The Trans-Pacific Partnership has an important impact on different business areas, including Intellectual Property , which is developed in Chapter 18 of the multilateral Treaty.
Whereas this treaty has generated a great deal of expectation in Peru about intellectual property matters, especially in the patents matters, test data and its impact on the pharmaceutical and biotechnology products TTP.
We focus on three important aspects of the TTP.
Regarding Patentable Matter
TTP mentioned in Article 18: 37.1 that “each party shall make the patents available for inventions claimed as at least one of the following: new uses of a known product, new methods of using a known product, or new methods of using a known product. A party may limit such new procedures to vindicate those who do not use the product as such. ”
However , Peru being member country of the Andean Community is governed by the rules of the Decisions of the CAN as Decision 486 about Intellectual Property , according to the Resolution of the Andean Court Process 09 -IP- 2014 , makes use preliminary interpretation regarding the uses mentioned : “in conclusion a patent is the solution to a technical problem and that in turn can be protected either as a patent product or process which innovates to respond to the need to be present in the field of industry. However, uses as such are not protected, so that the claims itself , must be clear and defined so that the examiner can itself define what contribution the invention to prior art and thus to decide if it is suitable for protection or not. That is, before the Andean Community uses are not protected subject matter.
If using is allowed, potentially national inventors will be benefited because, according to analysis of indicator of the 2015 Peruvian PTO (INDECOPI) are shown the national applications, the invention patents were 87 versus 197 applications for utility model patents. We can infer that there is more innovation in engineering in Peru. Likewise, the amount of patent application of utility model filed in 2015, 91.6% are national applicants (197 national applications versus 18 foreign applications), ergo there is more improvements in existing technologies (Derived technology) rather than to innovate.
On the other hand in the article 18.37.3 states: “that a part may be excluded from patentability: (a) diagnostic, therapeutic and surgical methods for treating humans or animals; (b) plants and animals other than micro-organisms, and essentially biological processes for the production of plants or animals other than non-biological and microbiological processes. However, in accordance with paragraph 1 and without prejudice to paragraph 3, each party confirms that patents shall be available at least for inventions derived from plants. ”
These articles are in accordance with the provisions of Article 27.3 paragraphs a and b, respectively, the TRIPS Agreement in which the power was provided to the Member Country exclude patentability these matters, which was also taken at the time by the Regional Policy of the Andean Community under Article 20 of Decision 486, standard governing Peru on Intellectual Property.
Taking into consideration the article Article 20 of Decision 486 excludes patentable plant subject matter, Peru as a member of UPOV ( International Union for the Protection of New Varieties of Plants ) should be given a system of protection of plant varieties improved . This sui generis patent system is called ” Breeder´s Rights Protection “, which is regulated by Decision 345 of the CAN and in accordance with Article 27.3 b of the TRIPS: “”Plants and animals (…) “ Members shall provide for the protection of plant varieties either by patents or by an effective sui generis system or by any combination thereof”
To date Peru has implemented these exclusions and sui generis protection systems in accordance with the TRIPS Agreement, Decision 486 and Decision 345. In that sense, one could say that the only “real” change in patentable subject matter. It is that through the treaty TPP would be protectable new uses, new methods or procedures of a product which could fall on a machine or composition.
However, Peru will have to request opinion from the CAN before applying this article of the treaty.
Regarding the pharmaceutical related measures – Unreasonable adjustment
The measures ” Unreasonable adjustment” in the patents are taking place in our country since the Legislative Decree No. 1075 referred to in Article 32 that “The competent leadership , exclusively at the request of a party” shall adjust the patent term where an unreasonable delay has occurred in the granting process, except where the patent is for a pharmaceutical product or procedure. With the TPP this measure would also apply to pharmaceutical products”. With the APTA this measure would also apply to pharmaceutical products , according to what is mentioned in Article 18.48.1 : “With respect to a pharmaceutical product that is subject to a patent, each Party shall provide to within one adjust patent to compensate the owner for unreasonable reductions to the effective patent term resulting from the marketing approval process:
Also, Decision 486 – Common Regime on Industrial Property, in conformity with its amendment Decision 689, Chapter V, Title II on patents provides that with the exception of pharmaceutical patents, to establish the means to compensate the patent owner for unreasonable delays in the National Office in issuing it, restoring the terms or patent rights. Member Countries deemed unreasonable delays superior to five years from the date of filing the patent application or three years from the request for examination of patentability, as long as the periods attributable to actions of the patent applicant are not included in the determination of such delays.
Whereas Decision 486, Andean law governing the Peruvian patent system provides that unreasonable delay settings do not apply to pharmaceutical patents, and unlike the APTA provides that if these should be applied to pharmaceutical patents.
Peru shall request the opinion of the Andean Community on the applicability of this provision, as mentioned in Annex 18-D , in order to avoid defaulting on agreements made : “Under the Andean Decision 486, Common Regime of Industrial Property and the Decision 689, Adequacy of certain articles of Decision 486, restricts Peru to implement its obligations under the Article 18.48.2 (Setting the patent term for unreasonable delays), Peru commits to make its best efforts to obtain a waiver from the Andean Community that allows it to in a manner consistent with Article 18.46.3 ( … ) “.
Protection of test data or other undisclosed – Biological Products
To date, the Legislative Decree No. 1072 is the standard that regulates the protection of test data and other undisclosed Pharmaceutical, pointing through its Article 3: “No other person other than that whom submitted the undisclosed test data needed to determine the safety and efficacy of a product may, without the consent of such person, use such data to support an application for approval of a health record for the period of protection normally be five years”.
It is worth mentioning that the D.L. 1072 only applies to pharmaceuticals chemical, so the “Test Data Protection ” of biological products are not covered by this standard..
About the APTA in Article 18.51 states that “A Party shall either: ( A) with respect to the first marketing authorization in a Party of a new pharmaceutical product is or contains a biological protection have effective commercial implementation of Article 18.50.1 (Protection of test data or other undisclosed data ) and Section 18.50.3 , mutate mutandis , for a period of at least eight years from the date of first marketing authorization for that product in that Party; or alternatively ( B ) with respect to the first marketing authorization in a Party of a new pharmaceutical product it is or contains a biological , having effective trademark protection: (i) through the implementation of Article 18.50.1 (Protection of test data or other undisclosed data and Section 18.50.3 , mutatis mutandis , for the period of at least 5 years from the date of first marketing authorization product in that Party , (ii) through other measures, and (iii) recognizing that business conditions also contribute to effective trade protection to provide comparable results in the market.
In this sense, it is decision of the signatory to choose one of the options described. Thus, in the case of Peru to be an importer of drugs , perhaps the best adaptation option is literal (B) arising from the treaty, that is, provide five years of protection for test data of biological products as is currently being done with data from test chemicals, provided that previously fit their business conditions.
It is clear that the Data Protection Test is not an extension of protection of the patent system, but is another form of protection for results from clinical trials and not to the invention as such, as in the case of patents.
Regarding biosimilars, the TTP only mentions the regulation of test data more biotech products does not regulate the parameters of acceptance or not these. So it is the prerogative of each country regulation. What happens in Peru is that to date there is no directive regulating the entry of biosimilar; Peru does not have a standard to establish the parameters for assessing these drugs with the reference biological product.
Finally, pursuant to Article 18.53.1 the TPP states: “If a Party permits, as a condition of the marketing authorization of a pharmaceutical product, other than the one who originally submitting safety and efficacy, based on evidence or information concerning the safety and efficacy of which was previously authorized product , such as evidence of prior marketing authorization by the Party or in another territory, that Party shall provide : “a system that gives notice to the holder of the patent or to allow the patentee to be notified , prior to the marketing of the pharmaceutical product that the other person is looking to market that product during the term of the applicable patent covering the licensed product or method of use authorized”.
Consequently, the TTP requires Peru to implement a system in which to link the information of the patent system (INDECOPI) and the marketing authorizations of medicines ( DIGEMID).