Preliminary opinions: 3
Non-Priority Opinions: 10
Rule 36: 0
Longest pending case from argument: Zafer Construction Company v. United States#21-1547 (104 days)
Shortest (not rule 36) pending case from argument: tie in between Polaris Innovations Limited v Advanced Micro Devices, Inc.No. 21-1917 (13 days), and Davis vs McDonoughNo. 21-1904 (13 days)
Case of the week: CareDx, Inc. vs. Natera, Inc.No. 22-1027
Blackboard: Judges Lourie, Bryson and Hughes, with Judge Lourie writing the Opinion
You should read this case if: You have a patent matter, particularly in the field of medical diagnostics
The Supreme Court recently declined to include patentability American Axis, with any clarification of Section 101 (by the Court or Congress) set aside for another day. In the meantime, however, the Federal Circuit will continue to rule on Section 101 issues in accordance with existing case law. In this week’s case of the week, the Federal Circuit used these precedents to invalidate medical diagnostic claims.
The patents in suit claim methods for diagnosing organ transplant rejection. When a recipient’s body rejects a transplanted organ, the recipient’s immune system destroys the cells of the donor organ and releases the donor’s DNA into the recipient’s blood in the form of cell-free DNA (cfDNA). The claims here involve measuring the resulting elevations in the donor’s cfDNA levels to identify possible organ rejection. They involve four steps: (1) obtaining a blood sample from the transplant recipient, (2) determining the donor and recipient genotypes, (3) sequencing the cfDNA from the recipient blood sample, and (4) determining the amount of donor cfDNA in the sample .
The district court eventually found the claims void under Section 101, but only after a tortuous process of litigation. The court denied defendants’ motion to dismiss on Section 101 grounds. After an expert assessment, the court initially denied the summary judgment on § 101 due to factual disputes about the conventionality of the technologies in question. The defendants asked the district court to affirm the summary judgment’s denial for an immediate appeal under 28 USC § 1292(b). The district court then changed course and awarded the defendants non-inheritance in summary proceedings.
The Federal Constitutional Court confirmed. At step one of the Alice/mayo Patent Eligibility Framework, the court ruled that the claims related to natural phenomena: the presence of donor cfDNA in a transplant recipient and the correlation between donor cfDNA and transplant rejection. The court stated that “the claims amount to taking a body sample, analyzing the cfDNA using conventional techniques, . . . Identifying naturally occurring DNA from the donor organ and then using the natural correlation between elevated cfDNA levels and transplant health to identify possible rejection.” It paralleled previous cases, such as that of the Supreme Court mayo Decision to hold medical diagnostic claims inadmissible on similar grounds. And it distinguished other cases in which diagnostic claims were confirmed, noting that the claims there concerned an unconventional “method of preparation or a new measurement technique.”
at Alice/mayo In the second step, the court concluded that nothing in the claims “converts the natural phenomena into a patentable invention”. The joint specification of the patents “acknowledges that each step” in the claims “requires only conventional techniques and commercially available technology”. For example, the specification specifically noted that “any technique known in the art” could be used to collect the transplant recipient’s blood sample and that “well-known” techniques could be used to sequence the cfDNA in the sample.
The ordered combination of steps also did not provide an inventive concept for the purposes of step two. The specification stated that “sample collection, genotyping, sequencing and quantification” is “a simple, logical, and conventional method for detecting cfDNA.” In particular, this sequence of steps “has previously been used in other contexts, including cancer diagnostics and prenatal testing.”
Finally, the court overruled the plaintiffs’ procedural objections to the district court’s decision. For example, the Court saw no reversible “irregularity” in the district court’s “withdrawal of its initial challenge to summary judgment.” It found that the district court “had the right to reconsider its decision in summary judgment” based on further arguments on the records of conventionality.