Patentable Subject Matter in Biotechnology

©2012 Knobbe Martens, Olson & Bear, LLP all rights reserved. ©2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 1

Patentable Subject Matter in Biotechnology

October 19, 2012

Kerry Taylor

Tokyo

The recipient may only view this work. No other right or license is granted.

© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 2

Prometheus Labs., Inc. v. Mayo Collaborative Servs.

Background:

• 6-MP (6-mercaptopurine) drugs were previously known, were known to treat the claimed disease, and were known to metabolize to 6-thioguanine (6-TG).

• 6-MP drugs are metabolized to 6-TG by individuals at different rates, and different metabolic rates led to efficacy and toxicity concerns.

• Prior art suggested that an individual patient’s concentration of metabolites could predict clinical efficacy and toxicity in that individual.

• Inventors discovered the level at which concentration of the metabolite correlated with efficacy and toxicity


Prometheus – Representative Claim

1. A method of optimizing therapeutic efficacy for treatment of [a specific] disorder, comprising: (a) administering a drug providing 6-TG to a subject having said … disorder; and (b) determining the level of 6-TG in said subject having said … disorder, wherein the level of 6-TG less than about 230 [units] indicates a need to increase the amount of said drug subsequently administered to said subject and wherein the level of 6-TG greater than about 400 [units] indicates a need to decrease the amount of said drug subsequently administered to said subject.


Prometheus – Analyzing the Claims

• Administering step

– Limits claim scope to a particular environment or

audience

• Determining step

– Not specific; tells doctors to determine the level of

metabolites using any (current or future) process

– Routine and conventional activity

• Wherein clause

– Recitation of the natural law / natural phenomenon


Prometheus Opinion – Holding

• Claims are not patent eligible under 35 U.S.C. § 101

• The administering and detecting steps are not sufficient to transform correlations into specific patentable applications

• “Transformation” alone is not sufficient

– In “stating that the ‘machine-or-transformation’ test is an ‘important and useful clue’ …, we have neither said nor implied that the test trumps the ‘law of nature’ exclusion.”

• Limiting claims to a particular technological field is not the same as reciting a specific application and is insufficient


Prometheus Opinion – Application of Precedent

• Compare:

– “It is inappropriate to dissect the claims into old and new elements and then to ignore the presence of the old elements in the analysis. … The “novelty” of any element or steps in a process, or even of the process itself, is of no relevance in determining whether the subject matter of a claim falls within the §101 categories of possibly patentable subject matter.” (Diehr)

– “[Diehr] nowhere suggested that all these steps…were in context obvious, already in use, or purely conventional. …--they transformed the process into an inventive application of the formula.” (Prometheus)


Association for Molecular Pathology v USPTO (“Myriad”)

Isolated DNA Claims

• An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2.

Method Claims

• A method for detecting a germline alteration in a BRCA1 gene . . . which comprises analyzing a sequence of a BRCA1 gene or BRCA1 RNA from a human sample or analyzing a sequence of BRCA1 cDNA made from mRNA from said human sample . . .


Association for Molecular Pathology v USPTO (“Myriad”)

Method Claims

• A method for screening a tumor sample from a human subject for a somatic alteration in a BRCA1 gene in said tumor which comprises . . . comparing a first sequence . . . made from mRNA from said tumor sample with a second sequence . . . .

• A method for screening potential cancer therapeutics which comprises: growing a trans-formed eukaryotic host cell containing an altered BRCA1 gene . . . , growing said transformed eukaryotic host cell in the absence of said compound, determining the rate of growth . . . , wherein a slower rate of growth of said host cell in the presence of said compound is indicative of a cancer therapeutic.


Myriad – Panel Decision

• Fractured Three Judge Panel

• One Judge Concurring-in-Part, One Judge Dissenting-In-Part

• “[T]he [isolated DNA] claims are drawn to patentable subject matter because the claims cover molecules that are markedly different—have a distinctive chemical identity and nature—from those found in nature.”

• The method claims that recite only “‘comparing’ or ‘analyzing’ two gene sequences fall outside the scope of §101 because they claim only abstract mental processes.”

• The method claims for screening potential cancer therapeutics satisfies§101 because the “growing” step is transformative and does more than simply apply a law of nature.


Myriad – What’s Next?

This case is still going through the courts, but the Supreme Court is likely to take it up for consideration

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Strategies for Chemical and

Biotechnology Inventions


Claim Drafting Strategies

• Will modifying the claim to satisfy§101 raise other issues?

– Is the claim still useful against your competitor(s)?

– Will the claim raise issues of “divided infringement”?

– Will the claim embrace the prior art?

– Will the claim permit an Examiner to shift the burden in prosecution?

• Who is your audience?

– USPTO, Federal Circuit and Supreme Court may apply different standards.

– How likely are you to enforce your rights in court?


Would This Claim Satisfy§101?

1. A method of optimizing therapeutic efficacy for treatment of [a

specific] disorder, comprising:

(a) administering a drug providing 6-TG to a subject having said …

disorder;

(b) determining the level of 6-TG in said subject having said …

disorder,

wherein the level of 6-TG less than about 230 [units]

indicates a need to increase the amount of said drug

subsequently administered to said subject, and

wherein the level of 6-TG greater than about 400 [units]

indicates a need to decrease the amount of said drug

subsequently administered to said subject; and

(c) administering an increased or decreased amount of said drug

as indicated by said level of 6-TG.



1. A method of optimizing therapeutic efficacy for

treatment of [a specific] disorder, comprising:

administering a first amount of a drug providing 6-TG to a patient in need thereof,

administering an increased amount of said drug to the patient when an amount of 6-TG in the patient’s blood is less than 230 [units], and

administering a decreased amount of said drug to the patient when an amount of 6-TG in the patient’s blood is greater than 400 [units].

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1. A method of detecting cancer X comprising:

obtaining a tissue sample from a patient at risk of cancer X; and

measuring/detecting the level of marker Y in said sample,

wherein the presence of marker Y indicates the presence of cancer X.



1. A method of treating cancer X, comprising:

obtaining a tissue sample from a patient at risk of cancer X;

measuring/detecting the level of marker Y in said sample; and

administering treatment Z to said patient when marker Y is present in said sample.


Hypothetical – Effect on Biotechnology

• Compound X is naturally present in dandelion wine,

and acts as anti-cancer agent

• Researchers have successfully isolated compound X

from the dandelion wine


Would These Claims Satisfy § 101?

1. Isolated, purified compound X.

2. An orally-administered capsule comprising:

isolated, purified compound X, and a pharmaceutically acceptable carrier.

3. A method of treating cancer comprising:

administering the compound X to a patient in need thereof.


Kerry Taylor 12790 El Camino Real

San Diego, California 92130

[email protected]

Education

Patentable Subject Matter in Biotechnology