The Future Of Medical Treatment Patents

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An analysis of how the U.S. Supreme Court’s recent decision in Bilski v. Kappos will impact the patent-eligibility of medical diagnostic and treatment methods, and offering practical insights and best practices on how to defend or challenge medical method patents.

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The Future Of Medical Treatment Patents

  1. 1. The Future Of Medical Diagnostic And Treatment PatentsNewport Beach Corporate Counsel SeminarSeptember 28, 2010Presented by:Brett J. WilliamsonPaul Veravanich
  2. 2. 2Bilski v. KapposPTO GuidelinesEffect On Medical Treatment and Diagnostics PatentsBackground
  3. 3. 3Requirements For PatentabilityRequirements For Patentability• Utility/Patent-Eligible Subject Matter (35 U.S.C. §101)• Novelty (35 U.S.C. § 102)• Anticipation by prior art• Loss of right to patent invention• Non-Obviousness (35 U.S.C. § 103)• Objective standard• Secondary considerations• Sufficiency of Disclosure (35 U.S.C. § 112)• Written description• Best mode
  4. 4. 4Trend of Narrowing Patent Eligibility?Trend of Narrowing Patent Eligibility?• Lab Corp. v. Metabolite, 126 S. Ct. 2921 (2006)• Diagnostic method patent at issue (Measure level of amino acid,determine whether elevated level)• Lower courts upheld validity, but Fed. Cir. did not address § 101• Dismissed because writ of certiorari “improvidently granted” on §101 issue• Several amicus briefs argued that Sec. 101 was already clear basedon Supreme Court precedent• In re Bilski, 545 F.3d 943 (Fed. Cir. 2008)• Invalidated business method patent• Machine-or-transformation test• Association for Molecular Pathology v. USPTO (S.D.N.Y. 2009)• Invalidated gene patent, relied on In re Bilski
  5. 5. 5Bilski v. KapposPTO GuidelinesEffect On Medical Treatment and Diagnostics PatentsBackground
  6. 6. 6The Bilski CaseThe Bilski Case• Methods of hedging risk in the field of commodities trading• A method for managing the consumption risk costs of a commodity soldby a commodity provider at a fixed price comprising the steps of:• initiating a series of transactions between said commodity providerand consumers of said commodity wherein said consumerspurchase said commodity at a fixed rate based upon historicalaverages, said fixed rate corresponding to a risk position of saidconsumer;• identifying market participants for said commodity having acounter-risk position to said consumers; and• initiating a series of transactions between said commodity providerand said market participants at a second fixed rate such that saidseries of market participant transactions balances the risk position ofsaid series of consumer transactions
  7. 7. 7The Bilski CaseThe Bilski Case• PTO: Abstract idea of hedging is not patent-eligible subject matter• Focused on lack of implementation on a specific apparatus• Federal Circuit: Not patent-eligible subject matter• For method claims, the machine-or-transformation test is theexclusive test for determining patent eligibility• Bilski’s claimed method fails the test:•“Does not limit any process step to any specific machine orapparatus”•“Does not transform any article to a different state or thing”
  8. 8. 8The Supreme Court DecisionThe Supreme Court Decision• Affirmed finding of not patent-eligibility• Although the Court did not categorically exclude business methodsfrom patent-eligibility• But reversed and rejected Federal Circuit’s use of exclusive, bright linemachine-or-transformation test• There is no exclusive test• But machine-or-transformation test provides a “useful and importantclue” and “investigative tool”• Focused on 25-year-old precedent:• Parker v. Flook• Gottschalk v. Benson• Diamond v. Diehr
  9. 9. 9The Supreme Court DecisionThe Supreme Court Decision• “Guidelines”• Well-known exceptions to patent-eligibility:•Abstract ideas•Laws of nature•Physical phenomena•Ex. A math formula that determines the rate of a chemicalreaction• Practical applications of the above are patent-eligible•Ex. A procedure for molding uncured rubber into cured productsthat includes the use of that math formula for some of the steps
  10. 10. 10The Supreme Court DecisionThe Supreme Court Decision• Bilski consequences• Claims can still be rejected based on the machine-or-transformationtest• Claims can also be rejected if drawn to an abstract idea• Unlike Federal Circuit’s now-rejected test, there is little guidance
  11. 11. 11Bilski v. KapposPTO GuidelinesEffect On Medical Treatment and Diagnostics PatentsBackground
  12. 12. 12Recent USPTO GuidanceRecent USPTO Guidance• July 27, 2010 “Interim Guidance for Determining Subject Matter Eligibilityfor Process Claims in View of Bilski v. Kappos”• For examiners to use when determining patent-eligibility under 35 U.S.C.§ 101
  13. 13. 13FactorsFactors• Meets machine-or-transformation test?• Method involves or is executed by a particular machine• Does the machine implement the method steps• Extent to which machine imposes meaningful limits
  14. 14. 14FactorsFactors• Meets machine-or-transformation test?• Is the article identified with particularity• Nature of the article being transformed• Nature of the transformation• Does transformation impose a meaningful limit
  15. 15. 15FactorsFactors• Application of law of nature• Particularity of the application• Subjective determinations• Application meaningfully limits steps• The claim is more than a mere statement of a concept (abstract ideas)• Mere statement of concept, monopoly over concept• Covers known and unknown uses• Describes a particular solution to a problem to be solved v. states aproblem to be solved• Tangible implementation
  16. 16. 16““An Abstract Idea Is Not … Patent-Eligible”An Abstract Idea Is Not … Patent-Eligible”• Basic economic practices or theories (e.g., hedging, insurance, financialtransactions, marketing)• Basic legal theories (e.g., contracts, dispute resolution, rules of law)• Mathematical concepts (e.g., algorithms, spatial relationships,geometry)• Mental activity (e.g., forming a judgment, observation, evaluation, oropinion)• Interpersonal interactions or relationships (e.g., conversing, dating)• Teaching concepts (e.g., memorization, repetition)• Human behavior (e.g., exercising, wearing clothing, following rules orinstructions)• Instructing how business should be conducted
  17. 17. 17Questions For Public CommentQuestions For Public Comment• Invited public comments by September 27, 2010• “What are examples of claims that do not meet the machine-or-transformation test but nevertheless remain patent-eligible because they donot recite an abstract idea?”• “What are examples of claims that meet the machine-or-transformation testbut nevertheless are not patent-eligible because they recite an abstractidea?”• But PTO did acknowledge that “to date, no court, presented with a subjectmatter eligibility issue, has ever ruled that a method claim that lacked amachine or a transformation was patent-eligible.”
  18. 18. 18Bilski v. KapposPTO GuidelinesEffect On Medical Treatment and Diagnostics PatentsBackground
  19. 19. 19Medical TreatmentMedical Treatment• Method of optimizing therapeutic efficacy of a drug X• Administering a dose of the drug X to the patient• Determining the amount of drug X in the patient’s blood• Recalibrating the drug dosage based on the determination step•If the amount is less than Y, then increase the dosage•If the amount is greater than Z, then decrease the dosage• Patent-eligible subject matter?
  20. 20. 20Medical TreatmentMedical Treatment• Prometheus Labs v. Mayo Collaborative Servs., 581 F.3d 1336 (Fed. Cir. 2009)• Per district court: not patent-eligible subject matter• Per Federal Circuit: patent-eligible subject matter• Applied machine-or-transformation test• “When administering a drug … the human body necessarily undergoesa transformation. The drugs do not pass through the body untouchedwithout affecting it.”• “[T]he determination step … is also transformative and central to theclaimed methods. Determining the levels of [the drug] in a subjectnecessarily involves a transformation.”• After Bilski, Supreme Court vacated and remanded• Briefing by October 1 on effect of Bilski
  21. 21. 21Medical TreatmentMedical Treatment• Method of determining whether an immunization schedule affects theincidence or severity of an immune-mediated disorder• Immunizing mammals in a treatment group according to theimmunization schedule• Comparing the incidence, prevalence, frequency, or severity of theimmune-mediated disorder in the treatment group with a controlgroup• Patent-eligible subject matter?
  22. 22. 22Medical TreatmentMedical Treatment• Classen Immunotherapies v. Biogen Idec,2008 U.S. App. LEXIS 25661 (Fed. Cir. 2008)• Per Federal Circuit:• Not patent-eligible subject matter• Applied machine-or-transformation test• No machine-or-transformation• “Dr. Classens claims are neither tied to a particular machine orapparatus nor do they transform a particular article into a differentstate or thing.” (this was the entire “opinion”)• After Bilski, Supreme Court vacated and remanded
  23. 23. 23Medical TreatmentMedical Treatment• Method of using a muscle relaxant to treat a musculoskeletal condition• Providing the patient with a therapeutically effective amount of themuscle relaxant (with the “amount” undefined)• Informing the patient that the administration of the muscle relaxantwith food results in an increase in the absorption of the musclerelaxant compared to administration without food• Patent-eligible subject matter?
  24. 24. 24Medical TreatmentMedical Treatment• King Pharmaceuticals v. Eon Labs,2010 U.S. App. LEXIS 15947 (Fed. Cir. Aug. 2, 2010)• First post-Bilski Federal Circuit opinion• Inventors claimed an unexpected finding that administration ofmetaxalone with food increases both the rate and extent of absorptionvia the oral dosage form in human subjects• District court invalidated as both anticipated and not patent-eligible• “Informing” step did not transform the muscle relaxant into adifferent state or thing
  25. 25. 25Medical TreatmentMedical Treatment• King Pharmaceuticals v. Eon Labs,2010 U.S. App. LEXIS 15947 (Fed. Cir. Aug. 2, 2010)• Federal Circuit:• Did not reach the specific patent-eligible subject matter issuebecause invalid on other grounds• But, the method would have met the machine-or-transformationtest• “[W]hile the Supreme Court in Bilski made clear that our machine-or-transformation test is not the exclusive test for patentability … it alsomade clear that the test is a useful and important clue, an investigativetool, for determining whether some claimed inventions are”• “We therefore understand the Supreme Court to have rejected theexclusive nature of our test, but not necessarily the wisdom behind it.”
  26. 26. 26StrategyStrategy• Patent applicants• Comply with machine-or-transformation for data analysis• Practical application of abstract ideas or laws of nature• Ex. Measure levels of markers v. markers themselves• Patent owners• Reissues• Litigation – accused infringers• Analyze asserted claims• Pre-Bilski, district court trend of considering Sec. 101 defenses
  27. 27. 27Thank YouThank You• For more information, contact:Brett J. Williamson(949) 823-7947bwilliamson@omm.comPaul Veravanich(949) 823-6983pv@omm.comveravanich@yahoo.comhttp://www.linkedin.com/in/veravanichO’Melveny & Myers LLP610 Newport Center Drive, 17thFloorNewport Beach, CA 92660(949) 760-9600www.omm.comNewport Beach Corporate Counsel SeminarSeptember 28, 2010

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