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Biotechnology Written Description, Enablement, and Patent Eligibility
 

Biotechnology Written Description, Enablement, and Patent Eligibility

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  • Great presentation Gary. For everyone else, I highly recommend Gary as an attorney - a great guy and a great lawyer! Brad Kurtz, Senior Counsel, DuPont.
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    Biotechnology Written Description, Enablement, and Patent Eligibility Biotechnology Written Description, Enablement, and Patent Eligibility Presentation Transcript

    • www.schwabe.com Biotechnology Patents: Technology, Written Description, and Patentable Subject Matter University of Washington School of Law Advanced Patent Law Gary M. Myles, Ph.D. Schwabe, Williamson & Wyatt February 1, 2010 Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
    • www.schwabe.com Topics Covered • Biotechnology Primer – The Technology of Biotechnology – Biotechnology Products • Written Description Requirement – U. of California v. Eli Lilly (Fed. Cir. 1997), Superenablement – Enzo v. Gen-Probe (Fed. Cir. 2002), Rader Dissent – Ariad v. Lilly (Fed. Cir. 2009) • Patentable Subject Matter – In re Bilski (Fed. Cir. 2008), Patentability of Method Claims – Classen v. Biogen (Fed. Cir. 2008) – Prometheus v. Mayo (Fed. Cir. 2009) – Ariad v. Lilly (D. Mass, 2007) Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
    • www.schwabe.com A Biotechnology Primer Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
    • www.schwabe.com Biotechnology vs. Pharmaceutical • Biotechnology: The use of biomolecules to treat disease • Pharmaceutical: The use of small molecules to treat disease Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
    • www.schwabe.com What are Biomolecules? • Genetic Material – DNA – RNA • Proteins – Receptors and Ligands – Enzymes – Antibodies • Lipids • Carbohydrates Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
    • www.schwabe.com The Eukaryotic Cell Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
    • www.schwabe.com DNA Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
    • www.schwabe.com The Central Dogma of Molecular Biology Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
    • www.schwabe.com The Genetic Code Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
    • www.schwabe.com Amino Acids are the Building Blocks of Proteins Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
    • www.schwabe.com Proteins are Linear Polymers of Amino Acids Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
    • www.schwabe.com Proteins adopt Three-dimensional Structures Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
    • www.schwabe.com Therapeutic Biotech Products • Nucleic Acid-based Therapeutics – DNA-based Cancer Vaccines – RNAi and antisense – Viral Vectors for Gene Therapy • Protein-based Therapeutics – Cytokines and Soluble Receptors – Vaccines against Infectious Disease – Antibodies and other Immunotherapeutics Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
    • www.schwabe.com • Therapeutic Proteins are expressed through Recombinant DNA Technology Recombinant Protein Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
    • www.schwabe.com Seattle Biotechnology Products Approved for Marketing by the FDA BEXXAR Corixa/GlaxoSmithKline CD20-positive Non-Hodgkins Lymphoma Cialis ICOS/Eli Lilly Erectile Dysfunction Nov 2003 Enbrel Immunex/Amgen Rheumatoid Arthritis Nov. 1998 Recothrom ZymoGenetics Surgical Bleeding May 2008 Provenge Dendreon Prostate Cancer Pending Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
    • www.schwabe.com Recombinant Proteins as Therapeutics • Rheumatoid Arthritis Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
    • www.schwabe.com Recombinant Proteins as Therapeutics • Cytokines, such as tumor necrosis factor, promote an inflammatory response • Causes the clinical problems associated with autoimmune disorders such as rheumatoid arthritis Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
    • www.schwabe.com Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
    • www.schwabe.com Enbrel – Soluble TNF-R Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
    • www.schwabe.com Recombinant Proteins as Therapeutics • Enbrel (Immunex/Amgen) – Recombinant soluble TNF•-R – Binds soluble, extracellular TNF• thereby preventing its binding to cellular TNF •-R – Therapeutic efficacy for the auto-immune disease rheumatoid arthritis (RA) Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
    • www.schwabe.com Antibodies Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
    • www.schwabe.com Anti-CD20 Antibodies • Non-Hodgkin’s Lymphoma – B-cells expressing CD20, a phosphoprotein found on the surface of >90% of B cells from peripheral blood or lymphoid organs Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
    • www.schwabe.com Rituxan Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
    • www.schwabe.com Bexxar (Corixa/GlaxoSmithKline) Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
    • www.schwabe.com Cialis (Lilly/ICOS) • Cialis is a phosphodiesterase type 5 (PDE5) inhibitor marketed for treating erectile dysfunction Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
    • www.schwabe.com Levitra Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
    • www.schwabe.com Patentability of Biotech Inventions Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
    • www.schwabe.com The Statutory Requirements for Patentability • Prior Art – 35 U.S.C. § 102 Novelty • Single reference • Discloses every element of claimed invention – 35 U.S.C. § 103 Non-obviousness • Multiple references • Predictability • Motivation to combine • Teach or suggest claimed invention • Reasonable expectation of success Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
    • www.schwabe.com The Statutory Requirements for Patentability • Disclosure Requirements – 35 U.S.C. § 101 Patentability/Utility • Statutory subject matter • Specific, substantial, and credible utility – 35 U.S.C. § 112, ¶ 1 Specification • Enablement • Written Description • Best Mode Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
    • www.schwabe.com 35 U.S.C. § 112, ¶ 1 Written Description Requirement Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
    • www.schwabe.com 35 U.S.C. § 112, ¶ 1 Written Description The SPECIFICATION shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains … to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention. Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
    • www.schwabe.com U. of California v. Lilly (Fed. Cir. 1997) • Facts – UC disclosed: • Cloned rat cDNA encoding insulin protein • Amino acid sequences of human insulin protein • General method for obtaining the human cDNA – UC claimed: 1. A recombinant plasmid replicable in procaryotic host containing within its nucleotide sequence a subsequence having the structure of the reverse transcript of an mRNA of a vertebrate, which mRNA encodes insulin. 5. A recombinant procaryotic microorganism modified so that it contains a nucleotide sequence having the structure of the reverse transcript of an mRNA of a human, which mRNA encodes insulin. Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
    • www.schwabe.com U. of California v. Lilly (Fed. Cir. 1997) • District Court – Held claims invalid under § 112, ¶ 1, because “the specification, although it provided an adequate written description of rat cDNA, did not provide an adequate written description of the cDNA required by the asserted claims.” Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
    • www.schwabe.com U. of California v. Lilly (Fed. Cir. 1997) • Federal Circuit Upholds District Court – Claim 5 invalid • “whether or not [Example 6] provides an enabling disclosure, it does not provide a written description of the cDNA encoding human insulin.” – Claim 1 invalid • A description of rat insulin cDNA is not a description of the broad classes [genra] of vertebrate or mammalian insulin cDNA • A description of a chemical genus ‘requires a precise definition, such as by structure, formula, [or] chemical name.’ Quoting, Fiers v. Revel 984 F.2d at 1171 Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
    • www.schwabe.com U. of California v. Lilly (Fed. Cir. 1997) • Written description becomes a super- enablement requirement Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
    • www.schwabe.com Enzo v. Gen-Probe (Fed. Cir. 2002) • Rader Dissent – History of the Written Description Requirement • “Written description” first appears in Patent Act of 1793 • Evans v. Eaton (1822), S. Ct. construed description requirement to be an enablement requirement • J.E.M. AG Supply (2001), S. Ct. acknowledged only enablement as the disclosure quid pro quo of Patent Act Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
    • www.schwabe.com Enzo v. Gen-Probe (Fed. Cir. 2002) • Rader Dissent, cont. – In re Ruschig (1967), CCPA first separated new WD requirement from enablement • To police priority: Whether new claim/amended claim entitled to priority • Converted § 132 new matter rejection into § 112 WD rejection • “The function of the description requirement is to ensure that the inventor had possession, as of the filing date of the application relied on, of the specific subject matter later claimed by him.” Judge Rich Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
    • www.schwabe.com Enzo v. Gen-Probe (Fed. Cir. 2002) • Rader Dissent, cont. – In re Kaslow (Fed. Cir. 1983) • “The test for determining compliance with the WD requirement is whether the disclosure of the application as originally filed reasonably conveys to the artisan that the inventor had possession at the time of the later claimed subject matter, rather than the presence or absence of literal support in the specification for the claim language.” Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
    • www.schwabe.com Ariad v. Lilly (Fed. Cir. 2009) • Ariad Claims: 95. [A method for reducing, in eukaryotic cells, the level of expression of genes which are activated by extracellular influences which induce NF-•B-mediated intracellular signaling, the method comprising reducing NF-•B activity in the cells such that expression of said genes is reduced], carried out on human cells. Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
    • www.schwabe.com Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
    • www.schwabe.com Ariad v. Lilly (Fed. Cir. 2009) • District Court – April 28, 2006, held claims infringed and not invalid for anticipation, lack of enablement, and lack of written description – August 2006, held claims directed to patentable subject matter (see below) Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
    • www.schwabe.com Ariad v. Lilly (Fed. Cir. 2009) • Federal Circuit – In Rochester v. Searle, held similar method claims invalid for lack or written description “A method for selectively inhibiting PGHS-2 activity in a human host, comprising administering a non-steroidal compound that selectively inhibits activity of the PGHS-2 gene product to a human host in need of such treatment.” Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
    • www.schwabe.com Ariad v. Lilly (Fed. Cir. 2009) • Federal Circuit – Rochester v. Searle, cont. – Patent disclosure did not disclose any suitable compounds – Moreover, “Rochester did not present any evidence that the ordinarily skilled artisan would be able to identify any compound based on [the specification’s] vague functional description.” Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
    • www.schwabe.com Ariad v. Lilly (Fed. Cir. 2009) • Federal Circuit – “Regardless of whether the asserted claims recite a compound, Ariad still must describe some way of performing the claimed methods. … the specification suggests only the use of the three classes of molecules*** to achieve NF-•B reduction.” – *** The three classes of molecules include • Specific Inhibitors • Dominantly interfering molecules • Decoy molecules Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
    • www.schwabe.com Ariad v. Lilly (Fed. Cir. 2009) • Federal Circuit “Thus, to satisfy the written description requirement for the asserted claims, the specification must demonstrate that Ariad possessed the claimed methods by sufficiently disclosing molecules capable of reducing NF-•B activity.” Capon Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
    • www.schwabe.com Ariad v. Lilly (Fed. Cir. 2009) • Federal Circuit “A vague functional description and an invitation for further research does not constitute written disclosure of a specific inhibitor. *** written description requires more than a ‘mere wish or plan for obtaining the claimed chemical invention.’ ” UC v. Eli Lilly Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
    • www.schwabe.com Ariad v. Lilly (Fed. Cir. 2009) • Federal Circuit – Judge Linn’s Concurrance “I write separately to emphasize … my belief that our engrafting of a separate written description requirement onto 35 USC 112, paragraph 1 is misguided. *** [S]ection 112, paragraph 1 requires no more of the specification than a disclosure that is sufficient to enable a person having ordinary skill in the art to make and use the invention.” Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
    • www.schwabe.com Ariad v. Lilly (Fed. Cir. 2009) • Ariad appeals to Federal Circuit for en banc review – Whether 35 U.S.C. § 112, ¶ 1, contains a written description requirement separate from an enablement requirement – If a separate written description requirement is set forth in the statute, what is the scope and purpose of the requirement? • On August 21, 2009, Federal Circuit grants en banc review, vacating the court’s April 3, 2009 opinion Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
    • www.schwabe.com Ariad v. Lilly (Fed. Cir. 2009) • Ariad Amicus Brief • Lilly Amicus Brief Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
    • www.schwabe.com Practice Tips – Claim Drafting • Broad claims • Better claims • The goal is to get valid claims that will read on a competitor’s infringing composition/method/device Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
    • www.schwabe.com Practice Tip – Draft Nested Claims from Broad to Narrow 1. Broad Independent Claim 2. Narrow Dependent Claim 3. Still Narrower Dependent Claim 4. Narrowest “Picture” Claim Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
    • www.schwabe.com Practice Tips – The Specification • Support broad claims with multiple actual and prophetic examples representative of the full claim scope Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
    • www.schwabe.com Practice Tip -- Disclosure of Single Embodiments is Risky Claim Construction OK if construed reads on: · Your commercial product · Competitor’s commercial product 35 U.S.C. § 112, ¶1 Bend, OR | Portland, OR | Salem, OR | Seattle, WA | “Invalid” Vancouver, WA
    • www.schwabe.com Practice Tip -- Disclose Multiple Embodiments Claim Construction 35 U.S.C. § 112, ¶1 “Not Invalid” Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
    • www.schwabe.com 35 U.S.C. § 101 Utility/Patentable Subject Matter Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
    • www.schwabe.com 35 U.S.C. §101 Inventions Patentable/Utility 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 therefor, subject to the conditions and requirements of this title Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
    • www.schwabe.com The Utility Requirement • Historically was rarely an obstacle to a patent • In the late 1990s, became a substantial hurdle in chemistry and biotechnology Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
    • www.schwabe.com The Utility Requirement • Lowell v. Lewis (MA 1817), Justice Story – “All that the law requires is, that the invention should not be frivolous or injurious to the well- being, good policy, or sound morals of society. … But if the invention steers wide of these objections, whether it be more or less useful is a circumstance very material to the interest of the patentee, but of no importance to the public. If it not be extensively useful, it will silently sink into contempt and disregard.” Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
    • www.schwabe.com The Utility Requirement • Brenner v. Manson (S. Ct., 1966), Justice Fortas – Due to the unpredictability of the art, disclosure not sufficient to show likelihood that the steroid produced would function similar to its homologues (i.e. no credible utility). – “A process patent in the chemical field, which has not been developed and pointed to the degree of specific utility, creates a monopoly of knowledge which should be granted only if clearly commanded by the statute.” – “The basic quid pro quo contemplated by the Constitution and Congress for granting a patent monopoly is the benefit derived by the public from an invention with substantial utility.” Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
    • www.schwabe.com The Utility Requirement • Utility Guidelines (USPTO 1999) – An invention fulfills the utility requirement if: • The invention has a well-established use (well known, immediately apparent) in the art OR • The applicant has disclosed – a specific utility for the subject matter claimed – a substantial, real world, utility – A credible utility that is logical, factual, operable to a PHOSA Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
    • www.schwabe.com 35 U.S.C. §101 Inventions Patentable/Utility 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 therefor, subject to the conditions and requirements of this title Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
    • www.schwabe.com Patentable Subject Matter: Fundamental Principles • Funk Bros. v. Kalo (S.Ct. 1948) – Mixed culture of root-nodule bacteria for inoculating seeds of leguminous plants • No patentable subject matter – Each species infects same group of plants – No species acquires a different use – No change in the individual bacteria – No change in their individual utilities – Use in combination does not improve natural functioning – “Manifestations of nature are free to all men and reserved exclusively to none” • Laws of nature – E = mc2 – Law of gravity • Physical phenomena • Principles • Abstract ideas • Products of nature Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
    • www.schwabe.com Patentable Subject Matter: Fundamental Principles • Diamond v. Chakrabarty (S.Ct. 1980) – Chakrabarty: • Created oil-eating bacterium • Claimed “a bacterium from the genus Pseudomonas containing therein at least two stable energy- generating plasmids, each of said plasmids providing a separate hydrocarbon degradative pathway.” Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
    • www.schwabe.com Patentable Subject Matter: Fundamental Principles • Diamond v. Chakrabarty (S.Ct. 1980), cont. – USPTO • Rejected claim because a bacterium is – A “product of nature” – A living thing – Supreme Court • Upholds validity of Chakrabarty’s claim – “Anything under the sun that is made by man” Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
    • www.schwabe.com Are These Inventions Patentable? • “Biologically pure” bacterial culture – Yes per CCPA in In re Bergy (1977) – The culture is not a “product of nature” because the culture did not exist in nature in its pure form • “Purified and isolated” DNA sequences – Yes per Fed. Cir. In Amgen v. Chugai (1991) • “Purified and isolated” stem cells – Yes per USPTO (see, Q. Todd Dickinson, www.ogc.doc.gov/ogc/legreg/testimon/106f/dickinson0112.htm) • Hydrostatically altered Pacific polyploid oysters, which grow larger than normal oysters – Yes per Ex parte Allen (BPAI 1987) • A transgenic non-human mammal all of whose germ cells and somatic cells contain a recombinant activated oncogene sequence … – Yes per Phil Leder, US Patent No. 4,736,866; “The Harvard Mouse” Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
    • www.schwabe.com LabCorp v. Metabolite (S.Ct. 2006) • Claim at issue 13. A method for detecting a deficiency of cobalamin or folate in warm-blooded animals comprising the steps of: • assaying a body fluid for an elevated level of total homocysteine; and • correlating an elevated level of total homocysteine in said body fluid with a deficiency of cobalamin or folate Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
    • www.schwabe.com LabCorp v. Metabolite (S.Ct. 2006) • Lower Courts – Upheld the patent claim’s validity and found that LabCorp infringed the claim Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
    • www.schwabe.com LabCorp v. Metabolite (S.Ct. 2006) • Supreme Court – Granted cert to determine whether claim is invalid because it seeks to “claim a monopoly over a basic scientific relationship” (cobalamin/folate = homocysteine) – Dismissed writ of certiorari as improvidently granted – Justice Breyer dissented (joined by Stevens and Souter) Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
    • www.schwabe.com LabCorp v. Metabolite (S.Ct. 2006) • Breyer dissent – Laws of nature are unpatentable because “sometimes too much patent protection can impede rather than ‘promote the Progress of Science and useful Arts.’ ” U.S. Const., Art 1, § 8 – Policy for Unpatentable Subject Matter • “the enormous potential for rent seeking that would be created if property rights could be obtained in [those basic principles]” and • “the enormous transaction costs that would be imposed on would-be users” Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
    • www.schwabe.com LabCorp v. Metabolite (S.Ct. 2006) • LabCorp – “If the Court were to uphold this vague claim, anyone could obtain a patent on any scientific correlation -- that there is a link between fact A and fact B -- merely by drafting a patent claiming no more than ‘test for fact A and correlate with fact B’ … ” Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
    • www.schwabe.com LabCorp v. Metabolite (S.Ct. 2006) • Metabolite – Detecting a vitamin deficiency, with discrete testing and correlating steps, is: • Patentable as a “process” • A patentable “application of a law of nature” – (1) It entails a physical transformation of matter » alteration of a blood sample during whatever test is used … – (2) It produces a useful, concrete, and tangible result » detection of a vitamin deficiency Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
    • www.schwabe.com LabCorp v. Metabolite (S.Ct. 2006) • Breyer – “There can be little doubt that the correlation between homocysteine and vitamin deficiency set forth in claim 13 is a ‘natural phenomenon’ – “[t]he process described in claim 13 is not a process for transforming blood or any other matter. Claim 13’s process instructs the user to • (1) obtain test results and • (2) think about them” Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
    • www.schwabe.com A Few Questions? • Should a method for diagnosing a disease based on taking a measurement and correlating that measurement with a disease state be patentable? • Should we reward the intellectual contribution even in the absence of a physical transformation? • Why should a physical transformation be required? • Isn’t the key intellectual contribution the observation of the relationship, not the methodology for making a measurement? Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
    • www.schwabe.com So, what makes a process patentable? Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
    • www.schwabe.com In re Bilski (Fed. Cir. 2008) Claim 1. A method for managing the consumption risk costs of a commodity sold by a commodity provider at a fixed price comprising the steps of: (a) initiating a series of transactions … ; (b) identifying market participants … ; and (c) initiating a series of transactions … . Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
    • www.schwabe.com In re Bilski (Fed. Cir. 2008) • Examiner rejected claims as directed to unpatentable subject matter under § 101 • BPAI affirmed the Examiner’s § 101 rejections • Federal Circuit ordered en banc review and, on October 30, 2008, issued a 9-3 decision affirming BPAI’s § 101 rejections Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
    • www.schwabe.com In re Bilski (Fed. Cir. 2008) • Federal Circuit (Citing Diamond v. Diehr) – A “process” under § 101 excludes: • Fundamental principles – Laws of nature – Natural phenomena – Abstract ideas (including mathematical algorithms) • Mental processes – Processes of human thinking – Systems that depend for their operation on human intelligence alone Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
    • www.schwabe.com In re Bilski (Fed. Cir. 2008) • The § 101 inquiry – If a claim preempts substantially all uses of a fundamental principle, it is unpatentable subject matter – If a claim preempts only a particular application of a fundamental principle, it is patentable subject matter Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
    • www.schwabe.com In re Bilski (Fed. Cir. 2008) • Federal Circuit applies a machine-or- transformation test to determine preemption of a fundamental principle – A claimed process is directed to patentable subject matter under § 101 if it: (1) is tied to a particular machine or apparatus; or (2) transforms a particular article into a different state or thing Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
    • www.schwabe.com The Supreme Court will Review In re Bilski • Questions presented: – Whether the CAFC erred by holding that a “process” must be tied to a particular machine or apparatus, or transform a particular article into a different state or thing. . . . – Whether the Federal Circuit’s “machine-or- transformation” test for patent eligibility . . . contradicts the clear Congressional intent that patents protect “method[s] of doing or conducting business.” 35 U.S.C. § 273 Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
    • www.schwabe.com Diagnostic Tools and Personalized Medicine: The Future of Biotechnology? • Genomic Personalized Medicine – Information about a patient's genotype or gene expression profile used to tailor medical care • Provide a specific therapy for an individual's disease • Initiate a preventative measure suited to an individual • “Rational drug design" based on knowledge of disease pathophysiology Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
    • www.schwabe.com Diagnostic Tools and Personalized Medicine: The Future of Biotechnology? • Breast Cancer as an Example – Identify overexpression of HER2 in a subset of breast cancer patients – Indicate treatment of HER2 positive patients with HER2-specific therapy (e.g., Herceptin) Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
    • www.schwabe.com Classen v. Biogen (DC MD 2006) • Classen claims: – A method of determining whether an immunization schedule affects the incidence or severity of a chronic immune-mediated disorder…, comprising • immunization …; and • comparison of the incidence of chronic immune mediated disorders … relative to a control group Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
    • www.schwabe.com Classen v. Biogen (DC MD 2006) • DC MD – “The [ ] patent does not claim a specific technique or technical process of testing [ ] safety – Instead, the [ ] patent describes only a general inquiry of whether the proposed correlation between an immunization schedule and the incidence of chronic disorders exists – As such, the process is indistinguishable from the idea itself – Accordingly, the [ ] patent seeks to patent an unpatentable natural phenomenon” Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
    • www.schwabe.com Classen v. Biogen (CAFC 2008) • Federal Circuit – “In light of our decision in In re Bilski … we affirm the district court’s grant of summary judgment that these claims are invalid under 35 U.S.C. § 101 – Dr. Classen’s claims are neither ‘tied to a particular machine or apparatus’ nor do they ‘transform[ ] a particular article into a different state or thing’ Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
    • www.schwabe.com Ariad v. Eli Lilly (DC MA 2007) • Claim: A method of inhibiting the expression of a gene whose transcription is regulated by NF-•B in a eukaryotic cell comprising the step of: – reducing NF-•B activity in the cell such that the expression of said gene is inhibited • No particular agent or substance need be used, nor any particular steps performed, to reduce NF-•B activity in order to practice the invention Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
    • www.schwabe.com Ariad v. Eli Lilly (DC MA 2007) • Lilly alleged that Ariad’s claims are directed to unpatentable subject matter – The claims encompass the NF-•B autoregulatory loop, a natural process in cells that operates to reduce the activity of NF-•B – Natural phenomena are excluded from patentable subject matter • Ariad alleged that the claims are valid because: – Patent claims a process, which is subject matter specifically allowed by statute; and – Autoregulatory Loop is only a theory and has not been proven to exist in human cells in vivo Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
    • www.schwabe.com Ariad v. Eli Lilly (DC Mass 2007) • DC Mass – “While not all processes are patentable, I find that Lilly has failed to show that the proposed model of the Autoregulatory Loop actually exists in nature and thus that a natural phenomenon is encompassed by the [ ] patent’s claims” • Holman’s Biotech IP Blog – “The court’s reasoning in Ariad was quite bizarre … The court appears to have been bamboozled into adopting an unduly narrow definition of the relevant natural phenomenon, and then found that the evidence supporting this narrowly defined phenomenon was insufficient to overcome the statutory presumption in favor of patent validity” Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
    • www.schwabe.com Prometheus v. Mayo (SD CA 2008) • Prometheus Claim 1 – A method of optimizing therapeutic efficacy…, comprising: • administering a drug providing 6-thioguanine to a subject…; and • determining the level of 6-thioguanine in said subject … wherein – 6-thioguanine less than about 230 pmol per 8x108 red blood cells indicates a need to increase the amount of said drug – 6-thioguanine greater than about 400 pmol per 8x108 red blood cells indicates a need to decrease the amount of said drug Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
    • www.schwabe.com Prometheus v. Mayo (SD CA 2008) • District Court – Claimed correlations between certain thiopurine drug metabolite levels and therapeutic efficacy and toxicity are natural phenomena • Result from innate metabolic activity in human body • Inventors did not “create” the correlation; the correlation results from a natural body process • Claims wholly preempt use of the correlations – The only practical use of the correlation is in drug treatment for autoimmune diseases Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
    • www.schwabe.com Prometheus v. Mayo (Fed. Cir. 2009) • September 2009, Federal Circuit reverses district court upholding patentability of methods for calibrating a drug dosage under 35 USC § 101 Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
    • www.schwabe.com Prometheus v. Mayo (Fed. Cir. 2009) • Federal Circuit, cont. – Applying the Bilski Machine or Transformation test, CAFC rules that the required administration of a drug “transforms an article into a different state or thing.” – Distinguish diagnosis claims that merely require data gathering and correlation rather than an injection or drugs Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
    • www.schwabe.com Prometheus v. Mayo • In October 2009, Mayo Clinic filed a petition for writ of certiorari to the U.S. Supreme Court • Question Presented “Whether 35 U.S.C. § 101 is satisfied by a patent claim that covers observed correlations between patient test results and patient health, so that the claim effectively preempts all uses of these naturally occurring correlations” Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
    • www.schwabe.com Lingering Question • In a method claim, is a physical transformation a meaningful distinction over an intellectual transformation? • Compare – Method of optimizing, comprising measuring, administering, and measuring – Method of diagnosing, comprising measuring, correlating measurement to disease Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
    • www.schwabe.com To Do List: • Is the death of a written description requirement that is separate from the enablement requirement imminent? – Read amicus briefs in and be on the lookout for Ariad v. Lilly (Fed. Circ. 2010) • Will the machine or transformation test for determining patentability of methods survive? – Are diagnostic method claims doomed? – Be on the lookout for Bilski v. Kappos (S.Ct. 2010) Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
    • www.schwabe.com Thank You! Gary M. Myles, Ph.D. Schwabe, Williamson & Wyatt gmyles@schwabe.com (206) 407-1513 Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA