Strategies for Protecting Biomarker Innovation in the US and Abroad - PowerPoint PPT Presentation

Strategies for Protecting Biomarker Innovation in the US and Abroad BayBio Lunch & Learn 19 February 2014 Django H. Andrews, Ph.D., J.D.

Roadmap • Definition of Biomarker • Types of Biomarker Innovations • Patent Eligibility of Biomarker Innovations � United States (Myriad, Prometheus) � Europe and Japan • IP Strategies for Protecting Biomarker Innovation • Business Models for Non-Patent Eligible Biomarker Innovation • Summary 2

Definition of Biomarker • “A distinctive biological or biologically derived indicator of a process, event, or condition.” – Merriam-Webster Medical Dictionary • Examples � Metabolite(s)/Level(s) � Gene mutation(s) � Antigen(s) � Protein(s) 3

4 Types of Biomarker Innovation • Identify biomarker • Develop test for biomarker Development Timeline • Identify therapeutic target(s) • Develop screening assay(s) • Identify therapeutic(s) • Develop dosing/treatment regimen

Biomarker Patent Eligibility, United States • Law � “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.” (35 U.S.C. § 101) � Broad coverage � Low hurdle with respect to obtaining US patent protection • US Supreme Court Interpretations on: � Metabolite Level(s) – Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S.Ct. 1289 (2012) � DNA and cDNA – Association for Molecular Pathology v. Myriad Genetics , 133 S.Ct. 2107 (2013) 5

Patent Eligibility, US: Prometheus • Challenged patent claims were to methods of determining the dosing effectiveness based on the measured level of drug metabolites. The only method steps are (a) administration and (b) measuring metabolite levels. “1. A method of optimizing therapeutic efficacy for treatment of an immune- mediated gastrointestinal disorder, comprising: (a) administering a drug providing 6-thioguanine to a subject having said immune-mediated gastrointestinal disorder; and (b) determining the level of 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder, wherein the level of 6-thioguanine less than about 230 pmol per 8 × 108 red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject and wherein the level of 6-thioguanine greater than about 400 pmol per 8 × 108 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.” � US 6,355,623 B2 , filed 08 April 1999 6

Patent Eligibility, US: Prometheus (cont.) • Claims held invalid for lack of patentable subject matter. • Supreme Court Summary: “Because the laws of nature recited by Prometheus’ patent claims—the relationships between concentrations of certain metabolites in the blood and the likelihood that a thiopurine drug dosage will prove ineffective or cause harm—are not themselves patentable, the claimed processes are not patentable unless they have additional features that provide practical assurance that the processes are genuine applications of those laws rather than drafting efforts designed to monopolize the correlations.” � (Significant tension in prior decisions) • Alternative Summary: Identification of the correlation between level of known metabolite and effective-safe dosing range of known drug is a law of nature and not patent eligible. 7

Patent Eligibility, US: Myriad • Challenged patent claims were to isolated DNA and cDNA encoding BRCA1 and BRCA2 genes. “1. An isolated DNA comprising an altered BRCA1 DNA having at least one of the alterations set forth in Tables 12A, 14, 18 or 19 [ note: identified patient mutations ] with the proviso that the alteration is not a deletion of four nucleotides corresponding to base numbers 4184-4187 in SEQ. ID. NO:1.’ � US 5,693,473 A , filed 07 June 1995 “2. The isolated DNA of claim 1, wherein said DNA has the nucleotide sequence set forth in SEQ ID NO:1 [ note : this is cDNA ].” � US 5,747,282 A , filed 05 May 1998 • Some claims held invalid for lack of patentable subject matter. • Supreme Court Summary: “A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but cDNA is patent eligible because it is not naturally occurring.” 8

Patent Eligibility, Europe • Everything is patent-eligible, except: � discoveries, scientific theories and mathematical methods; � aesthetic creations; � schemes, rules and methods for performing mental acts, playing games or doing business, and programs for computers; � presentations of information; � methods for treatment of the human or animal body by surgery or therapy, as well as diagnostic methods; and � the human body, at the various stages of its formation and development, and the simple discovery of one of its elements, including the sequence or partial sequence of a gene. – E.P.C., Pt. II, Ch. I, Art. 52 and decisions of the Enlarged Board of Appeal 9

Patent Eligibility, Japan • Any highly advanced creation of technical ideas utilizing natural laws, which involves novelty, inventive step, and industrial applicability is patentable. • Methods of surgery, therapy, or diagnosis of humans are unpatentable. Business methods not being a creation of technical ideas utilizing natural laws, are not patentable. • Plant and animal varieties, and computer programs may be patented. – Aoyama & Partners, Japan in Arnold & Siedsma (ed), Manual for the Handling of Applications for Patents, Designs and Trade Marks Throughout the World , (Kluwer Law International 1927, Supplement No. 153, February 2014) pp. 1 - 79 10

Patent Eligibility 1 of Biomarker Innovations United States 2 Europe 2 Japan 2 Innovation Isolated Yes 3 Yes 3 Yes Biomarker Biomarker Device: Yes Device: Yes Yes Assay Method: No Method: No Therapeutic No No Yes target Therapeutic screening Yes Yes Yes assay Therapeutic Yes Yes Yes Drug Dosing and treatment Yes Yes Yes regimen 1 These innovations may have other patentability issues. 2 These are generalizations, there are significant exceptions. Please consult a patent professional. 3 Except for gene sequences. 11

IP Protection Strategies Patent Trade Secret Pros: • Exclusivity • No disclosure • Enforceability • Potentially indefinite term (Make, use, sell, etc.) • Enforceability • Licensing (Only for theft/improper use) • Licensing Cons: • Disclosure • No exclusivity • Finite term • Jurisdictional variance • Jurisdictional variance Note: • Cannot have both • Need to choose path early 12

Proposed Business Models • In-house diagnostic testing � Retain proprietary information (trade secrets) in-house, low transaction costs � High infrastructure cost, may not overlap with core competencies • In-house therapeutic development � Retain proprietary target information (trade secrets) in-house � High cost, long development time • License correlation and/or target information � Low infrastructure cost, low capital risk � Higher transactional costs, less control of trade secrets, less upside 13

Conclusion • Patent eligible subject matter is evolving in the US and abroad • A global strategy is important when considering IP protection • Patent eligible subject matter should inform the business model and IP strategy • Important to make patent/trade secret decision early 14

Thank you. Presentation available from BayBio and Squire Sanders