpe Koenig, Dr. Douglas Bucklin, and food and drug lawyer and counsel at McGuire Woods, Kae Gruner.

There is a quid pro quo under the U.S. patent laws. In exchange for disclosing her invention, an inventor receives a limited monopoly. Recent developments, however, have made it harder for those in the biotechnology industry to obtain the benefit of this bargain. The written description requirement mandates that a patent specification convey to one of skill in the art that the inventors had possession of their invention as of the day they filed their patent application. Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010). Over the last decade, three areas have proven troublesome in the life sciences.

Artificial intelligence (AI) is a rapidly growing sector of the life sciences industry, with broad-ranging applications in drug discovery, biotechnology, medical diagnosis, clinical trials, precision and personalized medicine and patient monitoring. The recent uptick of AI use in this industry is likely due to the increasing availability of “big data.” AI technologies including machine learning, deep learning, and natural language processing can be harnessed to process vast data sets to identify new drug candidates, optimize drug dosing, match patients with drug trials and diagnose diseases. Recognizing this potential, global biopharma companies have invested heavily in AI technology—the AI in life sciences market was valued at USD 1092.44 million in 2019 and is expected to reach USD 3445.60 million by 2025.