Use of § 112(a) rejections on antibody patents

Use of § 112(a) rejections on antibody patents

By Katy Pearson

A patent property right gives the patentee the “right to exclude others from making, using, selling, offering for sale, and importing the invention into the country [for a statutory period of time].”[1] The quid pro quo for a private right to exclusion is that the patentee provides “a clear and enabling disclosure” of the invention to the public “for the benefit of society.”[2]

An essential part of a patentee’s disclosure is the specification in the patent application. 35 U.S.C. § 112(a) sets forth that “[t]he specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains…to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention”[3] (A “person having ordinary skill in the art” or a “person skilled in the art” will here on out be referred to as a “PHOSITA”). This statute has been interpreted by the courts to mean that (1) written description and (2) enablement are, “two separate requirements that valid patents must fulfill,” to satisfy the specification of a patent application.[4] Though the statute does not clarify what the extent of “to make and use the same” shall entail for the PHOSITA, it has been interpreted by the courts to require that the claimed invention be enabled so that any PHOSITA can make and use the invention without “undue experimentation.”[5] The specification must also “set forth the best mode contemplated by the inventor of carrying out the invention.”[6]

In 1988, the court in In re Wands ruled that the enablement requirement was the primary method for determining adequate disclosure in a patent application.[7] The Wands court outlined eight factors for an adequate disclosure determination[8]:

(1) the breadth of the claims;

(2) the nature of the invention;

(3) the state of the prior art;

(4) the level of one of ordinary skill;

(5) the level of predictability in the art;

(6) the amount of direction provided by the inventor;

(7) the existence of working examples;

(8) the quantity of experimentation needed to make or use the invention based on the content of the disclosure.

In 1997[9], the Federal Circuit extended the scope of the written description requirement in an attempt to capture what the Wands factors failed to address in assessing adequate disclosure in complex and emerging fields of technology.[10] The Wands factors consider “the predictability of the relevant art, [they do not] enumerate specific criteria for determining adequate disclosure in unpredictable arts.”[11] The Federal circuit was concerned that, “patents granted in unpredictable fields such as biotechnology may include overbroad claims that exceed the scope of what was known at the time the patent application was filed.”[12] In order to narrow the scope of claims for the unpredictable arts, the Federal Circuit revised their analysis for adequate disclosure to include written description in addition to the test for enablement.[13] As a result, the trajectory of antibody patents in particular “has dramatically shifted.”[14] Previously, “antibody patents were granted broad genus-type protection.”[15] From the early 2000s to present, “antibody patents [have come to] usually cover narrow specific antibodies that have well defined structures.”[16]

The 1997 precedent was initially circumvented for antibody patents by the USPTO’s doctrine referred to as the, “antibody exception.”[17] This exception allowed applicants to claim an antibody “without describing what the antibody really was,”[18] essentially without relying on the written description to satisfy the disclosure requirement. In 2011, Centocor Ortho Biotech, Inc. v. Abbott Laboratories narrowed the antibody exception.[19] The court invalidated the patent for lack of written description, finding that a “description of how to make one type of antibody…did not support a claim to make another type…[the written description] claimed more than it described.”[20] This resulted in patent applications having to describe, “examples of the specific types of antibodies they were claiming.”[21] In 2017, Amgen v. Sanofi[22], the court ruled that, “in order to obtain broad patent coverage for a class of antibodies that bind to a particular antigen and perform a particular function, companies must disclose a sufficient number of representative antibodies across the claimed genus or establish a clear relationship between the function of the antibody and the genus of the antibody in their specification.”[23]

So….What does this mean?

First, many patent scholars are concerned that a 112(a) analysis can be used and is used in a “discretionary fashion by courts or juries to invalidate almost any patent claim” by narrowing the scope of claimed inventions.[24] Second, research has found that antibody patents in particular face “many more 112(a) rejections compared to similar technology.”[25] For all other similar technologies, 35 U.S.C. § 102 (novelty) and 35 U.S.C. § 103 (non-obviousness) “are the primary [statutory] mechanisms that examiners use to reject subject-matter eligible patents and also the primary mechanism that courts use to invalidate patents.”[26]

The narrowing of antibody patent claims may not be solely due to the narrowing of written description readings. One research team argues that the broad scope of antibody patent claims during early antibody development was logical because antibodies’ primary use at the time was as research or diagnostic tools.[27] They found that antibody patent rejections based on § 112(a) began in 2006, when antibody patents became used more frequently in therapeutics as biotechnology developed further, and as a result the patents required more specific claiming.[28] Patent examiners began these more stringent § 112(a) rejections before PTO official guidelines or the courts had required them to do so for antibody patents, likely a reflection of their own understanding of the trajectory of the science.[29]

So….Why does this matter?

This is the point where all of this may seem solely for the sake of a reflexive exercise in patent theory. However, there are resounding real-world factors that need to be considered when debating the efficacy of patent theories.

The 1997 court in In re Wands had a legitimate concern about overbroad claims in the unpredictable arts, and antibodies specifically.[30] Antibodies are a multi-billion-dollar business. The antibodies market has an annual value of $145 billion.[31] Six of the bestselling antibody therapies in the United States generate a total of roughly $75 billion of revenue per year.[32] Antibodies used for research tools or diagnostics respectively generate $3.4 billion and $23 billion per year.[33] The top six antibody therapies alone (not all antibody therapies) are worth almost three times as much as antibody research tools and diagnostics combined – perhaps the tightening of the § 112(a) requirement seen throughout the late 1990s to present day is a responsible reflection of the patent and market trend towards therapeutics and towards significantly higher profits.

Patent no. US-20220356229-A1.

In February 2022 the U.S. Department of Health and Human Services (“HHS”) purchased 600,000 treatments of a monoclonal antibody to treat the omicron strain of COVID-19 from Eli Lilly and Co.[34] These monoclonal antibodies are called bebtelovimab.[35] In a January 2022 report on the bebtelovimab antibodies’ ability to neutralize SARS-CoV-2 variants, nineteen of the authors on this report were employees and/or stockholders of Eli Lilly and twenty-four were employees and stockholders of the pharmaceutical manufacturer AbCellera Biologics Inc.[36] AbCellera Biologics Inc. and the National Institute of Health (“NIH”)  (backed by HHS and HHS Secretary Becerra) filed patent application no. US17/192,243 on March 4^th, 2021, titled “Anti-Coronavirus Antibodies and Methods of Use.”[37] In May 2021, this patent application was assigned to both Eli Lilly and AbCellera Biologics Inc. The patent was published November 10^th, 2022 (U.S. patent no. US-20220356229-A1). In June 2022, the U.S. government bought an additional 150,000 doses of bebtelovimab from Eli Lilly for roughly $275 million.[38] The February 2022 order of 600,000 doses of bebtelovimab from Eli Lilly cost the government at least $720 million.[39] There was almost $1 billion in revenue from the U.S. government alone to Eli Lilly (and its stakeholders who contributed to the study on the antibodies’ efficacy) for manufacturing before the patent was even published. A majority of the listed inventors on the patent also contributed to the efficacy study.[40]

In order to “disclose a sufficient number of representative antibodies across the claimed genus,”[41] patent no. US-20220356229-A1 provided almost 1,700 different embodiments (detailed descriptions of the invention) of the claimed anti-coronavirus antibodies and methods of use.[42]

The profits are already enormous from even narrowed antibody patents, imagine the potential monopoly over market-shares patent owners (and logically pharmaceutical manufacturers would have) were the precedent on antibody patents (and biotech generally) to pre-date 1997.

Thought Exercises for Your Consideration

Are patent applicants filing multiple antibody patents with less independent claims, rather than one antibody patent with more independent claims to get around this narrowing doctrine? Has this narrowed the scope of claims in the unpredictable arts as intended?

Despite antibody patents facing more 112(a) rejections compared to similar technology, are 112(a) rejections driving the production of “better” antibody patent applications?

Does the opinion of the legal-minded courts regarding enablement and written description requirements carry any weight in balancing the exclusive rights of patents if the science-minded patent examiners adjust their review process prior to official ruling?

 

 

Image Source: https://www.news-medical.net/news/20200427/SARS-CoV-2-readily-infects-human-intestinal-cells-in-a-laboratory-model.aspx

[1] Larry Stauffer, Reducing the Risk of Patent Infringement 3037 (2023).

[2] Id.

[3] 35 U.S.C. § 112(a).

[4] Guang Ming Whitley, A Patent Doctrine without Bounds: The “Extended” Written Description Requirement, 71 U. Chi. L. Rev. 617, 617 (2004).

[5] In re Wands, 858 F.2d 731, 737 (1988).

[6] Larry Stauffer, Reducing the Risk of Patent Infringement 3037 (2023).

[7] In re Wands, 858 F.2d 731, 740 (1988).

[8] Id. at 737.

[9] Regents of the University of California v. Eli Lilly and Co., 119 F3d 1559, 1567 (Fed Cir 1997).

[10] Guang Ming Whitley, A Patent Doctrine without Bounds: The “Extended” Written Description Requirement, 71 U. Chi. L. Rev. 617, 618 (2004).

[11] Id.

[12] Id.

[13] Id.

[14] S. Sean Tu & Christopher M. Holman, Antibody Patents: Use of the Written Description
and Enablement Requirements at the Patent & Trademark Offices, 38 Berkeley Tech. L.J. 1, 3 (2023).

[15] Id.

[16] Id.

[17] Karen Carroll & Sharad Bijanki, The Evolution of Antibody Patents, IP Watchdog (Oct. 8, 2018), https://ipwatchdog.com/2018/10/08/evolution-antibody-patents/id=101971/.

[18] Id.

[19] Centocor Ortho Biotech, Inc. v. Abbott Labs., 636 F.3d 1341 (Fed. Cir. 2011).

[20] Karen Carroll & Sharad Bijanki, The Evolution of Antibody Patents, IP Watchdog (Oct. 8, 2018), https://ipwatchdog.com/2018/10/08/evolution-antibody-patents/id=101971/.

[21] Id.

[22] Amgen Inc. v. Sanofi, 872 F.3d 1367 (Fed. Cir. 2011).

[23] Karen Carroll & Sharad Bijanki, The Evolution of Antibody Patents, IP Watchdog (Oct. 8, 2018), https://ipwatchdog.com/2018/10/08/evolution-antibody-patents/id=101971/.

[24] Guang Ming Whitley, A Patent Doctrine without Bounds: The “Extended” Written Description Requirement, 71 U. Chi. L. Rev. 617, 619 (2004).

[25] S. Sean Tu & Christopher M. Holman, Antibody Patents: Use of the Written Description
and Enablement Requirements at the Patent & Trademark Offices, 38 Berkeley Tech. L.J. 1, 9 (2023).

[26] Id. at 4.

[27] Id. at 5.

[28] Id. at 29.

[29] Id.

[30] In re Wands, 858 F.2d 731 (1988).

[31] Mark A. Lemley & Jacob S. Sherkow, The Antibody Patent Paradox, 132 Yale L.J. 994, 994 (2023).

[32] Id. at 1010.

[33] Id.

[34] Secretary Becerra Announces HHS Purchase of 600,000 Treatment Courses of New Monoclonal Antibody That Works Against Omicron, U.S. Department of Health and Human Services (February 10, 2022), https://www.hhs.gov/about/news/2022/02/10/secretary-becerra-announces-hhs-purchase-600000-treatment-courses-new-monoclonal-antibody-that-works-against-omicron.html.

[35] Id.

[36] Kathryn Westendorf et. al., LY-CoV1404 (bebtelovimab) potently neutralizes SARS-CoV-2 variants, bioRxiv (Jan. 7, 2022), https://www.biorxiv.org/content/10.1101/2021.04.30.442182v5.

[37] U.S. Patent No. 20220356229A1 (filed March 4, 2021).

[38] Sasha Pezenik & Cheyenne Haslett, Government nearly exhausts monoclonal COVID treatment funding with new purchase, ABC News (June 30, 2022), https://abcnews.go.com/US/government-exhausts-monoclonal-covid-treatment-funding-purchase/story?id=86004696.

[39] Lilly will supply up to 600,000 doses of bebtelovimab to U.S. government in ongoing effort to provide COVID-19 treatment options, PR Newswire (Feb. 10, 2022), https://www.prnewswire.com/news-releases/lilly-will-supply-up-to-600-000-doses-of-bebtelovimab-to-us-government-in-ongoing-effort-to-provide-covid-19-treatment-options-301480282.html.

[40] U.S. Patent No. 20220356229A1 (filed March 4, 2021); Kathryn Westendorf et. al., LY-CoV1404 (bebtelovimab) potently neutralizes SARS-CoV-2 variants, bioRxiv (Jan. 7, 2022), https://www.biorxiv.org/content/10.1101/2021.04.30.442182v5.

[41] Karen Carroll & Sharad Bijanki, The Evolution of Antibody Patents, IP Watchdog (Oct. 8, 2018), https://ipwatchdog.com/2018/10/08/evolution-antibody-patents/id=101971/.

[42] U.S. Patent No. 20220356229A1 (filed March 4, 2021).