Patent Linkage in Mexico

By Moeller IP.

Patent Linkage in Mexico

The Mexican linkage system refers to the cooperation between the Mexican Institute of Industrial Property (IMPI) and the Federal Commission for Protection against Health Risks (COFEPRIS) to avoid the granting of marketing authorizations for allopathic drugs which may infringe any in-force patent.

This linkage system was issued on September 19, 2003. It is established in articles 167 bis of the Health Supplies Regulations and article 47 bis of the Industrial Property Regulations which state the system procedure.

Authorization for an allopathic drug

Allopathic drugs are defined in article 224 of the Mexican Health Law as natural or synthetic substances having therapeutic, preventive or rehabilitative effects, which may be identified by their pharmacological activity, physical, chemical or biological characteristics and are presented in a pharmaceutical form.

Whenever a marketing authorization application for an allopathic drug is submitted to COFEPRIS, the applicant is required to either submit the documents which demonstrate that owns the patent or patents related to the active pharmaceutical ingredient (API), possess the corresponding license, both registered at the IMPI, or, according to the Mexican Linkage Gazette, declare under oath that it complies with the provisions applicable in patent matters.

In the case of the latter, COFEPRIS will request IMPI to confirm this statement. COFEPRIS will file a form detailing the following information about the marketing authorization application and deliver it to IMPI:

• Applicant of the marketing authorization
• Name of the API, salts as APIs or International Nonproprietary Name
• Chemical name according to the International Union of Pure and Applied Chemistry
• Structural formula of the API
• Pharmaceutical formulation, API and excipients
• Dosage form
• Therapeutic indications
• Dosage
• Drug presentations
• Drug characteristics
• Any additional information submitted by the applicant

The above information is considered confidential, thus only COFEPRIS and IMPI are aware of its contents.

Authorization procedure

Based on the information received, IMPI will have ten business days to confirm whether an in-force patent may be infringed. If no patent is found to be infringed, the marketing authorization application will comply with this administrative requirement and follow its normal procedure. Otherwise, IMPI will notify COFEPRIS which in turn will notify the applicant of the possible infringement. COFEPRIS will request the applicant to submit the corresponding license and if the applicant fails to do so the marketing authorization will be denied.

Mexican Linkage Gazzete

Regarding the Mexican Linkage Gazette, this document is published semi-annually by IMPI and its purpose lies in keeping a record of the in-force Mexican patents associated with specific APIs.

Patents listed in the Mexican Linkage Gazette include those of composition of matter, formulations, medical uses or combination thereof. These are listed automatically by the IMPI whenever a patent is granted. Alternatively, patent owners may also request the Mexican PTO to include a certain patent in the Gazette. Lastly, patents related to processes or methods of producing the drugs are expressly excluded from being published in the Mexican Linkage Gazette.

Conclusions

Mexican Patent Linkage System is limited to cases related to IMPI and COFEPRIS involving potential patent litigation between patent owners and applicants submitting new marketing authorizations. It was designed to avoid unnecessary litigation from these private parties, thus Its current design does not allow the direct participation of the patent owners or applicants of new marketing authorizations.

Patent owners may participate indirectly through ensuring its most relevant patents are listed in the Mexican Linkage Gazette. On the other hand, applicants of new marketing authorizations may submit additional information to argue its product does not infringe the patents listed in the Mexican Linkage Gazette.

Given the limited participation from the parties in the current Patent Linkage System so far, patent owners have resorted to filing patent infringement procedures to prohibit the production and commercialization of the infringing products while applicants of new marketing authorizations have resorted to nullity actions over patents. Both procedures are handled by the IMPI and its ruling may be appealed before the Federal Court of Administrative Justice, which, in turn, may be appealed before the Collegiate Courts.

Overall, in our opinion, the Mexican Linkage System remains imperfect as it could benefit from increasing the transparency of the procedure to both parties, patent owners and applicants of new marketing authorizations.

Source: www.gob.mx/impi

EPO and Mexico Launch Reinforced Partnership

By José Santacroce. Partner and Head of Patent Department.

Agreement between Mexico and EPO

Memorandum of Understanding (MoU) – Reinforced Partnership

The EPO has signed a Memorandum of Understanding (MoU) on Reinforced Partnership with the Mexican Institute of Industrial Property (IMPI), further strengthening the longstanding co-operation between Europe and Mexico in the area of patents. The MoU was signed on 4 November 2019 in Mexico City by EPO President António Campinos and IMPI Director General Juan Lozano.

“Mexico is a very important partner for us, and our offices have already worked together to support innovation for 25 years” said EPO President Campinos. “Through our joint projects on the Cooperative Patent Classification, the EPO’s online patent search tool EPOQUE Net, comprehensive data exchange and judicial training we have brought our patenting procedures and work more closely in line. We are now entering a new phase in our co-operation, extending it to more strategic areas, with a view to making our patent systems as efficient, user-friendly and relevant as possible for innovators in both regions.”

The IMPI Director General Juan Lozano underlined the importance of the strategic alliance with the EPO to enhance the use of Mexican resources dedicated to the examination of national patents, as well as to accelerate applications previously examined by EPO, issuing “more patents, faster, as well as reducing the backlog”.

Memorandum aims

He said that the MoU will promote the exchange of information and good practices, and the Institute will be able to benefit from training, certification, tools and technical support provided by the EPO in a framework of collaboration.

Through the Reinforced Partnership, the EPO and IMPI will join forces to develop a number of activities aimed at increasing efficiency, timeliness and quality of the patent grant process with a view to promoting investment and technology transfer between Europe and Mexico. The EPO will support IMPI in strengthening search and examination in fast-growing and emerging technology fields such as the Internet of Things (IoT) and Industry 4.0. At the same time, IMPI will make effective use of EPO work products, tools and standards to ensure a high quality, timely and efficient examination of both national first and second filings.

According to figures from the World Bank and the European Commission, Mexico is the 11th largest economy in the world (EUR 2.2 trillion) with a strong focus on manufacturing and a population of almost 130 million. The country has strong macroeconomic institutions, and is open to trade and private investment. The EU is Mexico’s second-biggest export market after the United States.

Source: www.epo.org

Amendments to the Mexican Industrial Property Law

by Jose Santacroce

On March 13, 2018, the Mexican government and the Mexican Patent and Trademark Office (IMPI) made amendments to the Mexican Industrial Property Law.  These changes affect specifically the publication of utility model and industrial design applications, the definition of independent creation and significative degree concepts, the extension term of industrial designs and the shortened time period for third party pre-issuance patent submissions.

These amendments will go into effect beginning April 13, 2018 and a detailed description is below.

Publishing of Utility Model and Industrial Design applications

Under the current law only patent applications are published in the Official Gazette. Once formal requirements are duly fulfilled (Articles 30 BIS and 37 BIS) Utility model applications and design applications will also be published in the Official Gazette as soon as possible.  Granted utility models, industrial designs and patents will continue to be published as before.

Definition of Independent creation and significative degree concepts

Article 31 of the current Law defines as registrable designs that are new and susceptible to industrial applicability. On the hand, the same article defines as new the designs that are created independently the known designs or combinations of known features of designs, and which differ significantly therefrom. The amendment introduced a new Article 32 BIS defining independent creation and significative degree.

Independent creation is considered when no other identical industrial design has been made public before the filing date of the design application, or before the recognized priority date.

Significative degree is defined as the general impression produced by the industrial design to a person skilled in the art and that differs from the general impression produced by another industrial design, which has been made public before the filing date of the design application, or before the recognized priority date.

Restriction of Industrial design scope of protection

Article 33 was amended to specify that the drawings must be sufficiently clear for the comprehension of the design and its publication. The second section of this article was amended to require the identity of the product for which the design will be used, and deleting the previous requirement for the genre of the product. Considering the scope of the protection is defined both by the description and the drawings this amendment would appear to be aimed to restrict the scope of protection.

Extension of Term of Industrial Designs

The protection term for an industrial design (Article 36) is established for 5 years. It is renewable every 5 years up to 25 years, calculated from the filing date.

Both industrial design registrations and the renewal thereof will be published in the Gazette.

Renewal of Industrial Designs

According to Article 36 BIS, the industrial design renewal shall be requested by the owner within 6 months prior to the expiration of its term. However, the Mexican Institute will accept those requests filed within the grace period (6 months) contemplated by Article 80, section II of this Law.

Period Shortening of Third party pre-issuance patent submissions

The term for the third party pre-issuance patent submissions has been reduced from 6 to 2 months, in accordance to Article 52 BIS.

Official files open for to public after publication of the application

Once the corresponding application is published in the Official Gazette, the official files for pending utility model, industrial design and patent applications will be open for public inspection. Under the current law the files were considered confidential until the resulting patent was published in the Official Gazette (Article 186).

Transitional provisions

Industrial design registrations granted before the effective date of the amendment will maintain the original term of 15 years and will be subject to the payment of annuities (paid every 5 years), however, the same may be renewed by two five-year successive periods up to a total term of 25 years from the filing date. The first renewal must be requested within 6 months prior to the expiration of the original 15 year term.

Applicants may opt to prosecute pending design applications under the provisions of the amended Law. To this effect, applicant must file a request with the Mexican Institute within 30 working days from the effective date of the amendment (deadline: May 25, 2018).

Source:https://www.gob.mx/impi

Patent Prosecution Highway Programs in Mexico

By Moeller IP Advisors

A recent report by the WIPO placed Mexico among the first 15 countries for the number of patents granted per year.

According to the last data available, in 2016, the Mexican Intellectual Property Office (IMPI) received 17413 applications and granted 8652 patents.

The average pendency time for a first office action is only 3 months, while a final decision is provided, on average, in 36 months.

The pendency time depends on the quality of the application which should be complete, clear and concise; and on the complexity of the claim, which may require longer evaluations.

In order to further increase the speed of the process, the IMPI has signed several Patent Prosecution Highway programs with foreign patent offices. Notably, since 2011, PPH has been signed with the USA, Japan, Spain, Korea, Singapore, China, Canada, Portugal, the European Patent Office, Austria and with the other members of the Pacific Alliance – Colombia, Chile and Peru.

Through a PPH, when an applicant receives a final ruling from a first patent office saying that at least one claim is allowed, the applicant may request a fast-track examination of the corresponding claims to the second patent office.

This can eliminate any unnecessary overlapping, avoiding that the same claim is analyzed twice.

So far the most successful PPH seems to be the one signed with the US – as the pilot program which started in 2011 has been renewed in 2013. In 2016, 20% of applications before the IMPI were filed from non-residents, of which 36% were US applicants. The PPH signed with the EPO, the Japanese Patent Office and the Canadian Patent Office also proved to be particularly popular.

In order to benefit from a PPH, the applicant should make sure that the claims requested in the application, substantially correspond to the claims that had been granted by the office of first filing, that is, they are of the same or similar scope as the claims indicated as patentable/allowable in the office of first filing. It is not possible to benefit from the PPH if the second office has already started the substantial examination of the claim. The applicant should also provide a copy of all the official actions relevant to the patentability issued by the office of first filing.

Finally, the applicant should submit a claims correspondence table, which indicates how the claims in the second application sufficiently correspond to the claims determined to be patentable by the office of first filing. Design applications and utility models are excluded from the PPH.

PPH proved to be particularly useful for industries which are highly innovative and for which it is critical to obtain patent coverage in a short time frame, like mechatronics, biotech and pharmaceuticals.

Some matters, however, may not be deemed as worthy of protection by both offices. For instance, while the US Patent Office would grant patents to treatments, surgical or diagnostic methods, IMPI would not, as, under Mexican Industrial Property Law, those are not considered as inventions.