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Patenting Human Genes and Genetic Tests: Recent Developments National Advisory Council on Human Genome Research May 17, 2010 Jorge L. Contreras Washington.

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Presentation on theme: "Patenting Human Genes and Genetic Tests: Recent Developments National Advisory Council on Human Genome Research May 17, 2010 Jorge L. Contreras Washington."— Presentation transcript:

1 Patenting Human Genes and Genetic Tests: Recent Developments National Advisory Council on Human Genome Research May 17, 2010 Jorge L. Contreras Washington University in St. Louis School of Law Pilar N. Ossorio University of Wisconsin

2 Requirements for Patentability Patentable subject matter (§101) Patentable subject matter (§101) Utility (§101, 112) Utility (§101, 112) Novelty (§102) Novelty (§102) Non-obviousness (§103) Non-obviousness (§103)

3 Topics Patentable subject matter Patentable subject matter Association for Molecular Pathology v. USPTO (a/k/a ACLU v. Myriad) (S.D.N.Y. Mar. 2010) Association for Molecular Pathology v. USPTO (a/k/a ACLU v. Myriad) (S.D.N.Y. Mar. 2010) Utility Utility Eli Lilly v. Human Genome Sciences (UK Ct. Appeal, Feb. 2010) Eli Lilly v. Human Genome Sciences (UK Ct. Appeal, Feb. 2010) Non-obviousness Non-obviousness KSR v. Teleflex, US Supreme Ct. (2007) KSR v. Teleflex, US Supreme Ct. (2007) In re Kubin, Fed. Cir. (2009) In re Kubin, Fed. Cir. (2009) SACGHS Report on Gene Patents (Feb. 2010) SACGHS Report on Gene Patents (Feb. 2010)

4 Patent Law The intellectual property right is defined by a claim. Claims come at the end of a narrative description of the invention and the problem the invention is intended to solve. E.g., The intellectual property right is defined by a claim. Claims come at the end of a narrative description of the invention and the problem the invention is intended to solve. E.g., I claim an isolated nucleic acid molecule comprising a polypeptide at least 80% identical to amino acids of SEQ ID No. 2, wherein the polypeptide binds CD48.I claim an isolated nucleic acid molecule comprising a polypeptide at least 80% identical to amino acids of SEQ ID No. 2, wherein the polypeptide binds CD48.

5 Patent Litigation

6 Patentable Subject Matter Patentable Subject Matter

7 Patentable Subject Matter 35 USC § 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.

8 Association for Molecular Pathology v. USPTO (S.D.N.Y. Mar. 2010)

9 BRCA1 and Myriad Background Early 1980s: various groups (incl. Collins) begin to seek DNA sequences associated with breast cancer Early 1980s: various groups (incl. Collins) begin to seek DNA sequences associated with breast cancer 1988/89: Intl. Breast Cancer Linkage Consortium established 1988/89: Intl. Breast Cancer Linkage Consortium established 1990: Mary-Claire King (Berkeley) linkage analysis paper locating BRCA1 on long arm of chromosome : Mary-Claire King (Berkeley) linkage analysis paper locating BRCA1 on long arm of chromosome : Mark Skolnick (w/ W. Gilbert and P. Meldrum) founds Myriad to search for breast cancer genes 1991: Mark Skolnick (w/ W. Gilbert and P. Meldrum) founds Myriad to search for breast cancer genes Funding: VC, Lilly, NIH ($5M to Univ. UT)Funding: VC, Lilly, NIH ($5M to Univ. UT) Aug. 1994: Myriad (w/ NIEHS, Univ. UT, McGill & Lilly) clones BRCA1 Aug. 1994: Myriad (w/ NIEHS, Univ. UT, McGill & Lilly) clones BRCA1 Myriad files patent application on BRCA1Myriad files patent application on BRCA1

10 BRCA2 and Myriad Sept. 1994: BRCA2 localized through linkage analysis to chromosome 13 Sept. 1994: BRCA2 localized through linkage analysis to chromosome : BRCA2 race between Myriad and UK team (Michael Stratton at ICR and Sanger) 1995: BRCA2 race between Myriad and UK team (Michael Stratton at ICR and Sanger) Dec. 18, 1995: Myriad files US patent on BRCA2 Dec. 18, 1995: Myriad files US patent on BRCA2 Dec. 22, 1995: Stratton announces sequencing of BRCA2 and files UK patent Dec. 22, 1995: Stratton announces sequencing of BRCA2 and files UK patent Dec. 23, 1995: Stratton BRCA2 paper appears in Nature; Myriad releases sequence to GenBank Dec. 23, 1995: Stratton BRCA2 paper appears in Nature; Myriad releases sequence to GenBank

11 Myriad Patent Timeline Oct 1991: Univ. UT grants Myriad exclusive license to BRCA1 Oct 1991: Univ. UT grants Myriad exclusive license to BRCA1 Aug. 1994: Myriad files BRCA1 application Aug. 1994: Myriad files BRCA1 application Nov. 1994: Univ. UT grants Myriad exclusive license to BRCA2 Nov. 1994: Univ. UT grants Myriad exclusive license to BRCA2 Dec. 1995: Myriad files BRCA2 application Dec. 1995: Myriad files BRCA2 application Dec. 1997: first BRCA1 patent issues Dec. 1997: first BRCA1 patent issues Nov. 1998: first BRCA2 patent issues Nov. 1998: first BRCA2 patent issues

12 Competing Rights NIH NIH Initial Myriad BRCA1 application omitted NIH inventors Wiseman, FutrealInitial Myriad BRCA1 application omitted NIH inventors Wiseman, Futreal 1994: NIH settles dispute with Myriad/Utah and grants Utah exclusive license under BRCA1 rights1994: NIH settles dispute with Myriad/Utah and grants Utah exclusive license under BRCA1 rights Oncormed Oncormed 1997: Oncormed sues Myriad1997: Oncormed sues Myriad infringement of 1996 consensus wild-type BRCA1 sequence (NIH) infringement of 1996 consensus wild-type BRCA1 sequence (NIH) incorrect inventorship of 2 Myriad patents incorrect inventorship of 2 Myriad patents 1998: Myriad settles with Oncormed and obtains Oncormed patents1998: Myriad settles with Oncormed and obtains Oncormed patents

13 BRCA1/2 Testing/Enforcement 1996: Myriad begins to offer BRCA1/2 screening; U. Penn screens 500 patients/year 1996: Myriad begins to offer BRCA1/2 screening; U. Penn screens 500 patients/year 1998: Myriad sues U. Penn for patent infringement; Penn ceases testing 1998: Myriad sues U. Penn for patent infringement; Penn ceases testing 1999: Myriad requests Georgetown to stop testing for NCI’s Cancer Genetics Network Project (CGNP) 1999: Myriad requests Georgetown to stop testing for NCI’s Cancer Genetics Network Project (CGNP) 2000: Myriad cease and desist to Yale 2000: Myriad cease and desist to Yale Today: Myriad is the only U.S. provider of commercial BRCA1/2 screening Today: Myriad is the only U.S. provider of commercial BRCA1/2 screening Myriad permits research, but without provision of results to patientsMyriad permits research, but without provision of results to patients

14 Alleged Effects of Myriad’s Gene Patents Pricing ($3200/test) places testing beyond financial means of many patients Pricing ($3200/test) places testing beyond financial means of many patients Inability for patients to get confirmatory testing from second lab Inability for patients to get confirmatory testing from second lab Myriad testing is not state-of-the-art Myriad testing is not state-of-the-art Researchers cannot tell patients results of testing, conflicting with ethical obligations Researchers cannot tell patients results of testing, conflicting with ethical obligations General chilling effect on research into genetic tests General chilling effect on research into genetic tests Interference with ability to investigate complex multi-gene diseases Interference with ability to investigate complex multi-gene diseases

15 The Litigation On May 12, 2009, a group of plaintiffs represented by the American Civil Liberties Union (ACLU) sued Myriad, the Univ. of Utah and the USPTO to invalidate 15 claims of 7 Myriad BRCA1/2 patents On May 12, 2009, a group of plaintiffs represented by the American Civil Liberties Union (ACLU) sued Myriad, the Univ. of Utah and the USPTO to invalidate 15 claims of 7 Myriad BRCA1/2 patents

16 The Litigation: Plaintiffs Counsel: ACLU and Public Patent Foundation at Cardozo School of Law Counsel: ACLU and Public Patent Foundation at Cardozo School of Law Plaintiffs: Plaintiffs: Associations – Assn. for Molecular Pathology (AMP), Am. Coll. Of Medical Genetics (AMCG), Am. Soc. For Clin. Pathology (ASCP), Coll. Of Am. Pathologists (CAP)Associations – Assn. for Molecular Pathology (AMP), Am. Coll. Of Medical Genetics (AMCG), Am. Soc. For Clin. Pathology (ASCP), Coll. Of Am. Pathologists (CAP) Researchers – Kazazian, Ganguly (Penn), Chung (Columbia), Ostrer, Reich (NYU), Ledbetter, Warren (Emory), Matloff (Yale)Researchers – Kazazian, Ganguly (Penn), Chung (Columbia), Ostrer, Reich (NYU), Ledbetter, Warren (Emory), Matloff (Yale) Advocacy Groups – Breast Cancer Action (BCA), Our Bodies OurselvesAdvocacy Groups – Breast Cancer Action (BCA), Our Bodies Ourselves Patients – Ceriani, Limary, Girard, Fortune, Thomason, RakerPatients – Ceriani, Limary, Girard, Fortune, Thomason, Raker

17 The Patents 7 patents (5 BRCA1, 2 BRCA2) 7 patents (5 BRCA1, 2 BRCA2) 15 claims 15 claims Composition of Matter claimsComposition of Matter claims Method/Process claimsMethod/Process claims Terms extend from Terms extend from Myriad holds 16 other BRCA1/2 patents not in suit (expiring 2023) Myriad holds 16 other BRCA1/2 patents not in suit (expiring 2023)

18 Composition of Matter Claims “An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2” (‘282, cl.1) “An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2” (‘282, cl.1) “[Cl. 1]… wherein said DNA has the nucleotide sequence set forth in SEQ ID NO:1” (‘282, cl. 2)“[Cl. 1]… wherein said DNA has the nucleotide sequence set forth in SEQ ID NO:1” (‘282, cl. 2) “An isolated DNA having at least 15 of the nucleotides of the DNA of claim 1/2” (‘282, cl. 5/6)“An isolated DNA having at least 15 of the nucleotides of the DNA of claim 1/2” (‘282, cl. 5/6)

19 Patentable Subject Matter: Laws of Nature “The qualities of these bacteria, like the heat of the sun, electricity, or the qualities of metals, are part of the storehouse of knowledge of all men. They are manifestations of laws of nature, free to all men and reserved exclusively to none. He who discovers a hitherto unknown phenomenon of nature has no claim to a monopoly of it which the law recognizes” (Funk Bros. Seed Co. V.Kalo Inoculant Co. (US 1948) “The qualities of these bacteria, like the heat of the sun, electricity, or the qualities of metals, are part of the storehouse of knowledge of all men. They are manifestations of laws of nature, free to all men and reserved exclusively to none. He who discovers a hitherto unknown phenomenon of nature has no claim to a monopoly of it which the law recognizes” (Funk Bros. Seed Co. V.Kalo Inoculant Co. (US 1948) “Phenomena of nature, though just discovered, mental processes, and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work.” Gottschalk v. Benson (US 1972) “Phenomena of nature, though just discovered, mental processes, and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work.” Gottschalk v. Benson (US 1972)

20 Do Myriad’s Composition Patents Cover “Products of Nature”? Myriad’s arguments Myriad’s arguments USPTO Utility Examination Guidelines expressly allow patenting of isolated genetic materialUSPTO Utility Examination Guidelines expressly allow patenting of isolated genetic material Patents claim isolated DNA, which does not occur in naturePatents claim isolated DNA, which does not occur in nature

21 What is not a Product of Nature? To be patentable, a composition must have “markedly different characteristics” from any occurring in nature. (Diamond v. Chakrabarty (US 1980)) To be patentable, a composition must have “markedly different characteristics” from any occurring in nature. (Diamond v. Chakrabarty (US 1980)) Mere “purification” of a natural compound does not render it patentable. (Am Wood- Paper Co. v. Fibre Disintegrating Co. (US 1874) Mere “purification” of a natural compound does not render it patentable. (Am Wood- Paper Co. v. Fibre Disintegrating Co. (US 1874) Discredits Learned Hand’s 1911 holding in Parke-Davis v. Mulford, that isolated and purified adrenaline is patentableDiscredits Learned Hand’s 1911 holding in Parke-Davis v. Mulford, that isolated and purified adrenaline is patentable

22 Myriad’s Product of Nature Arguments M: Isolated DNA has different structural and chemical properties (chromatin, introns, methylation) than native DNA M: Isolated DNA has different structural and chemical properties (chromatin, introns, methylation) than native DNA Court: “In light of DNA’s unique qualities as a physical embodiment of information, none of the structural and functional differences cited by Myriad … render the claimed DNA ‘markedly different’.”Court: “In light of DNA’s unique qualities as a physical embodiment of information, none of the structural and functional differences cited by Myriad … render the claimed DNA ‘markedly different’.” M: Isolated DNA has functional utility in probes and primers that native DNA does not. M: Isolated DNA has functional utility in probes and primers that native DNA does not. Court: usefulness of isolated DNA in probes/primers exists only because of the identity of nucleotide sequence between isolated and native DNA.Court: usefulness of isolated DNA in probes/primers exists only because of the identity of nucleotide sequence between isolated and native DNA.

23 Myriad’s Product of Nature Arguments, cont. M: Invention required identification of genes plus isolation of sequences away from other DNA and cellular material M: Invention required identification of genes plus isolation of sequences away from other DNA and cellular material Court: Discovery is of the “handiwork of nature” and not patentable;Court: Discovery is of the “handiwork of nature” and not patentable; Isolation was “simply the application of techniques well-known to those skilled in the art” Isolation was “simply the application of techniques well-known to those skilled in the art”

24 Holding: Myriad’s BRCA Composition of Matter Claims Invalid “Because the claimed isolated DNA is not markedly different from native DNA as it exists in nature, it constitutes unpatentable subject matter …” “Because the claimed isolated DNA is not markedly different from native DNA as it exists in nature, it constitutes unpatentable subject matter …” Claims are thus invalid. Claims are thus invalid.

25 Method Claims A method for detecting a germline alteration in a BRCA1 gene, said alteration selected from a group consisting of the alterations set forth in Tables … 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 … (‘999, cl. 1) A method for detecting a germline alteration in a BRCA1 gene, said alteration selected from a group consisting of the alterations set forth in Tables … 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 … (‘999, cl. 1)

26 Method Claims: Unpatentable Subject Matter “Phenomena of nature, though just discovered, mental processes, and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work.” Gottschalk v. Benson (US 1972) “Phenomena of nature, though just discovered, mental processes, and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work.” Gottschalk v. Benson (US 1972) A claimed process may be patentable if it “transforms a particular article into a different state or thing” (In re. Bilski (Fed. Cir. en banc 2008, cert. granted 2009) A claimed process may be patentable if it “transforms a particular article into a different state or thing” (In re. Bilski (Fed. Cir. en banc 2008, cert. granted 2009)

27 Myriad’s Methods Not Transformative Simply “analyzing” and “comparing” DNA sequences is an abstract mental process Simply “analyzing” and “comparing” DNA sequences is an abstract mental process The preparatory isolation/purification steps are not part of these claims The preparatory isolation/purification steps are not part of these claims Any “transformations” associated with isolating and sequencing DNA are mere data gathering steps that are not central to patentability. Any “transformations” associated with isolating and sequencing DNA are mere data gathering steps that are not central to patentability. Holding: method claims are invalid Holding: method claims are invalid

28 Outcome All 15 of Myriad’s claims-in-suit are invalid All 15 of Myriad’s claims-in-suit are invalid Myriad has announced plans to appeal to the Federal Circuit Myriad has announced plans to appeal to the Federal Circuit At least some justices of the Supreme Court (Breyer) have indicated an interested in patentability issues At least some justices of the Supreme Court (Breyer) have indicated an interested in patentability issues 2-4 more years before a final resolution 2-4 more years before a final resolution

29 Myriad’s European Patents 1998: EPO allows patenting of genes (Council Dir. 98/44) 1998: EPO allows patenting of genes (Council Dir. 98/44) 2001: Myriad’s European patents on BRCA1 granted 2001: Myriad’s European patents on BRCA1 granted 2002: Institut Curie and other oppose Myriad patents 2002: Institut Curie and other oppose Myriad patents Feb. 2004: Cancer Res. UK gets patent on BRCA2 Feb. 2004: Cancer Res. UK gets patent on BRCA2 May 2004: EPO revokes first Myriad BRCA1 patent May 2004: EPO revokes first Myriad BRCA1 patent Jan. 2005: EPO limits claims of 2 remaining Myriad BRCA1 patents Jan. 2005: EPO limits claims of 2 remaining Myriad BRCA1 patents Jan. 2005: Myriad gets European patent covering BRCA2 test for Ashkenazi-Jewish women Jan. 2005: Myriad gets European patent covering BRCA2 test for Ashkenazi-Jewish women Nov. 2008: EPO limits BRCA1 patent to BRCA1 frameshift mutations only (not full BRCA1 gene) Nov. 2008: EPO limits BRCA1 patent to BRCA1 frameshift mutations only (not full BRCA1 gene)

30 Utility

31 Utility in the U.S. 35 USC § 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... §112: The specification shall contain a written description of the invention, and of the manner and process of making and using it… 35 USC §112: The specification shall contain a written description of the invention, and of the manner and process of making and using it…

32 Eli Lilly v. Human Genome Sciences (UK Ct. Appeal, Feb. 2010)

33 HGS’s neutrokine-a Patent 1996: HGS patents sequence for neutrokine-a, a protein identified using bioinformatics techniques 1996: HGS patents sequence for neutrokine-a, a protein identified using bioinformatics techniques Function is unknown, so a list of potential uses including therapies for solid tumors, schistosomiasis, and other parasitic diseases is listedFunction is unknown, so a list of potential uses including therapies for solid tumors, schistosomiasis, and other parasitic diseases is listed Eli Lilly, also developing neotrokine-a antibodies, challenges patent Eli Lilly, also developing neotrokine-a antibodies, challenges patent

34 Industrial Application Test Comparable to U.S. specific and substantial utility test Comparable to U.S. specific and substantial utility test Patent description must disclose a practical way of exploiting the invention in at least one field of industrial activity Patent description must disclose a practical way of exploiting the invention in at least one field of industrial activity Requirement is not satisfied by claiming an interesting research result without specified application Requirement is not satisfied by claiming an interesting research result without specified application Speculative indication of possible objectives not sufficient Speculative indication of possible objectives not sufficient

35 Challenges to Patent Jul 2008: UK Patent Court strikes down patent Jul 2008: UK Patent Court strikes down patent 2009: EPO Technical Board of Appeals upholds patent 2009: EPO Technical Board of Appeals upholds patent Feb. 2010: UK Court of Appeal strikes down patent Feb. 2010: UK Court of Appeal strikes down patent Possible appeal to UK Supreme Court Possible appeal to UK Supreme Court NOTE: UK decisions not binding in other EU states NOTE: UK decisions not binding in other EU states

36 Non-obviousness

37 Non-obviousness A patent may not be obtained… if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.

38 Biotech Non-obviousness 1990s to 2007: 1990s to 2007: Many scholars and firms believed that the court of national jurisdiction for patent appeals (CAFC) had developed the law in such a way that the non-obviousness requirement was too lenient.Many scholars and firms believed that the court of national jurisdiction for patent appeals (CAFC) had developed the law in such a way that the non-obviousness requirement was too lenient. Other requirements of the patent law are being applied so as only to uphold relatively narrow claims to DNA or protein sequences (§ 112 requirements).Other requirements of the patent law are being applied so as only to uphold relatively narrow claims to DNA or protein sequences (§ 112 requirements). The upshot: many DNA patents, none of which are worth much. Patent thicket? The upshot: many DNA patents, none of which are worth much. Patent thicket?

39 Biotech Non-obviousness In re. Bell, 991 F. 2d 781 (CAFC 1993) In re. Bell, 991 F. 2d 781 (CAFC 1993) DNA seq and cDNA seq for Insulin- like Growth Factor 1 and 2 (IGF1 & 2) are not obvious in light of the complete protein sequences for each and a well-known method for cloning the DNA.DNA seq and cDNA seq for Insulin- like Growth Factor 1 and 2 (IGF1 & 2) are not obvious in light of the complete protein sequences for each and a well-known method for cloning the DNA. CAFC: Not obvious!CAFC: Not obvious!

40 Biotech Non-obviousness In re Deuel, 51 F. 3d 1552 (Fed. Cir. 1995) In re Deuel, 51 F. 3d 1552 (Fed. Cir. 1995) Claim for DNA seq and cDNA seq for heparin binding growth factor (HBGF) not obvious over method of cloning, and a partial protein seq (amino terminus.Claim for DNA seq and cDNA seq for heparin binding growth factor (HBGF) not obvious over method of cloning, and a partial protein seq (amino terminus. PTO argued that when a protein sequence or part of it was put into the public domain, then so was the DNA sequence because a person of ordinary skill in the art would be motivated to clone the gene and would know how to do it. CAFC disagreed! PTO argued that when a protein sequence or part of it was put into the public domain, then so was the DNA sequence because a person of ordinary skill in the art would be motivated to clone the gene and would know how to do it. CAFC disagreed!

41 Biotech Non-obviousness Protein seq plus a method of cloning the gene does not make DNA seq obvious because: Protein seq plus a method of cloning the gene does not make DNA seq obvious because: The relationship between DNA seq and protein seq through the genetic code does not establish a prima facie case of obviousness. The relationship between DNA seq and protein seq through the genetic code does not establish a prima facie case of obviousness. Redundancy of the genetic code precludes a scientist from formulating an idea of the exact DNA sequence just by knowing a protein sequence.Redundancy of the genetic code precludes a scientist from formulating an idea of the exact DNA sequence just by knowing a protein sequence. No structural similarity between nucleotides and amino acids  there is no structurally similar compound in the prior art for somebody to modify to create the specific, structurally defined DNA molecule. No structural similarity between nucleotides and amino acids  there is no structurally similar compound in the prior art for somebody to modify to create the specific, structurally defined DNA molecule. It is not enough that the general idea of the claimed molecule exists in scientists minds. It is not enough that the general idea of the claimed molecule exists in scientists minds.

42 Biotech Non-obviousness From Deuel and Bell: From Deuel and Bell: The existence of a method of cloning is “essentially irrelevant” in the absence of information in the field suggesting the exact structure of the DNA molecule (including every base in each codon). The existence of a method of cloning is “essentially irrelevant” in the absence of information in the field suggesting the exact structure of the DNA molecule (including every base in each codon). “A general incentive does not make obvious a particular result” and “obvious to try has long been held not to constitute obviousness.” Deuel at “A general incentive does not make obvious a particular result” and “obvious to try has long been held not to constitute obviousness.” Deuel at 1559.

43 Biotech non-obviousness Biology as an unpredictable art Biology as an unpredictable art Analogy to small molecule chemistry in which a very small change in the molecule can substantially alter its properties.Analogy to small molecule chemistry in which a very small change in the molecule can substantially alter its properties. Contrast to the “predictable arts,” e.g. mechanical and electrical arts Contrast to the “predictable arts,” e.g. mechanical and electrical arts DNA is just another chemical, and we have a chemistry jurisprudence already.DNA is just another chemical, and we have a chemistry jurisprudence already.

44 KSR International Co. v. Teleflex Inc., 127 S.Ct (2007)

45 Facts and Case History Teleflex holds an exclusive license to pt for an adjustable pedal assembly.Teleflex holds an exclusive license to pt for an adjustable pedal assembly. Teleflex sues KSR for infringing claim 4 of its patent. Teleflex sues KSR for infringing claim 4 of its patent. Claim for combining an electronic sensor with an adjustable automobile pedal so that the pedal’s position could be transmitted to a computer that controls the automobile’s throttle. Claim for combining an electronic sensor with an adjustable automobile pedal so that the pedal’s position could be transmitted to a computer that controls the automobile’s throttle. Supreme Ct. held that the trial court correctly applied the law when it found this invention obvious.Supreme Ct. held that the trial court correctly applied the law when it found this invention obvious.

46 Predictability & Non-obviousness After KSR, role of predictability in assessing obviousness: After KSR, role of predictability in assessing obviousness: An invention is obvious if…An invention is obvious if… It is a combination of familiar elements It is a combination of familiar elements According to known methods According to known methods That does no more than yield predictable results. That does no more than yield predictable results. An invention is obvious if…An invention is obvious if… It claims a structure already known in the field and does no more than It claims a structure already known in the field and does no more than Substitute one material or element for another known in the field Substitute one material or element for another known in the field And produces a predictable result. And produces a predictable result.

47 Biotech Non-obviousness Obvious to try test after KSR? Obvious to try test after KSR? Obvious to try +Obvious to try + Motivation to try from design need or market pressure (or regulatory pressure, or ???) +Motivation to try from design need or market pressure (or regulatory pressure, or ???) + Finite number of identified, predictable solutions +Finite number of identified, predictable solutions + Likelihood of success.Likelihood of success. If all of the above apply, then the invention was obvious. Repudiates Deuel’s formulation of the obvious-to-try doctrine. If all of the above apply, then the invention was obvious. Repudiates Deuel’s formulation of the obvious-to-try doctrine.

48 In re Kubin, 561 F. 3rd 1561 (Fed Cir 2009)

49 Kubin Claim for isolated DNA encoding a protein at least 80% identical to 199 amino acids of the NAIL protein (natural killer cell activation inducing ligand, aka P38), “wherein the polypeptide binds CD48.” Claim for isolated DNA encoding a protein at least 80% identical to 199 amino acids of the NAIL protein (natural killer cell activation inducing ligand, aka P38), “wherein the polypeptide binds CD48.” Protein had previously been reported, there was a commercially available MAb to NAIL/p38, a mouse ortholog had been cloned and had bound to human DNA. Protein had previously been reported, there was a commercially available MAb to NAIL/p38, a mouse ortholog had been cloned and had bound to human DNA. Previous patent disclosed p38 receptor/NAIL protein and gave explicit instructions on how to clone the cDNA. Previous patent disclosed p38 receptor/NAIL protein and gave explicit instructions on how to clone the cDNA.

50 Kubin The CAFC upheld the Patent Office’s finding that the Kubin’s NAIL gene sequences were obvious. The CAFC upheld the Patent Office’s finding that the Kubin’s NAIL gene sequences were obvious. Here, the prior patent and lab manual taught the existence of the protein, provided motivation to clone the gene, and provided a step-by-step method for cloning this particular gene  Here, the prior patent and lab manual taught the existence of the protein, provided motivation to clone the gene, and provided a step-by-step method for cloning this particular gene  The prior art provided explicit motivation for somebody to try cloning the NAIL gene, and a “person of ordinary skill in the art” would have had a reasonable expectation of success in doing so given what was disclosed in the prior art.The prior art provided explicit motivation for somebody to try cloning the NAIL gene, and a “person of ordinary skill in the art” would have had a reasonable expectation of success in doing so given what was disclosed in the prior art. A person of “skill in this advanced art would find these claimed ‘results’ profoundly ‘predictable.’” p A person of “skill in this advanced art would find these claimed ‘results’ profoundly ‘predictable.’” p Granting patent protection to advances that would have occurred in the ordinary course of activities in the field retards innovation rather than advancing it.Granting patent protection to advances that would have occurred in the ordinary course of activities in the field retards innovation rather than advancing it.

51 Biotech Non-obviousness In the future, it will be at least somewhat more difficult for researchers to obtain patent protection for DNA sequences. In the future, it will be at least somewhat more difficult for researchers to obtain patent protection for DNA sequences. It remains to be seen how broadly the “obvious to try” doctrine will be applied.It remains to be seen how broadly the “obvious to try” doctrine will be applied. Will it apply to a DNA sequence when nothing about the protein was previously known? Will it apply to a DNA sequence when nothing about the protein was previously known? Will it apply to a DNA sequence when there was no explicit discussion in the literature of how to clone that exact protein? Will it apply to a DNA sequence when there was no explicit discussion in the literature of how to clone that exact protein? At least some existing DNA sequence claims likely will be held invalid under the Kubin standard. At least some existing DNA sequence claims likely will be held invalid under the Kubin standard.

52 Biotech Non-obviousness CAFC may be giving up its view that for a DNA seq to be obvious one needs to be able to predict exactly which nucleotides will be in the sequence! CAFC may be giving up its view that for a DNA seq to be obvious one needs to be able to predict exactly which nucleotides will be in the sequence!

53 SACHGS Report on Gene Patents and Licensing (Feb. 2010)

54 Scope of SACGHS Report Review of clinical impact of gene patents and licensing practices on access to genetic testing Review of clinical impact of gene patents and licensing practices on access to genetic testing Case studies Case studies Breast, ovarian and colon cancerBreast, ovarian and colon cancer Alzheimer’s DiseaseAlzheimer’s Disease Cystic FibrosisCystic Fibrosis Hearing LossHearing Loss HemochromatosisHemochromatosis Long QT SyndromeLong QT Syndrome Spinocerebellar AtaxiaSpinocerebellar Ataxia Tay-Sachs and Canavan DiseaseTay-Sachs and Canavan Disease

55 SACGHS Recommendations Exemption from infringement of gene patents for patient care and research Exemption from infringement of gene patents for patient care and research Require non-exclusive licensing of diagnostic genetic technologies Require non-exclusive licensing of diagnostic genetic technologies Ensure that clinically useful genetic tests are equitably available and accessible to patients Ensure that clinically useful genetic tests are equitably available and accessible to patients


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