CareDx v. Natera – Extrinsic Evidence Fails to Nullify Applicant’s Prior Admissions | Saul Ewing Arnstein & Lehr LLP

CareDx v. Natera – Extrinsic Evidence Fails to Nullify Applicant’s Prior Admissions | Saul Ewing Arnstein & Lehr LLP

The scenario issues a few Stanford patents accredited and asserted by CareDx: U.S. Patent Numbers 8,703,652 (asserted in opposition to Natera and Eurofins), and 9,845,497 and 10,329,607 (asserted in opposition to Natera). Natera and Eurofins each individual submitted motions for summary judgment of invalidity of the asserted patents under 35 U.S.C. § 101, which the Court docket at first denied in December 2020. The Courtroom then afterwards denied certification motions for interlocutory charm and instead dominated sua sponte to rethink its denial of summary judgment. Pursuing an evidentiary listening to, the Court reversed its preceding ruling to locate all claims of the asserted patents invalid underneath §101.

What You Need to have to Know:

  • Patent-qualified topic make any difference is described by 35 U.S.C. § 101 as any new and handy process, equipment, manufacture, or composition of make any difference, or any new and helpful enhancement thereof. Judicially-established limits of § 101 exclude laws of character, all-natural phenomena, and abstract thoughts.
  • Beneath Mayo and Alice, the Supreme Court docket developed a two-aspect eligibility check (i.e., “the Alice test”) which asks: (i) are the promises in issue directed to a patent-ineligible principle (i.e., a law of character, purely natural phenomenon, or abstract concept), and if so, (ii) do the unique or merged things of the asserted claims set forth an ingenious strategy? In Athena, the Federal Circuit held that at stage a single of the Alice inquiry, promises are directed to a pure regulation if they “recite only [a] normal legislation collectively with normal techniques for observing it.” 
  • The concept that a patentee is certain by the terms it utilizes in its patent – no matter whether in the promises or in other places in the specification – is a fundamental tenet of patent law.

The asserted patents share a solitary prepared description entitled “Non-invasive Diagnosis of Graft Rejection in Organ Transplant Patients.” The methods disclosed in the representative promises are summarized by the Courtroom as possessing 4 actions for detecting an organ donor’s cell-no cost DNA (cfDNA) in a transplant receiver:

  1. “obtaining” or “providing” a “sample” from the recipient that includes cfDNA
  2. “genotyping” the transplant donor and/or receiver to acquire “polymorphism” or “SNP” “profiles”
  3. “sequencing” the cfDNA from the sample using “multiplex” or “high-throughput” sequencing or accomplishing “digital PCR” and
  4. “determining” or “quantifying” the quantity of donor cfDNA.

The patents’ prepared description expressly states that the methods referred to in these methods are, “unless usually indicated, traditional procedures of immunology, biochemistry, chemistry, molecular biology, microbiology, cell biology, genomics, and recombinant DNA, which are inside the skill of the artwork.”[1] But, in accordance to the Courtroom, “nowhere in the composed description do the patents “otherwise indicate” that any of these techniques are nonconventional,” and in its place, “the composed description is replete with characterizations of the strategies in conditions that verify their conventionality.” This posture was shared by Defendants and their shared professional witness, Dr. John Quackenbush. 

CareDx unsuccessfully argued (i) that the admission in the published description that the claimed tactics are routine is extremely ubiquitous in patent purposes, and that to interpret it to be a intended voluntary confession that there is no creative strategy in the specification would be unfair (ii) that the patents do, in point, “otherwise indicate” that some of the particular person methods (i.e., electronic PCR and up coming generation sequencing) are nonconventional (iii) that the invention applies a under no circumstances-ahead of utilized blend of methods for the claimed purpose (i.e., that the novelty of the application of the recited approaches tends to make the strategies nonconventional) (iv) that the mixture of the recited techniques is by itself nonconventional and (v) that extrinsic evidence establishes that the recited methods had been not conventional, citing viewpoints of its very own skilled, Dr. Brian Van Ness, as well as 6 scientific content that reviewed the nascent character of some of the precisely disclosed techniques.

Relating to CareDx’s argument (v), the Court admonished that “[p]ermitting CareDx to now nullify with extrinsic proof an unambiguous representation it created to the PTO to secure its patents and exclude competition like Defendants from creating or utilizing the claimed creation would be basically at odds with the standard ideas underlying our patent process,” that it “would make Defendants’ proper to design all over meaningless,” and that it “would also reward CareDx for remaining dishonest – possibly when it explained to the PTO that the recited strategies have been standard or when it insisted right before this Court that they ended up not.”

This case highlights the want for patent applicants pursuing diagnostic strategies claims to expressly disclose in their applications (i.e., to “otherwise indicate”) the unique strategies in which their techniques are not regime or traditional. 

  1. The ‘652 patent at 5 :36-40.

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