Amici Filings in Amgen Encourage the Supreme Court to Correct the Federal Circuit’s ‘Unworkable’ Enablement Standard

“It was unnecessary and would have been extremely wasteful for Amgen to have attempted to make and specifically document all of the additional sequences that might also satisfy the requirement of binding to two or more of the 15 amino acids.” – Brief of the USIJ and Innovation Alliance

Supreme CourtOn January 3, a total of 14 amicus briefs and one motion for leave to participate in oral argument were filed with the U.S. Supreme Court on the question presented by Amgen Inc. v. Sanofi, for which the Supreme Court granted certiorari this past November. While organizations representing the most powerful interests in the technology industry supported the Federal Circuit’s holding that Amgen’s patent claims were invalid for lack of enablement, a wide swath of patent stakeholders are urging the Supreme Court to correct the enablement standard to continue the encouragement of genus patent claims. Below is a collection of arguments raised by several of the recent amicus filings from earlier this week.

Lemley and IP Professors Say Federal Circuit’s Standard Frustrates Chemical, Life Science Patenting

A group of 14 professors of intellectual property, headlined by Professor Mark Lemley of Stanford Law School who authored the brief, filed an amicus brief supporting petitioner Amgen. The IP professors urged the Supreme Court to rein in the Federal Circuit’s enablement requirement under 35 U.S.C. § 112. “[T]he Federal Circuit has changed the law dramatically in recent years, to the point where it is no longer possible to have a valid genus claim in the chemical and biotechnology industries,” the IP professors argue.

Historically, genus claims have long been patentable going back to the Telephone Cases in the 1880s, during which the Supreme Court held that enablement is satisfied if the patentee “describes his method with sufficient clearness and precision to enable those skilled in the matter to understand what the process is, and if he points out some practicable way of putting it into operation.” Genus claims are critical for patent protection, the IP professors argue, because they address the risk that a patentee will not be able to assert rights against infringers who make minor modifications of particular embodiments disclosed by the specification.

Enablement issues have not traditionally turned on an inquiry that only looks at the number of compounds in a claimed genus or the amount of time required for routine screening. The IP professors note that Federal Circuit’s new approach to enablement focuses on knowing exactly which species of a claimed genus will work, whereas Section 112 only requires the patentee to disclose information in the specification allowing persons skilled in the art to make and use the invention.

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A heightened enablement requirement is especially frustrating to patenting efforts in the chemical and life sciences sectors. “A chemical genus with any decently large number of species will never be able to satisfy the new enablement standard,” the IP professors argue. They added that Amgen’s disclosure of several details of the invention, including numerous embodiments of anti-PCSK9 antibodies and partial amino acid sequences for 26 antibodies, eliminated any concerns that Amgen was engaging in pure functional claiming.

HTIA and CCIA: ‘We Do Not Need a Patent System to Dream of Future Innovations’

Also filed on January 3 was an amicus brief submitted jointly by the High Tech Inventors Alliance (HTIA) and the Computer & Communications Industry Association (CCIA), both of which represent some of the most profitable companies in the technology and communications industries. Amici here argue that Amgen is a poor vehicle for altering the Federal Circuit’s enablement requirement, contending that the question presented is based on the false premise that the patent claims before the court have been fully construed to define their claimed embodiments and that Amgen’s claims are naked functional claims.

“We do not need a patent system to dream of future innovations, from time-travel machines to Star Trek transporters. Nor do some entrepreneurs need a patent system to create commercially successful products based on secret inventions, from Coca-Cola to Listerine. The genius of the U.S. patent system is that it induces inventors not only to invent real, working inventions—as opposed to mere ideas—but also to fully and clearly disclose them to the public so that they enter the public domain upon the patent’s expiration.”

HTIA and CCIA pushed back against the idea that Amgen’s claims were genus claims, noting that Amgen’s patents claim the genus by their function instead of their structures or acts performing the claimed function. Such nakedly functional claims preempt innovation in fields like software, amici contend, and allowing such claims “incentivizes dreamers to file aspirational patent applications before they have contributed anything to the public store of knowledge.” Amici likened Amgen’s claims in the present case to those rejected by the Supreme Court in General Electric Co. v. Wabash Co. (1938) and Halliburton Co. v. Walker (1946). The lack of any claim construction in the underlying case makes it difficult to analyze the claim under Section 112’s limited safe harbor for functional language, HTIA and CCIA argue, and amici here contend that precedent on the full scope requirement for enablement extends back 170 years to O’Reilly v. Morse (1853).

USIJ and Innovation Alliance: Don’t Encourage Further VC Shifts Away from R&D

The Alliance of U.S. Startups and Inventors for Jobs (USIJ), which represents startups who actually need patent rights to compete against dominant market interests, and the Innovation Alliance, which represents technology companies with a heavy research & development focus, filed an amicus brief saying that the Federal Circuit “appears oblivious” as to the impacts of its Amgen decision on the willingness of innovators to engage in lengthy and expensive R&D. USIJ and the Innovation Alliance argue that the decision “will diminish, if not destroy altogether,” patent-based incentives to engage in R&D, especially for startups operating on investor-supplied capital.

“Amgen was able to design a class of antibodies that will bind to the PCSK9 sweet spot and thereby disable the antigen from attaching to the LDL receptors. Amgen created and described in full detail the process for making, characterizing and testing 26 separate antibody sequences as representative examples of a larger class of antibodies that could bind effectively with two or more of the 15 specific amino acids within the sweet spot… It was unnecessary and would have been extremely wasteful for Amgen to have attempted to make and specifically document all of the additional sequences that might also satisfy the requirement of binding to two or more of the 15 amino acids.”

While Sanofi and Regeneron could have created their own technology for treating low-density lipoprotein (LPL) cholesterol, the USIJ and Innovation Alliance contended that Regeneron copied Amgen’s disclosed anchor antibodies and followed the patent claims to ensure that Regeneron’s antibodies would bind to the “sweet spot” identified by Amgen.

Overall, the trend towards weaker patent protections in the U.S. since 2006 have reduced the willingness of venture capitalists to invest in businesses that rely on strong patent protections, as shown by a 2019 study conducted by SMU Dedman School of Law’s David O. Taylor. While that study looked at VC investments based on patent eligibility under 35 U.S.C. § 101, the USIJ and Innovation Alliance note that “any patent law principle that is interpreted to allow copycat misappropriation of the benefits of massive investments will have precisely the same effect.”

NYIPLA Suggest Applying the Undue Experimentation Test When Determining Infringement

While the Federal Circuit’s enablement standard in Amgen goes beyond the literal requirements of the plain language of Section 112, the New York Intellectual Property Law Association (NYIPLA) filed an amicus brief arguing that the Federal Circuit’s reasoning addresses a valid concern. The Federal Circuit’s concerns in Amgen about granting patent protections to potentially millions of antibodies echo concerns raised by that same court in a footnote to McRO, Inc. v. Bandai Namco Games America, Inc. (2020), in which the Federal Circuit reiterated that undue experimentation can include the time and effort required to identify, “from among the many concretely identified compounds that meet the structural requirements,” compounds satisfying the claimed function. However, the NYIPLA argued that if the Federal Circuit’s enablement standard from Amgen is allowed to stand, it would incentivize chemical and biological invention patentees to only disclose what the inventor has been able to test and not the invented genus, “which perhaps comprises the most important part of that discovery.”

In response, the NYIPLA proposed a solution that would allow patentees to claim a genus while limiting the scope of the granted patents based on undue experimentation when evaluating infringement instead of validity.

“If at the time of infringement, it is determined that undue experimentation was needed to make the species accused of infringement (here, a particular antibody with dual functionality), that species would be considered outside the scope of the patent claim and not infringing. On the other hand, if all the alleged infringer did was to follow the disclosure of the patent without undue experimentation, the accused species would be within the scope of the patent and an infringement.”

The NYIPLA contended that such a solution would continue encouraging broader patent disclosures and reduce patent examination burdens on the U.S. Patent and Trademark Office while addressing the Federal Circuit’s concerns on overly broad patents. Such patent disclosures would also serve as prior art to other patentees claiming inventions within the same genus on antibodies that would have required undue experimentation under the first patent’s specification.

National Association of Patent Practitioners: Federal Circuit’s Full Scope Test is Unworkable

The National Association of Patent Practitioners (NAPP), a professional organization representing attorneys and agents specializing in patent practice before the USPTO, argued in its amicus brief that the Federal Circuit’s enablement standard in Amgen “leaves patent practitioners guessing about how to advise client-inventors regarding the extent of disclosure required in patent applications to satisfy the court-established standards for enablement.”

NAPP’s amicus brief supported Amgen’s arguments in its merits brief as well as the reasoning of the brief filed by Mark Lemley and the IP professors. The NAPP wrote separately from the professors, who focused mainly on the impact of Amgen’s enablement standard on pharmaceutical patents, to highlight the concerns of that standard spilling over into other fields of invention like software, mechanical or electrical. Resolving those policy issues could be achieved by restoring the Supreme Court’s nearly 200-year-long standard, which applied only a reasonable burden on inventors as described in the Telephone Cases and Minerals Separation, Ltd. v. Hyde (1916).

Faulting Amgen for the amount of experimentation required to reach the full scope of the claimed invention is a key error in its decision, the NAPP argues, because substantial time and effort has never been the standard for enablement. Rather, courts have looked to the reasonableness of an artisan’s effort to make a desired embodiment following the roadmap laid out by the patent. Any issues about granting overly broad claims are properly addressed by the novelty and non-obviousness statutes at 35 U.S.C. § 102 and 35 U.S.C. § 103.

CHAL Requests to Participate in Oral Argument

The Chemistry and the Law Division of the American Chemical Society (CHAL) filed a motion for leave to participate in oral argument and for divided argument, asserting that the case presents the “extraordinary circumstances” requisite for such a motion to be granted. The brief argues that “CHAL has a paramount and unique institutional interest and perspective in this case that merits granting oral argument time” because the central issue in the case is of exceptional importance to CHAL and its members. The brief notes that CHAL has alerted both parties in the case to its request but neither side has taken a position. CHAL is asking the Court to grant it five minutes of argument time by either reducing the petitioner’s time to 25 minutes or extending the total time to 70 minutes and granting CHAL five minutes of that expanded time to argue as amicus curia in favor of petitioners.

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