1. Bilski: Will It Affect Bioscience Method Claims? Mark T. Skoog, Ph.D. Merchant & Gould MIPLA Biotech/Chemical Law Committee November 2009

2. Introduction Before Bilski Bilski Briefly Amicus Briefs Claims to Consider –From the Briefs –From A Pending Application A Recent Federal Circuit Decision What Is To Be Done?

3. Introduction, cont’d Patentable subject matter (35 U.S.C. § 101) Not patentability (§§§ 102, 103, or 112)

4. Before Bilski Anything under the sun that is made by man –A useful, concrete, and tangible result was persuasive, and little need to excuse data gathering –Certainly no need to recite or assert a machine or transformation –Who could possibly think that detecting, assaying, etc. could be done without a machine or transformation?

5. The Bilski Test A claimed process is patentable under 35 U.S.C. § 101 if (a) the process is tied to a particular machine or apparatus, or (b) the process transforms a particular article into a different state or thing (The Machine or Transformation Test). §§

6. The Bilski Test, cont’d Involvement of the machine or transformation must not be insignificant, extra-solution activity, such as gathering data. A claim simply to natural phenomena, mental processes, and/or abstract ideas is not patentable.

7. The Bilski Questions 1. Whether the Federal Circuit erred by holding that a “process” must be tied to a particular machine or apparatus, or transform a particular article into a different state or thing (“machine-or-transformation” test), to be eligible for patenting under 35 U.S.C. § 101, despite this Court’s precedent declining to limit the broad statutory grant of patent eligibility for “any” new and useful process beyond excluding patents for “laws of nature, physical phenomena, and abstract ideas.”

8. The Bilski Questions 2. Whether the Federal Circuit’s “machine-or-transformation” test for patent eligibility, which effectively forecloses meaningful patent protection to many business methods, contradicts the clear Congressional intent that patents protect “method[s] of doing or conducting business.” 35 U.S.C. § 273.

9. The Amicus Briefs Invoke –“Any” –The Wisdom of the Supreme Court Flexibility (citing KSR and Festo) –Personalized Medicine –Thomas Jefferson or Abraham Lincoln

10. The Amicus Briefs Decry –Rigid Tests –Destruction of the Pharmaceutical and Biotech Industries and their existing patent portfolios –Increased Suffering and Death

11. PhRMA’s Brief “[S]ignificant risk” –that lower courts will find “critical medical processes that make use of pharmaceuticals” to be unpatentable Transformation –Use of pharmaceuticals involves transformation of the medicine and the patient Doubt –Due to Prometheus case –For medical processes that do not use pharmaceuticals

12. PhRMA’s Brief If Bilski test stands: –Under that test, medical processes, particularly processes involving administering pharmaceuticals, are patentable; or –The test is limited to business method patents and other tests may be appropriate for medical-process or other patents.

13. Method of Treatment Claims PhRMA worries Practitioners worry less about method of treatment claims and more about diagnostic methods –Clearly there’s a transformation involved! And, the Federal Circuit agrees

14. BIO’s Brief Claims to diagnosing or prognosing diseases and to biomarkers –Processes employing correlations –These process inventions are not abstract ideas, laws of nature, or natural phenomena. Rather each provides a useful and tangible end, potentially bringing the industry closer to addressing serious societal issues, including those due to unsolved medical needs.

15. BIO’s Brief –Inventions that also are specific and concrete (are not abstract ideas), that result from human intervention (are not natural phenomena) and that are applications yielding a new and useful end (are not laws of nature).

16. BIO’s Hypothetical Claims 1. A method of diagnosing Disease X in a patient in need thereof, which comprises detecting elevated Protein Y levels in a body fluid sample from said patient.

17. BIO’s Hypothetical Claims 2. A method of determining whether a malignant tumor in a patient in need thereof is susceptible to Anti-Cancer Drug X, which comprises measuring the level of expression of Gene Y in said malignant tumor compared to a control non-malignant tissue from said patient, wherein expression levels of Gene Y in said malignant tumor greater than twice that of said control non-malignant tissue correlate with susceptibility of said tumor to Anti-Cancer Drug X.

18. BIO’s Hypothetical Claims 3. A process for determining blood oxygenation including: determining a blood pressure pulse wave; deriving a blood oxygenation parameter from the pulse wave using equation X; and communicating the blood oxygenation parameter to medical personnel.

19. BIO’s Real Claims U.S. Patent No. 5,674,680 –1. A method for predicting the time of onset of the development of clinical signs of immunodeficiency [AIDS] … determining … ; and correlating …. –Used to develop drug cocktails

20. BIO’s Real Claims U.S. Patent No. 6,395,481 –21. A method for screening individuals for variation in glucuronidation activity comprising detecting polymorphisms … ; and determining …. –Used to identify patients who require a low dose of chemotherapy for colorectal cancer.

21. BIO’s Real Claims U.S. Patent No. 4,968,603 –1. A method for screening patients to determine disease status, said method comprising: measuring … HER-2 … gene… ; and classifying …. –Currently, HER-2 testing is required to determine whether a breast cancer patient can receive Herceptin therapy.

22. Other Amicus Briefs Caris Diagnostics Medtronic Prometheus Laboratories

23. Cases Discussed by Amici Three Supreme Court Justices, in the dissent in Lab Corp., would have found a diagnostic method to be unpatentable subject matter. Lab. Corp. of Am. Holdings v. Metabolite Labs., Inc., 126 S. Ct. 2921 (2006) 13. A method for detecting a deficiency of cobalamin or folate … comprising … : assaying … elevated level of … homocysteine; and correlating …with a deficiency of cobalamin or folate.

24. Cases Discussed by Amici In an unpublished decision that’s shorter than the claim, the Federal Circuit stated: –“In light of our decision in In re Bilski, 545 F.3d 943 (Fed. Cir. 2008) (en banc), we affirm the district court’s grant of summary judgment that these claims are invalid under 35 U.S.C. § 101. Dr. Classen’s claims are neither “tied to a particular machine or apparatus” nor do they “transform[] a particular article into a different state or thing.” Bilski, 545 F.3d at 954. Therefore we affirm.” –Non-precedential disposition 2008 WL 5273107 (Fed. Cir. Dec. 19, 2008)

25. Cases Discussed by Amici 1. A method of determining whether an immunization schedule affects the incidence or severity of a chronic immune-mediated disorder in a treatment group of mammals, relative to a control group of mammals, which comprises immunizing mammals in the treatment group of mammals with one or more doses of one or more immunogens, according to said immunization schedule, and comparing the incidence, prevalence, frequency or severity of said chronic immune-mediated disorder or the level of a marker of such a disorder, in the treatment group, with that in the control group.

26. A Recent Federal Circuit Decision Prometheus v. Mayo

27. 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 8x108 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 8x108 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.

28. Prometheus v. Mayo Since court found a transformation, they did not address the machine prong of the test “The transformation is of the human body following administration of a drug and the various chemical and physical changes of the drug’s metabolites that enable their concentrations to be determined.”

29. Prometheus v. Mayo “The asserted claims are in effect claims to methods of treatment, which are always transformative when a defined group of drugs is administered to the body to ameliorate the effects of an undesired condition.” It’s a metabolite that’s active, so a transformation “is the entire purpose of administering these drugs.”

30. Prometheus v. Mayo “Determining the levels of 6-TG or 6-MMP in a subject necessarily involves a transformation, for those levels cannot be determined by mere inspection.” Although the “wherein” clauses are mental steps, they are only part of the claimed method.

31. Classen and Prometheus Classen wasn’t treating –Figuring out how to treat others –“Mere” data gathering

32. Supreme Court Oral Arguments And, the justices said …

33. A Case Study Independent Claims –1. A method for predicting the response of a patient to a drug employed in the treatment of X condition, the method comprising: determining the level of Y gene expression in the patient’s tissue.

34. A Case Study –2. A method for monitoring drug response in a patient receiving treatment for … –3. A method of determining the likelihood of a subject developing …

35. A Case Study The Specification –The isolated tissue was treated with A [a transformation]. –The quality and quantity of RNA was measured by spectrometry and gel electrophoresis [in a process that includes a machine and a transformation].

36. A Case Study –Gene expression profiling was performed by a microarray procedure that is known in the art [and that involves a transformation and a machine]. –Y, which is a secreted protein, can be detected in a tissue sample in measurable quantities [using a process that involves a transformation and a machine].

37. What Is To Be Done? For applications being written: –Include disclosure satisfying machine or transformation test; and –Include disclosure for traditional claims For applications filed but not yet examined: –Wait (and hope for clear and speedy resolution)

38. What Is To Be Done? –The wait could be long or short: In Bilski, Supreme Court addresses only business methods Remand to Federal Circuit USPTO changes its examination procedures to reflect decisions of Supreme Court and Federal Circuit

39. What Is To Be Done? For applications currently being examined: –Continue prosecution until decision(s) rendered –Suspend prosecution –Appeal –Accept narrow claims and file a continuation or divisional

40. What Is To Be Done? For issued patents with too narrow claims: –Continuation or divisional pending? –Reissue?

41. Thank You Mark Skoog mskoog@merchantgould.com