Presenting a live 90-minute webinar with interactive Q&A Biotech Patents and § 101 Rejections: Meeting Patent Eligibility Requirements Leveraging Recent Decisions and USPTO Guidance to Overcome Rejections THURSDAY, MARCH 10, 2016 1pm Eastern | 12pm Central | 11am Mountain | 10am Pacific Today’s faculty features: Denise M. Kettelberger , Ph.D., Counsel, Sunstein Kann Murphy & Timbers , Boston Dr. Katherine M. Kowalchyk, Ph.D., Partner, Merchant & Gould , Minneapolis The audio portion of the conference may be accessed via the telephone or by using your computer's speakers. Please refer to the instructions emailed to registrants for additional information. If you have any questions, please contact Customer Service at 1-800-926-7926 ext. 10 .
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Eligibility Under 35 USC § 101 Is the Tide Turning? Denise M. Kettelberger Sunstein Kann Murphy & Timbers LLP March 10, 2016
Forces of Eligibility § 101 • The Statute • US Supreme Court precedent • Federal Circuit decisions • District Court push-back • USPTO Guidance • USPTO examination • Proposed Legislative Reform 5
35 USC Section 101 Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefore, subject to the conditions and requirements of this title. 6
Exceptions • Laws of nature, natural phenomena, abstract ideas – Neilson v Harford (1841) – LeRoy v Tatham (1853) – O’Reilly v Morse (1854) – Mackay Radio v Radio Corp (1939) – Funk Brothers v Kalo (1948) ______1952 Patent Act______ – Gottschalk v Benson ( 1972) – Parker v Flook (1978) – Diamond v Chakrabarty (1980) – Diamond v. Diehr (1981) – Bilski v Kappos (2010) – Mayo v Prometheus (2012) – Alice, Myriad, Sequenom , …………. 7
Prometheus v. Mayo - Defining the Exceptions • Phenomena of nature, though just discovered, mental processes, and abstract ideas are not patentable, as they are the basic tools of scientific and technological work… ( Gottschalk v Benson, 67) • And monopolization of those tools through the grant of a patent might tend to impede innovation more than it would tend to promote it. ( Diamond v Diehr, 187; quoting Parker v Flook, 590 ) • The Court has recognized … that too broad an interpretation of this exclusionary principle could eviscerate patent law. For all inventions at some level embody, use, reflect, rest upon, or apply laws of nature, natural phenomena, or abstract ideas. Id. 8
Alice Corp. v CLS Bank, Int’l. – the 2-Step • Step 1: Is the claim directed to a patent ineligible concept ? • Abstract idea, law of nature, natural phenomenon • Step 2: Do the elements of the claim transform the nature of the claim into a patent-eligible application [of the concept]? • The claim must do more than simply state the law of nature while adding the words “apply it”. ( citing Benson 409 US at 71-72) • SIGNIFICANTLY MORE 9
USPTO – Significantly More • improvements to another technology field • improvements to the functioning of a machine • judicial exception using a particular machine • transformation to a different state or thing • limitation - not well understood, routine, conventional • Unconventional steps in a particular useful application • Other meaningful limitations beyond linking the exception to a particular technological environment 10
The Exception to the Exception • An application of a law of nature to a known structure or process may well be deserving of patent protection ( citing Diehr 450 US at 187) • If there is to be an invention from a discovery of a law of nature, it must come from the application of the law of nature to a new and useful end . ( citing Funk Bros. 333 US at 130) • Must do more than simply state the law of nature while adding the words “apply it”. ( citing Benson 409 US at 71-72) • SIGNIFICANTLY MORE 11
Bilski limits Benson, Flook • Finally in Diehr , the Court established a limitation on the principles articulated in Benson and Flook . • The application in Diehr claimed a previously unknown method for molding raw, uncured synthetic rubber into cured precision products using a mathematical formula to complete some of its several steps by way of a computer. • Diehr explained that while an abstract idea, law of nature, or mathematical formula could not be patented, “an application of a law of nature of a mathematical formula to a known structure or process may well be deserving of patent protection.” ( Bilski at p.14, citing Diehr at 187). 12
Diehr – Eligible Flook – Not Eligible • The patentees did not seek to preempt the use of the equation, but “ only to foreclose from others the use of that equation in conjunction with all the other steps in their claimed process .” Diehr, slip opinion, 12 • Lacking specificity, the claims recite nothing other than “providing an unpatentable formula for computing an updated alarm limit.” citing Flook at 586 . 13
Myriad Genetics – Not Eligible A method for detecting a germline alteration in a BRCA1 gene , said alteration selected from the group consisting of the alterations set forth in Tables 12A, 14, 18, or 19 in a human which [method] comprises: analyzing a sequence of a BRCA1 gene or BRCA1 RNA [or cDNA] from a human sample _____________________? with the proviso that said germline alteration is not a deletion of 14 nucleotides corresponding to base numbers 4184-4187 US 5709999 Myriad Genetics 14
Myriad Genetics – Eligible? A method for diagnosing the presence of breast cancer in a subject, comprising the steps of: a) isolating a BRCA1 gene, RNA or cDNA from a sample of the subject’s tissue or cells and determining the nucleic acid sequence of the isolated gene, RNA, or cDNA; b) analyzing the isolated sequence to detect the presence of a germline alteration in a BRCA1 gene selected from the group consisting of the alterations set forth in Tables 12A, 14, 18, or 19 in the subject’s gene, RNA, or cDNA, With the proviso that said germline alteration is not a deletion of 14 nucleotides corresponding to base numbers 4184-7 ; and c) providing a diagnosis of breast cancer where one or more of said germline alterations is detected. . 15
Ariosa Diagnostics v. Sequenom 2016 • Fed Cir 2016, en banc reh’g denied • “ Our hands were tied and it’s up to the U.S. Supreme Court to fix this ” – “[I]t is undisputed that before this invention, the amplification and detection of cffDNA from maternal blood , and use of these methods for prenatal diagnosis, were not routine and conventional . – But applying Mayo, we are unfortunately obliged to divorce the additional steps from the asserted natural phenomenon to arrive at a conclusion that they add nothing innovative to the process.” Judge Lourie 16
Ariosa v. Sequenom, enbanc denied Federal Circuit Pushes Back • Judge Newman’s dissent : – Decision mandated by Supreme Court – wrongly decided – product and metabolites known in Mayo, l eaving sparse room for innovative advance in use as diagnostic – Here the method was not known , nor the diagnostic knowledge and benefit implemented by the method • " Precedent does not require that all discoveries of natural phenomena or their application in new ways or for new uses are ineligible for patenting “ 17
Ariosa v. Sequenom, enbanc denied Federal Circuit Pushes Back • Judge Linn : the breadth of the 2 nd part is unnecessary to the decision in Mayo – this case represents the consequences – perhaps uninteded - excluding a meritorious invention from the patent protection it deserves… • Judge Lourie: It is unsound to have a rule that takes inventions of this nature out of the realm of patent- eligibility on grounds that they only claim a natural phenomenon plus conventional steps, or that they claim abstract concepts. • Judge Dyk: …a too restrictive test for patent eligibility with respect to laws of nature may discourage development and disclosure in the life sciences which are often driven y discovery of new natural laws… we are bound by the language of Mayo… 18
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