101

It has been a while since the Federal Circuit weighed in on the patent eligibility of so-called “natural product” claims. While the finding of non-eligibility in ChromaDex, Inc. v. Elysium Health, Inc. is not surprising, it is interesting that the court chose to distinguish Natural Alternatives instead of characterizing that decision as being based on a unique procedural posture.

In a decision underscoring that the U.S. stands (nearly) alone in holding most diagnostic methods to be not eligible for patenting, the Federal Court of Australia upheld Sequenom’s Australian patent directed to prenatal diagnostic methods that involve detecting fetal DNA in maternal blood samples. Those working to reform U.S. patent eligibility law might want to consult this decision for guidance.

Congress has taken an important step along the road to reforming patent eligibility law. As announced in this press release, Senators Tillis (R-NC) and Coons (D-DE) and Representatives Collins (R-GA-9), Johnson (D-GA-4) and Stivers (R-OH-15) have released a “bipartisan, bicameral draft bill” that would revise 35 USC § 101 and eliminate the current role of “judicial exceptions.” While patent reform often is a two-steps-forward-one-step-back process, any Congressional action on this issue may be seen as a step in the right direction.

The bevy of precedential decisions interpreting and applying 35 U.S.C. § 101 in recent years, from both the Supreme Court and the Federal Circuit, has created a thicket of patent eligibility rulings that have restricted the ability to patent certain technologies and can be difficult to apply with consistency.

In United Cannabis Corp. v. Pure Hemp Collective, Inc., Judge Martinez of the U.S. District Court for the District of Colorado determined that UCANN's CBD patent was not invalid under 35 USC § 101.

In a non-precedential decision, a three-judge panel of the Federal Circuit made clear that it would not give deference to USPTO patent eligibility guidance that it finds inconsistent.

In <EM>Endo Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc</EM>., the Federal Circuit distinguished method of treatment claims that involve personalized dosing from the claims invalidated in <EM>Mayo v. Prometheus</EM>, and found them to satisfy 35 USC 101 by analogy to <EM>Vanda.</EM>

In <EM>Natural Alternatives Internat’l v. Creative Compounds, LLC</EM>, the Federal Circuit vacated the district court decision that held the asserted claims invalid under 35 USC § 101 at the pleadings stage.

In Ni-Q, LLC v. Prolacta Bioscience, Inc., the United States District Court for the District of Oregon invalidated under 35 USC § 101 Prolacta’s patent on testing milk to establish or confirm the identity of the donor.