1. © 2011 Edwards Wildman Palmer LLP & Edwards Wildman Palmer UK LLP Patenting Methods of Medical Treatment in the United States AIPPI 2011 Forum/ExCo Peter C. Schechter, Esq. Partner October 14, 2011

2. 1 Scope of this Presentation ♦ Patent-Eligible Subject Matter In the United States ♦ The Mayo Collaborative Servs. v. Prometheus Labs Case ♦ The Classen Immunotherapies v. Biogen IDEC Case ♦ Statutory exceptions for medical practitioners and related health care entities

3. 2 Patent-Eligible Inventions “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.” Title 35, United States Code, § 101

4. 3 What Is A “Process”? The term “PROCESS” means: “a process, art or method, and includes a new use of a known process, machine, manufacture, composition of matter, or material.” Title 35, United States Code, § 101(b)

5. 4 “Wide Scope” of Patent Eligibility The United States Supreme Court has stated that Section 101 of the Patent Law is meant to be given “WIDE SCOPE” Bilski v. Kappos, 130 S. Ct. 3218, 3225 (2010)

6. 5 The “Only Exception” The ONLY EXCEPTION to the WIDE SCOPE of patent eligibility under Section 101 is a judicially- created rule that: “ laws of nature, natural phenomena, and abstract ideas ” are not themselves patentable Bilski v. Kappos, 130 S. Ct. 3218, 3238 (2010)

7. 6 Mayo v. Prometheus – History ♦ History of case: ♦ Trial court decided that Prometheus’s asserted medical treatment claims were drawn to patent-ineligible (i.e., “non-statutory”) subject matter ♦ U.S. Court of Appeals for the Federal Circuit (CAFC) initially REVERSED, deciding that the medical treatment method claims satisfied the “machine-or-transformation” test, which that court had declared was the “definitive test” for patent-eligible subject matter under Section 101

8. 7 Mayo v. Prometheus – History (cont.) ♦ History of case (continued): ♦ The U.S. Supreme Court subsequently rejected the “machine-or-transformation” test as the sole or definitive test, and told the CAFC to decide the case again, using a proper legal analysis ♦ The CAFC again decided that Prometheus’s asserted medical treatment method claims were drawn to patent- eligible subject matter ♦ Appeal of the second CAFC decision is now pending in the U.S. Supreme Court

9. 8 The Method Claims In Dispute 1.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 the level of 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder, wherein the level of 6-thioguanine less than about 230 pmol per 8x10 8 red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject and wherein the level of 6-thioguanine greater than about 400 pmol per 8x10 8 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.

10. 9 The Method Claims In Dispute 46. A method of optimizing therapeutic efficacy and reducing toxicity associated with treatment of an immune-mediated gastrointestinal disorder, comprising: (a) determining the level of 6-thioguanine or 6-methyl-mercaptopurine in a subject administered a drug selected from the group consisting of 6- mercaptopurine, azathioprine, 6-thioguanine, and 6-methylmercaptoriboside, said subject having said immune-mediated gastrointestinal disorder; wherein the level of 6-thioguanine less than about 230 pmol per 8×10 8 red blood cells indicates a need to increase the, amount of said drug subsequently administered to said subject, and wherein the level of 6-thioguanine greater than about 400 pmol per 8×10 8 red blood cells or a level of 6-methyl-mercaptopurine greater than about 7000 pmol per 8×10 8 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.

11. 10 The CAFC framed the issue as whether Prometheus’s claims are: a)Drawn to a natural phenomenon and are thus patent-ineligible, or b)Drawn only to a particular application of a natural phenomenon, and thus eligible for patenting within the scope of Section 101 CAFC’s Answer: b The Debate

12. 11 What the CAFC Actually Said “The inventive nature of the claimed methods stems not from preemption of all use of these natural processes, but from the application of a natural phenomenon in a series of steps comprising particular methods of treatment.” Prometheus Labs., Inc. v. Mayo Collaborative Servs., 628 F.3d 1347, 1355 (2010)

13. 12 What the CAFC Also Actually Said “We similarly reaffirm that the treatment methods … satisfy the transformation prong of the machine-or- transformation test, as they ‘transform an article into a different state or thing,’ and this transformation is ‘central to the purpose of the claimed process.’ The transformation is of the human body and of its components following the administration of a specific class of drugs and the various chemical and physical changes of the drugs’ metabolites that enable their concentrations to be determined.” Prometheus Labs., Inc. v. Mayo Collaborative Servs., 628 F.3d 1347, 1355- 56 (2010) (citation omitted)

14. 13 And … “[W]e also hold that the determining step, which is present in each of the asserted claims, is transformative and central to the claimed methods. Determining the levels of 6-TG or 6-MMP in a subject necessarily involves a transformation. … [T]his transformation is central to the purpose of the claims, since the determining step is, like the administering step, a significant part of the claimed method.” Prometheus Labs., Inc. v. Mayo Collaborative Servs., 628 F.3d 1347, 1357 (2010)

15. 14 Classen Immuno v. Biogen IDEC ♦ A case with history similar to that of Mayo v. Prometheus ♦ The U.S. Supreme Court vacated an earlier appellate decision by the CAFC and instructed further consideration in view of the Supreme Court’s Bilski v. Kappos decision

16. 15 Classen’s Patent Claims The claims of the ‘139 and ‘739 patents- in-suit recite the method whereby information on immunization schedules and the occurrence of chronic disease is "screened" and "compared," the lower risk schedule is "identified," and the vaccine is "administered" on that schedule.

17. 16 How The ‘139 and ‘739 Patent Claims Are Infringed According to Classen, these claims are infringed: “when a physician, hospital or other health care provider reads the relevant literature and selects an immunization schedule and immunizes a patient in accordance with the schedule which appears to have minimal risk.”

18. 17 Classen’s Other Patent Claims ♦ The claims of the ‘283 patent-in-suit recite the method of reviewing and comparing published information on the effects of immunization schedules in treated and control groups of mammals, with respect to the occurrence of immune-mediated disorders.

19. 18 How The ‘283 Patent Claims Are Infringed According to Classen, these claims are infringed: “when a person reviews relevant information, whether the person is a producer of vaccines, a health care provider, or a concerned parent.”

20. 19 A Little History …. ♦ All of Classen’s claims were deemed by the trial court to recite patent-ineligible subject matter ♦ The CAFC AFFIRMED the lower court in the first appeal based upon the machine-or-transformation test, but that CAFC decision was subsequently vacated for further consideration in view of the U.S. Supreme Court’s Bilski decision rejecting the sole use of that test

21. 20 The CAFC’s New Classen Decision The CAFC focused on one of its own prior decisions and referred to the role or function of Section 101 of the Patent Act as: “a coarse eligibility filter”

22. 21 The Patent-Eligible Claims The CAFC held: “The claims of the ‘139 and ‘739 patents are directed to a method of lowering the risk of chronic immune-mediated disorder, including the physical step of immunization on the determined schedule. These claims are directed to a specific, tangible application, … and in accordance with the guidance of Bilski v. Kappos that "[r]ather than adopting categorical rules that might have wide-ranging and unforeseen impacts," exclusions from patent-eligibility should be applied “narrowly,” … we conclude that the subject matter of these two patents traverses the coarse eligibility filter of § 101.”

23. 22 A New Test? ♦ What is the significance of the CAFC’s characterization of the claimed process as being directed to a specific, tangible application? ♦ Is this a new test for patent-eligible processes? ♦ If so, is the “specific, tangible application” test anything like the discredited State Street “useful, concrete and tangible result” test?

24. 23 The Patent-Ineligible Claims The CAFC further held: “Claim 1 of the ‘283 patent states the idea of collecting and comparing known information. … [M]ethods that simply collect and compare data, without applying the data in a step of the overall method, may fail to traverse the § 101 filter.”

25. 24 What next? It is widely assumed that the U.S. Supreme Court will review the CAFC’s second Classen decision in 2012

26. 25 Exceptions For Medical Practitioners and Related Health Care Entities Section 287(c)(1), Title 35, United States Code: ♦ With respect to a medical practitioner's performance of a medical activity that constitutes an infringement under section 271(a) or (b) of this title, the provisions of sections 281, 283, 284, and 285 of this title shall not apply against the medical practitioner or against a related health care entity with respect to such medical activity. ♦ 271(a):Direct infringement ♦ 271(b):Inducement of infringement ♦ 281:Remedy for infringement of patent ♦ 283:Injunction ♦ 284:Damages ♦ 285:Attorneys fees

27. 26 Definitions Relating to 287(c)(1) Exception ♦ "medical activity" means the performance of a medical or surgical procedure on a body, but shall not include (i) the use of a patented machine, manufacture, or composition of matter in violation of such patent, (ii) the practice of a patented use of a composition of matter in violation of such patent, or (iii) the practice of a process in violation of a biotechnology patent.

28. 27 Definitions Relating to 287(c)(1) Exception ♦ "medical practitioner" means any natural person who is licensed by a State to provide the medical activity described in subsection (c)(1) or who is acting under the direction of such person in the performance of the medical activity.

29. 28 Definitions Relating to 287(c)(1) Exception ♦ "related health care entity" shall mean an entity with which a medical practitioner has a professional affiliation under which the medical practitioner performs the medical activity, including but not limited to a nursing home, hospital, university, medical school, health maintenance organization, group medical practice, or a medical clinic.

30. 29 Definitions Relating to 287(c)(1) Exception ♦ "professional affiliation" shall mean staff privileges, medical staff membership, employment or contractual relationship, partnership or ownership interest, academic appointment, or other affiliation under which a medical practitioner provides the medical activity on behalf of, or in association with, the health care entity.

31. 30 No Remedy, No Lawsuit ♦ 35 U.S.C. 281 Remedy for infringement of patent. ♦ A patentee shall have remedy by civil action for infringement of his patent. Thus, if the exception of 35 U.S.C. 287(c)(1) applies, then no “remedy by civil action for infringement” is authorized under U.S. Patent Law.

32. 31 AIPPI and AIPPI-US Amicus Curiae Brief Filed in Mayo v. Prometheus U.S. Supreme Court Appeal

33. 32 THANK YOU for listening! Peter C. Schechter pschechter@edwardswildman.com +1-212-912-2934