Biological and Pharmaceutical Patents in Mexico

1. Biological and Pharmaceutical Patents in Mexico Ing. Eugenio Pérez

2. INDEX • Key facts • Patent division at IMPI • Flow chart of Patent Prosecution • Requirementsfor Patent Protection • PlantVarietiesProtection and TransgenicPlants • Biological and Genetic Material Patenting • Patent ProtectionforDiagnostics • Patent ProtectionforBiologicalPharmaceuticals and Pharmaceuticals. • Medical use-claims in Mexican Patent Practice. • Patent Linkage • BiologicalPharmaceuticals: Innovators vs Biosimilars

3. KEY FACTS • Total population in Mexicois of approximately113 millionpeople. • Mexicoisthesecondlargestmarket of pharmaceuticals in LatinAmerica and theeleventh in theworld. • Also, itisone of the ten largestdrugproducersworldwide. • This position in the global scenarioputsMexico in a strategic position for • thebiotech and pharmaceuticalindustry. • The total number of applications filed per year in our country, including all existent patent figures (patents, utility models and industrial designs) is of around 20,000.

4. PATENT APPLICATIONS FILED BEFORE IMPI DURING THE LAST 20 YEARS. http://www.impi.gob.mx/wb/IMPI/impi_en_cifras2

5. http://www.impi.gob.mx/wb/IMPI/impi_en_cifras2

6. Patent Divisionat IMPI IMPI is the Mexican Institute of Industrial Property, which is the officialauthority in Mexico for the protection of Industrial Property rights. PATENT DIVISION OF IMPI Formal Examination Department Substantive Examination Department Biotechnology, Pharmaceuticals and Chemistry Mechanical, Electrical, Utility Models and Industrial Designs * Theapproximatenumber of Patent Examiners at IMPI is of 140 .

7. FLOW-CHART OF THE PATENT PROSECUTION 18 monthsfromtheMexicanfiling date oritsrecognizedpriority 6 months 1-3 months

8. REQUIREMENTS FOR PATENT PROTECTION Article 16 of the MIPL- Inventions that are new, the result of an inventive step and susceptible of industrial application within the meaning of this Law shall be patentable, with the exception of: • Essentially biological processes for obtaining, reproducing and propagating plants and animals; • Biological and genetic material as found in nature; • Animal breeds; • The human body and the living matter constituting it; • Plant varieties.

9. Mexican legislation also contemplates what is not considered an invention: Article 19 of the MIPL: • Theoretical or scientific principles; • Discoveries of something that already exist in nature, even though it was previously unknown; • Schemes, plans, rules and methods for carrying out mental processes, playing games and doing business, and mathematical methods; • Computer Programs; • Methods of presenting information; • Esthetic creations and artistic or literary works; • Methods of surgical, therapeutic or diagnostic treatment applicable to the human body and to animals; • Juxtaposition of known inventions except where in reality they are so combined or merged that they cannot function separately, or where their characteristic qualities or functions have been so modified as to produce an industrial result or use not obvious to a person skilled in the art.

10. PLANT VARIETIES PROTECTION AND TRANSGENIC PLANTS • Patent protection for biological and chemical drugs is permissible in Mexico if and when, the requirements established in Article 16 of our legislation are duly complied. • Biological process are not patentable per se, while transgenic plants are patentable if a targeted genetic modification is present. • Plant varieties are not protectable as patents but are permissible under the figure Plant Breeders Rights ruled by the Federal Law of Breeder Rights (not administered by IMPI).

11. PROSECUTION FOR OBTAINING A “PLANT BREEDER REGISTRATION” Filing of a PlantBreederregistration (PBR) application. Formal Examinationprocess: Formal Requirements. Theexpedition of a filingCertificateisissuedbythe SNICS. Distinction, Uniformity and StabilityExamination (DUS) processtakes place whentheexpedition of theabovementionedcertificatetakes place. Whenthe DUS examinationsuccessfullyconcludes, thenthe SNICS grantsthePlantBreederRightsTitle. The process for granting a Plant variety takes about two years..

12. BIOLOGICAL AND GENETIC MATERIAL PATENTING Notwithstanding the patentability exceptions set out in article 16 of MIPL the Biologicaland Genetic material areconsidered candidates for patent protection under the following conditions: • Theyshould have been isolated, showing thehuman intervention for carrying out the invention, i.e. genes may be patented as long as they are not in the human or animal body or as found in nature but rather have been subject to lab work such as, at least, isolation and sequencingand; • Their biological activity, specific and industrial applicability have to be evident. • Examples: Isolatedcells, microorganisms and moleculessuch as proteins, antibodies, etc. are consideredbiological material.

13. PATENT PROTECTION FOR DIAGNOSTICS Products directed to diagnostic applicability and processes for making said products are indeed subject matter susceptible for patent protection. However, it is to note that, as established in Article 19 of the MIPL, subsection VII, methods of diagnosis that are applicable to humans or animals are not considered as inventionstherefore, not patentable. Diagnostic methods are patentable as long as they are in vitro. i.e. contacting a compound with a sample from the patient.

14. PATENT PROTECTION FOR BIOLOGICAL PHARMACEUTICALS AND PHARMACEUTICALS • Biological Pharmaceuticals are candidates for patent protection, their active substances include biological and/or genetic material patentable under the conditions previously mentioned. • The pharmaceuticals and biological pharmaceuticals may have a full coverage protection for product claims drawn to the active substances, pharmaceutical compositions, medicaments and for claims directed to process for making the same. • With regard to the medical and therapeutic indication of these types of inventions, article 19 of the MIPL, subsection VII forbids the patenting of methods of surgical, therapeutic or diagnostic treatment applicable to the human body and to animals.

15. MEDICAL USE CLAIMS IN MEXICAN PATENT PRACTICE • In order to provide a wide patent protection for the pharmaceutical and Biological pharmaceutical products in Mexico, the Mexican Institute of Industrial Property (MIIP) allows the medical use claims as follows: • A first medical use claim is permitted as long as the active substance is also claimed in the same patent application. • Product “X” for use as medicament. • Product “X” for use in the treatment of “Y.” • The second medical use drafting under the Mexican practice is the “Swiss-type” format. • Use of product “X” for the manufacture of a medicament for the prophylaxis/ treatment of the disease/condition “Y”.

16. SECOND MEDICAL USE CLAIMS Thesecond medical “use” claims, adopted in theMexicanpractice, avoidstatutoryrejectionsunderarticle 19 MIPL subsection VII withregardtomethods of treatmentapplicable to humans or animalsduringthe substantive examination. However, the “use” isnotconsidered as category of inventionunderarticle 45 of the MIPL and, theMexican Institute of Industrial Property (MIIP) still has not set a position about the subject matter that said claims cover for infringement purposes: Are they Products? Are they solely Processes?

17. ARE SECOND MEDICAL USE CLAIMS MOVING FORWARD? The “Swiss-type” format for second medical use claims in Mexico was adopted from the European Patent Office practice. Nowadays said type of claims fell into disuse in the EPO due to modifications in the European Patent Convention where the intended medical and therapeutic use is considered as a technical feature exclusively for pharmaceutical products. This changes in the EPO practice may be mirrored by IMPI in a near future, as recently stated by IMPI´s Patent Director.

18. PATENT LINKAGE • The patent – marketing authorization linkage system for pharmaceutical products involves interparty collaboration of IMPI and the Commission for the Protection against Sanitary Risks (COFEPRIS). • The linkage system provides that for one side IMPI is required to publish a linkage-gazette listing all valid patents covering allopathic drugs and, on the other side, the COFEPRIS is obliged to observe said gazette to deny marketing authorization for a drug that infringes any of the listed patents. • The linkage gazette mainly includes all valid and enforceable patents that claim: • Compounds (active substances) • The linkage system in the Article 47 bis of the Rules of MIPL expressly discards from the patent list of the linkage gazette the patents that are directed to production or formulation processes.

19. PATENT LINKAGE AND PHARMACEUTICAL FORMULATIONS At the beginning, the linkage gazette only listed those patents comprising a new active substance. On January 13, 2010, the Supreme’s Court decision (circumscribed to judicial and not to administrative authorities), interpreted that pharmaceutical products are not composed solely by their active substance and that ingredients of the composition may provide a therapeutic effect. Notwithstanding the Supreme’s Court decision does not have a direct effect on the administrative authorities practices, the MIIP decided to include in the linkage gazette those patents that claim pharmaceutical formulations(that may involve known active substances).

20. PATENT LINKAGE: IMPI-COFEPRIS INTERPARTY COLLABORATION • For the publication of a patent in the linkage gazette, the patentee has to file a request before IMPI mentioning the patent number, the generic name of the active substance, the chemical name of the active substance, the medicament involved and the claims directed to the active substance or pharmaceutical compositions. • Recently, and following IMPI´s practice, the interparty enquiry format that COFEPRIS submits before IMPI, with regard to specific patented medicaments has changed, now considering not only the generic, chemical name and chemical formula of the active substance but: • Salts. • Formulations. • Therapeutic indications. • Doses. • Types of administration. • Solvents. • Specific characteristics like isomers, polymorphisms.

21. PATENT LINKAGE AND SECOND MEDICAL USES Even though the Patent-Marketing authorization system has moved forward in favor of patent holders rights, at this point there still exists a gap between Patent protection and the Patent – Marketing authorization linkage system because the linkage system only considers patents involving new compounds and new pharmaceutical compositions. The patents directed to medicaments protected only by second medical use claims are not included in this system as they are interpreted as drawn to known compounds with a different therapeutic indication and do not claim per se a new product.

22. BIOLOGICAL PHARMACEUTICALS: INNOVATORS VS BIOSIMILARS FROM PATENT PROTECTION POINT OF VIEW In regard to Biosimilars (named Biocomparables in Mexico), recently Mexican health law was amended to include them and to differentiate them from generics of small molecules, therefore, the process to obtain an authorization in our country for biosimilars is different from that of chemical synthesis generics, marketing authorization before the Sanitary Registry for biosimilars requires submission of specific clinical trials and if applicable, in-vitro trials to demonstrate the safety, efficacy and quality of the product. The quantity and quality of required trials is determined on case by case basis by the Sanitary Authority.

23. BIOLOGICAL PHARMACEUTICALS: INNOVATORS VS BIOSIMILARS FROM PATENT PROTECTION POINT OF VIEW The main distinctions between the biosimilars and generics of small molecules are that the biosimilar and the innovator molecules are not identical mainly due to the production processes (i.e. bacterial vs animal cell systems). Biosimilar applicantshavetoprovidetheirown data withregardtotheintegrity of the active substancemolecule, thebiologicalactivity of themedicament, the safety and eficacyclinical data in patientswiththesamediseaseorcondition as theinnovator.Despiteallthoseconditions, notallthe biosimilar medicaments are interchangeable. When a biosimilar medicament shows different and improvedactivitiesduetoitsdifferencesagainsttheinnovator, itmay be patentable as selectioninvention.

24. PHARMACEUTICAL DATA PACKAGE EXCLUSIVITY (DPE) As a memberstate of International Treatiessuch as NAFTA and TRIPS, Mexicoisobligedtoprovide a 5-year exclusivityperiodfortheclinical data packagesubmittedforinnovativedrugsthatobtain a marketing authorization, thisexclusivityisindependent and unrelatedtoanypatent-derivedexclusivity. However, currentlyMexicanHealthlawdoesnotcontainanyprovisions in thisregard. In spite of theabove, in 2012, theMexicanregulatoryagency COFEPRIS, issuedaninternalcommunicationstatingthat a 5-year exlcusivityperiodshall be awardedtothe data packagesubmittedforany marketing authorizationissuedon a new molecule and therefore, a thirdpartywillnot be abletoobtain a marketing authorizationforthesamemoleculebasedonthe data providedbytheinnovatorwithinsaidperiod. The circular islimitedsolelyto new molecules and notto new formulationsorindications. A furtheruncertaintyexistsonwhetherthispracticewill be applicabletobiologicalsoronlytochemicalsynthesisproducts.

25. Thankyou ! EUGENIO PEREZ hamburgo 260, col. juárez cp 06600, d.f.méxico phone: 52 (55) 55 33 50 60 ext. 150 fax: 52 (55) 52 08 83 87 52 (55) 52 08 85 07 email: eugenioperez@uhthoff.com.mx