Posts Tagged: "treatments"

Federal Circuit says Cleveland Clinic Diagnostic Patents Ineligible Under § 101

The Cleveland Clinic’s diagnostic or “testing” patents at issue dealt with a process by which an enzyme was measured and correlated against known levels of the enzyme in patients who were healthy or had cardiovascular disease. The Federal Circuit applied the two step Alice analysis, affirming a finding of Section 101 ineligibility and a failure by plaintiff to state a claim of contributory or induced infringement.

District Court Broadens Scope of Patent Ineligibility Under § 101 for a Treatment Method

The ‘156 patent discloses methods of treating and/or preventing metabolic diseases, particularly diabetes, in patients for whom metformin therapy is inappropriate due to intolerability or contraindication against metformin, e.g., renal disease, metabolic acidosis, congestive heart failure. Defendants alleged that the asserted claims are patent ineligible because the claims recite a natural law. Plaintiffs argued claims of the ’156 patent are directed towards methods of treating the targeted patient population with metabolic diseases using non-naturally existing DPP-IV inhibitors, which alter the natural state of the body in a new and useful way, and hence do not fall within the natural phenomena exception… Superficially, this decision may appear to be consistent with Mayo – methods of treatment claims that manipulate natural biological processes are considered to be directed to patent ineligible subject matter under § 101. However… it is not perfectly clear that the treatment claims of the patent-at-issue are directed to a law of nature or an abstract idea. Claim 1 is directed to an active practical application of a compound for treatment… The decision also appears at odds with the USPTO Subject Matter Eligibility Examples.

Patents are Just the Start

Capitol Hill is frequently the setting for both grandstanding and pandering, and given the prevailing political and public sentiment it is also frequently a place where businesses find an inhospitable welcome. A recent case in point: Three senior members of Congress (Henry Waxman, Frank Pallone Jr., and Diana DeGette) have started a joint investigation into the pricing of Sovaldi, a breakthrough drug for hepatitis C produced by Gilead Sciences. Rather than applaud the health benefits that this drug will deliver, Congress is grilling the company on their pricing decision, striking fear in the investment community, and indirectly undermining the healthcare innovation that is so desperately needed.

The Importance of Protecting Incremental, Improvement Innovation

Innovation provides new therapies and breakthrough treatments that extend and enhance life. The scientific and financial resources required for these advances are an investment worth making and an important precedent for global health. Patents encourage those innovations, making cutting-edge treatments a reality. Patents give innovation life. Current efforts to amend existing intellectual property legislation to “fix” the patent system will only undermine the incentives that encourage innovation. All innovation, both breakthrough discoveries and incremental improvements, is valuable and should be protected and rewarded. India, Brazil, South Africa and other emerging economies should take note. Their proposed changes, aimed at weakening intellectual property rights protections, are misguided and potentially very damaging to public health.

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.