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Patents in Life Sciences Regenerative medicine Pharma / Medtech N. Giovannini, EPFL TTO, 21.11 2016 GENERALITIES WHAT ARE PATENTS USEFUL FOR WHAT CAN WE PATENT PREPARING A PATENT APPLICATION Drug development, drug delivery Medtech, microfluidics, Diagnostics, Medical imaging, Implants .. Personalised medicine Biomarkers, genomics, proteomic, epigenetics… .. STEM CELL THERAPY DISEASE MODELING REGENERATIVE MEDECINE CELL BASED THERAPY GENE THERAPY TISSUE ENGINEERING AND BIOMATERIALS, SYNTHETIC MATERIALS SMALL MOLECULE AND BIOLOGICS “Our working definition of regenerative medicine includes a broad range of products that leverage the body’s intrinsic abilities to heal itself.” “Regenerative medicine is the use of cells or entities that stimulate cells to repair or replace damaged tissues.” “We define regenerative medicine broadly. We include all technologies that are regenerative including cells, antibodies, gene therapies, small molecules, biologics, biomaterials, etc. Our company also considers stem cells for drug screening and safety toxicology testing as regenerative medicine. Immunotherapy is not positioned within our regenerative medicine group.” “Our team views ‘cell-based immunotherapy’as regenerative medicine with a large focus on oncology.” “Regenerative medicine means any therapy that will repair or restore cells and physiology leading to improved function. “Within our venture group we don’t have a specific definition, but from our understanding it can include a range of technologies including small molecules, biomaterials, cell-based therapies and stem cells. We would also include gene therapy.” Preclinical Clinical Trials 250 5 PHASE 1 PHASE 3 NUMBER OF VOLUNTEERS 20 - 100 3 – 6 Years PHASE 2 100 - 500 1,000 - 5,000 Years 6 6-8 – 7½ Years average 10-15 years / 0.5 - 5 BIO NDA SUBMITTED 5, 000 - 10, 000 Compounds IND SUBMITTED PRE- DISCOVERY Drug Discovery One drug approved (FDA /EMA) Phase 4: Post Marketing Surveillance Drug Discovery The evolution of the costs of pharma output Medical Devices Average 2-6 years Short comparison medtech time to market USA / Europe USA mix of sponsor time, FDA, insurance reimbursement status rapid EUROPE CE marking very rapid, insurance reimbursement status slower SHORT COMPARISON MEDTECH / PHARMA MEDTECH time to market 2-6, more patent coverage in time Scope of protection usually smaller than pharmaceuticals, example the stent market (2009): 24 BIO, >10’000 patents PHARMA time to market 8-12, less patent coverage in time Potential for scope of patent protection more important (average number of patents per drug: 2-3) CELL THERAPIES Until 2013, the FDA had approved only one stem cell product, Hemacord, a cord blood-derived product manufactured by the New York Blood Center and used for specified indications in patients with disorders affecting the body’s blood-forming system. 2014, First stem-cell therapy recommended for approval in EU of Holoclar (New treatment for rare condition caused by burns to the eye, the first advanced therapy medicinal product (ATMP) containing stem cells, as treatment for moderate to severe limbal stem cell deficiency (LSCD) due to physical or chemical burns to the eye(s) in adults. Estimate 2012 from the Reg. Medicine Annual Report 2012-2013): 60’000 stem cell transplants annually performed (oncology, blood disorders) for USD900Mio / 160K patients CELL THERAPIES cell therapy approvals (through out the world): 2002-2008: none 2008-2011: 5 approvals 2012: 7 approvals WHAT ARE PATENTS USEFUL FOR Product income PROFITABLE CNIES, PHARMA, BIOTECH Public, gvnt (no/light strings attached) Private funding (possible conditions) UNIVERSITIES Private investor, ecosystem support, angels, VC, .. START UPS Healthcare industry has low advantage to invest in product development costs without a patent protection because Healthcare companies bear the high costs of obtaining approval (FDA, EMA,..) only because they can charge high prices for PATENTED drugs USA EP • Assignee is protected by the priority date, as a counterpart he must disclose its invention (18 months) • Assignee is deciding about the commercial rights in the exploitation IMPORTANT a granted patent is not a market approval • Leverage for company investment • Research exemption Commercialisation and exploitation of licence revenues (revenue source) Asset value (negotiation tool) Licensing or cross-licensing (exchange of value, aera of collaborations) Blocking / Defensive uses (dissuasion weapon) Innovative image (marketing of a product, a company) PATENT APPLICATIONS ARE AHEAD One example of IP display Derwent pat database: Stem cell and medical device: Ab. 66 patents filed (quick search 2015) , owners inventors / institutions and a few cnies: MEDTRONIC TISSUETECH INC (1) MITRALIGN INC (1) MIT CAPITAL PARTNERS LLC IMRICOR MEDICAL SYSTEMS INC (1) BOSTON SCI SCIMED INC (1) CARDIO INC (1) Medtronic inc (1) BUT only one stem cell therapy approved by FDA (cord blood, for certain indications) GLOBAL STEM CELL PATENT APPLICATIONS / PATENTS Applications filed and patents granted at each office are shown for years 1986–2005. (Nature Biotechnology 2007) WHAT CAN YOU PATENT ? «AN INVENTION THAT PROVIDES A NEW TECHNICAL SOLUTION TO A TECHNICAL PROBLEM» PATENTABILITY CRITERIA An invention must be NEW never described before («prior art») INVENTIVE (Europe) or NON-OBVIOUS (US) ENABLED Described sufficiently to enable the skilled artisan to reproduce the invention without undue burden USEFUL (US) or have an INDUSTRIAL APPLICATION (Europe) PATENTABILITY CRITERIA An invention must be STATUTORY SUBJECT MATTER, not excluded by law (f (territory) Excluded subject matter is independent of novelty or inventiveness. “The categories of exclusions and exceptions may, depending on one’s moral, social or other point of view, appear acceptable or unacceptable, quixotic or outdated, liberal or conservative…” (Board of Appeal of the European Patent Office ). PATENTABILITY CRITERIA SIGNIFICANT DEGREE OF UNCERTAINTY AT THE MOMENT IF FILING FOR OBTAINING A PATENT APPLICATION, WHICH TYPES CLAIMS, WHICH SCOPE, ETC. Evolution of the legal context, evolution of case law, PREPARING A PATENT APPLICATION THE PRIOR ART Get a good knowledge of the field of your invention Be able to cite a certain number of publications, scientific and patent applications / patents PREPARING A PATENT APPLICATION PUBLIC DATABASES http://patentscope.wipo.int/search/en/result.jsf http://worldwide.espacenet.com/?locale=en_EP www.google.com/patents http://www.uspto.gov/patents/index.jsp https://www.lens.org/lens/ IPI subject search https://www.ip-search.ch/fileadmin/user_upload/ip- search/e/search_request_form_patentsearches_e.pdf PREPARING A PATENT APPLICATION THE PRIOR ART SEARCH Allows you to feel the landscape Allows you to bette interact with the patent attorney, raises the potential quality of the patent application Allow you to make business decisions Allow you to prepare and launch a patent monitoring PREPARING A PATENT APPLICATION THE PRIOR ART SEARCH – STARTER KIT A - Search with familiar names (authors, universities, companies) B - Get familiar with the scientific and technical language C - Search extension via classifications, .. With a view to analyze the patent trends in the field of regenerative medicine, it is important to note that the above-mentioned patent application pertains to the major international patent classification (IPC) of C12N 11/16, which generally relates to enzymes or microbial cells being immobilised on or in a biological cell. A quick search at the WIPO patent database reveals that there are 164 WIPO Patent Applications that include C12N 11/16 as primary patent classification. the following graph illustrates major players filing patents in this field. PATENT MONITORING YOU IDENTIFY POTENTIAL PARTNERS / COMPETITORS YOU IDENTIFY / FOLLOW THE ACTIVITIES OF YOUR PARTNERS / COMPETITORS GET A FEELING ON THE FREEDOM TO OPERATE .. IMPORTANT SUPPORT TO (BUSINESS) DECISIONS PREPARING A PATENT APPLICATION INVENTION DEFINITION - DECLARATION Background of the invention description, references Definition of the invention detailed description, reference to figures Embodiments of the invention Material and methods, detailed description, reference to figures Claims indicate types of claims (methods, device, new use, composition of matter,..) DO NOT BOTHER WRITE CLAIMS YOURSELF EPFL - TTO Technology transfer office Innovation Park Bât. J CH 1015 Lausanne Natalia Giovannini [email protected] +21 693 35 90 / +21 693 70 73 THANK YOU FOR YOUR ATTENTION Trade Related Aspects of Intellectual Property Rights (TRIPS) (1996) Members must grant patents for "inventions" in all "fields of technology" provided they meet all other patentability requirements MINTT (TRIPS) (1996) - Article 27(3) – exclusions Members may also exclude from patentability: a) the one "necessary to protect ordre public or morality"including when intended to protect human, animal or plant life or health or to avoid serious prejudice to the environment, provided that necessity is at stake, and not just convenience; and (b) a second group including: (i) diagnostic, therapeutic and surgical methods for the treatment of humans or animals, as well as (ii) plants and animals other than microorganisms, and (iii) plant or animal production essentially biological processes other than non-biological and microbiological processes” MINTT 70 60 50 40 30 20 Number of countries (TRIPS) (1996) – Country specific exclusions Article 27(3) – exclusions 90 80 10 0 Biotechnological inventions which can be used solely for one particular plant or animal variety Agricultural and horticultural methods Plant products Inventions Contrary to Laws of Nature Contrary to Sharia law Inventions for the protection of human, animal or plant health or life or the preservation of the environment New uses Processes for modifying the genetic identity of animals which are likely to cause them suffering without any… The human body and processes related to it Materials occurring in nature Inventions detrimental to human, animal or plant life or health and/or the environment Essentially biological processes for the production of plants and/or animals Plant and animal varieties Schemes, rules, methods etc for performing mental acts and/or intellectual activities Therapeutic, surgical and diagnostic methods for treating humans or animals Inventions contrary to law, public order, public policy, public interest and/or morality MINTT Patentable subject matter in US and Europe EPC art 52 (1) European patents shall be granted for any inventions, in all fields of technology, provided that they are new, involve an inventive step and are susceptible of industrial application. 35 U.S.C. 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 therefor, subject to the conditions and requirements of this title MINTT Biopatents-Subject matter exclusions Europe (Directive 98/44/EC)* - any invention whose commercial exploitation would be contrary to ordre public or morality (Art. 53(a) EPC) e.g. cloning in humans, modification of human germ lines, genetic identity, modification of animals causing them great harm; commercialisation human embryos - Invention concerning plant and animal varieties (Art. 53(b) EPC). - essentially biological processes for the production of plants and animals (Art. 53(b) EPC), i.e. classical breeding comprising crossing and selection - methods for treatment of the human or animal body by surgery or therapy, and diagnostic methods practiced on the human or animal body (Art. 53(c) EPC) - Discoveries (e.g. the mere discovery of natural substances, such as the sequence or partial sequence of a gene) are not patentable. * Implementation in European Patent Convention (EPC) USA (U.S. Code Title 35) 35 U.S.C. 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 therefor, subject to the conditions and requirements of this title Implicit judicial exceptions: - Abstract ideas - Laws of Nature/Natural principles - Natural phenomena - Natural products Leahy-Smith America Invents Act (2012) Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism. MINTT Eligibility test of subject matter – US law process, machine, manufacture, or composition of matter? - Abstract ideas - Laws of Nature/Natural principles - Natural phenomena - Natural products Identify marked difference? MINTT US patent law balancing act in assessing subject matter «All inventions at some level embody, use, reflect, rest upon or apply laws of nature, natural phenomena, or abstract ideas» Avoid Unwarranted monopoly … Promote Usefulness Social benefit … MINTT Basic differences in assessing subject matter • Must be a «process, machine, manufacture or composition» • Have a marked difference with what exists in nature or add something that is significantly different from Nature • Any biological material and/or process that has industrial applications + couple of exceptions • Biological material isolated from its natural environment or produced by a technical process even if it previously occured in nature is patentable . MINTT patentable subject matter methods for treatment by surgery, therapy and diagnostic methods on human/animals Europe USA Excluded except for products, in particular substances or compositions, for use in any of these methods Still accepted MINTT Non-biologicals for medical treatment/diagnosis MINTT Basic parts- human and other organisms DNA e.g. Genes, SNPs, introns* Recombinant DNA RNA lipids e.g. Therapeutic siRNAs e.g. Lipid encapsulation mRNA expression profile proteins glycans e.g. Antibodies e.g. Glycan biogels enzymes Drug target receptor for drug screening DNA carriers Recombinant protein MINTT Examples MINTT Cellular parts: human and other organisms Isolated cancer cells Adult stem cells Immortalized cells MINTT But not human embryonic cells (at least in Europe) MINTT No restrictions for Gene therapy except for germ cells MINTT No restriction for bioengineering patentable both US and EP MINTT Animals and plants: transgenics In Europe: only if technical feasibility is not confined to one variety MINTT Animals and plants: classical breeding Only allowed in the US Dairy cattle breeding for improved milk production traits in cattle MINTT Micro-organisms (Bacteria, viruses, ye Pure culture or transgenics now patentable only in Europe MINTT Synthetic Micro-organisms Allowed both in Europe and the United States MINTT Subject matter patentability - recap • Must be a «process, machine, manufacture or composition» • Have a marked difference with what exists in nature or add something that is significantly different from Nature • Essentially biologically processes (plant and animal breeding) • Not Isolated biological material • Any biological material and/or process that has industrial applications • Biological material isolated from its natural environment or produced by a technical process even if it previously occured in nature is patentable . • Inventions concerning animals and plants (e.g. transgenics) for which the technical feasibility is not confined to one species • microorganisms • Not Animal an plant varieties and essentially biological processes such as breeding • Not human germ and ES cells • Not methods of surgical and therapeutic treatment or diagnostics on human or any animal • Not inventions that are contrary to morality or public order MINTT Subject matter patentability - summary Europe : - Any isolated part of an organism or micro-organism - Inventions concerning animals and plants (e.g. transgenics) for which the technical feasibility is not confined to one species - microorganisms - Not Animal an plant varieties and essentially biological processes such as breeding - Not human germ and ES cells - Not methods of surgical and therapeutic treatment or diagnostics on human or any animal - Not inventions that are contrary to morality or public order USA: - Any invention that represents a process, machine, manufacture or composition Essentially biologically processes (plant and animal breeding) Not Isolated biological material – except for isolated micro-organisms MINTT Some history Take home messages - The patentability of an invention may differ from one country to another change during time change with the state of knowledge still not be covered by patent law If in doubt, don’t hesitate to contact the TTO (has a good network of Patent Attorneys) MINTT New use – Medical device Pain indication Neurorehabilitation paraplegics MINTT New use – Biomaterials Treatment of congestive heart failure Self-gelling alginate = Medical device is primarily physical in contrast to pharma exerting biochemical effect intended purpose is physical – does not achieve primary intended purpose by chemical action or being metabolized Encapsulation of Islet cells for injection into kidney MINTT 1. A method for inducing differentiation in stem cells, comprising, a) providing: i) a cell culture comprising human pluripotent stem cells, ii) a first inhibitor of Small Mothers Against Decapentaplegic (SMAD) protein signaling, wherein said first inhibitor is selected from the group consisting of Noggin, a disulfide-linked homodimer of Noggin, Dorsomorphin, LDN-193189, and mixtures thereof, and iii) a second inhibitor of Small Mothers Against Decapentaplegic (SMAD) protein signaling, wherein said second inhibitor is 4-[4-(1,3-benzodioxol-5-yl)-5-(2pyridinyl)-1H-imidazol-2-yl] benzamide (SB431542), and b) plating said stem cells in a culture medium, Example 13 c) contacting said plated pluripotent stem cells within 24-36 hours of said plating with said first inhibitor of Small Mothers Against Decapentaplegic (SMAD) protein signaling and said second inhibitor of Small Mothers Against Decapentaplegic (SMAD) protein signaling, and d) inducing differentiation of said contacted pluripotent stem cells into a population of cultured neuroectodermal precursor cells. 7. The method of claim 1, wherein said population of neuroectodermal precursor cells further differentiate into cells selected from the group consisting of central nervous system (CNS) progenitor cells, pattemable neuronal cells, dopamine positive neurons and motoneurons. US8642334 B2 (2014) MINTT Three related patents filed by Stanford • 400 licenses to apply the technique to commercial ends. • revenues of more than $255 million for the university, • creation of more than 2400 commercial products with aggregate sales exceeding $35 billion. MINTT In 1975, Boyer meets Silicon Valley venture capitalist Robert Swanson Genentech founded in 1976 MINTT Example of MRC / Institution X (2002) * Institution X grants the MRC a non-exclusive license under any and all of its intellectual property rights in vector X to manufacture and distribute HIV vaccine which incorporates the said vector or parts thereof together with the MRC HIV gene sequences. * For Developing Countries The license shall be world-wide and royalty-free for (World Bank classification). * For Developed Countries the license granted to MRC shall be world-wide and provide a royalty to Institution X (the royalty is only payable once the MRC has recovered all its reasonable direct costs expended on the development, manufacture and distribution of the HIV vaccine). MINTT