On September 28th, I will be moderating a panel on patenting diagnostic tests – and related subject matter – such as methods of medical treatment, at BIO’s annual IP & Diagnostics Symposium in Alexandria, VA. At the beginning of 2018, the outlook was bleak in this area. Following the Fed. Cir.’s Ariosa (natural product), Cleveland Clinic (law of nature, cert. petition filed) and Genetic Tech. v. Merial (law of nature), the challenge of getting a claim that would survive a s. 101 challenge seeming nearly insurmountable. The Mayo/Alice test was wielded like an anti-patent sword by district court judges, the PTAB and the Fed. Cir. to invalidate patents under 12(b)(6), e.g. at the pleadings stage of litigation, often before claim construction had been carried out.
In preparing my presentation, I reviewed all of the case law and related PTO materials that I had posted at Patents4Life. I had reviewed a pack of patents or applications confronted with s. 101 questions, and was surprised to see that, except for Cleveland Clinic – I had posted on their petition for cert. – Ex parte Patterson and Ex parte Nagy, a July decision on a method to diagnose Alzheimer’s Disease, all of the decisions listed below that addressed claims having diagnostic elements did not invalidate the patents or applications, as failing to pass s. 101 muster.
- Exergen v. Katz (Fed. Cir. 3-18-18) (Measuring core body temperature)
- Berkheimer v. HP (2-8-18) (Burden to support a lack of inventive concept rejection under Mayo/Alice Step 2).
- Vanda v. W-W (4-18-18) (Nearly a blanket endorsement of method of medical treatment claims)
- Ex parte Patterson (12-4-17) (Cervical cancer)
- Ex parte Galloway (5-14-19) (Prostate cancer)
- Ex parte Stone (5-3-18) (Bladder fullness)
- Ex parte Nagy (7-30-18) (Alzheimer’s Disease)
Computational genomics is not exactly diagnostic methodology, but claims to various “drugable” target-identification methodologies are becoming increasing common, and all of the cases listed below were found to be s. 101 compliant.
- Ex parte Young (7-18-17)
- Ex Parte Lehrer (8-29-18)
- Ex parte Friesner (9-10-18)
There are fewer decisions in the natural product arena but, of those listed below, only Bhagat and Buck failed the Mayo/Alice test.
- In re Bhagat (Fed. Cir. 7-16-18) (kits of fatty acids) and her petition for cert. (Big question here about the requirement for “markedly different” characteristics)
- Ex part Buck (4-10-18) (D vitamins)
- Ex parte Smith (5-16-18) (mutated flavivirus proteins)
- Ex parte Parenteu (8-22-18) (cultured tumor cells)
- Ex parte Ho (8-27-18) (cultured BMC)
I hope you can attend or listen in on what promises to be a very relevant symposium. Particularly after Berkheimer and the PTO’s Berkheimer memo to Examiners, it is very important to stop the Mayo/Alice inquiry at Step 1 (PTO Step 2A; see MPEP 2106). If you are swept quickly into Step 2 (PTO Step 2B), hopefully you will have established with the specification, extrinsic evidence or expert declarations, that the additional elements in your claims were not well-known, conventional or routinely practiced by the art as of your filing date. Stay tuned.