Patent & Utility Model

*Macrol MR Decision on Negative Declaratory Action Regarding Patents

European Patent, which belongs to defendant and the Turkish Patent Institute (TPI) patent, which is demanded to be invalidated are identical (a patent family). This patent has been cancelled by EPO. The defendant’s invention, subjected to the patent (nr.1998/00777) registration in TPI is within the scope of State-of-Arts and thus does not satisfy the conditions of patentability. On the other hand, in the abridged application of the plaintiff, the defendant’s products have been used as a reference, which may be accepted as a patent infringement. In the additional expert report it was determined that the licence for the plaintiff’s patent was granted because there was a different study, which differs from the defendant’s patented formula.

The request of the plaintiff made by his amendment petition is dismissed based on Patent Decree Law art.131 and therefore the case is partially accepted based on the fact that protection subjected to patent application was never granted at all. Furthermore it is decided that nr.1998/00777 patent is invalid and it should be repealed from the patent registry, Macrol MR 500 gram controlled release tablet, owned by the plaintiff, does not violate defendant’s patent, which is actually invalidated. Lastly, it is also determined that this pharmaceutical product has different characteristics compared to the formulation subjected to the patent application.

11th Civil Chamber of Supreme Court, 13.10.2009 Case No.2008/446, Decision No.2009/10535

*Venlafaksin Decision on Infringement of Pharmaceutical Patents

The scope of protection of the patent is not the active substance VENLAFAKSIN, but it is its prolonged dissolution formula. The protected thing is not a molecule patent. In the concrete case, there is no evidence that suggests the defendant has produced, exported or put on market in any way the disputed pharmaceutical product. The abridged licence applications are still on investigation period. There is no licence or authorization for sale that has been granted to the defendant for the related pharmaceutical products yet. Therefore it may not be stated that there is a patent infringement as there is no de facto act of production and/or putting on the market.

Another issue yet to be discussed is to decide whether to apply for abridged licence when there is 12 years ahead for the patent protection, would create a danger of violation of patent right or not. In art.75/(f), which was annexed in 2004, it states that the procedure of granting a licence shall not be acknowledged as a patent infringement regardless of how many years the protection will last. An explicitly legitimate act may not be deemed illegal depending on the grounds of early licence application. Therefore in the disputed case there is no patent infringement as well as danger of infringement. As a natural consequence of these findings, since there is no current violation or a danger of a violation it may be certainly stated that the plaintiff has no legal interest in the determination of a danger of a patent infringement or unfair competition with respect to a production of a future pharmaceutical product. It could be anticipated that this pharmaceutical product can be listed in the lists of social security organizations and thus there is actually an interest regarding determining the existence of an infringement from today, it is not appropriate for the economy of procedural law to start the proceedings since this alleged danger of infringement may occur after many years because during the investigation period there could be an amendment requests or the application could be withdrawn. Furthermore the licence application could even be refused as a result of the bioequivalence research and assessments. Therefore this case must be dismissed.

11th Civil Chamber of Supreme Court, 17.02.2011 Case No.2009/859, Decision No.2011/1835

*Kepra Decision on Data Exclusivity

It is legitimate to reference the data file that contains the test results and clinical trials on behalf of the plaintiff. We can reach to this conclusion by depending on the fact that this action, which is basically using the application right emerging from the legal regulations of Ministry of Health, which is the authority for approval or refusal of the application of pharmaceutical licences, shall not be recognized as an action that cause unfair competition danger according to the art.56 et seqq. of Turkish Commercial Code. This consequence would not change even when the defendant has made an abridged licence application depending on the art.9/a of the Medical Pharmaceutical Product Licensing Regulation.

11th Civil Chamber of Supreme Court, 29.09.2009 Case No.2007/14802, Decision No.2009/9797

*Olanzapin Decision on Invalidation of Pharmaceutical Patents

(1) Claim of the disputed patent is against precondition of granting a patent, drafted in the art.42/1-c of the Patent Decree law, expressed as “the claim(s) covering the elements of the invention for which protection is sought” and also against art.47, which states that the claims shall be explicit and concise to the point. Therefore according to the art.129/1-b, the patent shall be invalidated, since the subject matter of the invention has not been described in a sufficiently explicit and comprehensive manner so as to enable a person skilled in the concerned technical field to implement same.

On the other hand Claim (2) and (3) are directly related and tied to Claim (1). Claim (7) to Claim (17), where the polymer group that was selected for the formulation mentioned in the Claim (1) is described, are dependant to Claim (1). As a consequent, depending on the invalidation of independent Claim (1), other claims are invalid as well.

In the Claim (4), it is mentioned that the surfacing does not contain propylene glycol and this fact is expressed by the technical experts (There is no clarity or information as such about the surfacing in the description regarding propylene glycol, which is mentioned in Claim (4), this propylene is not a polymer, it is an auxiliary substance, which is used in different dosages because of its desiccant character, this substance is not used in lining a pill, there could actually be a mistake that this substance is here, the propylene glycol mentioned in the Claim (4) is different from polyethylene glycol mentioned in the description, they have different chemical structures and different uses). Since Claim (4) exceeds the contents of the description (the contents are not present in the description), which is a violation of art.47, both Claim (4) and other independent claims tied to Claim (4) are invalid. The rest of the dependent claims are not new as stated in the technical report in detail.

11th Civil Chamber of Supreme Court, 15.07.2010 Case No.2008/13038, Decision No.2010/8450

*Olanzapin Decision on Infringement Allegation for Pharmaceutical Patents

Since it is understood that the document regarding the method of procurement of Olanzapin Form I has submitted to the court as an appendix of the Ministry of Health’s official letter, dated to 31.03.2006 and since ethyl acetate has not determined in the Olanzapin synthesis information, which is explained in the document present in the expert report, dated to 15.07.2007, it is appropriate to dismiss the infringement claim with respect to claim 9, regarding Form II. Form II constitutes the novelty and invention step of the patent 1017/B and consist of the plaster method for ethyl acetate and obtaining crystallize state of the solution.

11th Civil Chamber of Supreme Court, 21.01.2011 Case No.2010/15685, Decision No.2011/497

*Ing Ludwig Decision on Compulsory Licence

According to the art.96 of Patent Decree Law, Nr.551, if there is no production with respect to patented invention for 3 years or if the defendant is refusing to grant a licence to the plaintiff or if there is consistent loss of export and exchange due to the non existence of the production, then it may be stated that the conditions for compulsory licence are met.

11th Civil Chamber of Supreme Court, 17.2.1998 Case No.1998/367, Decision No.1998/943

*Tiotropium Decision on Bolar Exception on Pharmaceuticals

According to the art.75/f of Patent Decree Law, nr.551, it is not a violation of a patent right for the defendant to apply for an abridged licence application to the Ministry of Health with respect to the disputed pharmaceutical since there has been no licence granted for the same product yet.

11th Civil Chamber of Supreme Court, 27.09.2011 Case No.2009/11675, Decision No.2011/11018

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