7th International VPM Days Hannover. Patenting in the US and in Europe. Dr. Jürgen Meier

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Strategies t post "Prometheus" " and "Myriad" Dr.

1 Patentanwälte t Rechtsanwälte 7th International VPM Days Hannover Patenting in the US and in Europe Strategies t post "Prometheus" " and "Myriad" Dr. Jürgen Meier München Basel Berlin

2 The Patent Offices and Courts take the decisions 2

3 How do we deal with "DNA" and "Diagnostic" cases in the EPO? 3

4 Patentanwälte t Rechtsanwälte Diagnostic Inventions: G 1/07 München Basel Berlin

5 Method of Treatment or Diagnosis by Surgery TheclaimatstakeinG1/07 (EP )relatedtoanimaging method (magnetic resonance), which, when carried out, can maintain the life and health of a subject but comprises or encompasses an invasive step, i.e 1. A method for MRI imaging the pulmonary and/or cardiac vasculature using dissolved phase polarized 129 Xe, comprising the steps of: positioning a patient in an MRI apparatus [...] delivering polarized 129 Xe to a predetermined region of the patient s body [...] [...] 5

6 delivering polarized 129 Xe to the human body? In accordance with the application as filed, said delivery may comprise the direct injection of polarized 129Xe into the heart or via inhalation of the gas: i.e. invasive method involving a surgical step! 6

7 Question to the EBA Is a claim, such as the one at stake, to be excluded from patentability when said claim comprises or encompasses a step consisting of a physical intervention on the human or animal body if such astep is notperseaimed at maintaining i i life and health h (here imaging!)? Answer: YES! Excluded from patentability especially when such a step requires medical skills or involves health risks! 7

8 What Do We Learn From G1/07? Claims involving an invasive step or claims that encompass an invasive step on the human or animal body are excluded from patentability, basedonart.53(c)epc,when said invasivei step represents the coreof the medical profession However, the EBA also indicates that a method with surgical and nonsurgical variants can be patented by disclaiming the surgical variants (however, such a claim needs to be clear and enabled!) Furthermore, it was confirmed that methods that properly define the operation of a device (for example the operation of a pacemaker) can be patentable, if novel and inventive. 8

9 Patentanwälte t Rechtsanwälte Marker Diagnostic per se Are we endangered in the EPO by the U.S. US Approach? München Basel Berlin

10 USPTO Patentable Subject Matter/Invention: Anything Under the Sun Made by Man (Congress)...Really? Diamond v. Chakrabarty, 447 U.S. 303 (1980) (Genetically engineered Pseudomonas) Chief Justice Warren Burger: Judged in this light, respondent's micro organism plainly qualifies as patentable subject matter. His claim is... to a nonnaturally occurring manufacture or composition of matter a product of human ingenuity. 10

11 The Supreme Court 11

12 Mayo v. Prometheus (Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S. Ct. 1289, 1293 (2012)) "Medical Diagnostic Claims" are not patentable! non-patentable law of nature March 20, 2012! 12

13 Mayo v. Prometheus... the claim A method of optimizing therapeutic efficacy for treatment of an immune mediated gastrointestinal disorder, comprising: (a) () administering a drug providing 6 thioguanine to a subject having said immune mediated gastrointestinal disorder; and (b) determining the level of 6 thioguanine in said subject having said immune mediated dgastrointestinal disorder, d wherein the level of 6 thioguanine less than about 230 pmol per 8x10 8 red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject and wherein the level of 6 thioguanine greater than about 400 pmol per 8x10 8 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject. 13

14 New England Journal of Medicine 366;25 June 21,

15 Mayo v. Prometheus "diagnostic testing" NOT patentable!!!!! "because they represented conventional applications of laws of nature!!!! "transformation required "Personalized medicine" needs severe case to case analysis BEFORE filing! 15

16 Myriad BRCA breast cancer patent upheld on appeal... at first! Medical Progress Today.com Published by the Manhattan Institute 16

17 August 16, 2012 Judges Lourie, Moore and Bryson Association for Molecular Pathology (AMP) and ACLU v. USPTO and Myriad Genetics (Fed. Cir. 2012) 17

18 US 5,747,282 Myriad Genetics, Inc. 1. An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO: 2. but later 18

19 US 5,837,492 Myriad Genetics, Inc. 1. An isolated DNA molecule coding for a BRCA2 polypeptide, said DNA molecule comprising a nucleic acid sequence encoding the amino acid seqeunce set forth in SEQ ID NO. 2. but later 19

20 US 5,693,473 Myriad Genetics, Inc. 1. 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 in SEQ ID NO. 1. but later 20

21 Judge Bryson: Peter McLight 21

22 US 5,709,999 Myriad Genetics, Inc. 1. 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 of SEQ ID NO: 1. 22

23 US 5,710,001 Myriad Genetics, Inc. 1. A method for screening atumorsample from a human subject forasomaticalterationinabrca1geneinsaidtumorwhich comprises gene comparing a first sequence selected from the group consisting of abrca1gene from said tumor sample, BRCA1 RNA from said tumor sample and BRCA1 cdna made from mrna from said tumor sample with a second sequence selected from the group consisting of BRCA1 gene from a nontumor sample of said subject, BRCA1 RNA from said nontumor sample and BRCA1 cdna made from mrna from said nontumor sample, wherein a difference in the sequence of BRCA1 gene, BRCA1 RNA or BRCA1 cdna from said tumor sample from the sequence of the BRCA1 gene, BRCA1 RNA or BRCA1 cdna from said nontumor sample indicates a somatic alteration in the BRCA1 gene in said tumor sample. 23

24 US 6,033,857 Myriad Genetics, Inc. 1. A method for identifying a mutant BRCA2 nucleotide sequence in a suspected mutant BRCA2 allele which comprises comparing the nucleotide sequence of the suspected mutant BRCA2 allele with the wild type BRCA2 nucleotide sequence, wherein a difference between the suspected mutant and the wild type sequences identifies a mutant BRCA2 nucleotide sequence. 24

25 Judges Lourie, Moore and Bryson: All three judges denied patentability of claims that comprise analyzing; or comparing DNA sequences Unlike Prometheus, the claims to short isolated strands of DNA are not directed to the relationship between the mutation and cancer, but rather to a new tool that can be used to determine if that relationship exists 25

26 How do we deal with "DNA" and "Diagnostic" cases in the EPO? 26

27 T 1213/05 "Breast and ovarian cancer/university OF UTAH" (September 27, 2007) Opponents: Socialdemokratic Parliamentary Party of Switzerland Greenpeace e.v. et al. Institut Curie Assistance Publique Hopitaux de Paris Institut Gustave Roussy IGR Belgian Society of Human Genetics et al. The Heirs of Dr. Wilhelms, Rolf E. De Staat der Nederlanden Minister van Volksgezondheid, Welzijn en Sport Attack on DNA patentability in principle based on it s a discovery, ordre public and morality. Yet, decision confirms the practice established in the EPO before the EU Directive. 27

28 T 1213/05 "Breast and ovarian cancer/university OF UTAH" (September 27, 2007) The Claim: 1. An isolated nucleic acid which comprises a coding sequence for the human BRCA1 polypeptide, wherein said polypeptide has1863 amino acids, has a molecular weight of 208 kilodaltons, and comprises the amino acid sequence of SEQ ID NO: 82, said coding sequence being comprised in a genomic DNA which is obtainable by: (a) providing a human genomic library; (b) screening the genomic library Note: product by process format used to save priority. 28

29 T 80/05, "Method of Diagnosis /UNIVERSITY of UTAH" EP B A method for diagnosing g a predisposition p for breast and ovarian cancer in a human subject which comprises determining in a tissue sample of said subject whether there is a germline alteration that is a frameshift mutation in the sequence of the BRCA1 gene coding for a BRCA1 polypeptide altering the open reading frame for SEQ ID NO: 2, said alterationbeing indicative of a predisposition to said cancer. 29

30 T 666/05, "Mutation/UNIVERSITY of UTAH" EP B A method for diagnosing a predisposition for breast and ovarian cancer in a human subject which comprises determining whether there is germline alteration 185delAG ter39 in the BRCA1 gene in a tissue sample of said subject, said alteration indicating a predisposition to said cancer. 30

31 Patentanwälte t Rechtsanwälte Further (encouraging) EPO examples München Basel Berlin

32 EP B TheRegents of the University of Colorado 32

33 EP B TheRegents of the University of Colorado A method for evaluating bucindolol treatment for a patient comprising: obtaining sequence information regarding at least one polymorphism in an adrenergic receptor gene of a patient,, wherein (a) said sequence information comprises either (i) the sequence at nucleotide position 1165 in the coding sequence in one or both of the patient s β 1 AR alleles, or (ii) the amino acid at position 389 of the patient s β 1 AR proteins; and/or (b) wherein said sequence information comprises whether (i) the nucleotide sequence at positions has been deleted in one or both of the patient s α 2c AR alleles, or (ii) the amino acid sequence at positions has been deleted in the patient s α 2c AR proteins, wherein the patient is likely to exhibit a positive response to bucindolol if the patient is homozygous Arg389 in the β 1 AR gene or it the patient is homozygous wild type in the α 2c AR gene. 33

34 EP B and further! Stichting Katholieke Universiteit, The University Medical Centre Nijmegen PROGENSA 34

35 EP B and further! Stichting Katholieke Universiteit, The University Medical Centre Nijmegen 1. An in vitro method for diagnosing g or prognosing gprostate cancer in a patient, comprising: (i) amplifying a spliced prostate cancer specific PCA3 RNA which h lacks atleast intron 3, between exon 3 and exon 4, from a urine sample of a patient using a pair of primers; and (ii) detecting an amplification product derived therefrom with a probe which is specific for an exon 3 exon 4 junction of PCA3, wherein said amplification product is associated with the presence of prostate cancer or predisposition thereto in said patient. 35

36 EP B Stichting Katholieke Universiteit, University Medical Centre Nijmegen/The Johns Hopkins University 1. A nucleic acid molecule associated with prostate cancer and derived from exon sequences of the prostate cancer antigen (PCA3) nucleic acid molecule, comprising a polynucleotide sequence selected from the group consisting of: (a) a nucleotide sequence of exon 1 of the prostate cancer antigen (PCA3) nucleic acid molecule, as set forth between nucleotides 1 98 of SEQ ID NO: 1; (b) a nucleotide sequence of exon 2 of the prostate cancer antigen (PCA3) nucleic acid molecule, as set forth between nucleotides of SEQ ID NO: 1; () (c) a nucleotide sequence of exon 3 of the prostate tt cancer antigen (PCA3) nucleic acid molecule, as set forth between nucleotides of SEQ ID NO: 1; (d) a nucleotide sequence of exon 4a of the prostate cancer antigen (PCA3) nucleic acid molecule, as set forth between nucleotides of SEQ ID NO: 1; [ ] 36

37 EP B Stichting Katholieke Universiteit, University Medical Centre Nijmegen/The Johns Hopkins University 1. A method of determining whether a PCA3 nucleic acid is present in a test sample comprising RNA, said PCA3 nucleic acid exhibiting overexpression in prostate cancer cells relative to cells of normal prostate or benign prostate tissues, said method comprising the steps: (a) synthesizing cdna using RNA of the test sample as a template; and (b) detecting among the synthesized cdna a nucleic acid comprising an open reading frame (ORF) encoding SEQ ID NO:7, wherein Arg23 of the ORF is encoded by the codon AGA that results from RNA splicing of PCA3 exon 3 to PCA3 exon 4a, thereby determining that the PCA3 nucleic acid is present in the test sample. 37

38 EP B Stichting Katholieke Universiteit, The University Medical Centre Nijmegen 1. A method for prognosticating prostate cancer in a biological sample of a patient comprising: (a) assessing the amount of a prostate cancer specific PCA3 mrna and theamountof PSA in said biological lsample; (b) determining a ratio value of said amount of said prostate cancer specific PCA3 mrna over said amount of PSA; and (c) comparing said ratio value to at least one predetermined cut off value, wherein a ratio value above said predetermined cut off value is indicative of a higher risk of mortality of prostate cancer as compared toaratio value bl below said predetermined dt dcut off value. 38

39 Further claims? 2nd medical use claims directed to the therapeutic use: Compound X for use in the treatment of disease Y characterized in that the patient has the genetic marker Z. Possible problem with novelty? Some Examiners at the EPOtake this position. Reasoning: Not novel if it is beyond reasonable doubt that patients having said genetic marker have already been treated with compound X in the prior art (implicit disclosure). For any normally occurring genetic marker (i.e. an allele present in a population with a normally occurring frequency), the number of patients treated with any given marketed/approved drug will be sufficient to come to the conclusion that a patient with said genetic markerhasbeen treated in the prior art. ERGO: "not novel!" 39

40 Still further claims? 2nd medicaluse claimsalso including the diagnosticstep: Compound X for use in the treatment of disease Y characterized in that the patient has the genetic marker Z and the method of treatment comprises the step of determining whether or not the patienthas thegenetic marker Z. The EPO indicated that such a claim may be acceptable. Problem: Would anybody infringe such a claim? Diagnosis and treatment are normally separate actions. 40

41 Thank you very much!!! Questions? 41

42 ..for some Answers Hans-Rainer Jaenichen / Jürgen Meier / Leslie A. McDonell / James F. Haley jr / Yoshinori Hosoda From Clones to Claims The European Patent Offices's Case Law on the Patentability of Biotechnology Investions in Comparison to the United States and Japanese Practice Heymanns Intellectual Property 5th Edition

43 Our Offices MÜNCHEN (Main Office) Siebertstraße 3 D München Tel: Fax: BASEL Nadelberg 3 CH 4051 Basel Tel: Fax: BERLIN Joachimstaler Straße 34 D Berlin Tel: Fax: Website: info@vossiusandpartner.com i 43

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