HUMAN GENETIC TESTING PATENTS : ELIGIBILITY AND ENFORCEMENT

Transcription

1 HUMAN GENETIC TESTING PATENTS : ELIGIBILITY AND ENFORCEMENT FRENCH APPROACH DENISE HIRSCH HEAD OF IP

2 THE ENVIRONNENT Patentability of living organism was a public debate in France focusing on ethical issues superseding economic issues Very important role of French national ethics Committee* Important role of French Bioethics law of 1994 regarding the respect of the human body ( the human body, its elements and products can not be subject to a patrimonial right ) The National Ethics Advisory Committee has always taken stand against patentability of the human genome and disagreed with the European Directive 98/44/EC on Legal protection of biotechnological inventions 2

3 IMPLEMENTATION OF DIRECTIVE 98/44/EC Strong opposition to articles 5&3 of Directive. ART 5.2 An element isolated from the human body or otherwise produced by means of a technical process, including the sequence or partial sequence of a gene, may constitute a patentable invention, even if the structure of that element is identical to that of a natural element. ART 3.2. Biological material which is isolated from its natural environment or produced by means of a technical process may be the subject of an invention even if it previously occurred in nature. Implementation after 53 month delay with two main statutes (August 6, 2004-?) with result that article 5.2 & 3.2 are not/not correctly implemented Suppression of An element isolated from the human body or otherwise produced by means of a technical process Additional limitation: Article L implies that the patent is limited to the function of the gene which allows the industrial application and not the gene itself. 3

4 THE APPLICATION OF THE DIRECTIVE BY FRENCH COURTS Only a few decisions on biotechnology matters Mainly concerned with HIV diagnostic kits ( Institut Pasteur) First decision of the French Cour de Cassation in a case for infringement of a molecular biology patent on 23 November 2010 (Institut Pasteur v. Chiron Healthcare & Novartis Vaccines & Diagnostics) 4

5 THE CASE LAW : INSTITUT PASTEUR VS. CHIRON, COUR DE CASSATION,NOV 23, 2010 THE CASE Action for Infringement by Institut Pasteur based on EP Cloned DNA sequences, hybridizable with genomic RNA of lymphadenopathyassociated virus (LAV) against diagnostic kits for the detection of HIV in blood samples sold by Chiron. Most of the claims amended before the EPO, during examination or opposition proceedings, particularly in light of European patent filed by the NIH on 19 August 1985 and thus relevant for novelty considerations only.(article 54.3 EPC) Opposed claims A method for the in vitro detection of viral infection due to the LAV virus which comprises contacting a biological sample originating from a person to be diagnosed for LAV infection and containing RNA, in a form suitable for hybridization, with the probe of claim 7 under hybridizing conditions and detecting the hybridized probe.[claim 8] The purified RNA of LAV virus which has a size from 9.1 to 9.2 kb and which corresponds to the cdna contained in lambda-j19 (CNCM 1-338). [Claim 11 ] 5

6 THE CASE LAW :INSTITUT PASTEUR VS CHIRON RULING OF THE COURT OF APPEAL CONFIRMED BY COURT DE CASSATION Scope of protection Rules applying: Art. 69 EPC. The claims have a scope corresponding to their literal wording, and not the extensive scope requested by Institut Pasteur. The extent of the protection conferred by a patent shall be determined by the wording of the claims; This rule applies even to a pioneer patent which can have a general scope only if the claims are drafted with a broad scope; Changes made during examination and opposition proceedings must be taken in consideration Claim 8: can only be construed so as to cover a method for the in vitro detection of HIV using the probes of claim 7 Language used# general means Prior art already disclosed a general method for the detection of HIV consisting of hybridizing DNA probes with viral RNA Claim 11: Amended during examination proceedings The [prior art ] would have anticipated claim 11, if said claim had been construed broadly. 6

7 THE CASE LAW :INSTITUT PASTEUR VS. CHIRON RULING OF THE COURT OF APPEAL CONFIRMED BY COURT DE CASSATION Non infringement of Claim 8 Probes of the kit do not implement the probes of claim 8 Other features of claim 8 are not reproduced either: The Chiron ON are not DNA probes but chimeric ON partly composed partly of DNA and partly of RNA# cloned DNA The amplification primers contain DNA absent from the retroviral genome contained in clone λ-j19 Institut Pasteur cannot rely on the doctrine of equivalents since Claim 8 does not cover a general means for the detection of LAV Non infringement of Claim 11 Contributory infringement only applies when the means relate to an essential feature (contribute to the result of the invention) Claim cover a product not a method Implementation of kit does not allow isolation of specific RNA corresponding to DNA of λ-j19 CLAIM 1:[A cloned DNA which contains a DNA corresponding to the LAV retroviral genome and contained in λ-j19] 7

8 THE CASE LAW: OTHER DECISIONS Institut Pasteur vs. Siemens: TGI Paris May 28, 2010-HIV diagnostic kit (EP ) «It follows that the amendments made to the claims by INSTITUT PASTEUR during the Examination and opposition proceedings which must be taken into account failing which legal certainty for third parties would be violated resulted in limiting the scope of the invention, which was voluntarily limited in order to obtain the grant and the maintenance of the patent at stake» Institut Pasteur vs. Abbott: HIV diagnostic kit Protein gp110 Settlement INSTITUT PASTEUR/NIH + INSTITUT PASTEUR/NIH giving access to licensees to the existing technology comprising list of patents involved in interference proceedings Institut Pasteur contending that Abbott diagnostic kits infringed patent Dismissal of Institut Pasteur s claims It results from the context of that governed the elaboration of the 1994 agreement, which must be read in reference to the 1987 agreement, from the propose which the parties declared they wanted to pursue and from the definition of the licensed products that the gp 110 (the accused protein) falls within the scope of the licensed products 8

9 THE CASE LAW: OTHER DECISIONS GenOway vs. Cellectis (TGI Paris November 12, 2009 )(1)/ Taconic Farms vs. Cellectis (Paris, May 4, 2012) (2) Facts License provides right to production of transgenic mice by homologous recombination license granted by Cellectis without right to sub-license The licensee sells the offspring of genetically modified mice Decisions: The agreement of the owner of the rights on the patented process is necessary in order to proceed to the reproduction of the licensed product and the company [Genoway ) that has not been granted a right to sublicense cannot validly grant said right to reproduce to its clients (1) the fact that the genetic modification was performed directly by the (sub)licensee or was transmitted by its ancestries which have themselves been subject to said operation amounts to the same result insofar as this genetic modification directly results from the implementation of the patented process (2) 9

10 CONCLUSION Strict application of EPC rules Interpretation of Article 69 Would the decision be different if the gene were human genes? Counterclaims based on invalidity of genes? Convergence of European case law ( Monsanto) and French position? 10