Patent-eligible Subject Matter Cle

Pre p a re d b y E co Te ch La w G ro u p , P. C .

Patent-Eligible Subject Matter Under 35 U.S.C. § 101 1

Patent-Eligible Subject Matter Under 35 U.S.C. § 101 2

35 U.S.C. § 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” 3

Roadmap of Life Science Process Claims 

Process claims reciting steps of: (1) inducing a correlation, (2) data gathering, and (3) correlating

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Prometheus

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Process claims reciting steps of: (1)data gathering and (2)correlating 

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Process claims reciting only a step of correlating 

Metabolite

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Myriad

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Outline of Presentation • • Laboratory Corp. v. Metabolite Labs* • In re Bilski** • Prometheus Laboratories, Inc. v. Mayo Collaborative Services et al.*** • Association for Medical Pathology et al. v. USPTO, Myriad Genetics & the Directors of the University of Utah Research Foundation****  * ** *** ****  

548 U.S. 124 (2006). 545 F.3d 943 (Fed. Cir. 2008) (en banc), cert. granted, 129 S. Ct. 2735 (June 1, 2009). No. 2008-1403, U.S. App. Lexis 20623 (Fed. Cir. Sept. 16, 2009). Complaint filed on May 12, 2009 in the Southern District of New York.

5

Metabolite Facts • • The Metabolite patent at issue claimed methods for detecting deficiencies of cobalamin and/or folate • Deficiency in either of these vitamins leads to serious diseases • Cobalamin and folate assist in metabolizing the amino acid homocysteine

6

Metabolite District Court Ruling • 

• Jury found Laboratory Corporation of America Holdings (“LabCorp”) induced infringement of the Metabolite patent • • Metabolite awarded double damages for willful infringement 7

Metabolite Claim at Issue 

13. A method for detecting a deficiency of cobalamin or folate in warm-blooded animals comprising the steps of:  assaying a body fluid for an elevated level of total homocysteine; and  correlating an elevated level of total homocysteine in said body fluid with a deficiency of cobalamin or folate 

• •

8

LabCorp’s Unaddressed Argument • • LabCorp appealed the District Court’s construction of the claim term “correlating,” arguing that this construction rendered claim 13 invalid under 35 U.S.C. § 101 for attempting to obtain patent protection for a natural phenomenon

• • Federal Circuit affirmed the District Court’s claim construction without addressing the above argument •

9

LabCorp’s Supreme Court Appeal • • A writ of certiorari on LabCorp’s appeal was initially granted and then later dismissed as improvidently granted 

• Justice Breyer, in a non-binding dissent, analyzed whether Claim 13 is invalid because it seeks to claim a monopoly over a natural phenomenon, i.e., the correlation between elevated levels of homocysteine and deficiencies in cobalamin or folate AND therefore 10 addressed LabCorp’s argument

Metabolite’s Response to the Unaddressed Argument • • Metabolite conceded that correlation between homocysteine and vitamin deficiency is a natural phenomenon 

• Metabolite argued that Claim 13 is still patentable because it recites a process for detecting vitamin deficiency with discrete testing and correlating steps and that a process is not unpatentable simply because it contains a natural phenomenon •

11

Metabolite’s Response to the Unaddressed Argument (cont.) 

Metabolite also argued that Claim 13 is a patentable application of a natural phenomenon because: • it entails a physical transformation of matter (e.g., alteration of blood sample during whatever test is used); and • it produces a useful, concrete, and tangible result (i.e., detection of vitamin deficiency) 



12

Breyer’s Dissent in Metabolite • • Breyer states that claim 13 is invalid because it recites ineligible patent subject matter as it covers a natural phenomenon, i.e., the correlation itself 

• Breyer believes that Metabolite claimed a natural law in the abstract natural language of a process because the additional assaying step is superfluous • 

•

13

Outline of Presentation • • Laboratory Corp. v. Metabolite Labs* • In re Bilski* • Prometheus Laboratories, Inc. v. Mayo Collaborative Services et al.*** • Association for Medical Pathology et al. v. USPTO, Myriad Genetics & the Directors of the University of Utah Research Foundation****  * ** *** ****  

548 U.S. at 124 (2006). 545 F.3d 943 (Fed. Cir. 2008) (en banc), cert. granted, 129 S. Ct. 2735 (June 1, 2009). No. 2008-1403, U.S. App. Lexis 20623 (Fed. Cir. Sept. 16, 2009). Complaint filed on May 12, 2009 in the Southern District of New York. 14

Recent § 101 Cases Before Bilski • • • Federal Circuit held that patent claims relating to a mandatory arbitration system involving legal documents, such as wills or contracts were not patentable subject matter because they “depend for their operation on human intelligence alone” to solve practical problems  In re Comiskey, 499 F.3d 1365, 1378-79 (Fed. Cir. 2007). 

• Federal Circuit held that claims to a signal with an embedded digital watermark encoded according to a given encoding process were not directed to statutory subject matter under Section 101 15  In re Nuijten, 500 F.3d 1346, 1353-54 (Fed. Cir.

Market Landscape Before Bilski • Internet fueling new business method patents • Business method patents were being directed to significant commercial activity • Increasing number of diagnostic patents in personalized medicine space directed to correlations

16

Bilski’s Claim 1 Original Language

Simplified Language

A method for managing the consumption risk costs of a commodity sold by a commodity provider at a fixed price comprising the steps of:

A method of managing a commodity broker’s risk

initiating a series of transactions between said commodity initiating transactions between a broker and buyers (e.g., provider and consumers of said commodity wherein said coal power plants) by which the buyers buy the commodity consumers purchase said commodity at a fixed rate based upon (e.g., coal) at a fixed price; historical averages, said fixed rate corresponding to a risk position of said consumer; identifying market participants for said commodity having a counter-risk position to said consumers; and

identifying sellers of the commodity (e.g., coal mines); and

initiating a series of transactions between said commodity initiating transactions between the broker and sellers, at a provider and said market participants at a second fixed rate suchsecond fixed price, such that the buyers’ and sellers’ that said series of market participant transactions balances the respective risk positions balance out risk position of said series of consumer transactions 17

Federal Circuit’s Analysis • • Analyzed prior Supreme Court rulings regarding meaning of “process” • Rejected its test regarding when a “process” is eligible subject matter • Adopted the “machine-ortransformation” test as the only test to determine eligible subject matter 18

Prior Supreme Court Ruling • • Meaning of “process” as used in § 101 is narrower than its ordinary meaning  Parker v. Flook, 437 U.S. 584, 593 (1978). • The ordinary meaning of “process” is: “[a] procedure . . . [a] series of actions, motions, or operations definitely conducing to an end, whether voluntary or involuntary”  WEBSTER'S NEW INTERNATIONAL DICTIONARY OF THE ENGLISH LANGUAGE 1972 (2d ed. 1952). • A claim is not a patent-eligible “process” if it claims “laws of nature, natural phenomena, [or] abstract ideas”  Flook, 437 U.S. at 589. 19

Federal Circuit Rejects Its Own Tests • • Federal Circuit rejects the following tests used in prior decisions to determine patent-eligible “process”: Freeman-Walter-Abele test; Useful, concrete and tangible result test; and Technological arts test • Federal Circuit clarified that the following are also not the proper test: Business method exception; and Mental process that lacks significant “physical steps” 20

Freeman-Walter-Abele Test • • Based on three Custom Court of Appeals decisions  In re Freeman, 573 F.2d 1237 (CCPA 1978); In re Walter, 618 F.2d 758 (CCPA 1980); and In re Abele, 684 F.2d 902 (CCPA 1982).

• • This test requires:  (1) determining whether the claim recites an “algorithm” within the meaning of Benson, then (2) determining whether that algorithm is “applied in any manner to physical elements or process steps”  21 Abele, 684 F.2d at 905-07.

Useful, Concrete and Tangible Result • • • “[A] process tied to a particular machine, or transforming or reducing a particular article into a different state or thing, will generally produce a ‘concrete’ and ‘tangible’ result . . .”  Bilski, 545 F.3d at 959. 

• “[C]ertain of mathematical subject matter, standing alone, represent nothing more than abstract ideas until reduced to some type of practical application”  In re Alappat, 33 F.3d 1526, 1543 (Fed. Cir. 1994).  

22

Technological Arts Test • • A claimed process is technological to the extent it applies laws of nature to new ends  Benson, 409 U.S. at 67.

• • By contrast, a process is non-technological where its inventive concept is the application of principles drawn not from the natural sciences but from disciplines such as business, law, sociology, or psychology

23

Machine-or-Transformation Test The claim is tied to a particular machine 

OR

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The claim transforms an article  

AND

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The involvement of a machine or transformation in the process must not merely be insignificant extra-solution activity

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Application to Bilski’s Claim 1 • • • No machine tied to the claim  “The examiner noted that Applicants had admitted their claims are not limited to operation on a computer, and he concluded that they were not limited by any specific apparatus”  Bilski, 545 F.3d at 950.

• • Claim does not transform an article  “[C]laim 1 does not involve the transformation of any physical object or substance, or an electronic signal representative of any physical object or substance”  Bilski, 545 F.3d at 964. 25

Dyk’s Concurrence • • English Law: under patent clause of the Statute of Monopolies, patent subject matter was limited by the term “manufacture,” and did not include organization of human activity • Patent Act of 1790: incorporated and was consistent with the English Law • Patent Act of 1793: introduced some of the language of § 101, had the word “art” instead of “process,” and was also consistent with English law • Patent Act of 1952: replaced the word “art” with “process,” but the Supreme Court has concluded that this change did not alter the substantive understanding of the statute

26

Newman’s Dissent • • • Majority’s narrow reading of “process” “excludes many of the kinds of inventions that apply today’s electronic and photonic technologies, as well as other processes that handle data and information in novel ways. Such processes have long been patent eligible, and contribute to the vigor and variety of today’s Information Age”  Bilski, 545 F.3d at 976. 

• “Uncertainty is the enemy of innovation. These new uncertainties not only diminish the incentives available to new enterprise, but disrupt the settled expectations of those who relied on the law as it existed”  27 Bilski, 545 F.3d at 977.

Newman’s Dissent (cont.) 

Newman notes that machine-ortransformation test has been rejected as the only test by the Supreme Court in • Gottschalk v. Benson • Parker v. Flook • Diamond v. Chakrabarty • Diamond v. Diehr 

28

Mayer Dissent • • Agrees with Majority that § 101 should not extend to protecting process which structure commercial transactions • Fervently believes that there should be no protection for business method patents • Criticizes machine-or-transformation test for not being an appropriate test because it can be easily circumvented by non-technological methods, such as business methods • Supports the technological arts test: regardless of a “physical transformation,” a claimed process should not be patent eligible unless it is directed to an advance in science or technology 29  Bilski, 545 F.3d at 1009.

Rader Dissent • • Machine-or-transformation test applies to archaic technology and does not apply to innovation in the modern era • There is no limit on what is considered “process” under § 101 • § 101 does not cover laws of nature, natural phenomenon and abstract ideas Laws of nature and natural phenomenon cannot be invented Abstract ideas must be applied to or transformed to practical use before they qualify for protection

•

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Supports Diagnostic Patents  

“Before the invention featured in Lab Corp., medical science lacked an affordable, reliable, and fast means to detect this debilitating condition. Denial of patent protection for this innovation—precisely because of its elegance and simplicity (the chief aims of all good science)—would undermine and discourage future research for diagnostic tools. Put another way, does not Patent Law wish to encourage researchers to find simple blood tests or urine tests that predict and diagnose breast cancers or immunodeficiency diseases?” 



31

Outline of Presentation • • Laboratory Corp. v. Metabolite Labs* • In re Bilski** • Prometheus Laboratories, Inc. v. Mayo Collaborative Services et al.*** • Association for Medical Pathology et al. v. USPTO, Myriad Genetics & the Directors of the University of Utah Research Foundation****  * ** 

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***

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548 U.S. at 124 (2006). 545 F.3d 943 (Fed. Cir. 2008) (en banc), cert. granted, 129 S. Ct. 2735 (June 1, 2009).

No. 2008-1403, U.S. App. Lexis 20623 (Fed. Cir. Sept. 16, 2009). Complaint filed on May 12, 2009 in the Southern District of New York.

32

Prometheus v. Mayo • • • Involves methods for calculating proper dosage of thiopurine drugs, i.e., 6-MP and AZA (which upon administration convert to 6-MP)

• • 6-MP is broken down by the body into metabolites: 6-MMP, 6-TG and their nucleotides

• • Drugs that deliver 6-TG are widely used for

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Representative Claim Claim 1 of U.S. Patent No. 6,355,623 states:





treatment of comprising: 

to a gastrointestinal 

subject disorder 

about 230 to

A method of optimizing therapeutic efficacy for an immune mediated gastrointestinal disorder, (a) administering a drug providing 6-thioguanine subject having said immune-mediated disorder; and (b) determining the level of 6-thioguanine in said having said immune-mediated gastrointestinal (c) wherein the levels of 6-thioguanine less than pmol per 8x108 red blood cells indicates a need increase the amount of said drug subsequently administered to said subject and

(d) wherein the levels of 6-thioguanine greater than about 400 pmol per 8x108 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject 

34

District Court Ruling • • • “6-TG and 6-MMP are products of the natural metabolizing of thiopurinedrugs, and the inventors merely observed the relationship [or the correlation] between these naturally produced metabolites and therapeutic efficacy and toxicity” Prometheus, slip op. at 9. • The correlations were natural phenomena because they resulted from a natural body process • The administering and determining steps are merely necessary data-gathering steps for any use of the correlations • The claims wholly preempt the correlations 35 because they cover the correlations

Representative Claim Claim 1 of U.S. Patent No. 6,355,623 states:





treatment of comprising:

A method of optimizing therapeutic efficacy for an immune mediated gastrointestinal disorder,

TRANFORMATIVE → (a) administering a drug providing6thioguanine to a STEP subject having said immunemediated gastrointestinal disorder; and 

TRANFORMATIVE → (b) determining the level of 6-thioguanine in said subject STEP having said immune-mediated gastrointestinal disorder 

MENTAL STEP → less than about 230 indicates a need to subsequently 

(c) wherein the levels of 6-thioguanine pmol per 8x108 red blood cells increase the amount of said drug administered to said subject and

MENTAL STEP → (d) wherein the levels of 6-thioguanine greater than about 400 pmol per 8x108 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject 

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Federal Circuit’s Ruling   

 Is a machine or transformation involved? Yes, because: (1) following administration of a man-made drug, the human body undergoes transformation; (2) the drug transforms into metabolites; and (3) the tissue sample upon analysis is transformed

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 If so, is the machine or transformation central to the purpose of the claim? Yes, the claim recites a step to provide thiopurine drugs for the purpose of treating disease, and a step for measuring the drugs’ metabolite levels for the purpose of assessing the drugs’ dosage during the course of treatment 37

Administering Step • • • Transformation is the effect on the body after metabolizing the artificially administered drugs, which provide 6-TG to a subject and are thought to be the active metabolite in the treatment of disease  Prometheus, slip op. at 25. 

• Administration of a drug to a subject to treat, i.e., transform, the subject is not a natural process  Id.

38

Determining Step • • “Determining the levels of 6-TG or 6-MMP in a subject necessarily involves a transformation, for those levels cannot be determined by mere inspection”  Prometheus, slip op. at 26.

• • The court noted that it is necessary to extract the metabolites from a bodily sample and determine their concentration  Id. (quoting Prometheus’s expert (“[A]t the end of the process, the human blood sample is no longer human blood; human 39 tissue is no longer human tissue.”))

Transformation is the Central Purpose • • Mayo did not dispute that the determining step is transformative, but instead argued that the transformation was merely a necessary data-gathering step for using the correlations

• • In response, the court noted:  “On the contrary, this transformation is central to the purpose of the claims, since the determining step is, like the administering step, a significant part of the claimed method of treatment” 40  Prometheus, slip op. at 27.

Important Holding 

When a defined group of drugs is administered to the body to ameliorate the effects of an undesired condition, it is always transformative Prometheus, slip op. at 23. • 

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Federal Circuit Criticizes District Court • • • Federal Circuit criticized the District Court for following Judge Breyer’s dissent in Metabolite

• • Claims at issue in Metabolite are different from the claims in Prometheus because no drug is involved

• • Federal Circuit also stated that Judge Breyer’s reasoning in Metabolite was unpersuasive and appears to disagree with that analysis because the claim was not analyzed as a

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Outline of Presentation • • Laboratory Corp. v. Metabolite Labs* • In re Bilski** • Prometheus Laboratories, Inc. v. Mayo Collaborative Services et al.*** • Association for Medical Pathology et al. v. USPTO, Myriad Genetics & the Directors of the University of Utah Research Foundation****

•  

* **

 

***

****

548 U.S. at 124 (2006). 545 F.3d 943 (Fed. Cir. 2008) (en banc), cert. granted, 129 S. Ct. 2735 (June 1, 2009).

No. 2008-1403, U.S. App. Lexis 20623 (Fed. Cir. Sept. 16, 2009). Complaint filed on May 12, 2009 in the Southern District of New York.

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Myriad’s Amicus Brief in Prometheus Claim 1 in Prometheus states:



A method of optimizing therapeutic efficacy for treatment of an immunemediated gastrointestinal disorder, comprising: 

(a) administering a drug 6-thioguanine to a subject having said immunemediated gastrointestinal disorder; and 

(b) in said subject having said immunemediated gastrointestinal disorder 

(c) wherein the levels of 6-thioguanine less than about 230 pmol per 8x108 red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject 



and

(d) wherein the levels of 6-thioguanine greater than about 400 pmol per 8x108 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject 



M yria d a rg u e s: A d m in iste rin g a n u n n a tu ra ld ru g is o n e va lid b a sis fo r fin d in g th e Pro m e th e u s cla im s p a te n t- e lig ib le

•

M yria d a sks th e C o u rt to fin d Pro m e th e u s’ cla im s a s p a te n t e lig ib le o n a m o re fu n d a m e n ta lle ve l C la im s a t issu e d o n o t se e k to p re e m p t th e u se o f a co rre la tio n ; ra th e r, th e y se e k to fo re clo se o th e rs fro m u sin g th a t co rre la tio n in co n ju n ctio n w ith th e o th e r cla im e d ste p s W h e n th e p re a m b le is a lim ita tio n o n th e cla im s, a s it is in Prometheus ( and Metabolite) the claims are drawn to a specific and practical application of a correlation 44

Background • • Declaratory judgment action brought by ACLU on behalf of a large group of sympathetic plaintiffs 

• Seeking to invalidate Myriad Genetics’ patent claims relating to breast cancer genes BRCA1 and BRCA2 

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Plaintiffs • • Four prominent, national organizations (suing on behalf of members, some of whom are ready, willing and able to engage in research and clinical practice involving BRCA1 and BRCA2 genes if the patents are invalidated) Association for Molecular Pathology American College of Medical Genetics American Society for Clinical Pathology College of American Pathologists 46

Plaintiffs (cont.) • • Six preeminent geneticists (prohibited from doing routine screening for BRCA1 and BRCA2 genes for research and clinical practice; ready and willing to perform the tests) Haig Kazazian, M.D. (received cease and desist letter) Arupa Ganguly, Ph.D. (received cease and desist letter) Wendy Chung, M.D., Ph.D. Harry Ostera, M.D. David Ledbetter, Ph.D.

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Plaintiffs (cont.) • • Two genetic counselors (having only one laboratory prevents independent confirmation of test results and interpretations of the meaning of variants of uncertain significance; ready, willing, and able to utilize alternative testing facilities for tests) Ellen Matloff, M.S. Elsa W. Reich, M.S.

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Plaintiffs (cont.) • • Six individual women (Myriad will not accept some health care coverage; “genetic variant of uncertain significance;” seeking second opinions; seeking additional BRCA testing that looks for other large genetic rearrangements) Lisbeth Ceriani Runi Limary Genae Girard Patrice Fortune Vicky Thomason Kathleen Raker 49

Defendants • • • United States Patent and Trademark Office: granted the patents-in-suit and authored policies that authorized patent grants on the composition of matter claims

• • Myriad Genetics: co-owner of one patent and formerly coowner of several other patents; has an exclusive license for all of the patents-in-suit

• • 10 Directors of the University of Utah Research Foundation: owner or part-owner of all the patents-in-suit 

• Other part-owners of patent-in-suit: not named because 50 Myriad, as exclusive licensee of all patents, is capable of

Procedural History • • Case filed May 12, 2009 in the Federal District Court for the Southern District of New York • USPTO and Myriad/Directors of the University of Utah Research Foundation have filed separate motions to dismiss on procedural grounds – the motions have been fully briefed • At least 10 amicus briefs have been filed on behalf of Plaintiffs, none to date on behalf of Defendants • Plaintiffs brought a summary judgment motion on August 26, 2009 51

The Patents-in-Suit • • • • 5,747,282 (“the ’282 patent”): claims 1, 2, 5, 6, 7 (composition) and 20 (process) • 5,693,473 (“the ’473 patent”): claim 1 (composition) • 5,709,999 (“the ’999 patent”): claim 1 (process) • 5,710,001 (“the ’001 patent”): claim 1 (process) • 5,753,441 (“the ’441 patent”): claim 1 (process) • 5,837,492 (“the ’492 patent”): claims 1, 6, 7 (composition) • 6,033,857 (“the ’857 patent”): claims 1 & 2 (process) 

These patent claims cover breast cancer genes BRCA1 (chromosome 17) and BRCA2 (chromosome 13) 

52

BRACAnalysis® • • • BRACAnalysis® is Myriad’s genetic screening test that assesses a woman’s risk of developing breast or ovarian cancer based on detection of mutations in the BRCA1 and BRCA2 genes

• • Due to patent protection, BRACAnalysis® is the only means for women to diagnose susceptibility to breast cancer or ovarian cancer related to BRCA1 and BRCA2 mutations

•

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Causes of Action • • • Because human genes are products of nature, laws of nature and/or natural phenomena, and abstract ideas or basic human knowledge or thought, the challenged claims are invalid under Article 1, section 8, clause 8 of the United States Constitution and 35 U.S.C. section 101 

• All of the challenged claims represent patents on abstract ideas or basic human knowledge and/or though and as such are unconstitutional under the First and 54 Fourteenth Amendments to the United States

Prayer for Relief • • Declaratory Judgment of invalidity and/or unenforceability • • Enjoin defendants from taking any action to enforce the claims at issue • • Attorneys’ fees and costs 55

Types of Process Claims at Issue • • • Analyzing genes to determine if they contain certain mutations

• • Analyzing whether genes in a particular patient differ from the wild-type gene

• • Analyzing whether two genes are different and whether that difference indicates a predisposition to breast cancer

• 56

• Comparing growth rates of a cell with a mutated BRCA

Analyzing Genes for Certain Mutations  

A method for detecting a germline alteration in a BRCA1 gene, said alteration selected from the group consisting of the alterations set forth in Tables 12A, 14, 18 or 19 in a human 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 with the proviso that said germline alteration is not a deletion of 4 nucleotides corresponding to base numbers 4184-4187 of SEQ ID NO: 1 57 



Comparing Two Genes and Correlating Differences to Alterations  

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, wild-type 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 e.g., claim 1 of the ‘441 patent. 58 

Comparing Two Genes and Correlating Differences to Susceptibility to Breast Cancer  

A method for diagnosing a predisposition for breast cancer in a human subject which comprises comparing the germline sequence of the BRCA2 gene or the sequence of its mRNA in a tissue sample from said subject with the germline sequence of the wild-type BRCA2 gene or the sequence of its mRNA, wherein an alteration in the germline sequence of the BRCA2 gene or the sequence of its mRNA of the subject indicates a predisposition to said cancer e.g., claim 2 of the ‘857 patent. 59 

Comparing a Cell’s Growth Rates in the Presence and Absence of a Drug  

A method for screening potential cancer therapeutics which comprises: growing a transformed eukaryotic host cell containing an altered BRCA1 gene causing cancer in the presence of a compound suspected of being a cancer therapeutic, growing said transformed eukaryotic host cell in the absence of said compound, determining the rate of growth of said host cell in the presence of said compound and the rate of growth of said host cell in the absence of said compound and comparing the growth rate of said host cells, wherein a slower rate of growth of said host cell in the presence of said compound is indicative of a cancer therapeutic e.g., claim 20 of the ‘282 patent 



60

Plaintiffs’ Arguments on the Process Claims • • • The process claims require comparing characteristics, e.g., sequences or cellular growth rates

• • Plaintiffs argue that such a comparison is merely a mental step

• • Similarities or differences resulting from comparison are not the creation of an inventor

61

Plaintiffs’ Arguments on the Process Claims (cont.) • • • The claims do not disclose a particular method of sequencing or a particular method of looking for mutations. They simply claim the “idea” of looking for a mutation. A person infringes by noting natural facts about whether two genes are the same or different

• • “Phenomena of nature, though just discovered, mental process, and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological 62 work”

Plaintiffs’ Policy Arguments • • •

The patent system is intended to promote technological growth

• •

There is evidence that patents were not necessary to sequence and analyze the BRCA1 and BRCA2 genes

• •

The gene sequence claims in effect patent any use of the BRCA genes. The patents cover the genes themselves. Because the function of the genes both in the body and in the defendant’s lab is to convey information, they cover all of the information for all of its uses, and consequently, chill further research

• •

Defendants have gained critical scientific evidence of previously 63 unknown alteration, including deleterious mutations, and have

Plaintiffs’ First Amendment Arguments

• Plaintiffs’ Argue That the Process Claims Violate the First Amendment 

 Free speech protection prevents the government from limiting thought 64

Defendants’ Legal Arguments on the Process Claims • • Claims at issue do not seek to preempt the use of a correlation; rather, they seek to foreclose others from using that correlation in conjunction with the other claimed steps • • When the preamble is a limitation on the claims, the claims are drawn to a specific and practical application

65

Defendants’ Policy Arguments on the Process Claims • • • Because there are numerous possible correlations for a particular disease character, a patent monopoly on a particular diagnostic use of a particular correlation would actually incentivize scientists to discover new correlations and develop better personalized medicine products

• • Patent claims to diagnostic use of correlations are necessary to incentivize and reward the massive investment required to research and develop personalized medicine products

•

66

Types of Composition Claims at Issue • • Purified and isolated natural human genes • • Purified and isolated natural human genes with natural mutations 

67

Purified and Isolated Natural Human Genes “An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2” e.g., Claim 1 of the ’282 patent • 

 

68

Purified and Isolated Natural Human Genes With Natural Mutations “An isolated DNA comprising an altered BRCA1 DNA having at least one of the alterations set forth in Tables 12A, 14, 18 or 19 with the proviso that the alteration is not a deletion of four nucleotides corresponding to base numbers 4184-4187 in SEQ. ID. NO:1” e.g., claim 1 of the ’473 patent. • 

69

On Patenting DNA Sequences • • Courts have not yet addressed patentability of DNA sequences under 35 U.S.C. § 101 • • Courts have been very lenient with affirming claims to DNA sequences on non-obviousness grounds 70

Plaintiffs’ Arguments on the Composition Claims • • A genetic sequence is biological information itself

• • All the claims embody products and laws of nature

• • Merely extracting, purifying, or changing a natural product does not render that product patent-eligible, unless a fundamentally new product is created

•

71

Is Purifying and Isolating Enough to Warrant Patentability? • •

• The following Supreme Court cases hold that patentability requires more than removing a natural product from its environment and purifying it. There must be a change in function: American Wood Paper, 90 U.S. 566, 570 (1874) Cochrane v. Badische Anilin & Soda Fabrik, 111 U.S. 293 (1884) American Fruit Growers, Inc. v. Brodgex Co., 283 U.S. 1, 11 (1931) Funk Brothers, Seed Co., 333 U.S. 127, 128-31 (1948)

• • But, genes are products of nature, and sequencing genes does not produce something with a new function. Sequencing is designed solely to reveal the functions of 72 the gene dictated by nature

USPTO’s Position(s) on Patentability of Genes • • • Discoveries can be patentable (“by securing for … Inventors the exclusive Right to their respective … Discoveries”)

• • An excised gene is eligible for a patent as a composition of matter or as an article of manufacture because that DNA molecule does not occur in that isolated form in nature

• • Synthetic DNA preparations are eligible for patents because their purified state is

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USPTO’s Position(s) on Patentability of Genes • • • •

Comments to Utility Examination Guidelines, 66 Fed. Reg. No. 4 at 1093 (January 5, 2001)

• •

Relies on: Louis Pasteur claimed “[y]east, free from organic germs of disease, as an article of manufacture”  U.S. Patent No. 141,072. In an early patent covering adrenaline, the court noted that purified adrenaline “became for every practical purpose a new thing commercially and therapeutically”  Parke-Davis & Co. v. H.K. Mulford Co., 189 F. 95, 103 (S.D.N.Y. 1911). 74 Regarding a patent on purified prostaglandins, “What appellants claim . .

How Will Myriad Be Resolved? • • Procedural Hurdles: Declaratory Judgment requires: (1) the patent owner must have taken some affirmative action relevant to the plaintiff; and (2) the plaintiff must have a concrete plan to take potentially infringing action 

• Summary Judgment?: Plaintiff bears burden of proof at trial No discovery Plaintiffs must get helpful claim construction Plaintiffs must assert a novel reading of patent law (no instances of “isolated” genes being found an unpatentable product of nature) 75

How Will Myriad Be Resolved? (cont.) • Trial court unlikely to find the composition claims invalid under current law

• • Opportunity to narrow process claims

• • Appeal is an almost certainty

• • Federal Circuit?

•

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How Will Myriad Be Resolved? Significance? (cont.)  

• Patents-in-suit will expire in 2015-16 

• The Human Genome Project has made the entirety of the genome, along with all of its encoded proteins, prior art 

• Composition claims on DNA are likely to be more difficult as obviousness rejections become more likely  In re Kubin, 561 F.3d 1351 (Fed. Cir. 2009) (holding claim to DNA sequence obvious where protein was known and DNA sequence was determined by conventional methodologies known to those skilled in77

Summary of Life Science Process Claims 

Process claims reciting steps of (1)inducing a correlation, (2)data gathering, and (3)correlating are patent eligible

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Process claims reciting steps of (1)data gathering and (2)correlating may or may not be patent eligible 

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Prometheus

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• • • 

Metabolite

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  

Process claims reciting only a step of correlating are least likely to be patent eligible 

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Myriad 78

Practice Recommendations • • Presenting many claims of varying scope

• • If applicable, explicitly recite a transformation or at least a transformative step

• • If possible, tie claims to machine or composition

• • For diagnostic claims, body of claims should include purpose (typically found in preamble)

• • Tie diagnostic correlation to a method of

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Questions for Consideration Questions 

• • Should the Supreme Court’s test under § 101 should address whether progress in science and technology is advanced or impeded by these types of patents?

• • What is the Supreme Court going to do with Bilski?

• • What place does Breyer’s rationale in Metabolite have in future decisions?

• • How should the Metabolite decision be considered in light of Prometheus? 80