The Future Of Medical Treatment Patents

The Future Of Medical Diagnostic And Treatment Patents

Newport Beach Corporate Counsel SeminarSeptember 28, 2010

Presented by:Brett J. Williamson

Paul Veravanich

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Bilski v. Kappos

PTO Guidelines

Effect On Medical Treatment and Diagnostics Patents

Background

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Requirements 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

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Trend of Narrowing Patent Trend of Narrowing Patent Eligibility?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 based on 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

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Bilski v. Kappos

PTO Guidelines


Background

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The 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 sold by a commodity provider at a fixed price comprising the steps of:

• initiating a series of transactions between said commodity provider and consumers of said commodity wherein said consumers purchase said commodity at a fixed rate based upon historical averages, said fixed rate corresponding to a risk position of said consumer;

• identifying market participants for said commodity having a counter-risk position to said consumers; and

• initiating a series of transactions between said commodity provider and said market participants at a second fixed rate such that said series of market participant transactions balances the risk position of said series of consumer transactions

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The 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 the exclusive test for determining patent eligibility

• Bilski’s claimed method fails the test:

•“Does not limit any process step to any specific machine or apparatus”

•“Does not transform any article to a different state or thing”

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The Supreme Court DecisionThe Supreme Court Decision• Affirmed finding of not patent-eligibility

• Although the Court did not categorically exclude business methods from patent-eligibility

• But reversed and rejected Federal Circuit’s use of exclusive, bright line machine-or-transformation test

• There is no exclusive test

• But machine-or-transformation test provides a “useful and important clue” and “investigative tool”

• Focused on 25-year-old precedent:

• Parker v. Flook

• Gottschalk v. Benson

• Diamond v. Diehr

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The 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 chemical reaction

• Practical applications of the above are patent-eligible

•Ex. A procedure for molding uncured rubber into cured products that includes the use of that math formula for some of the steps

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The Supreme Court DecisionThe Supreme Court Decision• Bilski consequences

• Claims can still be rejected based on the machine-or-transformation test

• Claims can also be rejected if drawn to an abstract idea

• Unlike Federal Circuit’s now-rejected test, there is little guidance

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Bilski v. Kappos

PTO Guidelines


Background

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Recent USPTO GuidanceRecent USPTO Guidance

• July 27, 2010 “Interim Guidance for Determining Subject Matter Eligibility for Process Claims in View of Bilski v. Kappos”

• For examiners to use when determining patent-eligibility under 35 U.S.C. § 101

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FactorsFactors• 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

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FactorsFactors• 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

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FactorsFactors• 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 a problem to be solved

• Tangible implementation

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““An Abstract Idea Is Not … Patent-An Abstract Idea Is Not … Patent-Eligible”Eligible”• Basic economic practices or theories (e.g., hedging, insurance,

financial transactions, 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, or opinion)

• Interpersonal interactions or relationships (e.g., conversing, dating)

• Teaching concepts (e.g., memorization, repetition)

• Human behavior (e.g., exercising, wearing clothing, following rules or instructions)

• Instructing how business should be conducted

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Questions 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 do not recite an abstract idea?”

• “What are examples of claims that meet the machine-or-transformation test but nevertheless are not patent-eligible because they recite an abstract idea?”

• But PTO did acknowledge that “to date, no court, presented with a subject matter eligibility issue, has ever ruled that a method claim that lacked a machine or a transformation was patent-eligible.”

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Bilski v. Kappos

PTO Guidelines


Background

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Medical 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?

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Medical 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 undergoes a transformation. The drugs do not pass through the body untouched without affecting it.”

• “[T]he determination step … is also transformative and central to the claimed methods. Determining the levels of [the drug] in a subject necessarily involves a transformation.”

• After Bilski, Supreme Court vacated and remanded

• Briefing by October 1 on effect of Bilski

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• Method of determining whether an immunization schedule affects the incidence or severity of an immune-mediated disorder

• Immunizing mammals in a treatment group according to the immunization schedule

• Comparing the incidence, prevalence, frequency, or severity of the immune-mediated disorder in the treatment group with a control group


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• 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. 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.” (this was the entire “opinion”)

• After Bilski, Supreme Court vacated and remanded

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• Method of using a muscle relaxant to treat a musculoskeletal condition

• Providing the patient with a therapeutically effective amount of the muscle relaxant (with the “amount” undefined)

• Informing the patient that the administration of the muscle relaxant with food results in an increase in the absorption of the muscle relaxant compared to administration without food


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• 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 of metaxalone with food increases both the rate and extent of absorption via 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 a different state or thing

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• 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 issue because invalid on other grounds

• But, the method would have met the machine-or-transformation test

• “[W]hile the Supreme Court in Bilski made clear that our machine-or-transformation test is not the exclusive test for patentability … it also made clear that the test is a useful and important clue, an investigative tool, for determining whether some claimed inventions are”

• “We therefore understand the Supreme Court to have rejected the exclusive nature of our test, but not necessarily the wisdom behind it.”

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StrategyStrategy

• 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

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Thank YouThank You• For more information, contact:

Brett J. Williamson(949) [email protected]

Paul Veravanich(949) [email protected]@yahoo.comhttp://www.linkedin.com/in/veravanich

O’Melveny & Myers LLP610 Newport Center Drive, 17th FloorNewport Beach, CA 92660(949) 760-9600www.omm.com

Newport Beach Corporate Counsel SeminarSeptember 28, 2010

Technology

The Future Of Medical Treatment Patents