Athena v. Mayo Part II – Iancu v. The Federal Circuit(?)

The 2019 Revised Subject Matter Eligibility Guidance published on January 7th purported to revise the procedures for determining whether a patent claim or patent application claim is “directed to a judicial exception (laws of nature, natural phenomena, and abstract ideas) under step 2A” of the USPTO’s Mayo/Alice Rule Guidance in two ways. First, the Revised Guidance seeks to clarify just what an abstract idea is by stated that abstract ideas can be grouped as, e.g., mathematical concepts, mental processes and the like. More important to life sciences patenting, the Revised Guidance explains that a patent claim that recited a judicial exception is not ‘directed to’ the judicial exception if the judicial exception is integrated into a practical application of the judicial exception.” If the claim is not directed to a judicial exception, the dreaded 2B analysis must be carried out.

The majority of the Fed. Cir. panel clearly disagrees with this Revision in the case of any diagnostic claim that recites a naturally occurring correlation, along with the manipulative steps required to reach a diagnosis. The majority of the panel in Athena v. Mayo – and perhaps a majority of the Fed. Cir. Judges – inevitably find that a diagnostic claim that recites the application of a naturally occurring correlation reach a diagnostic conclusion is directed to a natural law, despite the presence in the claim of the steps wherein the “hand of man” is applied to convert the discovery of the in vivo correlation into a practical application of the natural law. Once the claim is found to be directed to a such a correlation, which is a natural law, the court moves on the Step 2B, in which it examines the remaining steps – sampling, measuring the biomarkers in question and comparing them to a reference amount of the biomarker, and drawing a diagnostic conclusion from the data – in isolation, to see if they represent an “inventive step” apart from their application to reach a diagnostic conclusion. In other words, the recognition of the utility of the in vivo correlation cannot provide the required “inventive step” when applied in vitro, unless there is a second “invention” that arises when the in vitro assay is carried out.

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Mayo Wins in Another s. 101 Appeal – Discovery of a Useful Natural Correlation is not Patent Eligible

By now, once you see the claim, I would not be surprised if any of my loyal readers could not predict how it would fare at the Fed. Circuit. However, this is a worthwhile decision to review, particularly since the dissent by Judge Newman brings the analytical flaws in the majority’s opinion into such sharp focus. A representative doomed claim is below, compressed for readability:

7. A method for diagnosing neurotransmission or developmental disorders related to [the marker protein MuSK] in a mammal comprising:

contacting MuSK… having a suitable label thereon with [a] bodily fluid,

immunoprecipitating any antibody/MuSK complex… from the,

bodily fluid and

monitoring for said label on any of said antibody/MuSK complex…,

wherein the presence of said label is indicative of said mammal suffering from said… disorder related to [MuSK].

The claim is the result of the discovery that 20% of myasthenia gravis (“MG”) patients do not express autoantibodies to the acetyl choline receptor, but do generate autoantibodies against MuSK, a membrane protein. “Prior to this discovery, no disease had been associated with MuSK.” Slip op. at 4.

So, this is an example of an “If A, then B” diagnostic claim, with some wrinkles. The user does not simply measure the level of a biomarker, following the administration of a drug known to yield the biomarker, as in the 6-TP metabolite used as the marker in Mayo. In this claim, a hypothetical user would need to obtain the labeled MuSK protein (e.g., radiolabeled), add it to the test fluid, so that any antibody/MuSK complex is immunoprecipitated, measure the level of the label, and conclude that the patient does or does not have MG. This looks a lot like the hand of man at work, but these steps did not impress the majority of Judges Lourie and Prost. Perhaps they have become “strict constructivists” of the Mayo/Alice Rule.

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Barry v. Medtronic – Be Careful What You Use and Sell!

In my last post, I discussed the Supreme Court’s opinion in Helsinn Healthcare v. Teva Pharms., holding Helsinn’s patent on a drug was invalid on the basis that Helsinn’s semi-secret sale of the drug to a marketing partner triggered the AIA s. 102 on-sale bar. I use the term, semi-secret, because Helsinn issued a press release announcing the deal more than a year before they filed their patent application, but the press release did not disclose the dose of the drug that was sold, and the deal involved an NDA between Helsinn and the marketer. The Supreme Court considered this to be a “secret sale” that violated the policy against an inventor’s commercializing the invention for an indefinite period, while keeping features of the invention secret, and then filing an application to protect it after competition was threatened.

Barry v. Medtronic, Inc., Appeal no. 2017-2463 (Fed. Cir., January 24, 2019), in a split decision that addressed both the “public use” and “on-sale” bars of s. 102(b) in a case involving much more factual detail than Helsinn. Dr. Barry is a surgeon who obtained patents on methods and systems for correcting spinal column anomalies, such as those due to scoliosis, by conducting a surgical procedure with a surgical device that applied force to multiple vertebrae at once. He based his applications on the results of three surgeries that he conducted outside the one-year grace period of s. 102 (the “critical date”). The patients all had follow-up visits – two were outside the grace period, but the third was within it. After the third follow-up showed the procedure had been successful, Barry submitted an abstract to a professional meeting.

Multiple personnel were present in the operating room, and Dr. Barry charged his usual fee for performing the operation. The patients were not told that they were test subjects for the new device. He testified that all three follow-ups were necessary to determine whether or not the surgery was successful, but apparently testified that he could determine the likely outcome while the patient was still undergoing the procedure. Medtronic began its alleged infringement in 2004.

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Supreme Court Rules That “Secret Sales” Can Qualify as Prior Art

United States Supreme Court Building, Washington, DCPre-AIA, 35 USC 102(b) stated that a person is entitled to a patent unless “the invention was patented or described in a printed publication… or in public use or on sale in the country, more than one year prior to the date of the application for patent in the United States.” The AIA altered this section, now 102(a) (1) to read “the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention….” This opened the door for patentees to argue that a “sale” had to be available to the public in order to trigger the “on-sale bar” of the statute. Since the “use” of the invention had to be public, they argued, “otherwise” must modify “sale” and exempt secret sales from the scope of the on-sale bar.

The Federal Circuit had disagreed and invalidated the patent in question on the basis that public knowledge of the existence of the sale was enough trigger the AIA on-sale bar. The facts were somewhat similar to those at issue in MedCo. v. Hospira, a 2016 en banc pre-AIA Fed. Cir. decision in which the court ruled that “a contract manufacturer’s sale to the inventor of manufacturing services [to prepare a drug] where neither title to the embodiments nor the right to market the same passes to the supplier does not constitute an invalidating sale.” However, the court cautioned that there was no blanket “supplier exception” to the on-sale bar, and noted, inter alia, that where the supplier “receives blanket authority to market the product” … even the transfer of product to the inventor may constitute a commercial sale under s. 102(b). About three years later, Helsinn, in Helsinn Healthcare S.A. v. Teva Pharms. USA, Inc. No. 17-1299 (January 22, 2019), found out that its semi-secret sales to a distributor also fell within the on-sale bar.

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