Posts Tagged ‘Supreme Court’

Justice Breyer to Diagnostic Test Patentees – “Abandon Hope All Ye Who Enter Here.”

Friday, April 29th, 2016

danteKevin Noonan recently posted an article entitled “The Fantastical World of Justice Stephen Breyer” that demonstrates, via Breyer’s quotes during various oral arguments, his suspicion that the patent system is, for example, issuing broad, hard to understand, claims that lead to “national monopolies” and encourage trolls to  harass “small businessmen.” Breyer certainly appears to be leading the court in this area – he authored Mayo after all. No matter what Dr. Noonan thinks about his rhetoric, his anti-patent bias is clear, and has been for some time.

Noonan’s article encouraged me to re-read Breyer’s dissent from the Court’s refusal to decide whether or not the diagnostic claim at issue in Laboratory Corp. of Amer. Holdings v. Metabolite Labs., Inc. was patent-eligible under s. 101. (Breyer’s “Metabolite Labs. Dissent.”) (A copy can be found at the end of this post.) This remand occurred in 2006. The Fed. Cir. was still using the “useful, concrete and tangible result” test of State Street Bank, which morphed into the machine or transformation test by the time Bilski was decided. Both “tests” were urged to be applicable to the diagnostic claim at issue, but Breyer found no transformation recited in the claims and no precedent in the u-c-t test.

(more…)

Genetic Technologies Affirms Ariosa/Myriad With An Introduction By The Sequenom Petition for Cert.

Monday, April 11th, 2016

iStock_000067055603_SmallOn April 1st, Lilly filed an amicus brief in favor of Sequenom’s petition for cert. seeking to reverse Ariosa, that caused a lot of buzz in the IP community. (A copy is available at the end of this post.) To summarize, it argued that the courts’ attempts to interpret and define the judicial exceptions to s. 101 patent-eligibility was leading them to an unwarranted expansion of these policy-driven exceptions that threaten concrete technological advances that would otherwise be eligible for patent protection under the patent statute. In other words, the brief argued that the proper application the strictures of ss. 102 (requirement for physicality), 103 (inventiveness), 112(a)(WDR) and (f)(means plus function claiming) are sufficiently developed so that the court should abrogate the judicial exceptions that presently exclude what I will refer to as PAIN (phenomena of nature, abstract ideas and natural laws). (I checked that definition of “abrogate” and it does mean “do away with or to abolish by formal of official means.”)

I have written numerous posts in the last six years about the rise in importance of the written description requirement, as well as the evolution of s. 103 and I am willing to accept Lilly’s arguments. For example, the s. 102 requirement for novelty is sufficient to guard against issuance of patents on natural phenomena like fire, since fire is in the prior art. Pure concepts like blocking the NF-kB signaling  pathway to treat a condition ameliorated by blocking the NF-kB pathway would fail the written description requirement. Mental steps are permissible in a claim, but the claim cannot be entirely mental steps or disembodied functional language (See 112(f)). (This brief is worth reading just for its discussion of the mental steps doctrine at pages 18-21.)

(more…)

Happy Birthday to Us! We are 7 Years Old!

Monday, April 4th, 2016

7th birthdayIn fact, Patents4Life’s birthday was in late March of 2009, but the earliest posts were short papers I wrote for an IP newsletter that no longer exists. However, the s. 101 storm clouds were gathering even then. One article (in the archives for March 2009) was on how the Fed. Cir. affirmed the invalidation of immunization claims in Classen, using the Bilski machine-or-transformation standard for patent eligibility. (When Classen was revisited after the S. Ct. repudiated the M or T test, the claims reciting immunization were found to meet the requirements of s.101, while the claims that were directed to selection of the optimal immunization schedule did not make it through the coarse filter of 101.)

However, my co-author on this paper, an M.D., saw the threat to diagnostic claims pretty clearly:

“[Unlike diagnostic method claims that alter the body – like immunization] many diagnostic claims do not require the conversion of substance A into substance B. For example, consider claims to a simple blood test in which the presence of a particular substance predicts or diagnoses a disease. [Myriad-type diagnostic claims] involve ‘comparing’ genetic sequences and ‘diagnosing’ the presence of mutations… However, courts may not recognize a molecular transformation such as [the steps necessary to isolate the gene and detect it], or they may not consider it ‘central to the purpose of the claimed process’, as required by Bilski. Thus, Bilski could turn out to be quite problematic for comparison-type diagnostic claims.”

Even though the S. Ct. replaced the M&T test with the Mayo/Alice Rule, the language of this passage could have been written about Ambry (“Myriad II”) or Ariosa. I was going to write an April Fool post in which the Fed. Cir. affirms the patent-ineligibility of a basic chemical composition or treatment method of some sort but how does one top gunpowder or the incredibly convoluted PTO analysis of “amazonic acid?” Maybe I could sing a few verses of “Send in the Clowns” (“Don’t bother, they’re here.”)

Bristol-Myers Squibb v. Merck – Mayo/Alice Rule Reaches Medical Treatment Methods.

Friday, April 1st, 2016

In Bristol-Myers Squibb v. Merck, Civil Action No. 150572-GMS (D. Del., 2016), Bristol-Myers sued Merck for inducing infringement of U.S. Pat. No. 9,073,994. Claim 1 reads:

“A method of treating a metastatic melanoma comprising intravenously administering an effective amount of a composition comprising a human or humanized anti-PD-1 monoclonal antibody [and a carrier] to a human with the [cancer], wherein the administration of the composition treats the [cancer] in the human.”

It would be hard to write a more straightforward method of medical treatment claim. Merck moved for dismissal of the Complaint on the basis that it could not infringe a patent that is facially invalid under s. 101:

“According to Merck, [the patent] is directed to a natural phenomenon and the patent claims do not transform such natural phenomenon into a patent-eligible invention because the claims contain no inventive concept. Merck asserts that the ‘994 patent claims that the natural phenomenon is the body’s own mechanism for regulating the immune system… Merck claims the [patent] recites no inventive contribution beyond the natural phenomenon itself.”

(more…)