Myriad-Go-Round, CBA IP Mar 2013 Myriad-Go-Round The current state of gene patents.

Myriad-Go-Round, CBA IP Mar 2013Myriad-Go-Round, CBA IP Mar 2013

Myriad-Go-RoundMyriad-Go-Round

The current state of gene patentsThe current state of gene patents


Biotechnology and Bioengineering Biotechnology and Bioengineering

Our understanding has developed the Our understanding has developed the level of specificitylevel of specificity that we perceive as that we perceive as recognized manipulation of living recognized manipulation of living processes. processes.

+ =

A B AB


LEVELS OF SPECIFICITY!LEVELS OF SPECIFICITY!

+ =

A B AB

O X

vs


Artificial Selection ( A+B=AB)Artificial Selection ( A+B=AB)


Genetically Modified OrganismsGenetically Modified OrganismsX+O = XX+O = X

X+X = XXX+X = XX

Ø+O = ØØ+O = Ø

transforming O transforming O

OX


Genetically Modified OrganismsGenetically Modified Organisms

RoundUp Ready CropsRoundUp Ready Crops

Harvard OncoMouseHarvard OncoMouse


Gene SequencesGene SequencesSpecificity:

How low can you go?


Gene SequencesGene Sequences

Getting Specific.


PCR & Genetic TestingPCR & Genetic Testing


Breast CancerBreast Cancer

>200,000 American >200,000 American ♀ ♀ diagnosed/year; diagnosed/year; 40,000 die40,000 die

12% chance in general 12% chance in general population for ♀population for ♀

http://http://www.breastcancer.orgwww.breastcancer.org/symptoms//symptoms/understand_bc/understand_bc/statisticsstatistics


Myriad Genetics’s BRCAMyriad Genetics’s BRCA

Of those who develop BC, 5 -10% have Of those who develop BC, 5 -10% have inherited inherited mutationmutation = 40 - 85% risk of BC = 40 - 85% risk of BC BRCA1: Ch17 (80million nucleotides), gene (80k with BRCA1: Ch17 (80million nucleotides), gene (80k with

introns) 5,500 nucleotidesintrons) 5,500 nucleotides BRCA2: Ch13 (114million nucleotides), 10,200 baseBRCA2: Ch13 (114million nucleotides), 10,200 base


Industry/Market SampleIndustry/Market Sample

In-vitro (not vivo) results in different FDA In-vitro (not vivo) results in different FDA requirements (no long clinical trials)requirements (no long clinical trials)

Most basic diagnostic test costs $12, and Most basic diagnostic test costs $12, and the method is public knowledgethe method is public knowledge

Myriad charges up to $2400 for testMyriad charges up to $2400 for test

As of March 15, 2013 Myriad had a market As of March 15, 2013 Myriad had a market capitalization at $2.09B (testing and capitalization at $2.09B (testing and treatment of several cancers)treatment of several cancers)


Thomas JeffersonThomas Jefferson

Patents = Patents = “embarrassments to the “embarrassments to the public” (McLaughlin, 1989)public” (McLaughlin, 1989)


TJ’s PolicyTJ’s Policy

He who receives an idea from me, receives instruction himself He who receives an idea from me, receives instruction himself without lessening mine; as he who lights his taper at mine, receives without lessening mine; as he who lights his taper at mine, receives light without darkening me. That ideas should freely spread from light without darkening me. That ideas should freely spread from one to another over the globe, for the moral and mutual instruction one to another over the globe, for the moral and mutual instruction of man, and improvement of his condition, seems to have been of man, and improvement of his condition, seems to have been peculiarly and benevolently designed by nature, when she made peculiarly and benevolently designed by nature, when she made them, like fire, expansible over all space, without lessening their them, like fire, expansible over all space, without lessening their density in any point, and like the air in which we breathe, move, and density in any point, and like the air in which we breathe, move, and have our physical being, incapable of confinement or exclusive have our physical being, incapable of confinement or exclusive appropriation. Inventions then cannot, in nature, be a subject of appropriation. Inventions then cannot, in nature, be a subject of property. property. Society may give an exclusive right to the profits Society may give an exclusive right to the profits arising from them, as an encouragement to men to pursue arising from them, as an encouragement to men to pursue ideas which may produce utility, but this may or may not be ideas which may produce utility, but this may or may not be done, according to the will and convenience of the society, done, according to the will and convenience of the society, without claim or complaint from anybodywithout claim or complaint from anybody...(letter to Isaac ...(letter to Isaac McPherson, 1813 as cited in Kock & Peden, 1972).McPherson, 1813 as cited in Kock & Peden, 1972).


Patentable Subject MatterPatentable Subject Matter

35 USC §10135 USC §101: 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.


What is Excluded:What is Excluded:

““This is not to suggest that § This is not to suggest that § 101101 has no has no limits or that it embraces every discovery. limits or that it embraces every discovery. The laws of The laws of naturenature, , physical physical phenomenaphenomena, and abstract ideas have , and abstract ideas have been held not patentable.” been held not patentable.” Diamond v. Diamond v. ChakrabartyChakrabarty, 447 U.S. 303, 206 USPQ , 447 U.S. 303, 206 USPQ 193 (1980) 193 (1980)


Rule BreakdownRule Breakdown

Natural Laws, Phenomenon, Abstract Ideas

Compositions Processes/Methods

“Markedly Different” “Machine or Transformation”**


Exclusion TreatmentExclusion TreatmentLeroy v. TathamLeroy v. Tatham, 55 US 155 (1852), 55 US 155 (1852)American Wood-Paper Co v. Fibre DisintegratingAmerican Wood-Paper Co v. Fibre Disintegrating, 90 US 566 (1874), 90 US 566 (1874)Cochrane v. Badische Anilin & Soda FabrikCochrane v. Badische Anilin & Soda Fabrik, 111 US 293 (1884), 111 US 293 (1884)Hartranft v. WiegmannHartranft v. Wiegmann, 121 US 609 (1887), 121 US 609 (1887)

American Fruit Growers v. Brodgex CoAmerican Fruit Growers v. Brodgex Co, 283 US 1 (1931), 283 US 1 (1931)Funk Bros Seed Co v. Kalo InoculantFunk Bros Seed Co v. Kalo Inoculant, 333 US 127 (1948), 333 US 127 (1948)

Goltschalk v. BensonGoltschalk v. Benson, 409 US 63 (1972), 409 US 63 (1972)Parker v. FlookParker v. Flook, 437 US 584 (1978), 437 US 584 (1978)Diamond v. ChakrabartyDiamond v. Chakrabarty, 447 US 303 (1980), 447 US 303 (1980)Diamond v. DiehrDiamond v. Diehr, 450 US 175 (1981), 450 US 175 (1981)In re MeyerIn re Meyer, 688 F.2d 789 (CCPA 1982), 688 F.2d 789 (CCPA 1982)

J.E.M. Agricultural Supply v. Pioneer Hi-Bred Int’lJ.E.M. Agricultural Supply v. Pioneer Hi-Bred Int’l, 534 US 124 (2001), 534 US 124 (2001)Mayo Collaborative Services v. Prometheus, IncMayo Collaborative Services v. Prometheus, Inc., 566 U.S. –– (2012)., 566 U.S. –– (2012)


Bilski: will the FedBilski: will the FedCir ever learn?Cir ever learn?

A “claimed process is surely patent-eligible under §101 if: 1) it is tied to a particular machine or apparatus, or 2) it transforms a particular article into a different state or thing.” --In re Bilski, 545 F.3d 943, 88 U.S.P.Q.2d 1385 (Fed. Cir. 2008).

Bilski v. Kappos: (paraphrase) Your heart was in the right place, but let’s avoid all-encompassing rules because who is to say where technology will go in the future?


Procedural History: S.D.NYProcedural History: S.D.NY

Assoc. for Molecular Pathology, et al. v. Assoc. for Molecular Pathology, et al. v. Myriad Genetics, 669 F.Supp.2d 365 Myriad Genetics, 669 F.Supp.2d 365

(S.D.N.Y. 2009)(S.D.N.Y. 2009)



P’s @ issue ClaimsP’s @ issue Claims Type Type (Comp/Method)(Comp/Method)

57472825747282 1/2/5/6/7/20 1/2/5/6/7/20 C*/C/C/C/C/CC*/C/C/C/C/C

5837492 1/6/75837492 1/6/7 C/C/CC/C/C

56934735693473 1 1 CC

57099995709999 1 1 M*M*

57100015710001 1 1 MM

5753441 15753441 1 MM

6033857 1/26033857 1/2 M/MM/M



Composition Claims: Products of Nature = Composition Claims: Products of Nature = “Markedly Different” Rule“Markedly Different” Rule

““the patentee has produced a new the patentee has produced a new bacterium with markedly different bacterium with markedly different characteristics from any found in nature characteristics from any found in nature and one having the potential for significant and one having the potential for significant utility. His discovery is not nature’s utility. His discovery is not nature’s handiwork, but his own…” handiwork, but his own…” ChakrabartyChakrabarty, , 447 U.S. at 310.447 U.S. at 310.



[A]nalysis:[A]nalysis:

Purified is largely rejected as being patent eligiblePurified is largely rejected as being patent eligible

Purified = isolated (DNA) [because the nature of Purified = isolated (DNA) [because the nature of the information was the same, and literal the information was the same, and literal differences incidental]differences incidental]

Isolated DNA (aka. strand excluding introns) =Isolated DNA (aka. strand excluding introns) =

Intron 1 Intron 2



Method Claims: Abstract Ideas= Method Claims: Abstract Ideas=

Bilski M/Xformation TestBilski M/Xformation Test1) tied to a particular machine or apparatus, or

2) transforms a particular article into a different state or thing.

A) Comparing & [A]nalyzing Sequences ≠ Transformation

B) Theraputic Observations ≠ Transformation


Procedural History: Fed CirProcedural History: Fed Cir

653 F.3d 1329 (Fed. Cir. 2011) (Post 653 F.3d 1329 (Fed. Cir. 2011) (Post BilskiBilski))Composition Claims: “Markedly Different”Composition Claims: “Markedly Different”

REVERSEDREVERSEDThe “claim is not a hitherto unknown natural The “claim is not a hitherto unknown natural

phenomenon, but to a nonnaturally phenomenon, but to a nonnaturally occuring manufacture or composition of occuring manufacture or composition of matter—a product of human ingenuity matter—a product of human ingenuity having distinctive name, character [and] having distinctive name, character [and] use.” use.” ChakrabartyChakrabarty, 121 U.S. at 615., 121 U.S. at 615.



Purified ≠ Isolated = “because the claims Purified ≠ Isolated = “because the claims cover molecules that are markedly cover molecules that are markedly different—have a distinctive chemical different—have a distinctive chemical identity and nature—from molecules that identity and nature—from molecules that exist in nature.”exist in nature.”

cDNA, baby!cDNA, baby!



Method Claims: M/XformationMethod Claims: M/XformationReversed: method observing therapeutic Reversed: method observing therapeutic

growth rates are patentable (growing cells growth rates are patentable (growing cells = transformation)= transformation)

Affirmed: method comparing and analyzing Affirmed: method comparing and analyzing sequences are ineligible (sequences are ineligible (PrometheusPrometheus).).

Remand in Aug: 689 F.3d 1303 (Fed. Cir. Remand in Aug: 689 F.3d 1303 (Fed. Cir. 2012) (no significant changes)2012) (no significant changes)


S.Ct. Arguments In AprilS.Ct. Arguments In April

12-398, Monday April 15 12-398, Monday April 15 http://www.supremecourt.gov/Search.aspx?FileName=/docketfiles/1http://www.supremecourt.gov/Search.aspx?FileName=/docketfiles/11-725.htm1-725.htm

Many patients seek genetic testing to see if they have mutations in their Many patients seek genetic testing to see if they have mutations in their genes that are associated with a significantly increased risk of genes that are associated with a significantly increased risk of breast or ovarian cancer. Respondent Myriad Genetics obtained breast or ovarian cancer. Respondent Myriad Genetics obtained patents on two human genes that correlate to this risk, known as patents on two human genes that correlate to this risk, known as BRCA1 and BRCA2. These patents claim every naturally-occurring BRCA1 and BRCA2. These patents claim every naturally-occurring version of those genes, including mutations, on the theory that version of those genes, including mutations, on the theory that Myriad invented something patent--eligible simply by removing Myriad invented something patent--eligible simply by removing ("isolating") the genes from the body. Petitioners are primarily ("isolating") the genes from the body. Petitioners are primarily medical professionals who regularly use routine, conventional medical professionals who regularly use routine, conventional genetic testing methods to examine genes, but are prohibited from genetic testing methods to examine genes, but are prohibited from examining the human genes that Myriad claims to own. This case examining the human genes that Myriad claims to own. This case therefore presents the following questions: therefore presents the following questions:


Questions PresentedQuestions Presented

Questions Presented:Questions Presented:1.1. Are human genes patentable? Are human genes patentable?

2. Did the court of appeals err in upholding a method claim by Myriad 2. Did the court of appeals err in upholding a method claim by Myriad that is irreconcilable with this Court's ruling in Mayo Collaborative that is irreconcilable with this Court's ruling in Mayo Collaborative Servs. v. Prometheus Labs., Inc.,132 S. Ct. 1289 (2012)? Servs. v. Prometheus Labs., Inc.,132 S. Ct. 1289 (2012)?

3. Did the court of appeals err in adopting a new and inflexible rule, 3. Did the court of appeals err in adopting a new and inflexible rule, contrary to normal standing rules and this Court's decision in contrary to normal standing rules and this Court's decision in MedImmune, Inc. v. Genentech, Inc., 549 U.S. 118 (2007), that MedImmune, Inc. v. Genentech, Inc., 549 U.S. 118 (2007), that petitioners who have been indisputably deterred by Myriad's "active petitioners who have been indisputably deterred by Myriad's "active enforcement" of its patent rights nonetheless lack standing to enforcement" of its patent rights nonetheless lack standing to challenge those patents absent evidence that they have been challenge those patents absent evidence that they have been personally threatened with an infringement action? personally threatened with an infringement action?


Additional ConsiderationsAdditional Considerations

TRIPS – WTOTRIPS – WTO

Other Nation’s positionsOther Nation’s positions

Desire to maximize public disclosure Desire to maximize public disclosure

Historical progression of Court’s treatmentHistorical progression of Court’s treatment

Experimental Use Exception applicationExperimental Use Exception application

How many others?How many others?


EU Patent ConventionEU Patent Convention

EPC Art 52EPC Art 52(1) EU patents granted “for any inventions which (1) EU patents granted “for any inventions which are susceptible of industrial application, which are susceptible of industrial application, which are new and which involve an inventive step.”are new and which involve an inventive step.”(2) defines patentable subject matter by way of (2) defines patentable subject matter by way of exclusion: “a) discoveries, scientific theories, exclusion: “a) discoveries, scientific theories, and mathematical methods; b) aesthetic and mathematical methods; b) aesthetic creations; c) schemes, rules, and methods for creations; c) schemes, rules, and methods for performing mental acts, playing games or doing performing mental acts, playing games or doing business, and programs for computers; and d) business, and programs for computers; and d) presentations of information.”presentations of information.”


EU Court TreatmentEU Court Treatment

http://www.epo.org/law-practice/case-law-appeals/recent/http://www.epo.org/law-practice/case-law-appeals/recent/t050666eu1.htmlt050666eu1.htmlEurope revoked Myriad’s patents in 2004 as being “not inventive Europe revoked Myriad’s patents in 2004 as being “not inventive enough to qualify for patent protection.” Andrew Pollack, enough to qualify for patent protection.” Andrew Pollack, Technology; Patent on Test For Cancer Is Revoked By EuropeTechnology; Patent on Test For Cancer Is Revoked By Europe, , New York Times (May 19, 2004) (New York Times (May 19, 2004) (available atavailable at: : http://www.nytimes.com/2004/05/19/business/technology-patent-on-http://www.nytimes.com/2004/05/19/business/technology-patent-on-test-for-cancer-is-revoked-by-europe.html) (last accessed Mar 22, test-for-cancer-is-revoked-by-europe.html) (last accessed Mar 22, 2013).2013).““Myriad subsequently appealed to the EPO’s Board of Appeals, and, Myriad subsequently appealed to the EPO’s Board of Appeals, and, in 2008, was able to maintain its patents in an amended form that no in 2008, was able to maintain its patents in an amended form that no longerlonger contains “claims directed to the BRCA1 gene itself or to contains “claims directed to the BRCA1 gene itself or to mutated forms thereof.”mutated forms thereof.” Press Release, European Patent Office Press Release, European Patent Office (Nov 19, 2008).(Nov 19, 2008).Technical Board of Appeal T 0156/08-3.3.04 (14 Jan 2011)Technical Board of Appeal T 0156/08-3.3.04 (14 Jan 2011)


AU DecisionAU DecisionCancer Voices Australia v. Myriad Genetics Inc, [2013] FCA 65 (15 Feb 2013)Sec 18(1) “... an invention is a patentable invention for the purposes of a standard patent if the

invention, so far as claimed in any claim:(a) is a manner of manufacture within the meaning of section 6 of the Statute of Monopolies; and(b) when compared with the prior art base as it existed before the priority date of that claim: (i) is novel; and (ii) involves an inventive step; and(c) is useful; and(d) was not secretly used in the patent area before the priority date of that claim by, or on behalf of, or

with the authority of, the patentee or nominated person or the patentee’s or nominated person's predecessor in title to the invention.”

Sec18(2)-(4): (2) Human beings, and the biological processes for their generation, are not patentable inventions.(3) For the purposes of an innovation patent, plants and animals, and the biological processes for the

generation of plants and animals, are not patentable inventions.(4) Subsection (3) does not apply if the invention is a microbiological process or a product of such a

process.


AU DecisionAU Decision

“There is no doubt that naturally occurring DNA and RNA as they exist inside the cells of the human body cannot be the subject of a valid patent. However, the disputed claims do not cover naturally occurring DNA and RNA as they exist inside such cells. The disputed claims extend only to naturally occurring DNA and RNA which have been extracted from cells obtained from the human body and purged of other biological materials with which they were associated.”


TRIPS (WTO)TRIPS (WTO)Article 8 Article 8 Principles: Principles: 1. Members may, in formulating or amending their laws and 1. Members may, in formulating or amending their laws and regulations, adopt measures regulations, adopt measures necessary to protect public healthnecessary to protect public health and nutrition, and and nutrition, and to promote the public interest in sectors of vital importance to their socio-economic to promote the public interest in sectors of vital importance to their socio-economic and technological development, provided that such measures are consistent with the and technological development, provided that such measures are consistent with the provisions of this Agreement.provisions of this Agreement.Article 27 Article 27 Patentable Subject Matter: Patentable Subject Matter: 2. Members may exclude from patentability inventions, the 2. Members may exclude from patentability inventions, the prevention within their territory of the commercial exploitation of which is necessary to prevention within their territory of the commercial exploitation of which is necessary to protect protect ordre publicordre public or morality, including or morality, including to protect human, animal or plant life or to protect human, animal or plant life or healthhealth or to avoid serious prejudice to the environment, provided that such exclusion or to avoid serious prejudice to the environment, provided that such exclusion is not made merely because the exploitation is prohibited by their law.is not made merely because the exploitation is prohibited by their law.

3. Members may also exclude from patentability:3. Members may also exclude from patentability:(a) (a) diagnostic, therapeutic and surgical methods for the treatment of humansdiagnostic, therapeutic and surgical methods for the treatment of humans or or

animals;animals;(b) plants and animals other than micro-organisms, and essentially biological processes (b) plants and animals other than micro-organisms, and essentially biological processes

for the production of plants or animals other than non-biological and microbiological for the production of plants or animals other than non-biological and microbiological processes. However, Members shall provide for the protection of plant varieties either processes. However, Members shall provide for the protection of plant varieties either by patents or by an effective by patents or by an effective sui generissui generis system or by any combination thereof. The system or by any combination thereof. The provisions of this subparagraph shall be reviewed four years after the date of entry provisions of this subparagraph shall be reviewed four years after the date of entry into force of the WTO Agreement.into force of the WTO Agreement.


US Experimental Use ExceptionUS Experimental Use Exception

““It has been held, and no doubt is now well settled, that It has been held, and no doubt is now well settled, that an experiment with a patented article for the sole an experiment with a patented article for the sole purpose of gratifying a philosophical taste, or curiosity, or purpose of gratifying a philosophical taste, or curiosity, or for mere amusement, is not an infringement of the rights for mere amusement, is not an infringement of the rights of the patentee.” of the patentee.” Peppenhause v. FalkePeppenhause v. Falke, 19 F. Cas. , 19 F. Cas. 1048, 1049 (C.C.N.Y. 1861). 1048, 1049 (C.C.N.Y. 1861). ““Although the courts recognize an exception to patent Although the courts recognize an exception to patent infringement known as the “experimental use privilege,” infringement known as the “experimental use privilege,” this judicially created doctrine has been described as this judicially created doctrine has been described as very narrow and rarely applied.” Thomas, John R., very narrow and rarely applied.” Thomas, John R., Scientific Research and the Experimental Use Privilege Scientific Research and the Experimental Use Privilege in Patent Lawin Patent Law, CRS RL32651, note 5 (Oct, 24 2004)., CRS RL32651, note 5 (Oct, 24 2004).


My two-centsMy two-cents


The End.The End.

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Myriad-Go-Round, CBA IP Mar 2013 Myriad-Go-Round The current state of gene patents.

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