Biotech Patentable Subject Matter After Bilski

BIOTECH Patentable Subject Matter Post Bilski

Patentable Subject Matter: 35 U.S.C. § 101

• Whoever invents or discovers a 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.• 35 U.S.C. §101: two prongs

– Utility • Concrete, tangible, useful• Scope of claims (§102, 103, 112)

– Patentable subject matter

§ 101 Eligible Inventions (Discoveries)

• “Processes”

• “Machines”

• “Manufactures”

• “Compositions of matter”

*Notably lacking is “information” arguably an intangible product.

But Exclusive of (via stare decisis):• Phenomena of Nature• Laws of Nature• Abstract Intellectual Concepts (information?)• Mental Processes• Naturally Occurring Organisms• Legal Contracts• Games• Companies• per se

– Algorithms

– Transitory Signals

– Human beings

– Computer programs

Rationales For Exclusions

• Policy:– Assure basic tools of scientific and

technological work are available to all to support innovation (Article 1, § 8, US Constitution)

– Prevent “preemption” of an entire field• Problem: “entire field” is difficult to determine

BIOTECH PATENTS

• Diamond v Chakrabarty Differentiated Naturally Occurring Organisms and Phenomena of Nature Exclusions From Transformed Cell Lines.– “Anything under the sun made by man”

concept introduced

• Isolated DNA became patentable

Post Chakrabarty 35 USC § 101 Was Boring For Biotech Until:

• A solar eclipse for “anything under the sun made by man”, particularly for diagnostics?– Lab. Corp. v Metabolite Labs (SCOTUS)– Bilski (SCOTUS)– Prometheus Labs v Mayo (SCOTUS)– Classen Immunotherapies v Biogen IDEC

(SCOTUS)– King Pharmaceuticals v Eon Labs (CAFC)– Association for Molecular Pathology v USPTO

(Gene patents) (pre-CAFC)

Lab. Corp. v Metabolite Labs (Diagnostic Patent)

• Claims a method of detecting folate deficiency– Assaying a body fluid for elevated level of

homocysteine– Correlating the level in body fluid with a deficiency

of folate• Gather information step and infer step• District Court held claim valid • CAFC found claim valid rejecting Lab Corp’s argued

invalidity based on indefiniteness, lack of written description, non-enablement, anticipation and obviousness

SCOTUS: Lab. Corp. v Metabolite

• SCOTUS granted certiorari on question of “correlation” being basic scientific principle (law of nature)

• SCOTUS dismissed certiorari as improvidently granted– Lab Corp never explicitly raised § 101 issue

in lower courts– Three justices dissented on dismissal and

opined that claim was invalid under § 101 • SCOTUS action left CAFC decision intact

Bilski: Claim 1 (paraphrased) steps

• A method for managing risk comprising the steps:

– initiating a series of transactions between providers and consumers wherein consumers purchase a commodity at a fixed rate;

– identifying market participants for the commodity having a counter risk position to the consumers; and

– initiating a series of transactions between commodity providers and the counter risk market participants at another fixed rate so that the positions for risk between consumers and other market participants are balanced.

Bilski: Prosecution and Court History

• Rejected by Examiner (directed to abstract idea and not implemented on an apparatus)

• BPAI rejected (mental step directed to abstract idea)

• CAFC en banc affirmed: NOT PATENT ELIGIBLE– Sole Test for Method Eligibility is MOT:

• Must be tied to a particular Machine or apparatus (State Street) Or

• Must Transform an article into a different state or thing

Legal Theories For Non-patentable Claims Before SCOTUS

• Method not tied to a machine and does not transform an article

• Method involves a method of conducting business

• Method is merely an abstract idea

SCOTUS: MOT Not The Standard• SCOTUS rejected the CAFC concept that a

process/method must be tied to a particular machine or apparatus or must transform an article into a different state or thing

• MOT concept is a clue but is too limiting

• Standard for patentable process is:– Definition of process in § 100(b) and

– Guidepost in Benson, Flook and Diehr

– Consider the claim as a whole

Claims A Process (Business Method)

• § 100(b) “Process” means process, art or method including a new use of a known process, machine, manufacture, composition of matter or material (doesn’t exclude business methods)

• § 273 (a)(3) Business method: A method of doing or conducting business

• Under some circumstances, business methods may be patent eligible (4 justices disagreed (Stevens et al.))

SCOTUS Affirms: Not Patentable

• Unanimously found claims Not Patentable because they claim an abstract idea instead of a process

• Precedent is:– Benson (algorithm for binary to

hexadecimal/abstract idea)– Flook (monitoring catalytic process conditions and

recalculating/abstract idea (post solution activity))– Diehr (unknown method for molding rubber into

products using a formula in a computer to complete some steps, i.e., abstract idea (formula) may be incorporated in an industrial process/patentable)

Effects of Bilski on Biotech

• District Courts and CAFC have based many decisions on MOT (e.g., Prometheus, Classen, King Pharmaceuticals, Association for Molecular Pathology (in part))

• SCOTUS, post-Bilski, granted certiorari in Prometheus and Classen and immediately remanded to CAFC (CAFC asked for briefs on effect of Bilski)

Prometheus Labs v Mayo

• Method claims for optimizing therapeutic efficacy– Administering a dose of 6-thioguanine prodrug;– Determining the drug/metabolite conc. in blood; and– Comparing the conc. to an upper and lower value

• District Court: Directed to data gathering on natural body process and an abstract idea ineligible under § 101

• CAFC reversed: Method claims are eligible– Meet MOT test: Administering drug and determining

levels were transformative of the body or composition/blood sample

Why Was Prometheus Remanded?

• SCOTUS: MOT is a useful tool for § 101 analysis

• CAFC reversed District Court based on MOT

• Post-Bilski: no certiorari for Ferguson v USPTO– CAFC denied business method claim based on

MOT

• Did SCOTUS think CAFC Prometheus decision “wholly preempts” the use of a biological correlation?

CAFC Reaffirms Previous Decision

• Claims directed to only a particular application of a natural phenomenon as in Diehr, i.e., do not preempt all uses

• Claims recite administration of a drug and determination of a metabolite which are both transformative

• Administering and determining steps are not merely data gathering but are part of a transformative treatment protocol

• Claims as a whole are §101 eligible and are distinguishable from the algorithm of in re Grams

Classen Immunotherapies v Biogen IDEC

• Claims method of immunization (any vaccine)– Immunizing patients on schedules– Comparing the incidence of immune mediated

disorders in treatment groups with different schedules

– Immunizing patients by the low risk schedules• District Court held that claims were to a natural

phenomenon/abstract idea and invalid• CAFC confirmed stating that claims are not tied to a

machine or apparatus or transformation of an article (does not meet MOT test for a method)

King Pharmaceuticals v Eon LabsPost SCOTUS Bilski Decision

• Claims method of increasing oral bioavailability of metaxalone by administering with food and informing patient that food results in increased bioavailability

• District Court held method claim invalid based on MOT test (informing (only novelty) was non-transforming)

• CAFC traversed asserting a method of treatment claim is always transformative citing Prometheus but held claim invalid for inherent anticipation (giving with food known) since informing cannot distinguish from the prior art (In re Gulack)

• CAFC avoided clear guidance on medical treatment methods under § 101

Association for Molecular Pathology v USPTO and Myriad (Gene patents)

• Question: Are “isolated genes” a “product of nature” or patentable and is “comparing genes” an “abstract idea” beyond MOT?

• 7 patents and 15 claims directed to:– Isolated DNA and cDNA containing all or portions of

BRCA1 and BRCA2 gene sequence– Methods for comparing these sequences to identify

mutations correlative to predisposition to breast cancer

• Suit brought in NY District

AMP’s Legal Theory

• Claims invalid under 35 U.S.C. 101(Excluded)

• Unconstitutional under the First Amendment (inhibits free speech and thought)

• Claims invalid under Article 1, Section 8, Clause 8 of the Constitution (preempts progress in innovation)

Court Recognized Issues

• USPTO grants patents on DNA sequences so long as they are claimed in the form of “isolated DNA”

• Patentability is premised on view that isolated DNA is treated as any other chemical compound and that when isolated from nature is transformed into something “distinctly different in character” (See 66 Fed. Reg. 1092)

Court Traversed “Different In Character”

• DNA is distinct from other chemicals in being a physical embodiment of laws of nature (laws that define the construction of the human body)

• Isolating DNA or cDNA does not alter this distinction nor does it change the biological information it encodes

• Because the isolated DNA is not distinctly different in character from DNA in the body, it remains a “product of nature” and is unpatentable subject matter under § 101

Court Finds All Claims Invalid

• Comparing the natural BRCA1 and BRCA2 gene sequences to patient DNA sequences are “abstract mental processes” and, therefore, constitutes unpatentable subject matter under § 101

• Court granted partial summary judgement to plaintiffs (ACLU and friends)

• Case is on appeal to the CAFC

How Will Higher Courts Decide?

• CAFC has upheld validity of gene patents on a number of occasions but the eligibility under § 101 has never been addressed by CAFC or SCOTUS

• SCOTUS reaffirmed “laws of nature, physical phenomena and abstract ideas” are not patentable in Bilski

• CAFC Judge Dyk, sua sponte, raised gene patentability issue in Intervet v Merial (CAFC 2010) where only claim construction was at issue

Dyk’s Comments

• Chakrabarty required a product of nature to be qualitatively different from the product occurring in nature with “markedly different characteristics from any found in nature”

• The mere fact that a DNA molecule does not occur in isolated form in nature does not, by itself, answer the question (contrast this with USPTO position 66 Fed Reg 1092)

• Could one patent the leaves of a plant merely because the leaves do not occur in nature in their isolated form?

How Will Higher Courts Decide?

• 30 amicus briefs have been filed

• US brief supports cDNA patentability but not isolated DNA patentability

• Oral arguments began in early April, 2011

• Could be interesting at CAFC or en banc but would SCOTUS grant cert.?

Practice For Embracing & Mitigating Uncertainty

• Method claims or diagnostics

– Kit claims (could include the device with means +?)– Tie claims to a device, e.g. an auto analyzer– Present as a method for determining a course of

treatment wherein the ultimate step would be administering a drug (transformation of body test)

– Avoid explicit human comparing steps or claiming a correlation unless tied to a transformation

• Focus claims to synthetic or engineered DNA• Consult Fed Reg 75, 143, p43911-43928, (Interim

Guidance to Examiner post Bilski)