Posts Tagged: "Antibodies"

An antibody can take various forms, including the following: a monoclonal, polyclonal, mouse, human, humanized, monospecific, bispecific, glycosylated (sugar chain-modified), Fc-modified, or ADC (antibody-drug conjugate) antibody; an antibody fragment (e.g., Fab, scFv, diabody, sdAb, tandem scFv); or an antibody of different class or subclass (e.g., IgG (e.g., IgG1, IgG2, IgG3, IgG4), IgM, IgE, IgA). If claim 1 recites an “antibody”, whether or not the antibody includes each of the above forms can be an issue in an infringement lawsuit. In Baxalta Inc. v. Genentech, Inc. (Fed. Cir. 2020), Baxalta alleged that Genentech’s Hemlibra® (emicizumb-kxwh) product infringed its U.S. Patent No. 7,033,590 (’590 patent). In this lawsuit, the issue was whether or not the “antibody or antibody fragment thereof” in claim 1 of the ‘590 patent should comprise a bispecific antibody (the form of Hemlibra).

Allele Biotechnology and Pharmaceuticals, Inc. (Allele) has accused Regeneron Pharmaceuticals, Inc. (Regeneron); Pfizer, Inc. (Pfizer); and BioNTech SE and BioNTech US, Inc. (collectively BioNTech) for allegedly infringing U.S. Patent No. 10,221,221 (the ’221 patent), which is directed to an artificial flourescent, i.e. mNeonGreen, used for testing COVID-19 assays against vaccine candidates.  Allele argues that Regeneron, Pfizer and BioNTech have been infringing the ‘221 patent by taking mNeonGreen “for their own unauthorized commercial testing and development.” Regeneron has been in the news lately for famously providing the “antibody cocktail” given to President Donald Trump shortly after he tested positive for COVID-19 last week. The cocktail is name in the complaint as one of the allegedly infringing technologies.

The U.S. Supreme Court’s 2013 ruling in Association for Molecular Pathology v. Myriad Genetics changed the landscape of what is considered patentable material in the context of genetic inventions. In the five years since Myriad, companies have pushed the boundaries of patenting certain types of genetic materials. Despite Myriad’s express statement that it was not considering “the patentability of DNA in which the order of the naturally occurring nucleotides has been altered,” the courts have not yet established the contours of how much nucleotide sequences need to be altered in order to “create something new” in order to be patentable. However, as we discuss in the next section, we expect the Court to address these questions as biotechnology companies increasingly invest resources into emerging, expensive technologies involving genes and seek to protect their investments through patents.

As the pharmaceutical industry continues to shift toward biologic-based drugs, including monoclonal antibodies, protecting the underlying technology has been and continues to be a priority for companies. As with any drug, patenting therapeutic monoclonal antibodies as early as possible in the drug development process is crucial to protect the underlying invention. In the early days of antibody discovery for therapeutic development, protection could be obtained with minimal disclosure of the actual antibody. But as the art and case law have evolved, companies now need far more data to obtain the broadest scope of protection. For that reason, it has become more of a challenge to determine the best time to file with the U.S. Patent and Trademark Office (USPTO). After the America Invents Act (AIA), it is a race to the USPTO to be the first to claim your invention, but you may lack the requisite data to enable you to obtain patent protection in the end.

The Amgen v. Sanofi decision put most functional antibody claims into question, including epitope and competitive binding claims, as well as antibody claims based on a newly characterized antigen. After Amgen v. Sanofi, non-sequence based antibody claims may become more difficult to obtain before the USPTO from a written description standpoint.  Yet, to fully protect the essence of the invention and avoid design-arounds, such claims are extremely valuable to patent owners. To obtain antibody genus claims beyond those defined by sequences, the patent applicant will need to make and test a sufficient number of representative antibodies across the claimed genus, or establish a clear structure/function relationship among the members of the genus.  Patent applicants should carefully assess the amount of data they have acquired, in comparison to the scope of claims that they wish to obtain, before rushing to the Patent Office.

The memorandum points to Amgen for stating that the “newly characterized antigen” test could not stand because it contradicted the quid pro quo of the patent system whereby in order to obtain a patent one must describe an invention (the antibody, not the antigen recognized by the antibody). The memorandum states that in view of Amgen, “adequate written description of a newly characterized antigen alone should not be considered adequate written description of a claimed antibody to that newly characterized antigen, even when preparation of such an antibody is routine and conventional.”

This article analyzes obviousness issues related to antibody patents at the Patent Trials and Appeal Board (PTAB) and in federal courts. We review several cases categorized by type of claims in search of trends on what types of antibody-related claims are more likely to survive an obviousness challenge… These cases are highly fact-specific, but a few broad observations may be made. To our knowledge, no claims directed to an antibody claimed purely by structure have been challenged, except for those of an ADC (KADCYLA®), where both the antibody part and the drug part of the conjugate were previously known. An antibody broadly claimed by function may be considered obvious “[i]f any one method of achieving any single embodiment [of such claim] would have caused a person of ordinary skill in the art to anticipate success.” Abbott GMBH, 971 F. Supp.2d at 186. Objective indicia of nonobviousness have been helpful, but only where there was a clear nexus between the objective evidence and the claims.