Recent Developments in Australian & US Patent Law & their Impact ...

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Recent Developments in Australian & US Patent Law & their Impact ...

Ausbiotech 2012

RECENT DEVELOPMENTS

IN US AND AUSTRALIAN

PATENT LAW

Melbourne Convention and Exhibition Centre

1 November 2012


Ausbiotech 2012 – Australian and US Patent Law 1 November 2012 2

Presenters

Chairperson: Dr Jenny Petering, FB Rice

Dr Lisa Haile, DLA Piper (San Diego)

Nicholas Tyacke, DLA Piper (Sydney)

Dr Helen Mutimer, CSL


Ausbiotech 2012 – Australian and US Patent Law 1 November 2012 3

Outline

Part A:

Part B:

Patent eligible subject matter

• Infringement exemptions –

experimental use and regulatory

approval


USA –

Patent Eligible Subject

Matter


Patent eligibility

Ausbiotech 2012 – Australian and US Patent Law

1 November 2012

5

Are genes patentable?

Are diagnostic tests patentable?

What is the current state of the law in the U.S.

and Australia surrounding personalized medicine?


Personalized Medicine

Intellectual Property Protection

Ausbiotech 2012 – Australian and US Patent Law

1 November 2012

6

ACLU et al. v. USPTO and Myriad Genetics

(Fed. Circ., 2012)

Mayo Collaborative Services et al. v.

Prometheus Laboratories Inc. (Supreme Court,

2012)


Personalized Medicine –

Gene/Biomarker Patents

Ausbiotech 2012 – Australian and US Patent Law

1 November 2012

7

5,882,914 (HIF-1α - Expires 2016)

• An isolated polynucleotide encoding the human hypoxia-inducible factor-1 alpha polypeptide of SEQ ID

NO:2.

5,593,884 (JNK - Expires 2014)

• An isolated polynucleotide sequence encoding a polypeptide characterized by:

a. having a molecular weight of 46 kD as determined by reducing SDS-PAGE;

b. having serine and threonine kinase activity; and

c. phosphorylating the c-Jun N-terminal activation domain.

5,827,733 (GDF-8/myostatin - Expires 2013)

• An isolated polynucleotide selected from the group consisting of: a) SEQ ID NO:11; b) SEQ ID NO:13; c)

SEQ ID NO:11, wherein T can also be U; d) SEQ ID NO:13, wherein T can also be U; e) nucleic sequences

complementary to SEQ ID NO:11…

6,132,728 Hedgehog (Expires 2017)

5,777,079 Green Fluorescent Protein (GFP) (Expires 2015)


Personalized Medicine –

Myriad Genetics US Patent Nos. 5,710,001 and 5,753,441

Ausbiotech 2012 – Australian and US Patent Law 1 November 2012 8

(‘001) 1. 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… BRCA1 gene from

said tumor sample…with a second

sequence…BRCA1 gene from a non tumor sample

of said subject…wherein a difference in the

sequence of the BRCA1 gene...from said tumor

sample from the sequence of the BRCA1 gene,

from said non tumor sample indicates a somatic

alteration in the BRCA1 gene in said tumor sample.

(‘441) 1. A method for screening germline of a

human subject for an alteration of a BRCA1 gene

which comprises comparing germline sequence of

a BRCA1 gene or BRCA1 RNA from a tissue

sample from said subject or a sequence of BRCA1

cDNA made from mRNA from said sample with

germline sequences of wild-type BRCA1 gene, wildtype

BRCA1 RNA or wild-type BRCA1 cDNA,

wherein a difference in the sequence of the BRCA1

gene, BRCA1 RNA or BRCA1 cDNA of the subject

from wild-type indicates an alteration in the BRCA1

gene in said subject.


Personalized Medicine –

Myriad Genetics US Patent No. 5,710,001

Ausbiotech 2012 – Australian and US Patent Law

1 November 2012

9

(‘001) 1. A method for screening a tumor sample from a human subject for a somatic

alteration in a BRCA1 gene in said tumor which comprises:

a) extracting a nucleic acid sample from the tumor sample;

b) isolating and sequencing the nucleic acid from step a); and

c) comparing a first sequence… from said tumor sample with a second

sequence…from a non tumor sample of said subject…

wherein a difference in the sequence of the BRCA1 gene…from said tumor sample

from the sequence of the BRCA1 gene…from said non tumor sample indicates a

somatic alteration in the BRCA1 gene in said tumor sample,

wherein a determination of the presence of a somatic alteration in the BRCA1

gene is indicative of a higher risk of invasive breast cancer or a therapeutic

regimen in the subject.


Personalized Medicine –

Prometheus Labs US Patent No. 6,355,623

Ausbiotech 2012 – Australian and US Patent Law

1 November 2012

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1. A method of optimizing therapeutic efficacy for treatment of an immune-mediated

gastrointestinal disorder, comprising:

(a) administering a drug providing 6-thioguanine to a subject having said immunemediated

gastrointestinal disorder; and

(b) determining the level of 6-thioguanine in said subject having said immunemediated

gastrointestinal disorder,

wherein the level of 6-thioguanine less than about 230 pmol per 8 x 10 8 red blood cells

indicates a need to increase the amount of said drug subsequently administered to

said subject and

wherein the level of 6-thioguanine greater than about 400 pmol per 8 x 10 8 red blood

cells indicates a need to decrease the amount of said drug subsequently administered

to said subject.


Personalized Medicine –

Prometheus Labs US Patent No. 6,355,623

Ausbiotech 2012 – Australian and US Patent Law

1 November 2012

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1. A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder,

comprising:

(a) administering a drug providing 6-thioguanine to a subject having said immune-mediated gastrointestinal

disorder; and

(b) determining the level of 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder,

[[wherein the level of 6-thioguanine less than about 230 pmol per 8 x 10 8 red blood cells indicates a need to increase the amount of said drug

subsequently administered to said subject and

wherein the level of 6-thioguanine greater than about 400 pmol per 8 x 10 8 red blood cells indicates a need to decrease the amount of said drug

subsequently administered to said subject]]

(c) comparing the level of 6-thioguanine in said subject with a reference standard of a subject not having an

immune-mediated gastrointestinal disorder; and

(d) determining whether the subject with the disorder has a level of 6-thioguanine less than about 230 pmol per 8

x 10 8 red blood cells or greater than about 400 pmol per 8 x 10 8 red blood cells,

wherein when the subject has less than about 230 pmol per 8 x 10 8 red blood cells,

(e) administering a subsequent increased dose of 6-thio to the subject, wherein steps (b)-(d) are optionally

repeated.

or wherein when the subject has greater than about 400 pmol per 8 x 10 8 red blood cells,

(f) administering a subsequent decreased dose of 6-thio to the subject, wherein steps (b)-(d) are optionally

repeated.


Personalized Medicine –

Legal and strategic considerations

Ausbiotech 2012 – Australian and US Patent Law

1 November 2012

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Legal considerations:

• Diagnostics and theranostics/companion Dx are still patentable

• Include ACTIVE method steps to move past “natural phenomena”

Strategic considerations:

• Claim diagnostic and drug combinations

• Claim novel combinations of markers

• In view of AIA, consider:

• Claims of narrow scope

• Opposition or third party submission threats


Australia –

Patent Eligible Subject

Matter


Australia –

Raising the Bar Act 2012

Ausbiotech 2012 – Australian and US Patent Law 1 November 2012 14

Doesn't address patent eligibility

Inventive/innovative step

• Limitation of common general knowledge to Australia and that prior art be limited to documents that would have

been "ascertained, understood and regarded as relevant" removed

Usefulness

• Specific, substantial & credible use

Disclosure

• Enablement across full scope of claim

Support

• Broader than existing fair basis test

Opposition

• Numerous reforms including those speeding up oppositions


Ausbiotech 2012 – Australian and US Patent Law 1 November 2012 15

Current legislation – Patent eligibility

Patent Eligibility in the

USA

• S 101 of 35 USC - any new and useful

process, machine, manufacture, or

composition of matter, or any new and

useful improvement thereof


Ausbiotech 2012 – Australian and US Patent Law 1 November 2012 16

Current legislation – Patent eligibility

Patent Eligibility in Australia

• Section 18 of the Patents Act 1990 (Cth)

• An invention is patent eligible if it is a manner of manufacture within the

meaning of section 6 of the Statute of Monopolies 1623

Statute of Monopolies

• Provides that patents are only available for manners of new manufacture

that are ‘not contrary to law nor mischievous to the state by raising prices of

commodities at home or hurt of trade or generally inconvenient’


Ausbiotech 2012 – Australian and US Patent Law 1 November 2012 17

Current legislation – Patent eligibility

‘Manner of manufacture' test – NRDC case 1959

• Need not involve manufacture

• Must be an artificially created state of affairs

• Must belong to the “useful arts” rather than the “fine arts”

• Must provide material advantage in a field of economic endeavour

Exclusions

• Discoveries, ideas, scientific theories and laws of nature


Ausbiotech 2012 – Australian and US Patent Law 1 November 2012 18

Life sciences patents in Australia

s 18(2) Human beings, and the

biological processes for their

generation, are not patent eligible

Patent eligible: Genetic

material, living organisms,

methods of treatment,

methods of diagnosis

Patent ineligible: IVF and

methods of cloning


Ausbiotech 2012 – Australian and US Patent Law 1 November 2012 19

Reform round-about

ALRC’s report, Genes and Ingenuity: Gene Patenting and Human Health

ACIP Patentable Subject Matter Report

Patent Amendment (Human Genes and Biological Materials) Bill 2010

Proposed private member's bill from Melissa Parke MP (Labor backbencher)

2012 – Review of Pharmaceutical Patents in Australia

Proposed reform to exclude inventions the commercial exploitation of which would be wholly offensive

Proposed reform of Manner of Manufacture test


Ausbiotech 2012 – Australian and US Patent Law 1 November 2012 20

The Courts' perspective

Cancer Voices Australia & Anor

v Myriad Genetics Inc & Ors

Apotex v Sanofi Aventis (No 2)

(Full Court of Federal Court)

• First Australian case to consider

whether isolated genetic material

(BRCA1 gene) is eligible for

patent protection

• Method of diagnosis claims not

challenged

• Decision of the Federal Court

reserved on 23 February 2012

• Case concerns a pharmaceutical

for the treatment of psoriasis and

psoriatic arthritis

• Case considers patent eligibility of

methods of medical treatment

•High Court appeal period has

passed


USA –

Infringement Exemptions


Infringement exemptions –

US Case Law

Ausbiotech 2012 – Australian and US Patent Law

1 November 2012

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Status of exemptions and the path to regulatory approval in the U.S.

Bolar Exception (Hatch-Waxman)

Experimental Use (e.g., Duke v. Madey)

Merck KGaA v. Integra Lifesciences Ltd. (Supreme Court, 2005)

Classen Immunotherapies, Inc. v. Biogen IDEC (Fed. Cir. 2011)

Momenta Pharmaceuticals v. Amphastar Pharmaceuticals, Inc. (Fed. Cir. 2012)


Bolar Exemption

(Roche v. Bolar (Fed. Cir. 1984)

Ausbiotech 2012 – Australian and US Patent Law

1 November 2012

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District Court of the Eastern

District of New York found

no infringement under

"experimental use"

Court of Appeals for the

Federal Circuit disagreed

that Bolar’s experiments

were covered by the

experimental-use exemption

(narrowly construed and

should not apply to

experiments which have a

commercial objective).

According to Roche v. Bolar,

experiments conducted for

use in an ANDA could not

take place prior to the expiry

of a patent.

In 1984, in response to the

Roche v. Bolar judgment,

the U.S. Congress passed

the Drug Price Competition

and Patent Term Act (known

as the Hatch-Waxman Act).

35 U.S.C.

§271(e)(1))/experimentaluse

exemption:

• "It shall not be an act of infringement

to make, use,

• offer to sell, or sell … a patented

invention … solely for

• uses reasonably related to the

development and

• submission of information under a

Federal law which

• regulates the manufacture, use, or

sale of drugs …"


Ausbiotech 2012 – Australian and US Patent Law

1 November 2012

24

Madey v. Duke University (Fed. Cir. 2002)

In 2002, the Court of Appeals for the Federal Circuit dramatically limited the scope of the research exemption in Madey

v. Duke University, 307 F.3d 1351, 1362 (Fed. Cir. 2002).

The court left only a "very narrow and strictly limited experimental use defense" for "amusement, to satisfy idle

curiosity, or for strictly philosophical inquiry.“

The court went on to state:

“…regardless of whether a particular institution or entity is engaged in an endeavor for commercial gain, so long as the

act is in furtherance of the alleged infringer’s legitimate business and is not solely for amusement, to satisfy idle

curiosity, or for strictly philosophical inquiry, the act does not qualify for the very narrow and strictly limited experimental

use defense. Moreover, the profit or non-profit status of the user is not determinative.”


Ausbiotech 2012 – Australian and US Patent Law

1 November 2012

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Merck KGaA v. Integra Lifesciences

In Merck KGaA v. Integra Lifesciences I, Ltd. 545 U.S.

193 (2005), the United States Supreme Court held that

the use of patented compounds in preclinical studies is

protected under 35 U.S.C §271(e)(1) if there is:

a reasonable basis to believe

that the compound tested

could be the subject of an

FDA submission; and

if the experiments will

produce the types of

information relevant to an

Investigational New Drug or

New Drug Application.


Classen Immunotherapies, Inc. v.

Biogen IDEC (Fed. Cir. 2011)

Ausbiotech 2012 – Australian and US Patent Law

1 November 2012

26

Federal Circuit found that the statute provided no protection for the activities of accused

infringers Biogen IDEC and GlaxoSmithKline related to timing of vaccinations.

The statute provides safe harbor for the use of a patented invention “solely for uses

reasonably related to the development and submission of information under a Federal law

which regulates the manufacture, use, or sale of drugs . . . . ”

The Court concluded that the safe harbor provision does not apply to information that is

routinely reported to the FDA after marketing approval has already been obtained, such as the

reporting by the accused infringers of vaccine relationships, recommendations in view of

relevant literature, adverse vaccine effects, or other regulation-required information to the

FDA.


Momenta Pharmaceuticals v. Amphastar

Pharmaceuticals, Inc. (Fed. Cir. 2012)

Ausbiotech 2012 – Australian and US Patent Law

1 November 2012

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Federal Circuit construed the safe-harbor provision to protect Amphastar’s post-marketing activities

because, even though the information is not submitted to the FDA, but merely kept available as proof

of compliance in the event of FDA inspection, the testing results are needed to comply with

Amphastar’s ANDA to ensure that each new batch of the generic drug meets the equivalency

requirements.

The court found ample support in the Supreme Court’s decision of Merck v. Integra (2005). So long

as the information is of the kind that would be submitted to the FDA, the activities are “reasonably

related” and thus fall under the exemption, even though the research was aimed at developing new

drugs and not at developing generic versions of an already approved drug.

Denying safe-harbor protection just because the information is ultimately not submitted would stifle

innovation as one cannot predict which drug candidate will be successful and lead to information that

will be submitted to the FDA.”


Australia –

Infringement Exemptions


Regulatory approval –

pharmaceuticals

Ausbiotech 2012 – Australian and US Patent Law 1 November 2012 29

s 119A

No infringement of a pharmaceutical patent if the invention is being exploited solely for

purposes connected with obtaining registration on the ARTG, or similar regulatory

approval under the law of a foreign country, for goods intended for therapeutic use.

Pharmaceutical Patent:

• pharmaceutical substance;

• a method, use or product relating to

a pharmaceutical substance,

including any of the following

• method of producing raw material

needed to produce the substance;

• raw material need to produce the

substance; or

• pro-drug; metabolite or derivative

of the substance.

Registration cannot be in

relation to a medical or

therapeutic device.

Exception does not apply to

exporting goods for overseas

registrations unless:

• there has been a patent term

extension; and the goods either

• contain a pharmaceutical

substance per se claimed in a

patent; or

• contain a pharmaceutical

substance when produced by

recombinant DNA technology

claimed in a patent


Regulatory approval –

non-pharmaceuticals

Ausbiotech 2012 – Australian and US Patent Law 1 November 2012 30

s 119B

if the act is done solely for purposes connected with

obtaining approval required by law to exploit a product,

method or process

Australia

(Commonwealth, State or

Territory) as well as other

countries or regions.

s 119B does not apply to

pharmaceutical patents.


Ausbiotech 2012 – Australian and US Patent Law 1 November 2012 31

Experimental Purposes

s 119C

if the act is done for experimental purposes relating

to the subject matter of the invention.

Determining

the

properties

Determining

the scope

of a claim

Improving

or

modifying

Determining

the validity

of the

patent or a

claim

Determining

infringing

acts


Ausbiotech 2012 – Australian and US Patent Law 1 November 2012 32

Experimental Purposes

Experimental Purposes

• 'experimental' should be given its ordinary English meaning. The exemption

should apply to tests, trials and procedures that a researcher or follow-on

innovator undertakes as part of discovering new information or testing a

principle or supposition.

• Experimental purpose must be primary purpose. Exemption still applies

even if there is a secondary commercial purpose

• Experimenter need not be aware of the relevant patents.

Research Tools

• Experimenting with a research tool is not exempt from infringement.

• Experimenting on a research tool is exempt from infringement.


Ausbiotech 2012

RECENT DEVELOPMENTS

IN US AND AUSTRALIAN

PATENT LAW

Melbourne Convention and Exhibition Centre

1 November 2012

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