In summary, Data Protection comprises a sui generis intellectual property right related to the clinical data of pharmaceutical or agrochemical products. Clinical data, the information used to demonstrate that a product is safe and effective to be administered, is guarded against unfair use or blocked for third parties who may depend on it during a regulatory approval process.
Data protection is considered by the Trade-Related Intellectual Property (TRIPS) Agreement, the document which sets the basic provisions governing intellectual property matters amongst members of the World Trade Organization, under a nondisclosure approach. Parties are required to avoid the disclosure of the data or protect it against an unfair commercial use (Article 39, paragraph 3, of the TRIPS Agreement).
Although the TRIPS Agreement establishes the basic provisions for data protection, multilateral treaties may require a higher level of protection. For Mexico, the North American Free Trade Agreement (NAFTA) further required it to protect the data by blocking third parties which may rely on it during the regulatory approval process.
During the period when NAFTA was in force, 1994 – 2020, Mexico did not explicitly establish a procedure in its national law for obtaining data protection. It is assumed that these rights were automatically conceded whenever an innovative marketing approval was approved. In addition, interested firms could also obtain these rights through judiciary or administrative proceedings. Upon a favorable decision from the Mexican judiciary or Administrative Court, the Mexican Regulatory Authority was forced to acknowledge this protection and block potential third parties marketing approvals.
In 2018 The Mexican Regulatory Authority replied to a public inquiry on the data protection given from 2013 until 2018. The response shows that data protection was linked either to marketing approvals or new indications.
Now, the NAFTA has been updated to the United States Mexico Canada (USMCA) Agreement and though some elements have been kept from the NAFTA, it establishes new rules for data protection; for example, data protection for agrochemical products is now granted for 10 years. Interested firms must consider these amendments when seeking to obtain data protection in Mexico.
According to the USMCA final provisions, Mexico may take up to five years to implement the obligations in regard to data protection; however, this does not seem to be a hindrance for interested firms as the agreements are currently in force.
Data protection remains a supplementary mechanism through which innovative firms may obtain the exclusivity of their products. There is previous data of its acknowledgment in the country, and, although it may take some time to incorporate it into the national law, interested firms could benefit without waiting for the amendments.Read More
Prosecuting a patent may take several years in many emerging markets but among the measures to tackle this problem, many jurisdictions have provided supplementary periods of protection for certain delays occurring during prosecution.
Mexico has entered some International Treaties containing provisions related to patent term extensions particularly in the first and second versions of its Free Trade Agreements with Canada and the US (NAFTA/USMCA) but it has been only recently that such remedy was obtained through successful strategic litigation in the local courts.
In this live and free event, we (lawyers and patent experts from Moeller IP) are going to cover this topic including the judicial case decided in October 2020 by the Supreme Court extending the term of a patent claiming a pharmaceutical product, which had been prosecuted for over 5 years.
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If you have any question contact us at firstname.lastname@example.orgRead More
An authorized third party by the Mexican Secretariat of Health comprises a natural or legal person authorized to issue opinions on the fulfillment of requirements established by applicable law, carry out equivalence studies or perform specific tests according to the official Mexican standards.
Authorized third parties are classified according to the activities they perform:
These perform clinical or analytical equivalence tests for pharmaceuticals or biocompatibility tests for biologics.
These perform analysis of common use products or different health supplies. The laboratories are approved to perform tests in accordance with the official Mexican standards.
They issue favorable or unfavorable opinions over the adherence of applicable law for healthcare establishments, marketing authorization applications for pharmaceuticals, medical devices, agrochemicals, or advertising activities for several products.
Although the above classification comprises a summary of the activities these authorized third parties may perform, these can be highly specific; for example, a testing laboratory for performing the official Mexican standard No. NOM-092-SSA1-1994, related to the plate count method of aerobic bacteria.
Once an applicant has a favorable opinion from one of these authorized third parties the Mexican Secretariat of Health is required by law to issue the corresponding permit or authorization or license in a short time.
The objective of these authorized third parties is to ease the administrative burden for the Mexican Secretariat of Health and expedite healthcare-related procedures which may otherwise take a long time.
A list of these authorized third parties is publicly available and updated continuously.
During the fourth quarter of last year, the Mexican Supreme Court of Justice (SCJN), the highest court of the Mexican judiciary, decided on extending Mexican patent No. 238942 because of the administrative delays incurred during its prosecution.
Extension of patent: A patent may be extended to compensate for the delays
In summary, the plaintiff requested the extension of patent No. 238942 at the Mexican Institute of Industrial Property (IMPI) based on article 1709 of the North American Free Trade Agreement (NAFTA) which establishes that a patent may be extended to compensate for the delays caused during its approval process. Accordingly, it took the IMPI around 6 and a half years to grant the corresponding patent, from January 12, 2000, to July 26, 2006.
IMPI denied the request arguing that, according to article 23 of the Mexican Industrial Property Law (IPL), the applicable law at the moment of the granting, term of protection of a patent cannot extend beyond 20 years, starting from the filing date of the patent application. Furthermore, that the application of article 1709 of NAFTA was discretionary; thus, no damage was caused.
The term of protection may never be less than 17 years starting from the date of the grant.
The plaintiff appealed IMPI’s decision through the Mexican judiciary eventually reaching the SCJN. Herein, the SCJN decided that IMPI and previous courts of the Mexican judiciary performed a wrongful interpretation of the applicable law which affected the rights of the plaintiff. Further, the SCJN interpreted that the term of protection may never be less than 17 years starting from the date of the grant.
The recent decision will have important repercussions on the extension of Mexican patents; specifically, those granted before NAFTA was updated to the Agreement between the United States of America, the United Mexican States, and Canada (USMCA).
New Regulation in Mexico related with cannabis
On January 12, 2021, a new regulation for the production, investigation, and use of medicinal cannabis was published in Mexico.
The document forms part of the judicial decision by Mexico’s Supreme Court of Justice on case No. 57/2019, and it comprises an effort towards improving the regulation of cannabis in Mexico.
What aspects does the new regulation for activities and products comprising cannabis?
The document is enforceable on the Mexican territory and aims to regulate the unprocessed material, active pharmaceutical ingredients, derivates, and medicaments comprising cannabis involved during manufacturing and investigational processes. Also, it sets forth obligations for the importation, importation, and exportation of these products and quality control labs and medical establishments involved in providing cannabis medicines.
What aspects does the new regulation for activities and products comprising cannabis?
The enforcing responsibility is divided into several entities from the Agriculture, Health and the Economic sectors, depending on the task:
National Service of Agrifood Health, Safety, and Quality (SENASICA): for regulating and certifying, and reducing risks associated with the unprocessed materials.
National Seed Inspection and Certification Service (SNICS): for regulating the production and commercialization of cannabis seeds.
Federal Commission for the Protection against Sanitary Risks (COFEPRIS): for regulating investigational and manufacturing activities, and medicines comprising cannabis.
Tax Administrative Service (SAT) and Secretary of Economy (SE): for verifying importation and exportation activities.
Although the regulation seems restricted to certain products and specific activities, it comprises an attempt on providing legal certainty to products and activities previously considered illicit.
Source: Reglamento de la Ley General de Salud en Materia de Control Sanitario para la Producción, Investigación y Uso Medicinal de la Cannabis y sus Derivados Farmacológicos, published on January 12, 2021, retrieved from https://www.dof.gob.mx/nota_detalle.php?codigo=5609709&fecha=12/01/2021
The recent agreement between the United States of America, the United Mexican States, and Canada (USMCA) was published on the Mexican Official Gazette on June 29, 2020, replacing the previous North American Free Trade Agreement (NAFTA). In Mexico, the entry of this treaty is expected to bring several changes to the intellectual property framework. For example, copyrights, industrial property, plant varieties, imports, and exports, among others.
On the industrial property, a recent proposal of amendment to the Mexican Industrial Property Law has been passed to lower chambers of the Mexican Congress. This proposal of amendment comprises several changes for which we highlight the following:
Empowering the Mexican Institute of Industrial Property (IMPI). IMPI is empowered to condemn and quantify the amount of the respective compensation resulting from the damages to the rights affected owners.
Improving on the electronic means of communication. Expanding on the electronic presentation and processing of applications, including the use of electronic mail, as well as the advanced electronic signature or any other means that allows the identification of individuals.
Modifying the Bolar clause. The proposal dismisses the period of three or eight years in which a third party makes the necessary preparations to obtain the marketing approval of a drug related to a patent that is about to expire.
Extending the protection for the utility models. The modification grants further protection time for utility models, from ten to fifteen years.
Providing further rules for the substantive examination of patents. IMPI will not be required to evaluate the fulfillment of any other patentability requirement when the impediment is seen on a lack of clarity, subject matter which may not be considered an invention, subject of a patent, or absence of an industrial application.
Patent term extension because of administrative delays. The interested party may request a complementary certificate to adjust the term of the patent whenever the IMPI incurs in a delay of more than five years, between the filing date of the application in Mexico and the granting of the patent.
The exclusion for the reduction of rights during a pending procedure. The waiver, rectification or limitation of rights will be discarded when there is pending resolution for a procedure regarding the validity of the patent.
The possibility that a trademark may cover several classes. A single trademark application may be claimed in different classes. Additionally, a trademark may be rejected when it does not meet its distinctive purpose.
Additional mechanisms for the protection of IP holders. New provisional measures related to the suspension of the free movement of goods destined for import, export or transit, and the suspension, blocking, removal of content, or cessation of acts that constitute a violation of the Law through any virtual, digital, or electronic means.
Special subjects such as the Mexican Linkage System may be changed once the proposal of the amendment is published. In summary, modifications are expected to allow further participation from the patent holder while maintaining the same responsibilities for the authorities in charge of the system.
Although some modifications may be controversial, it is clear that these aim to further improve the position of IP holders as well as increasing IMPI’s responsibilities.
LXIV Legislature. Parliamentary gazette of the senate. Retrieved from: https://www.senado.gob.mx/64/gaceta_del_senado/documento/109519
Office of the United States Representative. Agreement between the United States of America, the United Mexican States, and Canada 12/13/19 Text. Retrieved from: https://ustr.gov/trade-agreements/free-trade-agreements/united-states-mexico-canada-agreement/agreement-betweenRead More
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
- 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.
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.
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/impiRead More
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”.
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.orgRead More
Through the Madrid Protocol any national from a signatory country can file a trademark application through the World IP Office designating one or various other signatory countries, obtaining the registration of their mark in several countries with just one application. This saves time and money for the applicant.
In Latin America, Brazil, Colombia, Cuba and Mexico are signatories of the Madrid Protocol. Brazil will start implementing the Protocol in October 2019, and it will be possible to designate this country through WIPO.
However, this poses some risks. Most times, the application is filed designating several countries without the recommended prior registrability and availability search reports, increasing the risks of provisional refusals from the national trademark offices.
When an applicant designates a country, a formal study of the mark is conducted, and sent to each of the national trademark offices designated, who also study the application. The national examination studies the intrinsic registrability of a mark, as well as the prior marks, in search for any absolute or relative grounds for rejection.
In case any are found, a provisional refusal is issued and served to the applicant through WIPO, and given a term to reply to it, including whichever argumentation, agreements and limitations the applicant may deem sufficient to overcome the objection.
Recent amendement to WIPO
Unfortunately, due to a recent amendment to WIPO regulations, any limitation or clarification to the applications must be made through WIPO, and not directly before the national Offices. As a result, the reply to the objection would require a higher expense, both in time and money.
In light of an amendment to the Mexican Trademarks Law, which came into effect last August 2018, coexistence agreements are now binding for the Examiners, as long as the trademarks are not identical. If the owners of the marks consider that there is no risk of confusion in case of coexistence, the IP Office is compelled to admit said coexistence.
Registering Trademarks through the Madrid Protocol
Despite the fact that registering trademarks through the Madrid Protocol is indeed a simpler procedure, the implications and possible consequences of this must be taken in consideration, and the necessary preventive measures (availability searches, possible negative connotations of words or designs, negotiations, agreements, limitations in scopes of protection) should be undertaken.
Lastly, it must be mentioned that, despite the simpler application procedure, Madrid Protocol designations tend to be longer procedures, as there is an international and a national stage, whereas national applications just have the latter.
All in all, designations of international registrations through Madrid Protocol are really useful, and they do simplify the registration procedure for applicants that want to protect their brands worldwide, but the national consequences must be taken in consideration. The professional advice of an IP expert in the region is always recommended in order to avoid conflict and dilations. Contact us to register a trademark without problems.
Source: www.inpi.gov.br/Read More
Protection of personal data is an issue that has gained relevance in the last year in all parts of the world. An example of this phenomenon is the implementation of the General Regulation of Personal Data (GDPR) in the European Union in 2018 or the new laws, modifications to the current ones or judicial decisions on the matter, that Latin American countries began to implement to be in accordance with the community regulations.
In this respect, in a recent judicial ruling, the Supreme Court of Justice of the Nation of Mexico (SCJN) analyzed the pertinent period to keep personal data within the Law for the Protection of Personal Data in Possession of Obligated Subjects of the State of Guerrero and determined the invalidity of a portion of the regulations since it established generic terms for the preservation of personal data.
In this sense, the Court understood that this generic term was in violation of the right to the protection of these data, since the treatment of them requires individualization in each specific case, so to decide what deadlines to apply should be attended to the applicable provisions in the matter in question.
As a result of the aforementioned resolution, the Supreme Court ordered the Institute of Transparency, Access to Information and Protection of Personal Data of the state of Guerrero to issue, within 90 days, the guidelines to which the general law of the corresponding subject refers. Finally, it is important to note that this decision was applied to other states such as Jalisco, Michoacán and Sinaloa, in which the Institute of Transparency, Public Information and Protection of Personal Data was notified to adapt its regulations to this criterion, since it was improperly extended the term to one year, in the local law.
Source: www.elpuntocritico.comRead More