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Can downstream products be protected by reach through claims or are we simply swimming upstream

Why are Reach-Through Claims needed?. To allow those who perform and/or invest in important upstream research to obtain useful and enforceable patent protection for their inventionsParticularly important in Australia where both state and federal governments invest heavily in upstream biomedical re

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Can downstream products be protected by reach through claims or are we simply swimming upstream

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    1. Can downstream products be protected by reach through claims or are we simply swimming upstream? Michael Caine Partner Davies Collison Cave mcaine@davies.com.au

    2. Why are Reach-Through Claims needed? To allow those who perform and/or invest in important upstream research to obtain useful and enforceable patent protection for their inventions Particularly important in Australia where both state and federal governments invest heavily in upstream biomedical research, and where no home grown “big pharma”

    3. Can Reach-Through Claims Extending to Downstream Drug Products be Justified? Acknowledgment of the contribution of upstream research to the development of the downstream drug products Acknowledgment of the pioneering nature of many upstream inventions Potential to provide a benefit to the patentee commensurate to the benefit the invention provides to the public and those involved in downstream drug development

    4. Can Reach-through Claims Extending to Downstream Drug Products be Justified? Acknowledge the fact that many of those involved in upstream research do not have the resources or skills to take their inventions to commercial downstream products Encourage disclosure of the results of upstream research Encourage investment in upstream research 20 year patent term minimises enforceability of patents too far upstream

    5. Neuraminidase Inhibitors Relenza(Biota) v Tamiflu(Gilead) ANU and CSIRO research produced crystals of neuraminidase in 1978 Neuraminidase was recognised as a potential target to treat influenza but attempts to find an inhibitor which had in vivo activity were unsuccessful Funded by Biota, CSIRO unlocked the secret to design of neuraminidase inhibitors with in vivo activity in mid 1980s Working with VCP scientists Relenza was discovered in 1989

    6. Neuraminidase Inhibitors Relenza(Biota) v Tamiflu(Gilead) First patent applications for Relenza were filed in early 1990, including a “reach-through” application (PCT/AU90/00501) July 1999 FDA approval for Relenza October 1999 FDA approval for Tamiflu What happened to the reach-through application?

    7. Neuraminidase Inhibitors Relenza(Biota) v Tamiflu(Gilead) Abandoned! Claim 1: A pharmacologically active composition comprising : A virus-inhibiting amount of a compound that binds the active site of influenza virus neuraminidase and that displays in vivo activity against orthomyxovirus or paramyxovirus; and A pharmaceutically-acceptable carrier for said compound. Result Biota <3% Tamiflu 90% ($US330 million for 2003)

    8. The Scenario Professor Svensson provides the following information: Description of isolation of a novel receptor as well as its amino acid sequence Description of methods for screening compounds against receptor to identify compounds which activate the receptor (agonists) Clear evidence that absence of receptor function is associated with obesity Description of the pharmacological mechanism involved in the treatment or inhibition of obesity, explaining why activation of novel receptor treats or inhibits obesity

    9. The Claims Claim 1: An isolated and purified receptor, the sequence of which consists of SEQ ID NO: 1. Claim 2: A method of identifying an agonist of the receptor of claim 1 comprising: Preparing a candidate compound, Contacting a cell which expresses said receptor or its surface with said candidate compound, and Determining whether the candidate compound activates the receptor of claim 1, wherein a compound that activates the receptor of claim 1 is an agonist of said receptor.

    10. The Claims Claim 3: An isolated and purified receptor agonist identified by the method of claim 2. Claim 4: A method for the treatment of obesity comprising administering to a host in need thereof a therapeutically effective amount of the agonist identified by the method of claim 2, as an active agent. Claim 5: A monoclonal antibody which recognises the receptor of claim 1.

    11. The Claims Claim 6: A method for preparing a pharmaceutical composition for the treatment of obesity comprising: identifying an agonist of the receptor of claim 1 utilising the method of claim 2, preparing a quantity of the identified agonist (or derivative thereof), and incorporating the prepared agonist into a pharmaceutical composition.

    12. The Legislation An invention is patentable if it: Is a manner of manufacture Is novel Involves an inventive step Is useful, and Was not secretly used in Australia before priority date

    13. The Legislation A complete specification must: Describe invention fully including best method End with claims defining the invention The claims must be: Clear and succinct, and Fairly based on matter described in the specification

    14. Synaptic Pharmaceutical Corporation v Astra Aktiebolag (1998) Inventors were the first to isolate “human” 5-HT1D receptor Amino acid and nucleotide (cDNA) sequences for two subtypes of this receptor, termed 1D-1 and 1D-2, were provided Constructs were made, the receptors were expressed and plasmids and transfected cells were deposited with ATCC Binding assay performed using series of known drugs (including sumatriptan), transfected cells and labelled 5-HT List of diseases or conditions linked to 5-HT1D receptor activity (including migraine) was provided

    15. Synaptic Pharmaceutical Corporation v Astra Aktiebolag Claims: Claim1: An isolated nucleic acid molecule encoding a human 5-HT1D receptor Claim 2: An isolated protein which is a human 5-HT1D receptor Claim 12: A vector comprising the DNA molecule of claim 1…... Claim 20: A method for determining whether a ligand not known to be capable of binding to a human 5-HT1D receptor can bind to a human 5-HT1D receptor which comprises: contacting a mammalian cell comprising the vector of claim 12 with the ligand under conditions permitting binding of ligands known to bind to a human 5-HT1D receptor, detecting the presence of any of the ligand bound to a human 5-HT1D receptor, and thereby determining whether the ligand binds to a human 5-HT1D receptor

    16. Synaptic Pharmaceutical Corporation v Astra Aktiebolag Claim 23: A ligand detected by the method of claim 20 Claim 24: The method of screening drugs to identify drugs which specifically interact, and bind to, the human 5-HT1D receptor on the surface of a cell which comprises contacting a mammalian cell comprising the vector of claim 12 with a plurality of drugs, determining those drugs which bind to the mammalian cell, and thereby identifying drugs which specifically interact with, and bind to a human 5-HT1D receptor Claim 27: The pharmaceutical composition comprising a drug identified by the method of claim 24 and a pharmaceutically acceptable carrier Claim 47: An antibody directed to a human 5-HT1D receptor Claim 68: A pharmaceutical composition comprising an amount of a substance effective to alleviate the abnormalities resulting from overexpression of a human 5-HT1D receptor and a pharmaceutically acceptable carrier

    17. Synaptic Pharmaceutical Corporation v Astra Aktiebolag Are the claims fairly based on the disclosure? Can applicant claim all human 5-HT1D receptors/genes based on disclosure of two subtypes or should the claims be limited to the two identified subtypes? Referred to Federal Court decision in Genetics Institute, Inc v Kirin-Amgen, Inc 1998 740 FCA relating to Erythropoietin: a coding sequence can represent a “principle of general application” of the type considered in the English decision Biogen Inc v Medeva plc. Referred also to May & Baker v Boots Pure Drug Co Ltd 1991 RPC 23: a beneficial property common to a class entitled patentee to claim class even though only one or two made The disclosed coding sequences enabled other products of the class to be produced using reliable probes, and “demonstrate a beneficial property common to the class..” Claims fairly based even though they extend beyond disclosed sequences

    18. Synaptic Pharmaceutical Corporation v Astra Aktiebolag Are the claims fairly based on the disclosure? What types of claims are valid in light of applicant’s technical contribution? Hearing Officer referred to earlier decisions including: Olin Corp v Supercartridge Co p/l 14 ALR 149 - patentee is entitled to a claim which “embodies his inventive idea, but not for an article which, while capable of being used to carry his inventive idea into effect, is described in terms which cover things quite unrelated to his inventive idea, and which do not embody it at all” and Biogen (supra) “what seems to me in this particular case the critical issue..is not whether the claimed invention could deliver the goods, but whether the claims cover other ways in which they might be delivered in ways which owe nothing to the teaching of the patent or any principle which it disclosed” Claims1,2,12 20 and 24 are fairly based while claims 23,27 and 68 are not

    19. Synaptic Pharmaceutical Corporation v Astra Aktiebolag Claims: Claim #1 An isolated nucleic acid molecule encoding a human 5-HT1D receptor ? Claim #2 An isolated protein which is a human 5-HT1D receptor. ? Claim #12 A vector comprising the DNA molecule of claim 2…… ? Claim #20 A method for determining whether a ligand not known to be capable of binding to a human 5-HT1D receptor can bind to a human 5-HT1D receptor which comprises contacting a mammalian cell comprising the vector of claim 12 with the ligand under conditions permitting binding of ligands known to bind to a human 5-HT1D receptor, detecting the presence of any of the ligand bound to a human 5-HT1D receptor, and thereby determining whether the ligand binds to a human 5-HT1D receptor. ? Claim #23 A ligand detected by the method of claim 20. ? Claim #24 The method of screening drugs to identify drugs which specifically interact, and bind to, the human 5-HT1D receptor on the surface of a cell which comprises contacting a mammalian cell comprising the vector of claim 12 with a plurality of drugs, determining those drugs which bind to the mammalian cell, and thereby identifying drugs which specifically interact with, and bind to a human 5-HT1D receptor. ? Claim #27 The pharmaceutical composition comprising a drug identified by the method of claim 24 and a pharmaceutically acceptable carrier. ? Claim #47 An antibody directed to a human 5-HT1D receptor. ? Claim #68 A pharmaceutical composition comprising an amount of a substance effective to alleviate the abnormalities resulting from overexpression of a human 5-HT1D receptor and a pharmaceutically acceptable carrier. ?

    20. Synaptic Pharmaceutical Corporation v Astra Aktiebolag Are the claims clear? “human 5-HT1D receptor” Term is clear based on definition “not known” as used in claim 20 Not known to anyone in the world, Not known to person conducting assay, or Not published. Term is ambiguous and even if limited to one of the three meanings above results in clarity and fair basis problems

    21. Synaptic Pharmaceutical Corporation v Astra Aktiebolag Claims: Claim 1: An isolated nucleic acid molecule encoding a human 5-HT1Dreceptor. ? Claim 2: An isolated protein which is a human 5-HT1D receptor. ? Claim 12 A vector comprising the DNA molecule of claim 2…… ? Claim 20 A method for determining whether a ligand not known to be capable of binding to a human 5-HT1D receptor can bind to a human 5-HT1D receptor which comprises contacting a mammalian cell comprising the vector of claim 12 with the ligand under conditions permitting binding of ligands known to bind to a human 5-HT1D receptor, detecting the presence of any of the ligand bound to a human 5-HT1Dreceptor, and thereby determining whether the ligand binds to a human 5-HT1D receptor. ? Claim 23: A ligand detected by the method of claim 20. ? Claim 24: The method of screening drugs to identify drugs which specifically interact, and bind to, the human 5-HT1D receptor on the surface of a cell which comprises contacting a mammalian cell comprising the vector of claim 12 with a plurality of drugs, determining those drugs which bind to the mammalian cell, and thereby identifying drugs which specifically interact with, and bind to a human 5-HT1D receptor. ? Claim 27: The pharmaceutical composition comprising a drug identified by the method of claim 24 and a pharmaceutically acceptable carrier. ? Claim 47: An antibody directed to a human 5-HT1D receptor. ? Claim 68: A pharmaceutical composition comprising an amount of a substance effective to alleviate the abnormalities resulting from overexpression of a human 5-HT1D receptor and a pharmaceutically acceptable carrier. ?

    22. Synaptic Pharmaceutical Corporation v Astra Aktiebolag Are the claims novel? Sumatriptan was previously known to bind to human 5-HT1D receptor Sumatriptan was previously used to treat migraine Applicant unsuccessfully argued that the words “not known to be capable of binding to a human 5-HT1D receptor” excluded sumatriptan. Since “not known” is ambiguous applicant’s argument rejected Claims 23 and 27 lack novelty(and lack clarity) Applicant foreshadowed an amendment to add “when used to bind a 5-HT1D receptor” to the end of claims 23 and 27. Hearing Officer did not like amendment because sumatriptan inherently bound to the receptor in use (claim 23), and subsequent use of claim 24 screening method may make subsequent preparation of known formulations an infringement of claim 27.

    23. Synaptic Pharmaceutical Corporation v Astra Aktiebolag Amendments made after hearing to address issues: Claim 20: A method for determining whether a ligand [not known to be capable of binding to a human 5-HT1D receptor] can bind to a human 5-HT1D receptor which comprises contacting a mammalian cell comprising the vector of claim 12 with the ligand under conditions permitting binding of ligands known to bind to a human 5-HT1D receptor, detecting the presence of any of the ligand bound to a human 5-HT1D receptor, and thereby determining whether the ligand binds to a human 5-HT1D receptor. [Claim 23: A ligand detected by the method of claim #20.]

    24. Synaptic Pharmaceutical Corporation v Astra Aktiebolag Amendments made after hearing to address issues: Claim # 27 [The] A method of obtaining a pharmaceutical composition which comprises determining whether a ligand binds to a human 5-HT1D receptor according to the method of claim 20 and admixing said ligand with [comprising a drug identified by the method of claim 24 and] a pharmaceutically acceptable carrier, with the proviso that the ligand is not sumatriptan, methylergonavine, ergotamine, or pindolol.

    25. Synaptic Pharmaceutical Corporation v Astra Aktiebolag Amendments made after hearing to address issues: Claim #68 [The] A method of obtaining a pharmaceutical composition for treating migraine in a subject which comprises admixing [comprising an amount of a substance effective to alleviate the abnormalities resulting from overexpression of a human 5-HT1D receptor and] a pharmaceutically acceptable carrier and an amount of a chemical compound which selectively binds to and activates a human 5-HT1D receptor but not a 5-HT1A receptor, a 5-HT1E receptor, a 5-HT2 receptor, a 5-HT3 receptor, or a 5-HT4 receptor, effective to treat this subject’s migraine, wherein the human 5-HT1D receptor is a human 5-HT1D-1 receptor or human 5-HT1D-2 receptor, with the proviso that the compound is not sumatriptan, methylergonavine, ergotamine, or pindolol .

    26. Examination Guidelines Nov 2003 Novelty Claims to compounds identified or selected by screening should be interpreted as being directed to the compound per se Fair Basis Products claimed must owe something to the invention. Compounds that interact with a peptide or nucleotide do not necessarily owe anything to the invention. Sufficiency/Full Description Disclosure of a peptide or nucleotide sequence may provide structural information re interacting compounds such as antisense, antibodies etc, but generally no information re structure of interacting small molecules.

    27. Examination Guidelines Nov 2003 Reach-through method claims: Claims to methods of using candidate compounds may satisfy novelty, fair basis and sufficiency requirements, particularly where method involves modulation of activity of peptide or nucleic acid of the invention. Examples Agents that interact with the peptide ? Use of the peptide to screen for agents that interact with peptide ? Agents that interact with peptide, when identified using the peptide ? Agents that interact with the peptide, when isolated using the peptide ? Use of an agent that interacts with the peptide to treat a disease caused by inappropriate activity of the peptide. ?

    28. Back to the Scenario: The Claims Claim 1: An isolated and purified receptor, the sequence of which consists of SEQ ID NO: 1. ? Claim 2: A method of identifying an agonist of the receptor of claim 1 comprising: Preparing a candidate compound, Contacting a cell which expresses said receptor or its surface with said candidate compound, and Determining whether the candidate compound activates the receptor of claim 1, wherein a compound that activates the receptor of claim 1 is an agonist of said receptor. ?

    29. The Claims Claim 3 An isolated and purified receptor agonist identified by the method of claim 2. ? Claim 4 A method for the treatment of obesity comprising administering to a host in need thereof a therapeutically effective amount of the agonist identified by the method of claim 2, as an active agent. ? Claim 5 A monoclonal antibody which recognises the receptor of claim 1. ?

    30. The Claims Claim 6 A method for preparing a pharmaceutical composition for the treatment of obesity comprising: Identifying an agonist of the receptor of claim 1 utilising the method of claim 2, Preparing a quantity of the identified agonist (or derivative thereof), and Incorporating the prepared agonist into a pharmaceutical composition. ? Consider (but not too seriously!!) following claim if agonists are disclosed together with testing in acceptable animal model for obesity??? Claim 7 A method for preparing a patent application for an agent useful in treating obesity comprising identifying an agonist of the receptor of claim 1 utilising the method of claim 2, preparing a patent specification in respect of identified agonist and derivatives thereof and their use in the treatment of obesity, wherein claims of said specification are supported by data generated from method of claim 2 and/or data generated from an animal model for obesity.

    31. How Far do the Method Claims Reach? Method claims are infringed by using the method or by selling or offering to sell, importing etc “a product resulting from such use” Potentially the importation into Australia or the sale in Australia of a drug identified using a patented screening method could infringe (Consider “Saccharin Doctrine”) Contributory infringement? Experimental use?

    32. What do upstream researchers deserve?

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