Patents in Life Sciences Regenerative medicine Pharma / Medtech

Patents in Life Sciences Regenerative medicine Pharma / Medtech
N. Giovannini, EPFL TTO,

GENERALITIES WHAT ARE PATENTS USEFUL FOR WHAT CAN WE PATENT PREPARING A PATENT APPLICATION

REGENERATIVE MEDECINE
Drug development, drug delivery Medtech, microfluidics, Diagnostics, Medical imaging, Implants .. STEM CELL THERAPY DISEASE MODELING Personalised medicine Biomarkers, genomics, proteomic, epigenetics… .. REGENERATIVE MEDECINE CELL BASED THERAPY TISSUE ENGINEERING AND BIOMATERIALS, SYNTHETIC MATERIALS GENE THERAPY 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.”

Drug discovery ? Preclinical Studies Clinical Studies
H N CH3 S H2C N Formulation, stability scale up synthesis, chronic safety in animals Company file Investigational New Drug (IND) application with FDA Chemicals tested for efficacy and safety in test tubes and animals. Results used to choose drug candidate Research team formed and objectives set Novel chemicals synthesized Clinical Studies Phase I: Studies in healthy humans (toleration) Phase II: Studies in patients (efficacy) Phase III: large clinical trials in many patients Company files New Drug Application (NDA) FDA Reviews NDA Drug is approved for marketing

Drug Discovery PRE- DISCOVERY average 10-15 years / 0.5 - 5 BIO
Phase 4: Post Marketing Surveillance NDA SUBMITTED PRE- DISCOVERY Preclinical , ,000 6 – 7 Years PHASE PHASE 1 2 PHASE 3 Clinical Trials NUMBER OF VOLUNTEERS 5 6-8 ½ Years One drug approved (FDA /EMA) 5, , 000 Compounds 250 IND SUBMITTED Pharmas screen many candidate compounds before singling a winner compound- the costs can easily raise to 1-5 billion dollars in total LG-Scale Mfg.: large-scale manufacturing 3 – 6 Years average years / BIO

The evolution of the costs of pharma output

Medical Devices Average 2-6 years

Short comparison medtech time to market USA / Europe
mix of sponsor time, FDA, insurance reimbursement status rapid EUROPE CE marking very rapid, insurance reimbursement status slower

SHORT COMPARISON MEDTECH / PHARMA
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 ): 60’000 stem cell transplants annually performed (oncology, blood disorders) for USD900Mio / 160K patients

cell therapy approvals (through out the world):
CELL THERAPIES cell therapy approvals (through out the world): : none : 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 Check if picture with Watson and crick?

Healthcare companies bear the high costs of obtaining approval (FDA, EMA,..) only because they can charge high prices for PATENTED drugs Check if picture with Watson and crick?

USA EP Check if picture with Watson and crick?

Assignee is deciding about the commercial rights in the exploitation
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)

MINTT Extension of scope Filing on metabolites of drugs
Why is IP important in life sciences? Extension of scope Filing on metabolites of drugs Intermediates for production New uses New formulations Extension in time (Hatch Waxman Act / Supplementary protection certificate) Blockage of approval of the generic: 5 years from FDA approval (USA , 3 years if still under clinical investigation, until 5,5 in EP) Check if picture with Watson and crick? MINTT

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)

Why is IP important in life sciences? (suite)
.. “Today, there are more than 250 biotechnology products and vaccines approved by the U.S. Food and Drug Administration (FDA) that extend lives and provide new hope for patients living with debilitating diseases (1). And more than 600 new biotechnology medicines are currently either in clinical trials or under review by the FDA” .. (source Sci Transl Med 6 January 2010: Vol. 2, Issue 13, p. 13cm1 Sci. Transl. Med. DOI: /scitranslmed ) Check if picture with Watson and crick? MINTT

MINTT Many opportunites to collaborate-Open innovation Universities
Other firm’s market New market Internal technology base Licence, spin-out, divest Current market Internal/external Venture handling External technology base External technology insourcing Funnel shape innovation landascape A startup is a temporary organization in search of a repeatable, scalable business model A corporation, by contrast, is a permanent organization designed to execute a repeatable, scalable business model. Universities Start-ups and SMEs MINTT

Investors (VC, Angels…)
How can patents be used? Pharma Commercialisation and exploitation (revenue source) Marketing Benefit Bargaining Chip Industry Control/Influence Defensive uses Universities Start-up/Biotech Not for profit sponsors (Gvt, foundations…) Investors (VC, Angels…) MINTT MINTT

WHAT CAN YOU PATENT ? Biotechnology is the use of living systems and organisms to develop or make products, or "any technological application that uses biological systems, living organisms or derivatives thereof, to make or modify products or processes for specific use"

«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) Patenting in the life sciences- SV Inventions to be patentable must follow same general rules as for patents in any other field. Exclusions in patentability vary with societal context. While TRIPS sets overarching rules of a universal patent systems – there are points of freedom where each country Excluded subject matter or patents 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 ).

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 ).

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

PUBLIC DATABASES IPI subject search

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

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.

IMPORTANT SUPPORT TO (BUSINESS) DECISIONS
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

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

HUMAN CELLS EU US EU US EU US EU EU US US EU US
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. EU US EU US Stem cell technologies capable of commencing the process of development of a human being. : A ruling from the European Court of Justice lifts 2011 ban on patenting embryonic stem cells made from unfertilized eggs. parthenogenetis EU US

Technology transfer office Innovation Park Bât. J CH 1015 Lausanne
EPFL - TTO Technology transfer office Innovation Park Bât. J CH 1015 Lausanne Natalia Giovannini /

THANK YOU FOR YOUR ATTENTION

Trade Related Aspects of Intellectual Property Rights (TRIPS) (1996)
WTO members where TRIPS applies Umbrella agreement_. TRIPS established the minimum standards for patentability. Article 27.2 and 27.3 of TRIPS provide the possibility, but not obligation, to exclude certain inventions from patentability, for instance, inventions contrary to ordre public or morality, diagnostic, therapeutic and surgical methods for the treatment of humans or animals, plants and animals as well as essentially biological processes for the production of plants or animals TRIPS has 158 members 1996_TRIPS Agreement provides minimum standards concerning the availability, scope and use of intellectual property rights while incorporating older treaties such as Madrid, Paris Convention. PCT_ operational streamlining application among countries building on Paris Convention – one format, one language etc (managed by UN specialised agency : WIPO) Paris convention Member state of the World Trade Organization (WTO); dark green: member; light green: member of the EU and thus member; blue: observer; gray: no official Interaction with the WTO Members must grant patents for "inventions" in all "fields of technology" provided they meet all other patentability requirements MINTT

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” Patents must be granted for "inventions" in all "fields of technology" provided they meet all other patentability requirements Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) is an international agreement administered by the World Trade Organization (WTO) that sets down minimum standards for many forms of intellectual property (IP) regulation as applied to nationals of other WTO Members.[2] It was negotiated at the end of the Uruguay Round of the General Agreement on Tariffs and Trade (GATT) in 1994. History: Although the WTO is not a UN specialized agency, it has maintained strong relations with the UN and its agencies since its establishment in 1995 organization officially commenced on 1 January 1995 under the Marrakech Agreement, replacing the General Agreement on Tariffs and Trade (GATT), which commenced in 1948 MINTT

MINTT (TRIPS) (1996) – Country specific exclusions
Inventions contrary to law, public order, public policy, public interest and/or morality 84 Therapeutic, surgical and diagnostic methods for treating humans or animals 79 Schemes, rules, methods etc for performing mental acts and/or intellectual activities 75 Plant and animal varieties 70 Essentially biological processes for the production of plants and/or animals 57 Inventions detrimental to human, animal or plant life or health and/or the environment 22 Materials occurring in nature 18 The human body and processes related to it 15 Processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit, and animals resulting from such processes 9 New uses 6 Inventions for the protection of human, animal or plant health or life or the preservation of the environment 4 Contrary to Sharia law 2 Inventions Contrary to Laws of Nature Plant products 1 Agricultural and horticultural methods Biotechnological inventions which can be used solely for one particular plant or animal variety Article 27(3) – exclusions Number of countries If look at this table – left specific exclusions (including TRIPS) and to the right- the number of countries where exclusions applies- see many disparities –important to take into account if prosecuting a patent in many different countries. from table_ see many countries have adopted TRIPS but definitely not all, while other countries have onw specificities. MINTT

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 (2) The following in particular shall not be regarded as inventions within the meaning of paragraph 1: (a) discoveries, scientific theories and mathematical methods; (b) aesthetic creations; (c) schemes, rules and methods for performing mental acts, playing games or doing business, and programs for computers; (d) presentations of information. (3) Paragraph 2 shall exclude the patentability of the subject-matter or activities referred to therein only to the extent to which a European patent application or European patent relates to such subject-matter or activities as such. MINTT

Europe (Directive 98/44/EC)*
Biopatents-Subject matter exclusions Europe (Directive 98/44/EC)* USA (U.S. Code Title 35) 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. 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. The laws of nature, physical phenomena and abstract ideas” are not patentable subject matter. A “nonnaturally occurring manufacture or composition of matter — a product of human ingenuity—having a distinctive name, character, [and] use” is patentable subject matter. “[A] new mineral discovered in the earth or a new plant found in the wild is not patentable subject matter. Likewise, Einstein could not patent his celebrated E=mc2; nor could Newton have patented the law of gravity. Such discoveries are ‘manifestations of... nature, free to all men and reserved exclusively to none.’” (D) “[T]he production of articles for use from raw materials prepared by giving to these materials new forms, qualities, properties, or combinations whether by hand labor or by machinery” [emphasis added] is a “manufacture” under 35 U.S.C. 101. Concentrate on EU (Directive 98/44/EC) and US- - In europe anything is patentable if it has a technical character- Non-technical (e.g. abstract ideas, discoveries, methods of doing busness… ) + specific exclusions apply given by biotech directive. - In US no specific guidelines – patentability criteria are given by patent law that dates back to Jefferson whereby eligible subject matter may be process, machine, manufacture, or composition. EPO: Discoveries (e.g. the mere discovery of natural substances, such as the sequence or partial sequence of a gene) are not patentable. However, if an inventor provides a description of the technical problem they are intended to solve and a technical teaching they move from being a discovery to being a patentable invention (Art. 52(2)(a) EPC). TRIPs developments producing “a veritable revolution in patent protection at a universal level” Machine transformatoin test- US Also on United States, the patenting of human beings is prohibited under the 13 th amendment to the US Constitution which prohibits slavery and thereby any proprietory right in human beings. ^The legislative history of the AIA includes the following statement, which sheds light on the meaning of this provision: [T]he U.S. Patent Office has already issued patents on genes, stems cells, animals with human genes, and a host of non-biologic products used by humans, but it has not issued patents on claims directed to human organisms, including human embryos and fetuses. My amendment would not affect the former, but would simply affirm the latter. * Implementation in European Patent Convention (EPC) MINTT

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 US patent examination office published guidelines (2014) for identifying the patentability of subject matter that involves a judicial exception. For life science this means Natural ph and natural products. Aim of 12 defined questions is to define meaninful limits on the claimed invention if subject matter falls into a judical exception – there is marked difference Identify marked difference? MINTT

MINTT US patent law balancing act in assessing subject matter Avoid
«All inventions at some level embody, use, reflect, rest upon or apply laws of nature, natural phenomena, or abstract ideas» Avoid Promote Unwarranted monopoly … Usefulness Social benefit … US supreme court quote from Mayo vs prometheus MINTT

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
Method of surgery Diagnostic method Method for minimally invasive surgery in the digestive system Europe USA Check ref enforceability USA Excluded except for Still accepted products, in particular substances or compositions, for use in any of these methods MINTT

MINTT Non-biologicals for medical treatment/diagnosis US8315686 B2
US A1 MINTT

MINTT United States specific
Method of surgery and diagnosis practiced on human and animals allowed Method for minimally invasive surgery in the digestive system Check case law diagnostic MINTT

MINTT Basic parts- human and other organisms DNA RNA lipids proteins
glycans e.g. Genes, SNPs, introns* Recombinant DNA DNA carriers e.g. Therapeutic siRNAs mRNA expression profile e.g. Lipid encapsulation e.g. Antibodies enzymes receptor for drug screening Recombinant protein e.g. Glycan biogels Drug target Different approach US and EPO US: not per se but as part of a method EPO: if isolated from natural environment and industrial application. “biological material which is isolated from its natural environment or produced by means of a technical process even if it previously occurred in nature;” MINTT

Examples Courtesy affymetrix MINTT

MINTT Cellular parts: human and other organisms Isolated cancer cells
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, cannot constitute patentable inventions Isolated cancer cells Adult stem cells Henrietta lack (also know as Helen Lane for anonimity reasons)– not actualy patented but gave rise to thousands of patents using HelA- with the sequencing efforts of this major cell line- privacy concerns have arose for the descendants in her family. In fact a deal was struck with NIH who is funding sequencing effort to make HeLa genome data avaialble under restricted conditions. Oprah Winfrey planning producing a film based on the story – in 2010 HeLa (1st immortal cell line) Moore v. Regents of the University of California -The California Supreme Court ruled that Moore had no right to any share of the profits realized from the commercialization of anything developed from his discarded body parts Immortalized cells MINTT

MINTT But not human embryonic cells (at least in Europe)
Even methods of using ES stem cells to produce somatic cells MINTT

MINTT No restrictions for Gene therapy except for germ cells
The tools/intermediates are patentable Controversy following Germ cell genomoe editing using CRISPR – NIH bans funding for human germ cell editing MINTT

MINTT No restriction for bioengineering patentable both US and EP
MINTT

MINTT Animals and plants: transgenics Method of surgery allowed
Genes not eligible New drug dosage not eligible Could use skin from EPFL lab New mosquito species (Dengue eradication prgramme brazil), fish transgenics An "animal variety" is not legally defined in European patent law, but may be taken to be a group of animals of the same species which have been selected to constitute a breed having at least one significant and identifiable characteristic In Europe: only if technical feasibility is not confined to one variety MINTT

MINTT Animals and plants: classical breeding Only allowed in the US
Plant varieties generating by breeding in Europe have own protection under “International Union for the protection of plants” Dairy cattle breeding for improved milk production traits in cattle MINTT

Pure culture or transgenics now patentable only in Europe
Micro-organisms (Bacteria, viruses, yeast,…) Pure culture or transgenics now patentable only in Europe New mosquito species, fish transgenics MINTT

Allowed both in Europe and the United States
Synthetic Micro-organisms Allowed both in Europe and the United States MINTT

MINTT Budapest Treaty: depositing new microorganisms
Completely describing a microorganism is usually impossible. The Budapest Treaty ensures biological material deposited at one recognised institution so that it is recognised in all countries party to the Budapest Treaty. e.g. micro-organisms: bacteria, fungi, eucaryotic cell lines, plant spores; genetic vectors (such as plasmids or bacteriophage vectors or viruses) containing a gene or DNA fragments; organisms used for expression of a gene (making the protein from the DNA). e.g recognised depositry authority American Type Culture Collection (ATCC) Centraalbureau voor Schimmelcultures (CBS) Gottfried Wilhelm Leibniz Scientific Community (DSMZ) National Collection of Yeast Cultures (NCYC) World Federation for Culture Collections (WFCC) National Collection of Type Cultures (NCTC) Could use skin from EPFL lab New mosquito species, fish transgenics MINTT

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

MINTT Subject matter patentability - summary Europe : USA:
- 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

Law Science MINTT Time line biotech cases [US] Diamond v Chakrabarty
«anything under the sun made by man is patentable» Law 1970 1980 1990 2000 2010 2020 Science Rebergy was settled with chakraberty (patenting microorganism) i.e. life Insulin patent was granted a posteriori after chakrabarty settled. Relaxin -A DNA fragment encoding human H2-preprorelaxin, said H2-preprorelaxin having the amino-acid sequence set out in Figure 2 Brüstle case (2011) " (C-34/10), that Article 6(2)(c) of the EU directive excludes from patentability an invention which presupposes the destruction of a human embryo irrespective of the point in time at which such destruction takes place. USPTO was grnating patents for decades until Myriad… Mircroorganism landmark 1977 CCPA re Bergy Note Pasteur granted a patent on new yeast strain for brewing in 1873 novel method for producing yeast cultures. On 29 July 1873, microbiologist Louis Pasteur patented his improved yeast-making method at the French Patent Office. Synthetic insulin FDA approval biologics Dolly Animal cloning Human genome sequence Artificial bacteria FDA approval stem cell therapies prenatal diagnosis of alpha thalassemia Restriction enzymes Ligase, cDNA synthesis PCR Induced pluripotent stem cells 3D-printing Sanger DNA seq. Sale GM tomato genome seq. <2000$ embryonic stem cells monoclonal antibodies MINTT 1970 1980 1990 2000 2010 2020

MINTT Diamond v. Chakrabarty - (1980)
Patent for a «human made» oil eating bacteria challlenged by Diamond Commissioner of Patents and Trademarks- at a time when biotechnology was starting to take off. Challenged on basis that bacteria as living things and product of nature are not a patentable subject matter. A patent on living things would equate to patenting life. In perspective patenting micro-oragnisms not new –see Pasteur patents on yeast for optimised beer production (France) Patent filed in 1972 – resolved in 1980 MINTT

MINTT Diamond v. Chakrabarty (1980) US EP
Stable energy-generating plasmids exist within certain bacteria in nature. US EP 1. A stable energy-generating plasmid, which provides a hydrocarbon degradative pathway. 2. 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. But bacteria do represent a manufacture – use of raw material to give new qualities, properties, Life and living things not synonymous – distiction made. Genetic engineer Ananda Mohan Chakrabarty, working for General Electric, had developed a bacterium (derived from the Pseudomonas genus and now known as Pseudomonas putida) capable of breaking down crude oil, which he proposed to use in treating oil spills. General Electric filed a patent application for the bacterium in the United States listing Chakrabarty as the inventor,[2] but the application was rejected by a patent examiner, because under patent law at that time it was generally understood that living things were not patentable subject matter under Section 101 of Title 35 U.S.C «anything under the sun that is made by man» Author(s) Rebecca S. Eisenberg Source In Intellectual Property Stories, J.C. Ginsburg and R.C. Dreyfuss, eds. New York: Foundation Press, 2006; pp Summary This chapter explains how the courts came to decide that living things could be patented. Policy Relevance Neither the courts nor Congress have revived the older idea that some kinds of inventions should not be patented. Main Points Patent law says that any new or useful “process, machine, manufacture or composition of matter” can be protected by a patent. For many decades, the courts ruled that some kinds of inventions could not be patented, such as plants, products of nature, mathematical algorithms, and business methods. Some believe that the 1952 Patent Act abolished those exceptions. In the 1970s, inventors began filing more patent applications for biotech inventions like oil-eating bacteria. The PTO and the courts struggled to decide whether living organisms were patentable. Courts and judges disagreed whether new biotech and computer technology was patentable, or unpatentable, in the absence of explicit instructions from Congress. Many in the public and some experts feared the idea of genetic engineering, and some opposed patenting biotechnology because of this fear. In Diamond v. Chakrabarty, the Supreme Court ruled that: Assuming that unforeseen new technology was not patentable made little sense, because patents were intended to protect unforeseen advances. Judges should not add their own limits on patent law to the plain language of the patent statute. Biotechnology such as the oil-eating bacteria were not products of nature. The statement that the Patent Act covers “anything under the sun that is made by man,” comes from the legislative history of the 1952 Patent Act, and is still quoted in some cases today. Following this case, the patent office drastically expanded the kinds of inventions it was willing to patent, to include plants, animals, some computer technology, and business methods. Neither Congress, the Supreme Court nor other courts have stopped this expansion. MINTT Claim 1: A stable energy-generating plasmid, which provides a hydrocarbon degradative pathway. Non-naturally occurring because bacterium with multiple plasmids does not occur in nature, but instead was created by human manipulation. Claim 2: 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.

Law Science MINTT Landmark biotech cases Science
1970 1980 1990 2000 2010 2020 Science [US] Harvard Oncomouse [EPO] Harvard Oncomouse Science Rebergy was settled with chakraberty (patenting microorganism) i.e. life Insulin patent was granted a posteriori after chakrabarty settled. Relaxin -A DNA fragment encoding human H2-preprorelaxin, said H2-preprorelaxin having the amino-acid sequence set out in Figure 2 Brüstle case (2011) " (C-34/10), that Article 6(2)(c) of the EU directive excludes from patentability an invention which presupposes the destruction of a human embryo irrespective of the point in time at which such destruction takes place. USPTO was grnating patents for decades until Myriad… Mircroorganism landmark 1977 CCPA re Bergy Note Pasteur granted a patent on new yeast strain for brewing in 1873 novel method for producing yeast cultures. On 29 July 1873, microbiologist Louis Pasteur patented his improved yeast-making method at the French Patent Office. Synthetic insulin FDA approval biologics Dolly Animal cloning Human genome sequence Artificial bacteria FDA approval stem cell therapies prenatal diagnosis of alpha thalassemia Restriction enzymes Ligase, cDNA synthesis PCR Induced pluripotent stem cells 3D-printing Sanger DNA seq. Sale GM tomato genome seq. <2000$ embryonic stem cells monoclonal antibodies MINTT

MINTT Harvard OncoMouse (1984-2004)
Granted by United States Patent Office in Licenced to DuPont in 1999 Filed in Europe in 1985 and granted in 1992 after some hesitation whether excluded based on a 53 (b) – animal variety In Europe granted in 1992 but opposed until 2004-Board of Appeal of the European Patent Office, Decision of 6 July 2004, T 315/03 – by that time patent had expired. Grounds for opposition: the publication or exploitation of which would be contrary to ordre public or morality". And Article 53(b) excludes patents on "animal varieties or essentially biological processes for the production of…animals EPO applies the patent standards of the European Patent Convention, which contains two key relevant provisions: Article 53(a) excludes patents for inventions "the publication or exploitation of which would be contrary to ordre public or morality". And Article 53(b) excludes patents on "animal varieties or essentially biological processes for the production of…animals." EPO concluded that the usefulness of the oncomouse in furthering cancer research satisfied the likelihood of substantial medical benefit, and outweighed moral concerns about suffering caused to the animal. In the original application, the claims referred to animals in general, but in the course of the proceedings, the patent was amended and finally maintained with claims limited to mice. MINTT

MINTT Harvard OncoMouse (1984-2004) Harvard Oncomouse US EP
1. A transgenic non-human mammal all of whose germ cells and somatic cells contain a recombinant activated oncogene sequence introduced into said mammal, or an ancestor of said mammal, at an embryonic stage. 2. The mammal of claim 1 wherein said oncogene sequence comprises a coding sequence of a c-myc gene. EPO concluded that the usefulness of the oncomouse in furthering cancer research satisfied the likelihood of substantial medical benefit, and outweighed moral concerns about suffering caused to the animal. In the original application, the claims referred to animals in general, but in the course of the proceedings, the patent was amended and finally maintained with claims limited to mice. granted (1988) (grnated 1992) – opposed based on ordre public and morality and settled in 2004, revocation of the patent was eventually published on August 16, 2006, more than 20 years after the filing date (the normal term of a European patent under Article 63(1) EPC), for failure to pay the fees and to file the translations of the amended claims under Rule 58(5) EPC 1973. MINTT

Law Science MINTT Landmark biotech cases Law Science
prokaryotic genes (which do not include introns) derived from industrially valuable microorganisms Landmark biotech cases [US] Prometheus vs Mayo Cannot claim a naturally occuring correlation genomic biomarker sequences, e.g., short tandem repeats associated with disease outcomes or treatment success Law Law herapeutic ribosomal RNAs 1970 1980 1990 2000 2010 2020 Science enomic sequences differentially regulated by epigenetic mechanisms associated with disease [US] Association Molecular Pathology vs Myriad DNA is not a patentable subject matter (isolated cDNA is) [EPO]: gene sequences if industrial application (+isolation requirement) Science Rebergy was settled with chakraberty (patenting microorganism) i.e. life Insulin patent was granted a posteriori after chakrabarty settled. Relaxin -A DNA fragment encoding human H2-preprorelaxin, said H2-preprorelaxin having the amino-acid sequence set out in Figure 2 Brüstle case (2011) " (C-34/10), that Article 6(2)(c) of the EU directive excludes from patentability an invention which presupposes the destruction of a human embryo irrespective of the point in time at which such destruction takes place. USPTO was grnating patents for decades until Myriad… Mircroorganism landmark 1977 CCPA re Bergy Note Pasteur granted a patent on new yeast strain for brewing in 1873 novel method for producing yeast cultures. On 29 July 1873, microbiologist Louis Pasteur patented his improved yeast-making method at the French Patent Office. Synthetic insulin FDA approval biologics Dolly Animal cloning Human genome sequence Artificial bacteria FDA approval stem cell therapies prenatal diagnosis of alpha thalassemia Restriction enzymes Ligase, cDNA synthesis PCR Induced pluripotent stem cells 3D-printing Sanger DNA seq. Sale GM tomato genome seq. <2000$ embryonic stem cells monoclonal antibodies MINTT 1970 1980 1990 2000 2010 2020

Myriad (2012) spin-off of University of Utah specialising in molecular diagnostic company. BRCA 1and 2 cloned and patented from university of Utah in 90s – myriad exclusive licensee. Built business on BRCA genes and diagnostic for mutations in BRCA1 (&2) that dramatically increase a woman’s risk of developing breast cancer and ovarian cancer- owns many patents. Influenced Angelina Jolie’s decision to have a double mastectomy Myriad very agressive strategy in enforcing rights including for applied research or hospitals providing own test. Association for Molecular Pathology challengied the validity of gene patents in the United States. MINTT

Myriad (2012) EP- BRCA being Known “A method for diagnosing a predisposition for breast cancer associated with the BRCA2 gene locus which comprises determining a regulatory mutation of the BRCA2 gene in a tissue sample of said subject, said regulatory mutation being indicative of a predisposition to said cancer” BRCA1 biomarker for breast cancer patented by Myriad for genetic diagnostic test. US EP 1. An isolated DNA coding for a BRCA1 poly-peptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2 (i.e., the BRCA1 protein sequence). 2. The isolated DNA of claim 1 wherein the DNA has the sequence set forth in SEQ ID NO: 1 (i.e., the BRCA1 coding cDNA). Claims of patent allowed to exclude others form isolating DNA or producing synthetic cDNA. US Isolated segment of DNA is a product of nature- moreover even if the chemical bonds in the isolation process were servered the concern of the claim was the informatoin in the sequence. Myriad case overturned 30 years of gene patenting- BRCA Patent filed in 1995 – also mention relaxin ( pregnancy hormone ) case in EC – issued in 1991 Primers and probes not patentable Impact for diagnostic? Can highlight paradox under US- cell lines and ES cells are patentable –see Consumer Watchdog v. Wisconsin Alumni Research Foundation, No (Fed. Cir. 2013). EP: MINTT

Prometheus (2011) Thiopurine methyltransferase (TPMT) is a cytoplasmic enzyme that preferentially catalyzes the S-methylation of 6-MP and 6-TG to form S-methylated metabolites such as 6-MMP and 6-methylthioguanine (6-MTG), respectively. TPMT exhibits genetic polymorphism, with 89% of Caucasians and African Americans having high activity, 11% intermediate activity and 1 in 300 TPMT deficient. Clinical studies with AZA and 6-MP have shown an inverse relationship between TPMT activity and 6-TGN accumulation. Patients who less efficiently methylate these thiopurines have more extensive conversion to 6-TGN, which can lead to potentially fatal hematopoietic toxicity. Therefore, patients who have less active TPMT can be more susceptible to toxic side effects of 6-MP therapy. Thiopurine drugs are effective for treatment of gastrointestinal autoimmune diseases As inactive prodrugs, require intracellular activation, catalyzed by multiple enzymes The level of metabolite 6-thioguanine (6TG) correlates with efficacy or harmful effect Population heterogeneity in metabolising thiopurine drugs Last case concerns a personalised/compagnon diagnostic test for measuring the efficacy of Thiopurine drugs (individualise treatment). The case arose as a dispute between Mayo clinic and Prometheus- Mayo contesting the validity of prometheus patents. To understand patent need to understand pro-drug activation and variability of metabolism between patients. thiopurine drugs are purine antimetabolites widely used in the treatment of acute lymphoblastic leukemia, autoimmune disorders (e.g., Crohn's disease and Rheumatoid Arthritis) and of organ transplant recipients. As inactive prodrugs, 6-mercaptopurine (6-MP), 6-thioguanine (6-TG) and azathioprine (AZA) require intracellular activation, catalyzed by multiple enzymes, to exert cytotoxicity Prometheus is a specialty pharmaceutical and diagnostics company in the fields of gastroenterology and cancer; it was bought by Nestlé in 2011.[7] Prometheus sells diagnostic kits and also offers diagnostic service. Mechanism of action: as a diagnostic testing lab. Through metabolism, azathioprine is converted into 6-mercaptopurine, which is then converted into 6-thio-guanine. 6-thioguanine is converted into 2 metabolites: one that is incorporated into DNA (6-thioguanine nucleotides), and one that is incorporated into small GTPases (6-thio-GTP). Small GTPases play a role in various cell processes such as growth, differentiation, and movement. Rac1 is a member of the small GTPase protein family. We found that one of the azathioprine metabolites, 6-thioguanine triphosphate (6-thio-GTP) binds to Rac1 as a competitive antagonist of GTP. This binding suppresses the activation of Rac1, which leads to apoptosis. Essentially, through its effect on Rac1 activity, azathioprine converts a costimulatory signal into an apoptotic signal. ………………………………………………………………………………………………………………………………….. The case arose in a dispute between Mayo Collaborative Services and Prometheus Laboratories concerning a diagnostic test. Mayo Collaborative Services is a for-profit[3] diagnostic testing lab offering diagnostic services that operates as a subsidiary of Mayo Foundation for Medical Education and Research,[4] which is a nonprofit corporation[5] affiliated with the Mayo Clinic. Mayo Collaborative Services does business as "Mayo Medical Laboratories", has 3,200 employees working in 58 laboratories and offers services worldwide.[6] Prometheus is a specialty pharmaceutical and diagnostics company in the fields of gastroenterology and cancer; it was bought by Nestlé in 2011.[7] Prometheus sells diagnostic kits and also offers diagnostic services as a diagnostic testing lab. Prometheus is the exclusive licensee of these patents and sells diagnostic kits based on them.[1] Mayo bought and used these kits until 2004, when it decided to offer its own diagnostic tests to its clients at Mayo and worldwide, without buying the kit from Prometheus.[1] In June 2004 Prometheus sued Mayo for infringement in the Southern District Court of California, and in March 2008 the district court held the patents invalid under §101 (the section of US law governing patentable subject matter.)[11] MINTT

MINTT Prometheus (2011) > < 230 pmol per 8×108 red blood cells
ineffective harmful side effects defining with precision the concentration of 6-thioguanine metabolite levels associated with the thiopurine drug efficacy US EP 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 a level of 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder, wherein a 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 a 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. Claim 1, for example, states that if the levels of 6–TG in the blood (of a patient who has taken a dose of a thiopurine drug) exceed about 400 pmol per 8x108 red blood cells, then the administered dose is likely to produce toxic side effects. The relation itself exists in principle apart from any human action i.e. is a law of nature -> US: impact on personalised medicine and biomarkers. even if the relationship between parameter and the event it predicts is newly discovered or is very narrowly claimed, the claims may still be found ineligible. Accordingly, patent applicants who wish to claim diagnostic methods may need to convince the USPTO that the steps of their methods are not “well-understood, routine, [and] conventional- e..g using a partcular novel Ab intermediate.  EP: judged as inventive ( ) two US patents in the case are 6,355,623[8] and 6,680,302,[9] which are owned by Hospital Sainte-Justine in Montreal. Prometheus exclusive licensee. Prometheus’ patents set forth laws of nature—namely, relationships/correlation between concentrations of certain metabolites in the blood and the likelihood that a dosage of a thiopurine drug will prove ineffective or cause harm. If a law of nature is not patentable, then neither is a process reciting a law of nature, unless that process has additional features that provide practical assurance that the process is more than a drafting effort designed to monopolize the law of nature itself. Correlating a natural relation between enzymes and the drugs does not specifiy any particular process. It recites a natural law that is routine in clinic.  Brings undertainty for diagnostic in personal medicine. ………………………………………………………………………………………………………………………………….. The case arose in a dispute between Mayo Collaborative Services and Prometheus Laboratories concerning a diagnostic test. Mayo Collaborative Services is a for-profit[3] diagnostic testing lab offering diagnostic services that operates as a subsidiary of Mayo Foundation for Medical Education and Research,[4] which is a nonprofit corporation[5] affiliated with the Mayo Clinic. Mayo Collaborative Services does business as "Mayo Medical Laboratories", has 3,200 employees working in 58 laboratories and offers services worldwide.[6] Prometheus is a specialty pharmaceutical and diagnostics company in the fields of gastroenterology and cancer; it was bought by Nestlé in 2011.[7] Prometheus sells diagnostic kits and also offers diagnostic services as a diagnostic testing lab. Prometheus is the exclusive licensee of these patents and sells diagnostic kits based on them.[1] Mayo bought and used these kits until 2004, when it decided to offer its own diagnostic tests to its clients at Mayo and worldwide, without buying the kit from Prometheus.[1] In June 2004 Prometheus sued Mayo for infringement in the Southern District Court of California, and in March 2008 the district court held the patents invalid under §101 (the section of US law governing patentable subject matter.)[11] MINTT

Law Science MINTT Landmark biotech cases
prokaryotic genes (which do not include introns) derived from industrially valuable microorganisms Landmark biotech cases genomic biomarker sequences, e.g., short tandem repeats associated with disease outcomes or treatment success [US] Diamond v Chakrabarty «anything under the sun made by man is patentable» [EPO] Biotech Directive [EP] G02/06 - WARF Human stem cells not eligible Law herapeutic ribosomal RNAs 1970 1980 1990 2000 2010 2020 enomic sequences differentially regulated by epigenetic mechanisms associated with disease [US] Harvard Oncomouse Relaxin [EPO] Harvard Oncomouse [US] Association Molecular Pathology vs Myriad [US] Prometheus vs Mayo [EPO]: gene sequences if industrial application (+isolation requirement) Science Rebergy was settled with chakraberty (patenting microorganism) i.e. life Insulin patent was granted a posteriori after chakrabarty settled. Relaxin -A DNA fragment encoding human H2-preprorelaxin, said H2-preprorelaxin having the amino-acid sequence set out in Figure 2 «a hormone which relaxes the uterus during childbirth, and which, it was hoped, could have medical application in reducing the need for caesarean deliveries in difficult pregnancies” G0002/06 (Use of embryos/WARF) of In 1998 the named inventor using the methods suggested in the application was the first to successfully isolate and culture human embryonic stem cells that can grow in vitro. The provision of these is a major scientific breakthrough and pioneering invention opening up a new and very exciting field of research having great potential for promising medical therapies and other applications, and worthy of patent protection. EP PRIMATE EMBRYONIC STEM CELLS [ Brüstle case (2011) " (C-34/10), that Article 6(2)(c) of the EU directive excludes from patentability an invention which presupposes the destruction of a human embryo irrespective of the point in time at which such destruction takes place. USPTO was grnating patents for decades until Myriad… Mircroorganism landmark 1977 CCPA re Bergy Note Pasteur granted a patent on new yeast strain for brewing in 1873 novel method for producing yeast cultures. On 29 July 1873, microbiologist Louis Pasteur patented his improved yeast-making method at the French Patent Office. Synthetic insulin FDA approval biologics Dolly Animal cloning Human genome sequence Artificial bacteria FDA approval stem cell therapies prenatal diagnosis of alpha thalassemia Restriction enzymes Ligase, cDNA synthesis PCR Induced pluripotent stem cells 3D-printing Sanger DNA seq. Sale GM tomato genome seq. <2000$ embryonic stem cells monoclonal antibodies MINTT 1970 1980 1990 2000 2010 2020

MINTT 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) Re-Focus conclusion to second part – a method developed 10 years ago may be routine and obvious today where important investments are needed to bring out a product for commercialisation MINTT

MINTT New use – Medical device “Suitable for” Pain indication
Neurorehabilitation paraplegics US B2 WO A2 MINTT

MINTT New use – Biomaterials
a source of biocompatible occluding agent for establishing a therapeutically beneficial structural member within a vein for thickening and strengthening the myocardium of the heart; 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 EP – (from EPO search matters) Occluding agent is placed in the venous system of the heart in multiple locations so as to form a rigid or semi-rigid structure or scaffold within various segments of the cardiac venous system. The resulting structure, which may have multiple discrete parts, provides bulk to the myocardium and reinforces the myocardium in a pattern for the purpose of preventing, moderating, stopping or reversing negative cardiac remodeling due to various adverse cardiac conditions, both acute and chronic, or for the purpose of treating localize anomalies of the heart, or for both purposes. A suitable material is one that may be introduced preferably as an injectable agent in a low viscosity state into one or more sections of the venous system by preferably a minimally invasive technique, and that sets up into one or more rigid or semi-rjgid masses within the venous system to support the wall of the heart where desired. Optimization of alginate encapsulation of islets for transplantation US A1 Medical device is primarily physical in contras to pharma exerting biochemical effect 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 , 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-(2-pyridinyl)-1H-imidazol-2-yl] benzamide (SB431542), and b) plating said stem cells in a culture medium, c) contacting said plated pluripotent stem cells within 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. AiM: highlighting EP/US divide on stem cell patent -- IPS cells patentable under EP –still uncertain (can reproduce human being argument) – see EP B1 Induced pluripotent stem cells for use in regenerating cardiovascular tissue in a mammal US B2 –granted -2010 US B1 –granteed 2001 US B2 –granted 2014 European Court ruled last year (2013) that no patents can be granted for any technique based on human embryonic stem cells because it involved the destruction of something “capable of commencing the process of development of a human being.” Example 13 MINTT US 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

Building your claims in a life science patent
Abstract Background Summary of the Invention Specification/Description (i.e. decent scientific paper) Drawings CLAIMS Claims represent the «fences» that mark the edges of the patent holder’s rights Claims must be substantiated by evidence or an example

MINTT Yale Pressed to Help Cut Drug Costs in Africa
Yale Pressed to Help Cut Drug Costs in Africa By DONALD G. McNEIL Jr. New York Times, March 12, 2001 Trying a new tack to drive down the price of AIDS medicines, the medical charity Doctors Without Borders has asked Yale University to permit South Africa to import a generic version of a drug on which Yale holds the patent. The university, citing a patent contract with Bristol-Myers Squibb, has refused. But the Yale press office released a brief statement on Friday saying Yale had removed all barriers to Bristol-Myers in making the drug readily available in South Africa and hoped it would do so. A group of Yale law students, distressed that their university looks complicit in keeping the drug out of reach of thousands of dying South Africans while getting $40 million a year in license fees, have been planning to pressure Yale. A Bristol-Myers spokesman said the company was planning action because of the Yale protest, but declined to describe it. MINTT

Separate licensing revenue for developed and developing countries
A) INFLUENCE GLOBAL HEALTH B) SOCIALLY RESPONSIBLE PATENTING AND LICENSING POLICIES IN UNIVERSITIES University of Yale, Stavudine for HIV treatment. Exclusively licensed to Bristol Myers Squibb (trade name Zerit) Cost of treatment USD / year Action of MDS for South Africa Manufacturing in India for 40USA Check if picture with Watson and crick? MINTT

MINTT The Concept of Socially Responsible Licensing
SRL is the licensing of intellectual property (IP) so as to ensure - access to health technologies or products for underserved populations at affordable cost, while also seeking to encourage dissemination of know-how in all relevant markets. - SRL is a way to leverage IP to accelerate the development of solutions in a manner that leads to optimised access to medicines and other health technologies by populations most in need. Optimised access includes availability, affordability and acceptability of such technologies by the populations in need. MINTT

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

Conclusions Patents are critical in life sciences where the time to market can be long and risky Patents are a business tool Re-Focus conclusion to second part – a method developed 10 years ago may be routine and obvious today where important investments are needed to bring out a product for commercialisation MINTT

Patents in Life Sciences Regenerative medicine Pharma / Medtech

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Patents in Life Sciences Regenerative medicine Pharma / Medtech

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