Patent Law Biotechnology - JurisDiction

Patent Law Biotechnology - JurisDiction

Patent Law Biotechnology Melanie Szweras, Partner March 21, 2019 Patentable Subject Matter No common law patent rights Must look to Patent Act to determine what is patentable Only those things which fall into categories of proper subject matter under Relevant Act are patentable What is patentable may differ in

different jurisdictions 2 Statutory Subject Matter Section 2 of the Canadian Patent Act: invention means any new and useful art, process, machine, manufacture or composition of matter, or any new and useful improvement in any art, process, machine, manufacture or composition of matter 35 U.S. Code 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. 3 Life Forms The building blocks for biological inventions: Cells factory DNA - blueprints 4 Life forms

DNA codes for amino acids (every 3 nucleic acids code for an amino acid - like building blocks) Proteins strings of amino acids proteins responsible for a variety of functions in the body 5 Patentability of Life Forms Examples: Enzymes (Continental Soya Co. v. J.R. Short Milling Co. (1942)) Microbial cultures (Application of Abitibi Co. (Re) (1982))

Mammalian cell lines (Application for Patent of Connaught Laboratories (Patent No. 1,139,691) (Re) (1982)) 6 Higher Life Forms An old, scientific concept that was dismissed in the late 1800s 7 Higher Life Forms - Plants

Pioneer Hi-Bred Ltd. v. Canada (Commissioner of Patents), [1989] 1 S.C.R. 1623 Claimed a new soya bean plant variety derived from cross-breeding Two kinds of Genetic Engineering: Crossing: relies on natural process exception to patentability: law of nature (not an act of man) Molecular Manipulation (act of man) 8 Higher Life Forms - Plants Pioneer Hi-Bred Ltd. v. Canada (Commissioner of Patents),

[1989] 1 S.C.R. 1623 FCA: a variety of soya is not a composition of matter or manufacture under Section 2 of the Patent Act SCC: Not patentable case was decided on the basis of insufficient disclosure of the invention only the seed was filed 9 Higher Life Forms Plants (cont.) Plant varieties can be protected under the Plant Breeders Rights Act Gives the breeder of a new plant variety the exclusive

right to sell the propagating material for up to 25 years Registration is required Applies to reproductive material such as seeds, cuttings, bulbs and roots 10 Higher Life Forms - Animals Harvard College v. Canada (Commissioner of Patents), [2002] 4 S.C.R. 45 Facts: Made a transgenic animal that expressed a cancer gene called the oncomouse

The gene was injected into eggs, which were implanted into a female mouse and offspring were bred to produce mice that express the gene and are thus prone to cancer Claim 1: A transgenic non-human mammal whose germ cells and somatic cells contain an activated oncogene sequence introduced into said mammal or an ancestor of said mammal, at an embryonic stage. Issue: Are claims to an animal expressing this cancer-gene patentable? (act of man?) 11 Higher Life Forms Animals (cont.) Supreme Court of Canada Bastarache J. for the Majority (5:4):

Not patentable not a manufacture or composition of matter Definition of invention is exhaustive not clear that higherlife forms were intended to be patentable A higher life form is more than just a collection of atoms as opposed to a lower life form which is more chemical-like* [* Note from Don: scientifically, bunk. Its all just chemistry.] 12 Higher Life Forms Animals (cont.) Supreme Court of Canada Binnie J. Dissent: Higher life forms are compositions of matter Every cell in the mouse is different

Parliament didnt foresee this but like lower life forms and computers, they didnt intend to exclude (vs. majoritys intent to include) Line between lower and higher life forms is arbitrary Other countries allow patenting of higher life forms 13 Higher Life Forms (cont.) Monsanto Canada Inc. v. Schmeiser, SCC [2004] S.C.R. 902 Facts: Monsanto sells Round-Up Ready Canola seeds

(transgenic) to farmers in order to grow plants that are resistant to Round-Up and Monsanto licensed farmers to use the Round-Up Ready Canola Some seeds blew onto Schmeisers neighbouring farm and he saved the seeds for the following years crop Schmeiser never sprayed Round-Up on his crop but still is sued for infringement 14 Higher Life Forms (cont.) Monsanto (cont.) Issues: Since plants as higher life forms are not patentable

(Harvard mouse case), thus could the use of seeds and the growth of plants be an infringement of Monsantos cell and gene claims? Does the intent of Schmeiser (the alleged infringer) matter? Should profits be awarded to Monsanto? 15 Higher Life Forms (cont.) Monsanto (cont.) Held: 5:4 Claims to the gene and plant cells would protect use

of the plant containing them (effectively overturns Harvard mouse case?) 5:4 Finding of infringement (section 42 of the Patent Act exclusive right to make, construct, use, sell, etc.) The Court took a broad view of infringement: anything that interferes with the monopoly granted to the patentee Intent is irrelevant to infringement Schmeiser used the invention 16 Higher Life Forms (cont.) Remedy: Monsanto asked for an accounting of profits. Since

Schmeisers use of the plants didnt include spraying of Round-Up on the crop, there were no profits attributed to the invention Monsanto did not get legal fees 17 Higher Life Forms (cont.) Manual of Patent Office Practice (Chapter 17.02 Living Matters) Higher life forms: animals, plants, mushrooms, fertilized eggs and totipotent stem cells Animals: any stage of development from fertilized egg on, including totipotent stem cells capable of developing

into an animal Embryonic, multipotent or pluripotent stem cells are considered lower life forms. Plants: includes plant cutting, tuber, fruits, and seeds 18 Higher Life Forms (cont.) Manual of Patent Office Practice (Chapter 17.02 Living Matters) Lower life forms: Microscopic algae, unicellular fungi, bacteria, protozoa, viruses, transformed cell lines, hydridomas

Embryonic,* multipotent or pluripotent stem cells are considered lower life forms. [Note from Don: Sounds like a Sherlock Holmes story, The Case of the Disappearing Patentable Subject Matter] 19 Higher Life Forms (cont.) Manual of Patent Office Practice (Chapter 17.02 Living Matters) Organs and tissues are not compositions of matter and are not patentable.

Artificial organ-like or tissue-like structures, generated substantially by human intervention may be considered to be compositions of matter and therefore patentable subject matter. Note: In Europe, cannot patent an invention that required destruction of human embryos or their use as a base material 20 Higher Life Forms (cont.) United States Charkrabarty (1980): living things are patentable The distinction is between product of nature and man-made inventions

Europe Article 53 (b) EPC: plant or animal varieties or essentially biological processes for the production of plants and animals are not patentable. G1/98 (1999): transgenic plants are patentable so long as specific plant varieties are not claimed. Gene manipulation does not constitute essential biological processes. 21 Genes United States (Myriad decision): genomic DNA is considered a product of nature but cDNA is patentable

subject matter because not found in nature Implications for proteins, primers, probes, etc. Canada and Europe: Isolated proteins and nucleic acids including human genes are currently patentable The Canadian courts have not had a chance to address this issue. The most recent challenge to the validity of gene claims resulted in a settlement. (CHEO v Transgenomics, 2016) Europe: Rule 29(1&2) EPC: an element isolated from the human body [] including the sequence [] of a gene, may constitute a patentable invention even if [] identical to that of a natural element. 22

Biologics: Antibodies Functionally defined class of antibodies = patentable AbbVie Corporation et al. v. Janssen Inc., 2014 FC 55 Antibody must be against a novel, non-obvious antigen. Manual of Patent Office Practice (chapter 17.07) 23 Patentable Subject Matter Medical Treatments Section 2 of the Patent Act provides for the definition of invention as follows:

any new and useful art, process, machine, manufacture or composition of matter, or any new and useful improvement in any art, process, machine, manufacture or composition of matter Are processes performed on an animal patentable? 24 Medical Treatments (cont.) Tennessee Eastman Company et al. v. Commissioner of Patents, SCC [1974] R.C.S. 111 Method of surgically bonding tissues using a certain compound (new use for an old compound)*

Methods of medical treatment such as a process of surgery or therapy are unpatentable because such methods do not produce an essentially economic result in relation to trade, industry or commerce. Also noted that methods of surgery relied on professional skill and would not come under Art. [* Note from Don: Crazy Glue] 25 Medical Treatments (cont.) Any method that provides a practical therapeutic benefit to a subject by curing, preventing or ameliorating an ailment or pathological condition, or by treating a physical

abnormality or deformity is a method of medical treatment and is unpatentable. (Tennessee Eastman, 1974) Exclusions: non-surgical steps, treatment of natural conditions (e.g. cosmetics, antiaging, pregnancy, baldness, etc.) 26 Medical Treatments (cont.) Not patent-eligible: Cosmetic dental procedure with medical function (filling cavities/caries) (Imperial Chemical Industries Ltd. v. Canada (Commissioner of Patents), FCA [1986] 3 F.C. 40; 9 C.P.R. (3d) 289)

Method of medically treating non-humans (Re: Application No. 947803 [1974] C.D. 194, 32 C.P.R. (2d) 236 (PAB)) Patent-eligible: natural conditions Antiaging (Re: Senentek 77 C.P.R. (3d) 21) Contraception (Re: General Hospital Corporation 74 C.P.R. (3d) 544) 27 Medical Treatment vs. Use (compounds) A method of treating condition Y by administering compound X. (not patentable)

But can get around this issue by drafting use claims that do not include active steps: A use of compound X for treating condition Y. (Canadian Style) A use of compound X in the preparation of a medicament for treating condition Y. (Swiss style) Compound X for use in the treatment of condition Y. (New European Style) 28 New Uses of Known Compounds Shell Oil v. Canada (Commissioner of Patents) (1982), 67 C.P.R. (2d) 1 (SCC)

chemical compounds (new and old) mixed with an adjuvant discovered to be useful as plant growth regulators A new use for an old compound is patentable. Re: Application for Patent of Wayne State University (1988) 22 C.P.R. (3d) 407 (PAB) Applicant determined that an old compound could be used for reducing metastasis and neoplastic growth (cancer). A new medical use for an old compound is patentable. 29 Dosage Regimens Many dosage regimen limitations have been held invalid:

a dose of 13 to 15 mg/kg/day (Axcan v Pharmascience, 2006 FC 527) a dose of 50 to 300 units (PAB Decision no. 2009) 5 mg wherein the period between administrations is about one year (Novartis v. Cobalt, 2014 FCA 17; upholding 2013 FC 985) Any claim that prevents, interferes with or requires the professional skill of a physician is not patentable. 30 Dosage Regimens Limitations that have been upheld 1.0 mg tablet as a daily dose (Merck v Pharmascience, 2010

FC 510) 70 mg on a once-weekly basis (Merck v Apotex, 2005 FC 755) 40 mg preloaded syringe given on a 14 day dosing interval (AbbVie Biotechnology v Canada, 2014 FC 1251) Limitations which claim vendible product are allowable 31 Diagnostic Methods in Canada Courts have distinguished between: methods of medical treatment (not

patentable) and diagnostic methods (generally patentable) Re: Goldenberg 22 C.P.R. (3d) 159 Case involved detection of radioactive substances after injection into the human body Found patentable 32 Diagnostic Methods (cont.) Diagnostic methods have come under fire in the United States Challenged as non-patentable as abstract mental

processes or natural phenomenon Cases: Myriad Genetics, Prometheus v. Mayo, Classen v. Biogen, Athena v. Mayo Courts Reasoning: dont want to tie up the further use of a law of nature. Need to have additional elements that integrate the natural principle into claimed invention such that natural principle is practically applied. 33 USPTO Guidance on Laws of Nature/Natural Products

1. Is the claim directed to one of the four statutory categories of 35 U.S.C. 101? If Yes 2. Is the claim directed to a judicial exception? (incl. laws of nature/natural products). For a nature-based product, the answer is no if it has markedly different characteristics from its naturally occurring counterpart If Yes (or Maybe) 3. Does the claim recite additional elements that amount to significantly more than the judicial exception(s)? 34

Diagnostic methods in Canada Amazon (2010 FC 1011, affd in part 2011 FCA 328): The Court rejected the technological requirement for patentable subject matter The focus is on the practical application that the method as a whole provides, on the new and inventive method applying skill and knowledge and on whether such method yields a commercially useful result

Despite Amazon, Canadian Patent Office issued new practice guidelines, which look to determine whether solution to problem is a data acquisition or data analysis 35 Diagnostic Methods in Canada Patent Notice: Examination Practice Respecting Medical Diagnostic Methods PN 2015-02 (June 29th, 2015) Identify the problem and solution Data acquisition problem v. data analysis problem Determine essential elements using a purposive construction Elements that are essential to the problem, and not simply required

by the claim Determine whether the claim defines statutory subject matter Essential elements that are disembodied (e.g. mental process, lacking physicality, no practical application, etc.) will be identified as defective 36 Diagnostic Methods in Canada (PN 2015-02) Data acquisition v. Data analysis A diagnostic method outlines a sequence of steps to be followed to extract diagnostic meaning from data and will

often comprise steps to: Acquire data about an analyte (e.g., identifying, detecting, measuring, etc. the presence or quantity of X in a sample); and Analyze the significance of the acquired data (e.g., wherein the presence, increase/decrease of the quantity, etc. of X correlates to condition Y). 37 Diagnostic Methods and Medical Treatment Prosecution Suggestions Remove any steps of surgery or therapy in

Canada and Europe Avoid administering language even if phrased as a use claim Provide kit claims wherever possible Provide specific details of applications of the diagnostic method e.g. specific primers, methodology, etc. (additional elements?) 38 Melanie Szweras, Partner [email protected] March 21, 2019

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