patent (in)eligilbity in the united states...–step 2 –not needed • bascom v. at&t mobility...

2 February 2017

Patent (In)eligilbity in the United States

Konstantin Linnik, Ph.D., J.D.

UK BioIndustry Association

Lunch Seminar

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Nutter at a Glance

3More information found at www.nutter.com

US Supreme Court

Adapted from: Brougher & Linnik, Patents or Patients: Who Loses?

Nature Biotech., 32:877-880 (Sep 2014)

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35 USC § 101

Inventions patentable—

Whoever invents or discovers any 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.

5

6

“[G]roundbreaking, innovative, or even

brilliant discovery does not by itself satisfy the

§101 inquiry.”

Justice Thomas

Myriad (S. Ct. 2013)

35 USC § 101* *Supreme Court’s version

Inventions patentable—

Whoever invents or discovers any 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, provided that any such invention is significantly

more than an abstract idea or a law of nature or a natural

phenomenon.7

• Article 52(2) EPC

“[t]he following in particular shall not be regarded as inventions...:

(a) discoveries, scientific theories and mathematical methods...”

Related Exclusions: EPC, UK, Germany

• See also UK Patent Act, Section 1(2)(a)• See also German Patent Act, Section (1)(3)

• “any mere scientific principle or abstract

theorem” (Canadian Patent Act, Section 27(8))

• “discoveries with no means of putting them

into effect,” “mere ideas,” and “scientific

theories” (Australia)

Related Exclusions: Canada, Australia

10

Claim Dissection Supreme

11

USPTO Examiner Guidelines

Version 1.0

Version 2.0

Ariosa Diagnostics v. Sequenom

• Fed Circuit denied petition to rehear en banc rehearing

(Dec, 2015)

“[W]e are bound by the language of Mayo, and any further

guidance must come from the Supreme Court, not this court.”

(Judge Dyk)

Ariosa v. Sequenom

• US Supreme Court denied petition for certiorari (June

2016)

BMS v. Merck (Keytruda® anti-PD1)

Merck argues claim is directed to patent-ineligible subject matter under

Mayo v. Prometheus:

1. Antibodies to PD-1 were known.

2. Claims recite no features of anti-PD-1 mAbs other than those

coextensive with the natural phenomenon, encompasses all

methods of administering any PD-1 mAb that induces the body’s

immune system to kill cancer cells.

3. Thus, claims are directed to “natural phenomenon”

14

Claim 1. A method of treating a lung cancer comprising

administering a composition comprising a human or

humanized anti-PD-1 monoclonal antibody to a human

with the lung cancer, wherein the administration of the

composition treats the lung cancer in the human.

• Result: patent eligibility determinations differ

drastically when the US is compared to the rest

of the world (“Even China!”)

• Question: Does the problem lie with the

analytical legal framework rather than the

merits of the inventions?

15

Industry Position

“Harmonized, clear and predictable intellectual property

laws are essential for the smooth functioning of today’s

economy. Biomedical innovation, in particular, depends

on the proper balance of incentives as well as certainty

upon which billions of dollars are invested in our and

future generations’ health and well-being.”

“To find answers today, the Court

must increasingly consider foreign

and domestic laws together,

as if they constituted part of a

broadly interconnected legal

web.”

“The Court has increasingly sought

interpretations of domestic law that

would allow it to work in harmony

with related foreign laws, so that

together they more

effectively achieve common

objectives.”

Sequenom v Ariosa amici ex-US industry support

• The BioIndustry Association (UK)

• EuropaBio (pan-European)

• HollandBIO

• Swiss Biotech Association

• AusBiotech (Australia)

• BIOTECanada (Canada)

• Japan Bioindustry Association

19

Post-Mayo CAFC decisionsEligible

• Enfish v. Microsoft

• Rapid Litigation Management v. CellzDirect

• McRO v. Bandai Namco Games America

• BASCOM Global Internet Services v. AT&T Mobility

• Amdocs v. Openet

Ineligible

• TLI Communications v. Automotive

• Ariosa v. Sequenom

• Univ. of Utah v. Ambry In re Roslin Institute

• SmartGene v. Advanced Biological Labs

• PerkinElmer v. Intema

• Plus appx. 40 other cases (see spreadsheet)

Claim 1. A method of producing a desired preparation of multi-cryopreserved

hepatocytes, said hepatocytes being capable of being frozen and thawed at least two

times, and in which greater than 70% of the hepatocytes of said preparation are viable

after the final thaw, said method comprising:

(A) subjecting hepatocytes that have been frozen and thawed to density gradient

fractionation to separate viable hepatocytes from non- viable hepatocytes,

(B) recovering the separated viable hepatocytes, and

(C) cryopreserving the recovered viable hepatocytes to thereby form said desired

preparation of hepatocytes without requiring a density gradient step after thawing the

hepatocytes for the second time, wherein the hepatocytes are not plated between the first

and second cryopreservations, and wherein greater than 70% of the hepatocytes of said

preparation are viable after the final thaw.20

Rapid Litigation Management v. CellzDirect

• While the steps of the method were "well-understood,

conventional and routine," the claims must be

considered "as a whole."

• "a new combination of steps in a process may be

patentable even though all the constituents of the

combination were well known and in common use

before the combination was made."

• The record established that subjecting hepatocytes to

multiple freeze-thaw cycles was not "routine and

conventional.”

21

The Federal Circuit (CellzDirect)

• DDR Holdings v. Hotels.com (2014)– Subject Matter – Providing third party content within original

content provider’s own website

– Step 1 – Claim limitations, taken together, recites invention that was not merely routine or conventional use of Internet = Not likely an abstract idea

– Step 2 – Not likely needed

• Enfish LLC v. Microsoft Corp. (2016) – Subject Matter – Database software designed as a “self-

referential” table to improve flexibility and search time, and decrease memory requirements

– Step 1 – Claimed rules enable automation of animation tasks that could not previously be automated = Not an abstract idea

– Step 2 – Not needed

Abstract Idea – Claims Eligible


• McRO, Inc. v. Bandai Namco Games America Inc. (2016) – Subject Matter – Automated accurate and realistic lip synchronization

and facial expression generation

– Step 1 – Claimed rules enable automation of animation tasks that could

not previously be automated = Not an abstract idea

– Step 2 – Not needed

• BASCOM v. AT&T Mobility (2016)

– Subject Matter – Content filtering system

– Step 1 – Filtering content from an Internet computer network = Abstract

idea

– Step 2 – Ordered combination of known components with abstract idea

= “something more” because claimed filtering is not conventional, so a

technical improvement

• Amdocs (Israel) Ltd. v. Openet Telecom, Inc. (2016)

– Subject Matter – Distributed architecture for collecting and processing

computer network data

– Step 1 – Claims drawn to technical solution to a technical problem =

Not an abstract idea

– Step 2 – Not needed (but passes anyway because of the advancements

it provides for reduced network congestion and bottlenecks)


• Abstract idea examples 1-8 (Jan 27, 2015)

• Nature-based product examples 9-18 (Dec 16, 2014)

• Streamlined examples 19 and 20 (Mar 6, 2015)

• Abstract idea examples 21-27 (Jul 30, 2015)

• Life sciences examples 28-33 (May 4, 2016)

• Business method examples 34-36 (Dec 15, 2016)NEW

25

USPTO Examiners’ Guidance

Available at https://www.uspto.gov/patent/laws-and-

regulations/examination-policy/subject-matter-eligibility

26

(The Ingenious) Example 29Patent-eligible Patent-ineligible

1. A method of detecting JUL-1 in a patient, said method comprising:

a. obtaining a plasma sample from a human patient; and

b. detecting whether JUL-1 is present in the plasma sample by contacting the plasma sample with an anti-JUL-1 antibody and detecting binding between JUL-1 and the antibody.

3. A method of diagnosing julitis in a patient, said method comprising:

a. obtaining a plasma sample from a human patient;

b. detecting whether JUL-1 is present in the plasma sample by contacting the plasma sample with a porcine anti-JUL-1 antibody and detecting binding between JUL-1 and the porcine antibody; and

c. diagnosing the patient with julitis when the presence of JUL-1 in the plasma sample is detected.

27

Example 29 – cf. Sequenom

Patent-eligible (Ex. 29) Patent-ineligible (Sequenom)




1. A method for detecting a paternally inherited nucleic acid of fetal originperformed on a maternal serum or plasma sample from a pregnant female, which method comprises

amplifying a paternally inherited nucleic acid from the serum or plasma sample and

detecting the presence of a paternally inherited nucleic acid of fetal originin the sample.

Patent-eligible Patent-eligible




3. A method of diagnosing julitis in a patient, said method comprising:

a. obtaining a plasma sample from a human patient;

b. detecting whether JUL-1 is present in the plasma sample by contacting the plasma sample with a porcine anti-JUL-1 antibody and detecting binding between JUL-1 and the porcine antibody; and

c. diagnosing the patient with julitis when the presence of JUL-1 in the plasma sample is detected, provided that the method claimed amounts to significantly more than an abstract idea or a law of nature or a natural phenomenon.

Suggested Approach: Express Disclaimer

Conservative example of the “disclaimer approach”1. A method comprising introducing into a cancer cell an effective amount of a synthetic miR-215

molecule[..].

2. The method of claim 1, wherein the synthetic miR-215 molecule is non-naturally occurring and markedly different in sequence from naturally occurring miR-215.

3. The method of claim 1, wherein the synthetic miR-215 molecule is non-naturally occurring and markedly different in chemical structure from naturally occurring miR-215.

4. The method of claim 1, wherein the sequence of the synthetic miR-215 molecule is not naturally occurring.

5. The method of claim 1, wherein at least one nucleobase of the synthetic miR-215 molecule is chemically modified.

US Patent No. 9,068,219

1. A method comprising introducing into a cancer cell an effective amount of a synthetic miR-215 molecule[..].

2. The method of claim 1, wherein the synthetic miR-215 molecule is non-naturally occurring and markedly different in sequence from naturally occurring miR-215.

3. The method of claim 1, wherein the synthetic miR-215 molecule is non-naturally occurring and markedly different in chemical structure from naturally occurring miR-215.

4. The method of claim 1, wherein the sequence of the synthetic miR-215 molecule is not naturally occurring.

5. The method of claim 1, wherein at least one nucleobase of the synthetic miR-215 molecule is chemically modified.

Example of typically rejected claim1. A method for predicting the likelihood of long-term survival without recurrence of breast cancer from a fixed,

wax-embedded tissue sample obtained from a … breast tumor of a human breast cancer patient, comprising:

extracting RNA from the fixed, paraffin-embedded tissue sample;

reverse transcribing an RNA transcript of each of at least 15 genes, wherein the at least 15 genes include YFG1, YFG2, YFG3, and YFG4, to produce cDNAs of YFG1, YFG2, YFG3, and YFG4;

amplifying the cDNAs of YFG1, YFG2, YFG3, and YFG4;

producing amplicons from the cDNAs of the RNA transcripts of YFG1, YFG2, YFG3, and YFG4;

quantitatively assaying levels of the amplicons ... ;

normalizing said levels of the amplicons … to provide normalized YFG1, YFG2, YFG3, and YFG4 amplicon levels;

comparing the normalized YFG1, YFG2, YFG3, and YFG4 amplicon levels to YFG1, YFG2, YFG3, and YFG4 expression data obtained from reference breast cancer samples … ; and

predicting the likelihood of long-term survival without breast cancer recurrence,

wherein the normalized YFG1, YFG2, YFG3, and YFG4 amplicon levels are negatively correlated with an increased likelihood of long-term survival without breast cancer recurrence.

Example of successful allowance

1. A method for diagnosis of [Disease A] in a patient by detecting the presence of [Marker B] in a biological sample comprising:

(a) providing a diagnostic system, wherein said diagnostic system comprises one or more detection reagents selected from the group consisting of: a first detection reagent which is a fragment of [Reagent C] which comprises a polyhistidine tag at the end of said fragment of [Reagent C], and wherein the first detection reagent specifically binds [Marker B], further wherein the first detection reagent is detectably labeled, wherein the binding of [Marker B] to the detection reagent generates a signal that provides detection of a predetermined threshold level of [Marker B] in the sample in the form of a visual indication; a second detection reagent [same limitations as the first detection reagent];

(b) providing a biological sample from a patient;

(c) contacting the first detection reagent with the biological sample to provide a patient test sample;

(d) providing a control sample, wherein the control sample is from a subject without [Disease A];

(e) contacting the second detection reagent with the control sample to provide a normal control test sample;

(f) visualizing the diagnostic system to ascertain the signal generated by [Marker B] binding to the first detection reagent in the patient test sample;

(g) visualizing the diagnostic system to ascertain the signal generated by [Marker B] binding to the second detection reagent inthe normal control test sample, wherein a visually detectable greater signal of [Marker B] binding in the patient test sample relative to [Marker B] binding in the normal control test sample is a positive screen for [Disease A] in the patient.

Issues with “Biomarker” claims

1. A method of determining how to treat a subject having Disease D, comprising

determining whether the subject has Biomarker B, and

administering

wherein the presence of Biomarker B indicates that the subject will benefit from treatment with Compound C if the subject has Biomarker B.

The Mayo problem? +

the divided infringement problem

1. A method of treating a human subject having Disease D, which comprises

administering to the human subject a Compound C,

wherein said human subject has Biomarker B.

The inherent anticipation

problem but no Mayo?



administering to the human subject a Compound C,

wherein said human subject has based on said subject having been previously determined to have Biomarker B.

No inherent anticipation

problem and no Mayo?



selectively administering to the human subject a Compound C, and

said human subject having previously been determined to have has Biomarker B.

Novartis US Pat. App No. 12/999,744

Prediction of Anti-Viral Therapy Response


USSN 12/999,744

Alternative approach?

1. A method of treating a cancer associated with the p53 gene in a subject, comprising

administering to a subject in need thereof an effective amount of a composition comprising a nucleic acid, wherein the nucleic acid comprises [miR-34].

…

3. The method of claim 1, wherein said cancer is p53 negative.

US Patent No. 9,006,206

Thank you

Konstantin Linnik, PhD

Partner

Nutter McClennen & Fish LLP

Boston, MA

[email protected]

+1-617-439-2875

mailto:[email protected]

patent (in)eligilbity in the united states...–step 2 –not needed • bascom v. at&t mobility...

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