Mexico Faces Renewed Pressure to Implement the 1991 Act of the UPOV Convention

In 1997, as a result of the commitments arising from the North American Free Trade Agreement (NAFTA), and after the publication of the Federal Law on Vegetal Varieties drafted in accordance with NAFTA, Mexico officially adopted the International Union for the Protection of New Varieties of Plants (UPOV) Act of 1978.

As with all UPOV member states, the criteria for the protection of plant varieties in Mexico is that the plant variety be: (1) new, (2) distinctive, and (3) uniform and stable. However, the enforcement of plant breeder rights in Mexico substantially differs from other jurisdictions. As a signatory of the UPOV Act of 1978, instead of the updated 1991 Act, the term of protection for plant varieties is shorter than in most countries, namely, 18 years for perennial species (forest and fruit trees, vines and ornamentals) and their rootstocks) and 15 years for all other varieties.

In 2012, there was an attempt to approve a new Federal Law on Vegetal Varieties to bring Mexico in line with the UPOV Act of 1991 (1991 UPOV Act).  Unfortunately, due to the fragile state of the Mexican agricultural system along with several other issues, approval of the 1991 UPOV Act did not occur.  In 2012, the fragile state of Mexico’s agricultural system was due to the lack of regulations to properly address the social and economic complexities associated with the system as well as the challenges associated with obtaining access to financial resources to further develop the system within the country.

However, the recent negotiations of the Trans-Pacific Partnership (TPP) as well as the current renegotiation of the NAFTA Agreement have resulted in new initiatives from the agroindustry in Mexico to modify the law and implement the 1991 UPOV Act.  Implementation of the 1991 UPOV Act would provide additional rights for plant breeders and improve the economic development of the agricultural industry.

Regarding the new initiatives, three particular areas are specifically being highlighted

a) Extension of the term of protection from 15 to 18 years to 20 to 25 years (depending on the species), in order to provide an equitable remuneration for the breeder and also to distribute the cost of the investment

b) Extension of the scope of protection to cover not only propagating material but also the product resulting from the harvest; an

c) Incorporation of the concept of “essentially derived variety” for the purpose of encouraging

The main objective of these proposed initiatives is to increase the competitiveness of Mexican developed varieties by improving the research programs available for Mexican native species, strengthening the enforceability measures available for protected varieties in order to promote an environment of innovation and investment as well as facilitate access and the transfer of technologies.

The most recent initiative is currently under internal review by the Ministry of Agriculture, Livestock, Rural Development, Fisheries and Food (SAGARPA), however, there is a chance these may addressed sooner by the Mexican Congress.  However, the pace of the renegotiation of NAFTA will likely set the timetable for any movement on these initiatives.

This post was written by Lisa Mueller and Abraham Díaz and Erwin Cruz of Olivares.

Divisional Applications and the Patent Prosecution Highway Program between U.S. and Mexico

The Patent Prosecution Highway (PPH) Program between the Mexican Institute of Industrial Property (IMPI) and the United States Patent and Trademark Office (USPTO) was established as a permanent program on September 1, 2012. The object of this program is to accelerate the granting of Mexican applications that have a granted U.S. counterpart, having a common claim of priority, when both the Mexican and U.S. national phase applications derive from the same PCT application.

It is important to note that in order to request PPH examination in Mexico, the following issues should be considered:

  • The Mexican application must be published in IMPI’s gazette.
  • The request for PPH examination must be filed before the start of substantive examination.
  • At least one of the claims granted in the U.S. counterpart must be included in the Mexican application.
  • The PPH request must include a comparative table between the claims granted in the U.S. application and the claims pending in the Mexican application.

There is a practice in the Mexican Patent Office in which it is possible to request PPH examination for a parent application and, at the same time, request PPH examination for one or more divisional applications. In order for this to happen, the USPTO must have identified patentable matter in the claims of both the parent and the divisional application. In other words, in a single day, an applicant may file a PPH request for the parent case, a Mexican divisional(s) application(s) and a PPH request for the divisional(s) application(s). The reason this is possible is because divisional applications are not published in IMPI’s gazette until granted.

It is important to note that the above information is not contained in the guidelines for requesting participation in the PPH program at IMPI. This information has been generated according to Olivares’ experience in filing requests for PPH examination between USPTO and IMPI.

Requests for PPH examination are an attractive option for U.S. applicants because it is possible to obtain a Notice of Allowance for a corresponding Mexican application approximately 2 to 3 months after the PPH request is filed.

This post was written by Lisa Mueller, Mauricio Samano and Jose Luis Salgado of Olivares.

Can the Minimum Period of 5 years Established by NAFTA for Regulatory Data Exclusivity be Extended in Mexico for Biological Medical Products?

In Mexico, there is no specific body of legislation governing data protection exclusivity (DPE), also known as regulatory exclusivity, for chemical drugs, biological medical products and new indications. The authority responsible for enforcing the regulatory framework for drugs, biological medical products and medical devices, is the Federal Commission for Protection against Sanitary Risks (COFEPRIS), which is part of the Ministry of Health.

In 2012, in an attempt to provide guidance on DPE, COFEPRIS issued internal guidelines that provided a 5 year-term of data protection for new chemical entities only. The guidelines did not address DPE for biological medical products and new indications. Moreover, the reliability and legal value of these guidelines remains uncertain. However, up to now, these internal guidelines have not been challenged or contested by any generic companies.

Based on the interpretation of international treaties (namely, NAFTA and TRIPS), along with the Mexican legislation specifically related to approval of new molecules, innovator companies have successfully obtained regulatory data exclusivity of 5 years through litigation for new chemical entities, formulations and new indications.

Regarding the length of DPE protection, NAFTA states that it should be for at least 5 years. However, for biological medical products, some countries such as United States, Canada, the European Union, among others, grant a greater length of protection of regulatory exclusivity. 

Article 222 bis of the Mexican General Health Law defines a “biologic product” as any substance that has been manufactured by molecular biotechnology; has therapeutic, preventive or rehabilitative effects; is provided in a dosage form; and is identified as such by its pharmacological activity and physical, chemical and biological properties.

At the end of 2012, Janssen Cilag (Janssen) requested DPE for a biological medical product. Based on an interpretation of International Treaties, International Comparative Law and Mexican regulations for biological medical product approval, protection beyond the minimum period of 5 years established by NAFTA was requested. This request was ignored by COFEPRIS, which was understood as a tacit negative response. As a result of this reaction, at the beginning of 2013, the tacit negative response was challenged before the Federal Court for Tax and Administrative Affairs (FCTA). On November 2014, the FCTA confirmed the denial to grant the protection holding that the minimum period of 5 years established by NAFTA had already expired. The FCTA also concluded that foreign legislation was neither applicable nor mandatory and that the plaintiff failed to prove that considerable efforts were involved in the generation of data and information to prove the safety and efficacy of the biological medical product.

As a result of an appeal, in June 2015, a Federal Circuit Court issued a decision ordering the lower FCTA court to issue a new, accurate decision on the merits, providing certain guidelines as to how to decide the time of protection for clinical data of a biological medical product. In a complying decision issued in July 2015, the FCTA concluded that Janssen had demonstrated that the generation of data and information aimed to prove the safety and efficacy for the biological medical product involved considerable efforts. The FCTA also concluded that COFEPRIS did not accurately analyze the case. As a result, at that point of time, FCTA was unable to assess the applicable provisions in NAFTA, which established a possibility of granting a longer period of protection than the minimum period of 5 years. For this reason, FCTA held that it could not act as an administrative authority. Therefore, it ordered COFEPRIS to issue an accurate decision determining whether to expressly recognize a longer period of protection than the minimum of 5 years established by NAFTA. The FCTA’s decision is awaiting further action by COFEPRIS.

This case is very important because for the first time ever the Mexican courts are contemplating the possibility of having the minimum period of 5 years established by NAFTA as a minimum period of protection and not the only established period of protection for clinical data.

This post was written by Lisa Mueller, Mauricio Sámano and Ingrid Ortiz of Olivares.

Divisional Practice in the BRICs and Other Countries – Part 9 of a 9-Part Series: A Comprehensive Summary

This is Part 9 of a nine-part series examining divisional practice in the BRIC as well as several non-BRIC countries. To view Part 1 (Divisional Practice in Mexico), click here. To view Part 2 (Divisional Practice in Brazil), click here. To view Part 3 (Divisional Practice in the United States), click here. To view Part 4 (Divisional Practice in India), click here. To view Part 5 (Divisional Practice in Russia), click here. To view Part 6 (Divisional Practice in China), click here. To view Part 7 (Divisional Practice in Canada), click here. To view Part 8 (Divisional Practice in Europe), click here.

In this last post in the series, we at the BRIC Wall are pleased to provide a table summarizing the key aspects of divisional practice in the eight countries surveyed. We hope our readers have found this series to be education and informative.

Divisional Summary Table:  FINALDIVISONALTABLE 2

 

Divisional Practice in the BRICs and other Countries – Part 1 of a 9-Part Series

This is Part 1 of a nine-part series examining divisional practice in the BRIC as well as several non-BRIC countries.  Specifically, we will examine divisional practice in Brazil, Canada, China, Europe, India, Mexico, Russia, and the United States (in no particular order).  The last post in this series will summarize the similarities and differences in divisional practice in each of these countries in chart form.  We look forward to receiving your comments on these postings.

Divisional Practice in Mexico

Time Periods for Filing Divisional Applications
A divisional application can be filed in Mexico at one or both of the below time periods:

1.  When responding to an Office Action raising a lack of unity rejection; and/or

2.  Any time prior to the grant of a Mexican patent application (such a divisional application is referred to as a “voluntary” divisional application).

Divisional Applications filed in Response to a Lack of Unity Rejection
The Industrial Property Law (“Law”) provides that if an application fails to comply with the unity of invention requirement, an Applicant must be notified of such in an Office Action.  In addition, the Applicant is allowed to divide the application into one or more divisional applications depending on the number of inventions identified by the Mexican Institute of Industrial Property (“IMPI”).  An Applicant must file one or more divisional applications when responding to an Office Action containing a lack of unity rejection.

However, a question arises as to when such divisional applications must actually be filed.  For example, assume that an Applicant receives an Office Action containing a lack of unity rejection.  Specifically, in the Office Action, the Examiner argues that the claims are directed to 5 different inventions and requires the Applicant to elect a single invention for prosecution (or present arguments as to why the claims relate to a single inventive concept (If such arguments are not sufficient to convince the Examiner to remove the lack of unity rejection, then a further Office Action will be issued requiring the Applicant to elect a single invention and file one or more divisional applications)).   If the Applicant elects to pursue claims to the first invention in the originally filed (parent) application, is the Applicant required to file 1, 2, 3 or 4 divisional applications for any non-elected inventions when responding to the Office Action containing the lack of unity rejection (depending on whether the Applicant wanted to pursue some or all of the non-elected inventions)?

Strictly speaking, under the Law, an Applicant is required to file one or more divisional applications for all non-elected inventions when responding to an Office Action containing a lack of unity rejection.  Because no guidelines exist regarding such a scenario, IMPI allows Applicants to file a first (single) divisional application containing claims to all non-elected inventions when responding to an Office Action containing a lack of unity rejection.   What will ultimately occur, however, is that the Applicant will receive an Office Action in the first divisional application raising a lack of unity rejection.  At that time, the Applicant will be required to file a further (second) divisional at the time of responding to the Office Action for any non-elected inventions.

Claims of a Divisional Application and Double Patenting
A divisional application can be filed with one or more claims as originally filed.  However, if an Applicant files a divisional application containing one or more claims that are identical to claims that have previously undergone substantive examination by IMPI (such as in a previous parent or divisional application), then the Applicant should amend the claims in question so as not to be identical with any such previously examined claims.  The reason is IMPI will not conduct substantive examination twice for identically claimed subject matter in a pending divisional application when the same claimed subject matter has already been examined in a previous parent or divisional application.  However, an Applicant can pursue any claimed subject matter (including any claims that have been previously deleted in a parent or divisional application) in a divisional application that has not previously been substantively examined in another parent or divisional application by IMPI.  Therefore, when filing a divisional application in Mexico, Applicants should carefully consider the claims to be filed with the divisional application taking into account any claimed subject matter substantively examined by IMPI in a previous parent or divisional application.

Requirements for Filing a Divisional Application
When filing a divisional application, the following documents must be submitted:

1.  A copy of the description and drawings;

2.  A set of claims to be pursued; and

3.  If appropriate (namely, if the Applicant has assigned its rights in the parent application to a third party), an assignment and Power of Attorney.

Documentation relating to the priority claim and translation do not need to be submitted.

The current government fee for filing a divisional application is approximately $800.00 U.S. dollars.  An additional $110.00 U.S. dollars is required for each priority claim made. 

Examination and Publication of Divisional Applications
Like an original (parent) application, a divisional application is examined in chronological order.  However, this rule is not strictly applied in all substantive examination groups and in some groups, divisional applications are examined more quickly then non-divisional applications.

Additionally, divisional applications are not published until granted.  Therefore, it is not possible to know whether a divisional application corresponding to a parent application has been filed unless mention of the filing of a divisional application is made in the file wrapper of the parent application.

This post was written by Lisa Mueller and Pedro Herrera of Olivares.