Posts Tagged: "Mayo Collaborative Serivces"

Congress is Trying to Fix 101: To Do So, They Must Overrule Mayo

The state of patent eligibility in America is shocking. Between the passage of the 1952 Patent Act and 2012, when the U.S. Supreme Court decided Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S.Ct. 1289 (2012), the patent eligibility threshold was an exceptionally low hurdle. A group of Senators and Representatives are currently considering a legislative fix to this patent eligibility debacle created by the Supreme Court and perpetuated by a Federal Circuit unwilling to define the contours of a sensible patent eligibility test. These talks, which are being held in closed-door roundtable format, will seek legislative language to introduce soon. It is anticipated that bills will be introduced in both the House and Senate sometime this summer. What those bills will look like seems to be genuinely up in the air—or perhaps it’s better to say open for discussion. If the discussion should turn to the one thing Congress could do that would have the most impact, the answer would be clear. In order to have the most immediate, positive impact Congress must expressly overrule Mayo. The root of all the patent eligibility evil lies with that single Supreme Court decision.

Other Barks & Bites for Friday, February 8

This week in Other Barks & Bites: the Federal Circuit affirms a Section 101 invalidation of patent claims in favor of Mayo Collaborative Services; Apple wins an order to limit damages in Qualcomm patent case; Google frets over proposed European Union copyright rules; India proposes jail time for film piracy; patent validity challenges drag down the stock of a major pharmaceutical firm; and a snag in the U.S.-China trade talks throws Wall Street for a loop.

Patent-Ineligibility of Medical Diagnostics, Life Sciences Discoveries Arrests U.S. Progress

In a research project funded by the Austrian Science Fund (FWF), evidence emerged that a higher expression of the GIRK1 protein in malignant tissue samples was linked to higher relapse and mortality rates in breast cancer patients who have gone through surgery. The novel use of the GIRK1 protein as a biomarker could have a great impact on breast cancer diagnostics and treatments and further research could yield more discovery on the interdependence of GIRK1 with other important biological pathways critical to cancer management… Unfortunately, discovery of GIRK1 as a biomarker for breast cancer diagnostics would run into 35 U.S.C. § 101, the basic threshold statute for determining patentability of subject matter, under the Supreme Court’s March 2012 ruling in Mayo Collaborative Services v. Prometheus Laboratories, Inc. In that case, the Court held that processes involving correlations between blood test results and patient health is not patent-eligible subject matter because the process incorporates laws of nature. This would seemingly render any processes involving the application of GIRK1 as a biomarker for breast cancer prognoses unpatentable as well as the expression of GIRK1 occurs naturally.

Patent battle over generic Inomax leaves five Mallinckrodt patents invalid as naturally occurring phenomenon

A memorandum signed by Judge Sleet shows that Mallinckrodt’s patents were invalidated under the Section 101 patentability standard set by the U.S. Supreme Court in 2012’s Mayo Collaborative Services v. Prometheus Laboratories, Inc., a standard affirmed by SCOTUS’ 2014 decision in Alice Corporation v. CLS Bank International. Applying the two-step test for Section 101 patentability, the Delaware court found that the Mallinckrodt patents covered natural phenomenon which did not include an inventive step. The court found that patent claim limitations directed at echocardiography or severe adverse reactions did not satisfy the inventive concept step. “It does not matter what the severe adverse reaction is,” Judge Sleet’s memo reads. “Any reaction to treatment with iNO will be a natural phenomenon, dictated by the patient’s physiological response to the drug.”

Divining What Mayo Means: Exploring the SmartGene Case*

Trying to divine what Mayo Collaborative Services v. Prometheus Laboratories, Inc. means for the future in judging the patent-eligibility of claimed methods and processes under 35 U.S.C. § 101 is like using a Ouija board. The first inkling came 10 days after Mayo Collaborative Services in a motion for partial summary judgment in SmartGene, Inc. v. Advanced Biological Laboratories, SA, a case from the District Court of Columbia. When I first read this case, my initial reaction was “oh no, here comes the collateral damage we feared would come from Mayo Collaborative Services.” But having reflected on this case some more, and especially the claims involved, I think Judge Howell’s ultimate conclusion of patent-ineligibility of the claimed process and system under 35 U.S.C. § 101 is defendable. Even so, the reasoning expressed in Judge Howell’s opinion for reaching that conclusion gives pause for concern about the impact of Mayo Collaborative Services on rendering consistent and objective determinations of patent-eligibility under 35 U.S.C. § 101.