Invitation to Join Amicus Brief in Federal Circuit Rehearing of Athena Diagnostics v. Mayo

“The Athena decision omits an appropriate analysis of the wording of the statute it is applying.”

Athena Diagnostics filed a petition for en banc rehearing of the United States Court of Appeals for the Federal Circuit’s decision in Athena Diagnostics v. Mayo on April 8, 2019. Amicus briefs are due April 22, 2019. The Athena decision continues to apply U.S. Supreme Court-created common law to the analysis of 35 U.S.C. §101.

In its brief requesting rehearing, Athena argues that the decision is “precisely the evisceration of patent law against which the U.S. Supreme Court has long warned” and that the claims at issue were patent eligible, as they are “novel, man-made substances”, “do not preempt natural laws” and “serve a new and useful purpose of diagnosing serious diseases”.

“Methods applying natural law have always been eligible,” said the brief.

The brief asks the full panel of the court to consider the following questions:

  1. Whether this Court now recognizes a categorical bias against patent claims to methods of diagnosis, an impermissible expansion of the Supreme Court’s narrowly defined judicial exception to patent eligible subject matter under 35 U.S.C. § 101.
  2. Whether courts may now exclude claim elements that they deem “conventional” in determining whether the claim is “directed to” patent eligible subject matter, or does Supreme Court authority requiring that claims be assessed “as a whole” still apply in Section 101 analysis.

Knowles IP Strategies LLC (Sherry M. Knowles) and AddyHart (Meredith Addy) intend to file an amicus brief in support of neither party requesting that the Federal Circuit carry out its constitutional duty to apply strict statutory construction of the literal words of 35 U.S.C. §101 to decide the case (See, Unconstitutional Application of 35 U.S.C. § 101 by the U.S. Supreme Court; 18 J. Marshall Rev. Intell. Prop. L. 144 (2018)).

As with other recent Federal Circuit and U.S. Supreme Court cases on patent eligibility, the Athena decision omits an appropriate analysis of the wording of the statute it is applying (“Whoever invents or discovers”), and its opinion is inconsistent with the wording of the statute. Instead, it applies judicial exceptions to the statute, which have been created by the U.S. Supreme Court, as elaborated in its new common law on the subject. However, as recently well stated by the U.S. Supreme Court in Henry Schein, Inc. v. Archer & White, Inc. (No. 17-1272; January 8, 2019), “This Court may not engraft its own exceptions onto the statutory text”.

If you, your institution, or company have an interest in joining this brief, please send a request to by April 17, 2019.

The U.S. Constitution is not self-enforcing. The people and institutions of the United States must demand it.

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The Author

Sherry Knowles

Sherry Knowles is Founder of Knowles Intellectual Property Strategies and an intellectual property attorney with 30 years of experience in global corporate and private practice. From 2006-2010, Ms. Knowles was the Senior Vice President and Chief Patent Counsel at GlaxoSmithKline, where she served as the worldwide head of patents for all litigation and transactional matters, and managed a global department of over 200 people in 12 offices. At GSK, Ms. Knowles was a member of the Scientific Advisory Board, the Technology Investment Board, the Product Management Board, the Legal Management Team and she led the Global Patents Executive Team.

For more information or to contact Sherry, please visit her Firm Profile Page.

Sherry Knowles

Meredith Addy is a partner with AddyHart P.C., where she focuses her practice on a unique blend of business and legal strategy. Addy has over 25 years of litigation experience and has handled more than 30 cases before trial courts and argued more than 40 appeals to the Federal Circuit. Addy has held leadership positions at several AmLaw100 firms and is a recipient of many awards and honors. She has testified before Congress to address issues relating to the Federal Circuit and the state of patent law. Addy has been a member of the Federal Circuit’s Advisory Council and a member of the board of directors of the Federal Circuit Bar Association. She is also a founder of the Richard Linn American Inn of Court, which is directed to intellectual property, and she served as its first president. Addy has also been recognized as one of the Most Influential Women in IP Law by Law360. For more information, or to contact Meredith, please visit her profile page.

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Discuss this

There are currently 3 Comments comments.

  1. mike April 12, 2019 2:01 am

    I encourage everyone and their dog to join this brief.

    Sherry Knowles is 100% correct in her paper “Unconstitutional Application of 35 U.S.C. 101 by the US Supreme Court”, and Kavanaugh’s opinion in Henry Schein states what everyone who abhors Alice wants to hear: “[The Supreme Court] may not engraft its own exceptions onto the statutory text.”

    JOIN THIS BRIEF! Send your email to the address in the article above.

  2. Anon April 12, 2019 7:02 am

    With a reference to the Schein case, you have only one blade of the Kavanaugh Scissors here.

    The other blade is also from Kavanaugh in the oral arguments of the California Franchise Tax Board v Hyatt case.

    To use the Kavanaugh Scissors you will need a few things:
    a) the Scissors
    b) the will to use them,
    c) the recognition that a Gordian Knot exists to which the will and the Scissors are to be used to cut.

  3. GSR April 12, 2019 5:07 pm

    Do we know the identity of the amicus?