Patentable Subject Matter in Biotechnology

Patentable Subject Matter in Biotechnology Kerry Taylor

October 19, 2012 Tokyo

The recipient may only view this work. No other right or license is granted.
©2012 Knobbe, Martens, Olson & all rights reserved.
©2012 Knobbe Martens, Olson & Bear, LLPBear, LLP all rights reserved. 1

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

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

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


Strategies for Chemical and
Biotechnology Inventions

©2012 Knobbe, Martens, Olson & all rights reserved.
©2012 Knobbe Martens, Olson & Bear, LLPBear, LLP all rights reserved. 11

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].



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.


12790 El Camino Real
Kerry Taylor San Diego, California 92130
Kerry.Taylor@knobbe.com


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