The Evolution of Life Science Patent Protection in the US

Transcription

1 The Evolution of Life Science Patent Protection in the US Carolina Innovations October 3, 2013 Nathan P. Letts, JD, PhD Disclaimer The views expressed are my own and not those of the Eclipse Group LLP, others in my firm, or its clients. Nothing about this presentation or slide deck should be construed as legal advice on any specific matter. Every case presents its own unique facts that must be carefully analyzed in view of current, applicable law before legal advice may be rendered. 2

2 Overview 1. Introduction: Utility Patents 2. Cases a) Merck v Integra (pre clinical research) b) LabCorp v Metabolite (what s past is prologue) c) Mayo v Prometheus (natural phenomena/biology) d) AMP v Myriad (gene patents) 3. Implications/Strategies 3 US Constitutional Basis Enumerated right: Art. 1, Sec. 8, Clause 8. Congress shall have the power. to promote the progress of science and useful arts, by securing for limited times to authors and inventors the exclusive right to their respective writings and discoveries. 4

3 Utility Patents Overview Issued by the United States Patent and Trademark Office (the USPTO ) Inventions useful ( 101), new ( 102), nonobvious ( 103), recipe ( 112) Newly issued patents have a 20 year term (from date on which the app. was filed) A patent confers the right to exclude others from making, using, offering for sale, or selling the invention 5 Proprietary Product Wheel Enforcement Coke Recipe Product Pfizer Lipitor Pfizer Lipitor Patent Protection Discoveries 6

4 Why seek Patent Protection? Provides a barrier to entry offensive : block direct copycats defensive : block alternatives that might compete Command a higher price in the market place Generate licensing revenue Asset for sale/spinout Negotiation bargaining chip (shield if sued) 7 Why Patent? Reduce risk for investors (small Co. can t compete with big Co.) Provide visibility for inventors, technology, company Drafting may reveal new ideas or uses BUT are a roadmap for others to build on/design around 8

5 Perfect World Patents? COMPOSITIONS Small molecules, new chemical entities (NCEs) Nucleic acids (genomic DNA, mrna, native fragments, cdna, synthetic DNA, vectors) DNA patents An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2. The isolated DNA of claim 1, wherein said DNA has the nucleotide sequence set forth in SEQ ID NO:1. (cdna claim) 10

6 Perfect World Patents? COMPOSITIONS Small molecules, new chemical entities (NCEs) Nucleic acids (genomic DNA, mrna, native fragments, cdna, synthetic DNA, vectors) Proteins (native, recombinant) Antibodies Stem cells, cardiomyocytes Cell lines, transgenic animals Pharmaceutical formulations METHODS OF USE Therapeutics Diagnostics (tests, imaging) Merck v Integra (1) The General Rule: 35 USC 271(a) It is patent INFRINGEMENT if one: makes, uses, offers to sell, or sells any patented invention within the United States or imports into the US during the term of the patent 12

7 Merck v Integra (2) The Exception: 35 USC 271(e)(1) It is NOT patent INFRINGEMENT: to make, use, offer to sell, or sell a patented invention solely for uses reasonably related to the development and submission under a Federal law regulating the manufacture, use, or sale of drugs 13 Merck v Integra (3) SCT held 271(e)(1) exception applies To ALL drug studies conducted where a compound may work, through a particular biological process, to produce a particular physiological effect To BOTH clinical research conducted after IND approval AND pre clinical studies geared towards an IND submission 14

8 LabCorp v Metabolite (1) Metabolite sued LabCorp for: 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 CAFC upheld 15 LabCorp v Metabolite (2) LabCorp appealed and SCT took the question: Is the patent invalid because one cannot patent laws of nature, natural phenomena and abstract ideas? Received briefs, heard oral arguments Dismissed the case as improvidently granted case But Justice Breyer s dissent 16

9 LabCorp v Metabolite (3) 2006 Justice Breyer argued for invalidity because: The correlation between homocysteine and vitamin deficiency is a natural phenomenon The claim s process only requires: Generically obtaining a test result Thinking about the result 17 Mayo v Prometheus (1) 1. A method of optimizing therapeutic efficacy for treatment of an immune mediated gastrointestinal disorder, comprising: (a) administering a drug providing 6 TG to a subject (b) determining the level of 6 TG in said subject wherein the level of 6 TG less than about 230 pmol per 8x10 8 red blood cells

10 Mayo v Prometheus (2) Both DOJ and USPTO urged SCT to invalidate patent under novelty ( 102) or obviousness ( 103) SCT invalidated under 101 claims inform a relevant audience about certain laws of nature; any additional steps consist of well understood, routine, conventional activity already engaged in by the scientific community; the steps are not sufficient to transform unpatentable natural correlations Mayo v Prometheus (3) A method of optimizing therapeutic efficacy for treatment of an immune mediated gastrointestinal disorder, comprising: (a) administering a drug step simply refers to the relevant audience, namely doctors who treat patients with certain diseases with thiopurine drugs (b) determining the level of step tells doctors to engage in well understood, routine, conventional activity

11 Mayo v Prometheus (4) Bottom line: SCT novelty ( 102) and obviousness ( 103) merged into threshold 101 (new law of nature analysis) USPTO issued guidelines interpreting Mayo v Prometheus USPTO Interim Guidelines Process claims having a natural principle should be evaluated by determining whether the claim includes additional elements/steps sufficient to ensure that the claim amounts to significantly more than the natural principle itself. Or Is it more than a law of nature + the general instruction to simply apply it?

12 AMP v Myriad (1) ACLU and several medical groups sued Myriad to invalidate BReast CAncer (BRCA1/2 ) gene patents and uses under 101 SCT took case Are human genes patentable? DOJ argued cdna patentable not genomic DNA April 2013 oral arguments compared isolating BRCA gene to baking chocolate chip cookies, making baseball bats, or uprooting medicinal plants 23 AMP v Myriad (2) SCT found Myriad s DNA sequences that occur in nature unpatentable under 101 just because they were isolated from the surrounding genetic material But methods, cdna, modified nucleic acids are patentable 24

13 AMP v Myriad (3) No specific claim by claim legal analysis SCT Nor do we consider the patentability of DNA in which the order of the naturally occurring nucleotides has been altered. But Myriad s BRCA1 was a consensus sequence combination of sequences allowed construction of a composite full length BRCA1 Again SCT novelty ( 102) and obviousness ( 103) merged into threshold 101 (new law of nature analysis) 25 AMP v Myriad (4) Since June several companies launched BRCA testing Myriad has sued under cdna, PCR probe, method patents Patrick Leahy requested NIH exercise march in rights and force licensing Uncertainty for existing nucleic acid portfolios, natural products such as taxol or adrenaline, isolated viruses, stem cells 26

14 Perfect World Patents? COMPOSITIONS Small molecules, new chemical entities (NCEs) Nucleic acids (genomic DNA, mrna, native fragments, cdna, synthetic DNA, vectors) Proteins (native*, recombinant*) Antibodies* Stem cells*, cardiomyocytes* Cell lines, transgenic animals Pharmaceutical formulations METHODS OF USE Therapeutics Diagnostics # (tests, imaging) DNA/RNA Patents Chen et al 2013 Nat. Biotech 31:404 28

15 Implications/Strategies (1) Pendulum swinging against life science patents (hasty reaction patents add to healthcare costs) Patents Trade secrets BEEF UP PATENT DISCLOSURE: Classic onion layered patent claims, multiple orthogonal ways to define/differentiate invention DIAGNOSTICS: add disclosure of testing, e.g., lab, doctor; add mathematical analysis, statistical methods; dx/rx combo; support for rx; more detail the better 29 Implications/Strategies (2) An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2 The isolated DNA of claim 1, wherein said DNA has the nucleotide sequence set forth in SEQ ID NO:1. (cdna claim) An isolated DNA having at least 15 nucleotides of the DNA of claim 1 30

16 Implications/Strategies (3) Isolated nucleic acid encoding a SNP A cdna on a plate to hybridize to SNP A primer pair SEQ ID No 1 and 2 for SNP An engineered plasmid containing SNP 31 Implications/Strategies (4) An assay to measure methylation pattern associated with disease X An assay to measure methylation pattern associated with disease X plus an algorithm to analyze Method of treatment, taking a sample, measuring SNP, comparing SNP, administering specific drug Method of selecting/identifying patients, taking a sample, measuring SNP, comparing SNP, selecting/identifying patient for drug 32

17 Resources U.S. Patent and Trademark Office USPTO IP Tool Patent Lens (free full text patents) Blogs: Patently O ( Patents4Life ( U.S. Copyright Office Int l Trademark Association (trade group) American I.P. Law Assn. (trade group) Assn. of Univ. Technology Mgrs. Licensing Executives Soc. World Intellectual Property Org. NOLO books (Patent It Yourself; Patent, Copyright & Trademark: An IP Desk Reference; etc.) 33 About the Presenter Dr. Letts has many years of practice in IP law. He currently works as a Senior Counsel at The Eclipse Group LLP in Durham, NC. He is also an Adjunct Assoc. Prof. in the Economics Dept. at UNC CH. He received a PhD from Columbia University in organic chemistry under Prof. Ronald Breslow and a JD from Fordham University. He has worked at Cooper & Dunham as a scientific advisor/patent agent and Pennie & Edmonds (now Jones Day) as an associate. From he was sole in house counsel at diadexus (S. San Francisco, CA) and VP IP & Licensing. Contacts: or npl@eclipsegrp.com 34