1. Surviving Subject Matter in the Post Prometheus/Myriad World Lesley Rapaport LRR Patent Law Denise M. Kettelberger Sunstein Kann Murphy & Timers LLP Carmela DeLuca Bereskin & Parr LLP IPIC Presentation Main Heading Biotechnology Patents

2. 2014 © Intellectual Property Institute of Canada Patentable Subject Matter in Canada “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; “Art” means a mode, or method, or manner of accomplishing a certain result as distinct from the result. 2

3. 2014 © Intellectual Property Institute of Canada Patentable Subject Matter in Canada Non-patentable: Mere scientific principle or abstract theorem (S. 27(8)) Products of nature although “isolated” and “purified” products can be patentable Methods of medical treatment and surgery…. but Canadian style “use” claims patentable 3

4. 2014 © Intellectual Property Institute of Canada Patentable Subject Matter in Canada How is patentable subject matter determined? What is patentable? 4

5. 2014 © Intellectual Property Institute of Canada Patentable Subject Matter in Canada CIPO v Amazon, 2011 FCA 328 (“Amazon”) No technological requirement test in determining patentable subject matter Purposive construction whether “the subject matter defined by the claim,”[and not the contribution over the prior art], falls within the definition of “invention” determines PSM 5

6. 2014 © Intellectual Property Institute of Canada CIPO Practice Notice Respecting Purposive Construction 1)Using a fair, balanced and informed approach 2)Having identified the problem and solution 3)In the context of the application as a whole 4) To determine which elements of the claim solve the identified problem 5) By focusing on one solution to a problem 6

7. 2014 © Intellectual Property Institute of Canada CIPO Practice Notice Examination Practice Respecting Medical Uses released June 10 2013 Use claims in general patentable subject matter Not patentable if an essential element only serves to instruct a medical professional “how” to treat a patient (e.g. dosing schedule, administration site or narrowing treatment to a patient sub-population), rather than “what” to use to treat the patient (e.g. compound, dosage form) 7

8. 2014 © Intellectual Property Institute of Canada CIPO Practice Guidelines Examples of purposive construction analysis of medical use claims for statutory subject-matter evaluation released November 14, 2013 Personalized Medicine Use of a known compound X to treat a disease Y in a specific patient population having the gene mutation ABC and finds that the claim is not patentable 8

9. 2014 © Intellectual Property Institute of Canada MOPOP – Proposed Chapter 13 Revised Chapter 13 (Examination of Patents) released for public consultation July 14, 2014 - consistent with Amazon? IPIC submission August 1, 2014 addressed: - “problem and solution approach” - “essential elements necessary to solve a problem” - “inventor’s intention” 9

10. 2014 © Intellectual Property Institute of Canada MOPOP – Proposed Chapter 13 Update from CIPO? Effect on patentable subject matter of biotechnological inventions? Examples of claim construction in the context of biotechnological inventions have been removed Revised Chapter 12, Utility and Subject Matter, is expected shortly 10

11. 2014 © Intellectual Property Institute of Canada Patentable Subject Matter in Canada Patentable Diagnostic: CA 2,743,714 2014-09-23 1. A method for diagnosing a food sensitivity in a companion animal comprising the steps of: screening a sample of saliva from the companion animal to measure the level of IgA antibody to a particular food ingredient or IgM antibody to a particular food ingredient, and diagnosing a food sensitivity of the companion animal based on the measurement of at least one of the antibodies, the particular food antigen being selected from the group consisting of wheat, gluten, corn, soy, beef meat, fish protein, dairy, eggs, grains, botanicals, oils from seeds, fish, vegetables, and fruit. 11

12. 2014 © Intellectual Property Institute of Canada Patentable Subject Matter in Canada Patentable Biologic: CA 2563313 2014-06-03 1. An agent that reduces ligand-induced NKG2D activation of NKG2D-expressing leukocytes for use in the manufacture of a medicament for treating or preventing a syndrome associated with NKG2D-mediated activation in a human subject, wherein the syndrome is selected from the group consisting of ……, wherein the agent reduces the amount of NKG2D on the surface of the leukocytes, and wherein the agent comprises one or more of the group consisting of an antibody that binds to NKG2D, an NKG2D-binding antibody fragment, a multimeric MICA, a multimeric NKG2D-binding fragment of MICA, a multimeric MICB, a multimeric NKG2D-binding fragment of MICB, a multimeric ULBP, a multimeric NKG2D-binding fragment of ULBP, and a RNAi molecule encoded by a sequence selected from the group consisting of SEQ ID NO:10, SEQ ID NO:11, and SEQ ID NO:12. 12

13. 2014 © Intellectual Property Institute of Canada Patentable Subject Matter in Canada Patentable DNA CA 2,570,812 2014-07-29 1. An isolated nucleic acid comprising a polynucleotide encoding a polypeptide at least 90% identical to SEQ ID NO:9, wherein the polynucleotide or a complement thereof, is capable of suppressing expression of an endogenous IND1 gene when expressed in a plant. 13

14. 2014 © Intellectual Property Institute of Canada Denise M. Kettelberger, PhD, JD Sunstein Kann Murphy & Timbers LLP Boston, MA Subject Matter Eligibility United States Supreme Court Advocacy

15. 2014 © Intellectual Property Institute of Canada 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. 15

16. 2014 © Intellectual Property Institute of Canada Traditionally a low threshold of utility 16

17. 2014 © Intellectual Property Institute of Canada The Supreme Court’s Path to Alice Gottschalk V Benson 1972 Parker V Flook 1978 Diamond v Chakraborty 1980 Diamond V Diehr 1981 Bilski v Kapppos 2012 Mayo V Prometheus 2012 AMP v Myriad Genetics 2013 Alice Corp v CLS Bank 2013 17

18. 2014 © Intellectual Property Institute of Canada The Supreme Court’s Path to Alice Gottschalk V Benson 1972 Parker V Flook 1978 Diamond v Chakraborty 1980 Diamond V Diehr 1981 Bilski v Kapppos 2012 Mayo V Prometheus 2012 AMP v Myriad Genetics 2013 Alice Corp v CLS Bank 2013 18 …a method for converting binary coded decimals to pure binary, can be done without a computer… the mathematical formula has no substantial practical application except in conjunction with a digital computer… would wholly preempt… be a patent on the algorithm itself. 409 U.S.63.

19. 2014 © Intellectual Property Institute of Canada The Supreme Court’s Path to Alice Gottschalk V Benson 1972 Parker V Flook 1978 Diamond v Chakraborty 1980 Diamond V Diehr 1981 Bilski v Kapppos 2012 Mayo V Prometheus 2012 AMP v Myriad Genetics 2013 Alice Corp v CLS Bank 2013 19 A mathematical formula for computing alarm limits in a catalytic conversion process was also a patent-ineligible abstract idea., 437 US 584 594-595.

20. 2014 © Intellectual Property Institute of Canada The Supreme Court’s Path to Alice Gottschalk V Benson 1972 Parker V Flook 1978 Diamond v Chakraborty 1980 Diamond V Diehr 1981 Bilski v Kapppos 2012 Mayo V Prometheus 2012 AMP v Myriad Genetics 2013 Alice Corp v CLS Bank 2013 20 A live, human-made micro-organism is patentable subject matter under 35 U.S.C. § 101. Respondent's micro-organism constitutes a "manufacture" or "composition of matter" within that statute. 447 U.S. 303

21. 2014 © Intellectual Property Institute of Canada The Supreme Court’s Path to Alice Gottschalk V Benson 1972 Parker V Flook 1978 Diamond v Chakraborty 1980 Diamond V Diehr 1981 Bilski v Kapppos 2012 Mayo V Prometheus 2012 AMP v Myriad Genetics 2013 Alice Corp v CLS Bank 2013 21 Thus an invention is not rendered ineligible for patent simply because it involves an abstract concept. 450 US 175,187.

22. 2014 © Intellectual Property Institute of Canada The Supreme Court’s Path to Alice Gottschalk V Benson 1972 Parker V Flook 1978 Diamond v Chakraborty 1980 Diamond V Diehr 1981 Bilski v Kapppos 2012 Mayo V Prometheus 2012 AMP v Myriad Genetics 2013 Alice Corp v CLS Bank 2013 22 We have described the concern that drives this exclusionary principle as one of pre-emption...upholding the patent would preempt use of this approach in all fields and would effectively grant an monopoly over an abstract idea. 561 U.S. 611-612.

23. 2014 © Intellectual Property Institute of Canada The Supreme Court’s Path to Alice Gottschalk V Benson 1972 Parker V Flook 1978 Diamond v Chakraborty 1980 Diamond V Diehr 1981 Bilski v Kapppos 2012 Mayo V Prometheus 2012 AMP v Myriad Genetics 2013 Alice Corp v CLS Bank 2013 23...a court must first identify the abstract idea represented in the claim, and then determine whether the balance of the claim adds significantly more - 717 F.3d at 1286.

24. 2014 © Intellectual Property Institute of Canada The Supreme Court’s Path to Alice Gottschalk V Benson 1972 Parker V Flook 1978 Diamond v Chakraborty 1980 Diamond V Diehr 1981(2013) Bilski v Kapppos 2012 Mayo V Prometheus 2012 AMP v Myriad Genetics 2013 Alice Corp v CLS Bank 2013 24 We have long held that this provision [101] contains an important implicit exception: Laws of Nature, natural phenomena,, and abstract ideas are not patentable. 569 US ___ 2013.

25. 2014 © Intellectual Property Institute of Canada More Chatter for Alice Gottschalk V Benson 1972 Parker V Flook 1978 Diamond v Chakraborty 1980 Diamond V Diehr 1981 Bilski v Kapppos 2012 Mayo V Prometheus 2012 AMP v Myriad Genetics 2013 Alice Corp v CLS Bank 2013 25 The Alice Two Step derives from Judge Lourie’s concurrence in an equally split decision. We hold that the claims at issue are drawn to the abstract idea of intermediated settlement, and that merely requiring generic computer implementation fails to transform that abstract idea into a patent-eligible invention.

26. 2014 © Intellectual Property Institute of Canada USPTO Guidance post -Myriad 1. Is the claim directed to one of four statutory categories? Process, machine, manufacture, composition or matter – [or an improvement thereof] 2. Does the claim recite or involve a judicial exception? Abstract idea, law of nature, natural phenomena, natural principles, natural products 3. Does the claim as a whole recite something significantly different than the judicial exception ? 4. Claim is ineligible for patenting if 1=NO or 3=NO 26

27. 2014 © Intellectual Property Institute of Canada USPTO Myriad-Mayo Factors- Claim as a whole? Favor Eligibility: A) Product looked like a natural product, but turned out not to be one; B) Elements/steps in addition to the JudEx limit scope, narrow use of JudEx; C) Elements/steps in addition to the JudEx relate meaningfully to JudEx; D) Elements/steps in addition to the JudEx do more than say “apply it” E) Elements/steps in addition to the JudEx include machine or transformation F) Elements/steps in addition to the JudEx add feature not conventional Disfavor Eligibility: the opposite of A-F 27

28. 2014 © Intellectual Property Institute of Canada Myriad Guidance under Revision  Post-Alice revision – all technologies, one test  More than 80 comments on implementation post-Myriad  Alice 2-step is the last word, should determine outcome  USPTO may distinguish technologies, compositions, methods  Expected by November 1, 2014 28

29. 2014 © Intellectual Property Institute of Canada Alice 2-Step  Alice applies Mayo v. Prometheus framework to all claims  all technologies, all exceptions, all types of claims  First – determine if claim directed to statutory categories  process, machine, manufacture, composition – or improvement  Second – determine if claim is directed to a judicial exception  law of nature, natural phenomenon, abstract idea (Part 1)  Is claim a patent-eligible application of an exception (Part 2) 29

30. 2014 © Intellectual Property Institute of Canada Alice 2-Step – for Abstract Ideas  Step 1 – is the claim directed to an abstract idea?  fundamental economic practices;  organizing human activity;  mathematical formulae;  an idea of itself  Step 2 – do elements, alone or in combination, sufficient to ensure the claim is significantly more than the abstract idea itself?  improve another technology;  improve computer function;  more than generic computer. 30

31. 2014 © Intellectual Property Institute of Canada Thoughts on Living next door to Alice …..  Alice requires same test for all -  claims, technologies, exceptions  Alice 2-step test is not “factor” specific  Myriad factors are meaningless  Alice 2-step has room to maneuver  Mayhem continues 31

32. 2014 © Intellectual Property Institute of Canada What to do?  Prepare specifications with more defining content  machines, physical additions, artificial components  utilize a variety of claims, build in narrowing limitations  Avoid broad claims and claim terms  use “technical” steps, components, results  Keep a Continuation application pending 32

33. 2014 © Intellectual Property Institute of Canada dkettelberger@sunsteinlaw.com

34. 2014 © Intellectual Property Institute of Canada Follow Up Questions How can you protect a natural product that requires further isolation procedures, and has a never before discovered use? U.S.? Can?

35. 2014 © Intellectual Property Institute of Canada Follow Up Questions How would you protect the discovery of a biomarker panel where the level of gene expression of the 6 genes, when measured in combination with a new algorithm is indicative of disease X. U.S.? Canada?

36. Questions? Thank You