Posts Tagged: "patentability requirements"

On 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, on 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.

The patent world is trained on the upcoming Supreme Court Amgen v. Sanofi case. That case is the first time in over 75 years that the Supreme Court is evaluating the meaning and scope of the enablement requirement of 35 U.S.C. § 112. The case offers the Court an opportunity to correct a negative trend in enablement law that has made it more difficult to protect groundbreaking, pioneering inventions. Waiting in the wings, however, is an equally important Section 112 case: . There, the petitioner sought review on whether “the ‘written description of the invention’ [is] to be measured by the statutory standard of ‘in such full, clear, concise, and exact terms as to enable any person skilled in the art to make and use the same.’” As is apparent, Juno’s written description issue is highly intertwined with the Section 112 enablement issue in Amgen v. Sanofi.

Following the denial of Juno Therapeutics’ petition to the U.S. Supreme Court earlier this month, Juno last week petitioned the High Court for rehearing, arguing that the grant of certiorari in Amgen v. Sanofi warrants reconsideration. Juno explained that the issues presented in the Amgen case “are tightly related, and the outcome in Amgen is likely to at least affect, if not be outcome-determinative of, this case.” Juno is asking that the Court grant the petition for rehearing, vacate the denial of certiorari, and hold the case pending the outcome in Amgen.

The U.S. Court of Appeals for the Federal Circuit (CAFC) today issued a precedential decision affirming the Patent Trial and Appeal Board (PTAB) on two mixed inter partes review (IPR) decisions involving American National Manufacturing and Sleep Number Corp. that found some, but not all, of the challenged claims not unpatentable. The IPRs on appeal involve U.S. Patent Nos. 8,769,747 and 9,737,154. They “describe systems and methods that purport to adjust the pressure in an air mattress ‘in less time and with greater accuracy’ than previously known.” American National filed IPR petitions challenging many claims of both patents and asserting that most of the challenged claims would have been obvious over various prior art references.

On November 4, the U.S. Supreme Court granted Amgen’s petition for certiorari against the advice of the U.S. government – taking up Amgen’s challenge to the Federal Circuit’s enablement review of its PCSK9 antibody patents covering evolocumab (Repatha®). In its petition, Amgen asserts that the Federal Circuit has gone too far in invalidating its PCSK9 antibody patents by imposing a disclosure burden beyond the requirements of 35 U.S.C. § 112. Notably, the Supreme Court, albeit with a different composition, recently declined to hear several other similar cases raising issues with the Federal Circuit’s enablement precedent.

“Mathematical Formulas and Relationships” fall under the “Abstract Idea” exception to the categories of patentable subject matter. Characterizing the “Mathematical Formulas and Relationships” as “Abstract Ideas” has led to misrepresentation of mathematical concepts in patent law. A “Mathematical Formula or Relationship” is a means of expression and should be inspected to extract what it expresses. Next, the content that is being expressed may be evaluated to determine whether the “Mathematical Formula or Relationship” is expressing a “Tool” or a “Model,” both of which are used for building machines and devising technological processes and neither of which needs to be categorically excepted from patentability.

Over the last 15 years, the United States Supreme Court has mutated patent eligibility into an impossibly complex and confusing mess. The Court’s current eligibility test strays far from Congress’s original intent, erodes trust in predictability, and has left many remarking that innovation in the United States is falling behind due to uncertainty of patent eligibility law. Even more troubling, the resulting uncertainty of patent ineligibility for large swaths of innovation in critical technology areas, including artificial intelligence, poses significant risks to U.S. competitiveness, economic growth and national security. The Court has had opportunities to rectify its patent sinkhole but recently declined another chance to mend the chaos. When the Court denied certiorari in American Axle v. Neapco—despite the Solicitor General’s plea to hear the case—it became clear that Congress must step in to rescue U.S. innovation.

On November 7, the U.S. Supreme Court issued an order list showing that it had denied the petition for writ of certiorari filed in Juno Therapeutics, Inc. v. Kite Pharma, Inc. In denying the petition, the Court refused yet again to clarify the Federal Circuit’s questionable interpretation of U.S. patent code, this time within the context of the written description requirement of 35 U.S.C. § 112, and leaves in place an appellate court ruling that many believe will be very damaging to the United States’ life sciences innovation sector.

The U.S. Supreme Court granted petitions for certiorari in two intellectual property cases Friday, one dealing with the limits of extraterritorial application of the Lanham Act and another asking the High Court to weigh in on whether “enablement” means a specification must enable those skilled in the art “to reach the full scope of claimed embodiments” without undue experimentation.

It is sometimes said that a lie gets halfway around the world before the truth has a chance to get its pants on. We have found, however, that it is often the slow-and-steady truth that wins the race in our deliberative justice system, which for patents has both administrative and judicial components. Our case-in-point is the Federal Circuit’s recent decision in Cooperative Entertainment, Inc. v. Kollective Technology, Inc., which reversed a Rule 12(b)(6) dismissal on patent ineligibility under 35 U.S.C. § 101. This case demonstrates how an invention that is potentially assailable on eligibility grounds can be given its best chance by a focused, consistent and synergistic patent prosecution and litigation strategy. Thus, it is not coincidental that your authors are a patent litigator and a patent prosecutor, respectively.

Systemic-level studies and data regarding impact on investment and innovation, as detailed in Part II of this series, are not the only way to demonstrate the substantial harm that the current state of patent eligibility has inflicted on the U.S. innovation ecosystem. Other robust evidence shows that current Section 101 law has harmed innovation by removing the incentives to develop and commercialize particular inventions of public importance. As another form of harm, the vagueness and breadth of the Alice/Mayo framework have also enabled accused infringers to transmogrify Section 101 into a litigation weapon in inappropriate cases that has created unnecessary burdens and costs on innovators and the courts.

The muddled state of patent eligibility law has direct and significant negative consequences for U.S. R&D investment, and for innovation in key fields of medical, economic, and strategic importance to the United States and its citizens. Uncertainty reduces R&D investment, as has been well-documented, and reliable patent protection mitigates uncertainty and generates increased R&D investment. As we explained in Part I of this series, the experts overwhelmingly agree on these points.

On October 5, American biopharmaceutical firm Amgen filed a supplemental brief at the U.S. Supreme Court, which comes about two weeks after the U.S. Solicitor General’s office filed a brief urging the Court to deny certiorari on Amgen’s petition for writ. Amgen’s petition seeks Supreme Court review of rulings in the lower courts invalidating Amgen’s patent claims for lack of enablement. Amgen’s latest brief argues that Solicitor General’s own arguments further support Supreme Court review to clarify the proper standard for reviewing questions of enablement under 35 U.S.C. § 112.

Patent eligibility law in the United States is in a state of disarray that has led to inconsistent case decisions, deep uncertainty in the innovative, investment and legal communities, and unpredictable outcomes in patent prosecution and litigation. These facts have been extensively documented in multiple sources, including: the statements of all 12 active judges of the nation’s only patent court, the U.S. Court of Appeals for the Federal Circuit (confirmed prior to October 2021); the findings and reports of the Executive branch across all recent Administrations; the bi-partisan conclusions of Congressional committees; a robust body of academic studies; and at least forty separate witness statements at the 2019 hearings on this issue before the Senate Committee on the Judiciary Subcommittee on IP, including statements from advocates that oppose Section 101 reforms.

The United States Patent and Trademark Office (USPTO) announced today that it is seeking comment from the public on “proposed initiatives directed at bolstering the robustness and reliability of patents to incentivize and protect new and nonobvious inventions while facilitating the broader dissemination of public knowledge to promote innovation and competition.” During IPWatchdog’s LIVE event in Dallas, Texas, in September, USPTO Texas Regional Office Director Hope Shimabuku explained that issuing “robust and reliable patents”—which seems to have replaced the oft-maligned term, “patent quality,”—is a key focus for USPTO Director Kathi Vidal. The request for comment (RFC) tackles this problem from a number of angles, from fee-setting to terminal disclaimer and continuation practices, to improving prior art searches. The RFC stems in part from a July letter sent by the USPTO to the Food and Drug Administration (FDA) outlining the USPTO’s planned initiatives to help combat perceived links between patents and drug pricing problems.