Patent issues in Industrial Biotech:

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1 Patent issues in Industrial Biotech: Nucleic Acids, Life Forms & Natural Products Konrad Sechley PhD, Vancouver, Canada 18 April, 2016

2 OVERVIEW Gene patenting Life Forms & Natural Products Conclusions Sechley

3 3

4 EUROPEAN PATENT CONVENTION RULE 23(E) 1) 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. 2) An element isolated from the human body or otherwise produced by means of a technical process, including the sequence or partial sequence of a gene, may constitute a patentable invention, even if the structure of that element is identical to that of a natural element. 3) industrial application must be disclosed Sechley

5 MYRIAD GENETICS BRCA1: BACKGROUND Eight priority applications (P1-P8) filed European application - filed August P2: BRCA1 sequence with 9 incorrect amino acids - BRCA1 sequence published with 9 errors after P2 filed - P5: correct BRCA1 sequence (1863 amino acids) 5

6 MYRIAD GENETICS BRCA1: OPPOSITION 2004/05 Priority from P2 not available for correct BRCA1 sequence - not directly & unambiguously derivable Earliest priority for claims: P5 Myriad s publication with incorrect sequence relevant prior art 6

7 MYRIAD GENETICS BRCA1: OUTCOME Claims not inventive over Myriad s publication - differences in non-technical part of sequence - arbitrary selection; no technical effect Myriad s patent revoked November lack of inventive step Appeal filed January allowed, but claim scope limited Sechley

8 AMP V USPTO 09 CV MARCH 2010 ACLU challenged several product and method claims: Sechley

9 AMP V MYRIAD USSC 569 U.S. (2013) NO For the reasons that follow, we hold that a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but that cdna is patent eligible because it is not naturally occurring. cdna with a proviso: cdna retains the naturally occurring exons of DNA, but it is distinct from the DNA from which it was derived. As a result, cdna is not a product of nature and is patent eligible under 101, except insofar as very short series of DNA may have no intervening introns to remove when creating cdna. In that situation, a short strand of cdna may be indistinguishable from natural DNA Sechley

10 10 Univ of Utah/Myriad v Ambry December 2014

11 ISSUED US PATENTS NATURE BIOTECH MAY 2013, 31: Patents potentially at risk Sechley

12 Overturned trial and appeal court decisions Claims to isolated nucleic acid directed to information v. a chemical product; not a manner of manufacture (& not valid) Isolation of material from a natural source no longer sufficient to meet threshold for patentability Sechley

13 CANADA: LONG QT PATENTS TRANSGENOMIC (UNIVERSITY OF UTAH) Settlement reached March 2016 Transgenomic offered public sector labs right to test for long QT syndrome Patent eligibility of nucleic acids still untested in Canada Nucleic acids are patent eligible if they have utility Sechley

14 Impact of US and Australian rulings in Myriad? Genome projects: many sequences are now prior art native sequences typically insufficient for patentability novel property required; need value-add component Sechley modification of sequence; unexpected property

15 PATENTABILITY OF HIGHER LIFE FORMS Sechley

16 CA: HARVARD V COM OF PATENTS SCC 2002, 21 C.P.R. (4TH) 417 [155] Owing to the fact that the patenting of higher life forms is a highly contentious and complex matter that raises serious practical, ethical and environmental concerns that the Act does not contemplate, I conclude that the Commissioner was correct to reject the patent application Sechley

17 MONSANTO CANADA V SCHMEISER 2004 SCC 34 The patented genes are present throughout the genetically modified plant and the patented cells compose its entire physical structure. In that sense, the cells are somewhat analogous to Lego blocks: if an infringing use were alleged in building a structure with patented Lego blocks, it would be no bar to a finding of infringement that only the blocks were patented and not the entire structure. 17

18 CANADA: CURRENT STATUS Higher Life Forms (HLFs) are not patent eligible but HLFs may be protected if the gene or cell can be patented Methods to produce HLFs patent eligible Unicellular organisms are patent eligible Sechley

19 EUROPEAN PATENT CONVENTION RULE 23 23b(3) "Biological material" means any material containing genetic information and capable of reproducing itself or being reproduced in a biological system. 23c Biotechnological inventions shall be patentable if they concern: (a) biological material which is isolated from its natural environment or produced by means of a technical process even if it previously occurred in nature; (b) plants or animals if the technical feasibility of the invention is not confined to a particular plant or animal variety Sechley

20 EUROPEAN PATENT CONVENTION ARTICLE 53 Exceptions to patentability: European patents shall not be granted in respect of: (a) inventions the commercial exploitation of which would be contrary to "ordre public" or morality (b) plant or animal varieties or essentially biological processes for the production of plants or animals; this provision shall not apply to microbiological processes or the products thereof; (c) methods for treatment of the human or animal body by surgery or therapy and diagnostic methods Sechley

21 EP: BROCCOLI G 02/07 1. A method for the production of Brassica oleracea with elevated levels of 4- methylsulfinylbutyl glucosinolates, or 3-methylsulfinylpropyl glucosinolates, or both, which comprises: a) crossing wild Brassica oleracea species selected from the group consisting of Brassica villosa and Brassica drepanensis with broccoli double haploid breeding lines; b) selecting hybrids with levels of 4-methylsulfinylbutyl glucosinolates, or 3-methylsulfinylpropyl glucosinolates, or both, elevated above that initially found in broccoli double haploid breeding lines; c) backcrossing and selecting plants with the genetic combination encoding the expression of elevated levels of 4-methylsulfinylbutyl glucosinolates, or 3-methylsulfinylpropyl glucosinolates, or both; and d) selecting a broccoli line with elevated levels of 4-methylsulfinylbutyl glucosinolates, or 3- methylsulfinylpropyl glucosinlates, or both, capable of causing a strong induction of phase II enzymes, wherein molecular markers are used in steps (b) and (c) to select hybrids with genetic combination encoding expression of elevated levels of 4-methylsulfinylbutyl glucosinolates, or 3- ethylsulfinylpropyl glucosinolates, or both, capable of causing a strong induction of phase II enzymes Sechley

22 BROCCOLI & TOMATO G02/07 AND G01/08 DE 9, 2010 To patent a breeding method a technical step that introduces or modifies a trait in the plant genome is required Not patentable: - sexually crossing the whole genomes of plants and selecting plants is an essentially biological process - human intervention, that includes a step of a technical nature which serves to enable or assist the performance of the steps of sexually crossing the whole genomes of plants or of subsequently selecting plants is not enough Sechley

23 EPO: G 2/12 AND G 2/13 MARCH 25, 2015 Claims amended - methods claims cancelled Product claims referred to Enlarged Board of Appeal An edible Brassica plant, with elevated levels of 4- methylsulfinylbutyl glucosinolates, or 3-methylsulfinylpropyl glucosinolates, or both, produced by the [rejected] method Product (by process) claims allowed The exclusion of the process does not have a negative effect on the patentability of a product claim directed to a plant or plant parts, even if the product is defined by the method used to produce it. but, the claim must not be directed to a plant variety Sechley

24 CA: SEMINIS VEGETABLE SEEDS 2013, 118 C.P.R. (4 TH ) 362 Method of marker assisted plant breeding - back-crossing wild type and commercial tomato varieties - DNA extraction and amplification - identifying plants exhibiting pest resistance Patentable: [84] In the present case, we find that the steps of markerassisted selection do require significant human technical intervention. The complexity of the selection procedures involves selective PCR amplification of regions of chromosome 10 followed by identification of specific markers. These techniques do not follow the laws of nature Sechley

25 AMP V MYRIAD USSC 569 U.S. (2013) NO Concluding remarks: We merely hold that genes and the information they encode are not patent eligible under 101 simply because they have been isolated from the surrounding genetic material Sechley

26 155. A live-born clone of a preexisting, nonembryonic, donor mammal, wherein the mammal is selected from cattle, sheep, pigs, and goats. No markedly different characteristics Roslin s chief innovation was the preservation of the donor DNA such that the clone is an exact copy of the mammal from which the somatic cell was taken. Such a copy is not eligible for patent protection Roslin s claimed clones are exact genetic copies of patent ineligible subject matter. Accordingly, they are not eligible for patent protection Sechley

27 USPTO GUIDELINES REVISED DECEMBER 16,2014 If a product of nature exception chemicals derived from natural sources (antibiotics, fats, oils, petroleum derivatives, resins, toxins, etc.); foods (fruits, grains, meats and vegetables); metals and metallic compounds that exist in nature; minerals; natural materials (rocks, sands, soils); nucleic acids; organisms (bacteria, plants and multicellular animals); proteins and peptides; and other substances found in or derived from nature. Then markedly different characteristics based on structure, function and/or properties required Sechley

28 USPTO GUIDELINES REVISED DECEMBER 16, Gunpowder (eligible combination not found in nature) 2 Pomelo Juice (juice + preservative eligible not found in nature) 3 Amazonic Acid (ineligible; with solubilizing agent, eligible) 4 Purified Protein (ineligible; novel form, eligible) 5 GM Bacterium (ineligible; with novel plasmid, eligible) 6 Bacterial Mixtures (ineligible; unique combinations may be eligible) 7 Nucleic acids (ineligible, unless not found in nature) 8 Antibodies (ineligible same as purified protein) 9 Cells (ineligible; novel form, eligible) 10 Food (kit: goat milk + novel bacterial species, ineligible; culture comprising same, eligible) Sechley

29 Sechley Proposed patent eligible subject matter October 16, 2015

30 SUMMARY Gene patenting Myriad: US, Australia, Europe Isolated nucleic acids not patent eligible in US and Australia; Patent eligible (with utility) in Europe, Canada Natural products USPTO practice still evolving Markedly different characteristics required Canada - Harvard: HLFs are not patent eligible Schmeiser: modified cells provide protection for a HLF/plant Seminis: breeding involving technical step = significant intervention Plant Breeding Broccoli & Tomato: Europe Breeding involving technical step = essentially biological processes Product produced by rejected method patentable, if not a variety Sechley

31 Questions Konrad Sechley PhD Principal, Patent Agent Head, Life Science Industry Goup Vancouver, BC, Canada gowlingwlg.com Gowling WLG (Canada) LLP is a member of Gowling WLG, an international law firm which consists of independent and autonomous entities providing services around the world. Our structure is explained in more detail at gowlingwlg.com/legal

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