Healthcare Reform in the Ukraine and Investment Opportunities for the Private Sector

Since the time of the Soviet Union (USSR) and pursuant to Ukraine’s Constitution, medical care in Ukrainian public hospitals (most hospitals are public hospitals) is supposed to be “free of charge” for all citizens.  However, unlike the USSR, Ukraine is simply unable to sufficiently finance the extremely high costs associated with providing such free healthcare as well as maintain the outdated infrastructure of a number of public healthcare facilities. As a result, many patients in the Ukraine must pay for their healthcare, although these payments are often made “unofficially” (e.g., directly to doctors). Given this tension, as well as other weaknesses of Ukrainian healthcare system, many have called for its reform.

In November 2017, the Ukrainian Parliament approved a new law implementing this much awaited and needed healthcare reform.  As a result of this new law, the market in Ukraine for new pharmaceuticals is expected to grow fairly significantly due to the diversified funding for various medical services and drugs as well as a new drug reimbursement program.  Additionally, the diversified funding for healthcare in Ukraine will create a number of investment opportunities for the private sector which are expected to help grow the Ukrainian economy.  Highlights of the new law, the potential investment opportunities for the private sector, the timeline for implementation and unanswered questions and potential challenges regarding this new law are discussed in more detail below:

Highlights of the new law:

  • Diversified funding. The concept of universal and theoretically free healthcare, as inherited by Ukraine from the USSR, will now be limited. Specifically, Ukraine will annually allocate at least 5% of its GDP to guarantee full tax-funded coverage for a limited list of medical services and drugs (“guaranteed package”). Any medical services or drugs falling outside of the guaranteed package may be financed through official payments from patients, private medical insurance or other channels.
  • Service-based payments. Ukraine will directly pay providers of the guaranteed package for their services. Such payments will be based on nationwide tariffs and will be administered through agreements between providers and the National Health Service of Ukraine (“NHSU”).
  • Provider competition. Public and private healthcare providers will be equally eligible for state funding of the guaranteed package.
  • Drug reimbursement. Currently in the Ukraine, with respect to drugs, the market operates as follows:
    • the government and public healthcare institutions purchase drugs via public procurements;
    • a certain percentage of drugs are covered by an existing pharmacy-based reimbursement program; and
    • all remaining drugs are paid for by patients who purchase the drugs through pharmacies.

The new law is expected to make the market more balanced and flexible. The limits of drug coverage by the Government will be more clearly defined. Additionally, although Ukraine has implemented a pilot pharmacy-based reimbursement program for a limited number of pharmaceuticals and disease areas (such as cardiovascular diseases, diabetes and asthma), in view of the new law, this program will be significantly expanded. Specifically, beginning in 2020, drug reimbursement will automatically become a part of the guaranteed package. Moreover, the scope of pharmaceuticals subject to reimbursement will be defined based on the National Essential Medicines List and approved annually by the state budget law together with other elements of guaranteed package. Patients receiving ambulatory medical care will receive pharmaceuticals covered by the scheme through retail pharmacies based on reimbursement agreements with the NHSU.

Investment opportunities for the private sector based on the future diversified funding of healthcare in Ukraine:

  • Payment for medical services by the government and third parties will make involvement of the private sector in healthcare commercially viable.
  • National tariffs for the guaranteed package should make the economics of healthcare sector more predictable and permit longer term financial planning for service providers and investors in Ukraine.
  • Performance-based Public Private Partnership (PPP) contracts (based on the combination of availability of service-based payments and direct user charges) may be available. These PPP contracts will provide flexibility for the public and private partners in the management, control and upgrade of healthcare facilities.
  • Market practices relating to the guaranteed package will become transparent and unified. Specifically, equal payment terms and a competitive environment are expected to improve the cost-efficiency and quality of healthcare services available in the country.
  • A new drug reimbursement scheme should make the state funding of the Ukrainian pharmaceutical market more flexible and predictable, thus raising its investment attractiveness.

Timeline for implementation of the new law:

The new law will be implemented in stages, beginning on January 1, 2018 and continuing through 2024.  The key stages of implementation are provided below in more detail.

  • 2018:
    • Primary medical care (e.g., first level general consultations, diagnostics and treatment of most common diseases and conditions, preventive measures, referral for specialist care, etc.)
    • Procedures, the guaranteed package and tariffs to be approved by the Government
    • Partial financing will be available through traditional budget subsidies
  • 2018-2019:
    • Transition period for other levels of medical care (e.g., emergency, specialized, highly specialized, palliative, pregnancy and childbirth medical care, medical rehabilitation)
    • Gradual implementation of reform through pilot projects for selected regions, helathcare facilities and various types of medical services
    • Procedures, the guaranteed package and tariffs to be approved by the Government
    • Partial financing will be available through traditional budget subsidies
  • 2020:
    • All levels and types of medical care will be covered by the reform
    • Drug reimbursement becomes part of the guaranteed package
    • Guaranteed package and tariffs to be approved by the state budget law
  • 2024:
    • From 2018 through 2024, there will be a 20% limit on the scope of medical services that can be charged by public healthcare providers directly to patients

Unanswered questions and potential challenges of the new law:

  • Implementation of a new regulatory framework. Implementation of healthcare reform will require additional legislative changes and by-laws, the timing of which is currently unknown. In parallel, amendments to the PPP regulatory framework (including those involving concessions) are in the process of being developed to allow for the efficient implementation of PPP projects.
  • Constitutional concerns. The Ukrainian Constitution guarantees free medical care which is to be provided by the public healthcare institutions. It is unclear whether the new law comports with the constitutional requirements. Confirmation by the Constitutional Court of Ukraine may be required to settle this question.
  • Paying for such an extensive guaranteed package. The general scope of the guaranteed package, as described in the law, is broad and includes all types of medical care. This creates a concern as to whether the Ukrainian budget will provide sufficient resources necessary to ensure adequate coverage under the new law. More clarity is expected once the proposals by the Government are released on the specific services and drugs (including their volumes) to be included in the guaranteed package.

Continue to watch the BRIC Wall Blog for further updates on healthcare reform in Ukraine.

This post was written by Lisa Mueller and Viktoriya Podvorchanska, Roman Stepanenko and Kateryna Oliynyk of EPAP Ukraine.

The Patent Prosecution Highway (PPH) Pilot Program and the Brazilian PTO – Recent Updates


The Brazilian Patent and Trademark Office (Brazilian PTO, also known as the Instituto Nacional da Propriedade Industrial (INPI)), has made two major announcements regarding the Patent Prosecution Highway (PPH) Pilot Program in Brazil since the beginning of November.

PPH Program with the European Patent Office

On November 7, 2017, the Brazilian PTO published Rule #202/2017 implementing the PPH Pilot Program (Program) with the European Patent Office (EPO).  The hope is that the implementation of the Program will result in faster examination of pending Brazilian patent applications having a counterpart allowed by the EPO.

Logistically, the Program will accept applications belonging to patent families whose earliest application has been filed in the Brazilian PTO or the EPO, or for PCT applications, where either the Brazilian PTO or EPO was used as the Receiving Office.  All applications are eligible with one notable exception.  Specifically, while applications in the field of chemistry or related technologies applied to medicine may be eligible for the Program, drug-related patent applications are specifically excluded.  More specifically, the application must be classified under the International Patent Codes (IPC) listed in the below table to be accepted.  However, applications classified under any of the group of A61K subclass, with the exception of group A61K8, are also excluded from the program.  Generally, IPC group A61K relates to preparations for medical, dental, or toilet purposes.  Group A61K8 relates to cosmetics or similar toilet preparations.

Basic Chemistry A01N, A01P, C05#, C06#, C09B, C09C, C09D, C09F, C09G, C09H, C09J, C09K, C10B, C10C, C10F, C10G, C10H, C10J, C10K, C10L, C10M, C10N, C11B, C11C, C11D, C99Z
Organic and fine chemistry C07B, C07C, C07D, C07F, C07H, C07J, C40B, A61K8¹, A61Q
Polymeric and macromolecular chemistry C08B, C08C, C08F, C08G, C08H, C08L
Medical technologies A61B, A61C, A61D, A61F, A61G, A61H, A61J, A61L, A61M, A61N, H05G

To be accepted in the Brazilian PPH program, an application must:

  1. Have a notification of filing or entry in the national phase in Brazil published by the Official Gazette of the Brazilian PTO;
  2. Already have been published (which can be effected by international publication (such as by a PCT application, if applicable);
  3. Have submitted a request for examination;
  4. Have all annuity fees duly paid;
  5. Have no pending Office Action awaiting response by the Applicant;
  6. Not have been accepted in any other fast-track examination program in Brazil;
  7. Not have been involved in a lawsuit in Brazil; and
  8. Not be a divisional application (except in the situation where the divisional application results from an original parent application due to a rejection due to a lack of unity of invention).

A request for participation in the Program must be made by all the Applicants in electronic form.  In addition to the other documents required by Rule #202/2017, an Applicant must submit, together with the request:

  1. Documents proving that the application meets the requirements of the Program;
  2. A table providing the correspondence between the claims in the Brazilian application and the allowed claims in the European application; and
  3. A copy of any non-patent prior art documents.

The Brazilian PTO will evaluate applications based on the date on which the request is filed.  Any applications that do not meet the requirements will receive an Office Action setting a sixty (60) day period to allow for any irregularities to be corrected or will be otherwise be denied participation in the Program.  Any application denied participation will be examined according to the normal procedures of the Brazilian PTO.  An applicant denied participation in the Program has an opportunity to appeal such a decision within 60 days of receipt of notification of denial.

The Brazilian-EPO PPH Pilot Program will begin on December 1, 2017 and will receive applications for a period of two (2) years.  A maximum of 300 applications will be accepted each year during the two (2) year period (for a total of 600 applications).

Brazil and the Chinese Patent Office 

On November 13, 2017, the Brazilian PTO and the Chinese Patent Office (SIPO, also known as the State Intellectual Property Office of the People’s Republic of China) signed a memorandum of understanding establishing a future PPH Pilot Program (Program) between the two offices.  Much like the Program described above in connection with the EPO, Applicants will be able to request faster examination for a Brazilian patent application whose Chinese counterpart has already been approved.

A rule setting for the requirements for eligibility for the Program is expected to be published in February.

Please continue to watch the BRIC Wall Blog for further updates on the PPH Pilot Program in Brazil.

This post was written by Lisa Mueller and Roberto Rodrigues Pinho (

Draft Intellectual Property Policy of the Republic of South Africa – Introduction and Goals

On August 25, 2017, the Draft Intellectual Property Policy (Draft IP Policy) of the Republic of South Africa was published for public comments by November 17, 2017.  This Draft IP Policy follows from the IP Consultative Framework that was approved by the South African cabinet on July 6, 2016.  In this multi-part series, we will address the need for the policy, the goals, strategies to meet the goals, and the phases of implementation.  In this first post, we will focus on an introduction and the goals of the Draft IP Policy.   

South Africa’s National Development Plan (NDP) calls for a greater emphasis on innovation, improved productivity, an intensive pursuit of a knowledge economy, and the better exploitation of comparative and competitive advantages.  Intellectual Property (IP) is an important policy instrument in promoting innovation, technology transfer, research and development (R&D), creative expression, consumer protection, industrial development, and more broadly, economic growth.   Knowledge, innovation and technology are increasingly becoming the drivers of progress, growth and wealth.  Thus, there is a need to for South Africa to transition towards a knowledge economy and IP will play an imperative role in this transition.  

There has been significant progress made in the development of IP within South Arica, which has in in part, ensured that it has a legislative framework that protects IP.  However, there is a need for a comprehensive IP  Policy  that  will  promote  a  holistic,  balanced,  and  coordinated  approach  to  IP  that is mindful of the many obligations mandated under the South African Constitution.  The policy will aim to promote and contribute to South Africa’s socioeconomic betterment by encouraging innovation, promoting local manufacture, preserving and leveraging the country’s resources and heritage, and empowering domestic industries and individuals who seek to take advantage of the IP system.  

One factor of particular importance, in which South Africa aims to address with the Draft IP Policy, is the intersection of IP and public health.  A key issue has been the role of IP in delivering public health, making it not only an IP issue, but also a human rights issue.  Specifically, a substantial issue with optimizing the role of IP in public health is that South Africa does not conduct substantive search and examination prior to the grant of patents.  The South African patent laws and implementing regulations are such that the Registrar of Patents, housed within the Companies and Intellectual Property Commission (CIPC), only conducts examination in relation to the formalities of the application.  South Africa employs a so called “depository system.”  Under the depository system, the subject of a patent application is only examined against the substantive criteria of novelty, inventive step, and industrial applicability if the patent is challenged in litigation.  This challenge could be in relation to infringement or revocation. 

The depository system for patents was instituted in South Africa due to resource constraints, whereby the cost of substantive examination is placed on parties that are directly interested in the patent.  The State is then able to direct scarce technical skills toward infrastructure and other key developmental areas.  However, there are substantial drawbacks for both producers and users of IP.  For producers of IP, the lack of examination may call into question the integrity of their patents, since the grant of a patent does not guarantee that the subject of the patent meets patentability criteria in the country, or that it does not contain subject matter excluded by law.  Another study conducted at a leading South African university, recently found that a significant number of patents granted in South Africa would not be granted under an examining system.  For users of IP, subject matter that should be in the public domain may be unfairly monopolized by exclusive rights.  An underlying policy rationale of patents is to serve as an incentive to stimulate innovation.  Granting an exclusive right, in the absence of genuine innovation, goes against the bargain that the patent holder is supposed to strike with society, namely, disclosure in return for monopoly protection.  This may result in a disadvantage to society and overall negative consequences for both access and innovation. 

The Draft IP policy cites a recent comparative study conducted by scholars from Columbia and Harvard Universities.  The study revealed that South Africa grants a far higher percentage of patents from all applications filed in the country than virtually any other comparable country.  On average, 93% of patents applied for in South Africa were granted, as compared to 61% in the United States of America, 53% in Mexico, 51% in the European Union (51%), and only 29% in Japan.  World Intellectual Property Organization (WIPO) statistics demonstrate that within comparable developing countries, the figures from India and Brazil show even lower rates of granting: in 2015, India granted 19% of all patent applications, while Brazil granted a14%. 

Beyond compliance with international obligations, South Africa aims to play its part in shaping the global order at various forums where IP is discussed such as in World Intellectual Property Organization WIPO, the World Trade Organization (WTO), the World Health Organization (WHO), the Group of Twenty (G20), political formations such as the Brazil, Russia, India, China and South Africa form (BRICS) and in African regional organizations.  This requires a coordinated South African approach to IP that is informed by South Africa’s development imperatives.  International cooperation must aim to make IP a tool to achieve sustainable development within the country. 

In general, the South African Constitution provides a balanced approach to property rights by affording protection against arbitrary deprivation of property, while also taking into account the public interest.  Public interest includes the nation’s commitment to bring about reforms that promote equitable access to services and products involving IP, such as public health.  The Draft IP policy will be an instrument of addressing the aforementioned issues.  

The goals of the Draft IP Policy are:

·        To consider the development dynamics of South Africa and improve how IP supports small institutions and vulnerable individuals in society, including in the domain of public health;

·        To nurture and promote a culture of innovation, by enabling creators and inventors to reach their full potential and contribute towards improving the competitiveness of South Africa’s industries;

·        To promote South African arts and culture; and

·        To solidify South Africa’s various international obligations, such as the Convention on  Biological Diversity (CBD) and the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization (Nagoya Protocol on ABS), in the service of South Africa’s genetic resources and traditional knowledge associated with genetic resources.

The Draft IP policy includes strategies for meeting the outlined aims and key reforms.  The implementation of the comprehensive IP Policy will be implemented in a phased approach with this document, in Phase 1, focusing on IP and public health, coordination in international forums, and the implementation of commitments undertaken in international agreements.  This will be followed by a second phase that will focus on several remaining core concerns around IP.

Please continue to watch the BRIC Wall Blog for the remainder of the series on the Draft Intellectual Property Policy of the Republic of South Africa. 

This post was written by Lisa Mueller and Kate Merath of Michael Best and David Cochrane of Spoor & Fisher

Understanding Brazil’s Service Guideline #37 for the Examination of Patent Applications Claiming Pharmaceutical Products and Processes

On September 25, 2017, the Director of the National Sanitary Surveillance Agency (ANVISA) issued internal guidelines (Orientação de Serviço #37/2017) regarding the procedures to be used by the agency when examining patent applications claiming pharmaceutical products and processes in light of public health (in accordance with Article 229-C of Patent Statute #9,279/96, Resolution RDC #168, of 2017, the Joint Ordinance ANVISA/INPI #001, of 2017, and Ordinance GM/MS #736, of 2014).  According to these guidelines, ANVISA will follow the following procedures when reviewing applications claiming pharmaceutical products and processes.

  1. Upon receipt of a patent application from the Brazilian Patent Office (Instituto National da Propriedade Industrial (INPI)), ANVISA will assess the subject matter of the application to verify compliance with the provisions of Article 229-C of IP Law #9,279/96. Article 229-C provides that pharmaceutical patent applications shall receive a prior approval by ANVISA (often referred to as “prior approval” or “prior consent”). Specifically, Article 229-C provides that: “The grant of patents for pharmaceutical products and processes shall depend upon the prior approval from the National Sanitary Vigilance Agency.” 
  1. Once it is determined that prior approval or prior consent by ANVISA is required, an application is assessed with respect to its (1) health risk; and (2) interest under the drug or pharmaceutical assistance policies within the Brazilian Unified Health System (SUS). 
  1. The health risk of the application is assessed by determining whether the pharmaceutical product or process claimed comprises or results in substances included in List E (which is a list of prohibited plants which may give rise to narcotic and/or psychotropic substances) or List F (a list of substances banned in Brazil) based on Ordinance SVS/MS #344, of 12 May 1998, which relates to plants and substances (including salts and isomers thereof) that are prohibited for use in the country. Applications which do not claim a pharmaceutical product or process that comprise or result in substances included in Lists E or F are not considered to present a health risk.  If the application is considered to present a health risk, ANVISA will deny prior consent or prior approval and return the application to INPI, which will dismiss the application. 
  1. After determination of the absence of health risk, the application is reviewed to determine whether or not the pharmaceutical product or process is of interest to the drug or pharmaceutical assistance policies under SUS. An application is determined to be of interest to the drug policy or pharmaceutical assistance policy under SUS when:
    • The subject matter is related to one of therapeutic applications defined by Ordinance MS/GM #736, of 2014 as listed in Annex I (provided below); or
    • It is related to a product incorporated into SUS (except for drugs that are part of the Basic Component of Pharmaceutical Assistance (CBAF), which is guided by the National List of Essential Medicines (RENAME) in force); or
    • It is related to a product of potential interest to the SUS according to Annex II (provided below).

If the application is of no interest to the healthcare policy, ANVISA will grant prior consent or prior approval and send the application back to INPI for further processing.  However, if an application is determined to be of interest to the drug or pharmaceutical policies under SUS, ANVISA will send the application back to INPI for further processing along with a report providing an analysis of the patentability requirements to be used by INPI during examination.

An important take away is that according to the service guidelines, ANVISA is able to provide an opinion addressing the patentability requirements of applications claiming pharmaceutical products or processes.  Regrettably, this is a continued attempt by ANVISA to try and  work around case law that has clearly established that the agency is not allowed to evaluate the patentability requirements of such applications under Article 229-C.

Annex I 

Viral Diseases (antiviral and antiretroviral diseases)

Neglected diseases:


Chagas Disease


Rocky Mountain spotted fever





Systemic mycoses


Neurodegenerative diseases




Rheumatoid arthritis

Transplant rejection

Mental diseases (antipsychotics/anticonvulsants)


Psychosis / Schizophrenia

Neoplasias / Cancer (Oncology products)

Products obtained by biological routes

Provided that the therapeutic application is included in ordinance GM/MS 736/14

Vaccines and sera

Vaccines of the National Immunization Program

BCG vaccine

Hepatitis B vaccine

Diphtheria, tetanus, pertussis, hepatitis B and Haemophilus Influenza B vaccine

Diphtheria, tetanus and pertussis vaccine

Polio vaccine (VIP / VOP)

Pneumococcal vaccine (Pneumo 10, PN 23)

Human rotavirus vaccine

Meningococcal C vaccine

Yellow Fever vaccine

Hepatitis A vaccine

Measles, mumps and rubella vaccine

Measles, mumps, rubella, and varicella vaccine

Diphtheria and tetanus vaccine

HPV vaccine

Influenza vaccine

Rabies vaccine

Vaccines for sexually transmitted diseases

Vaccines for neglected diseases

Vaccines for cancer


Plasma concentration of factor VIII

Von Willebrand factor

Prothrombin complex (partially activated or human)

Recombinant activated factor VII concentrate

Plasma and recombinant factor concentrate

Plasma concentration of factor IX

Factor XIII concentrate

Excluded:  Fibrinogen, Tranexamic Acid and Desmopressin Acetate

Annex II

            Roadmap to identify patent applications of potential interest for SUS

  1. The patent application, to be identified as of potential interest to SUS, in addition to complying with Article 6 herein, should also comply with at least one of the following criteria:
    • Be related to a product registered with a sanitary authority of any country or region;
    • Be related to a substance under an active phase II clinical trial or higher, in any country or region, for a therapeutic application of interest to SUS;
    • Be related to high-cost drug that is part of the Specialized Component of Pharmaceutical Assistance (CEAF);
    • Be related to the drug provided in Partnership for Productive Development (PDP) or equivalent;
    • Be related to a request for priority examination made by the Ministry to Health to the INPI;
    • Has been filed with INPI less than six years ago.
  2. The patent application included in item A above may be exempted from a patentability examination for the purposes of supportive data if the application satisfies any of the below:
    • The product has its incorporation into SUS denied by the National Commission for the Incorporation of Technologies (CONITEC); or
    • The product is excluded from SUS; or
    • The invention is unlikely to be incorporated into SUS after conducting a prospective analysis.

Please continue to watch the BRIC Wall Blog for further updates on ANVISA and prior approval or consent in Brazil.

This post was written by Lisa Mueller and Roberto Rodrigues of Licks Attorneys.


Good News in China – Faster Approval for Innovative New Drugs Is on the Way

For decades in China, patient access to overseas developed innovative drugs has been partially hampered by the requirement that data be supplied from clinical trials conducted in China (this after the innovator had already completed multiple phases of clinical trials in their country of origin).  Unfortunately, this requirement adds significantly to the time period for approval which can often take as long as eight years.  As a result, China’s Food and Drug Administration (CFDA) has a tremendous backlog of drug approval applications which, in June, stood at 6,000 (compared to a high of 22,000 in 2015).  As a result, between 2001 and 2016, regulators in developed markets approved 433 new drugs whereas China approved just over 100.   Taken together, all of this helps explain why a new drug often appears on the market in China anywhere from five to seven years later than in Europe or the U.S.

Earlier this month, the General Office of the Communist Party of China Central Committee and the General Office of the State Council issued a guideline that allows data from overseas clinical trials to be used directly in the innovative drug and medical device application process.  The guideline notes that companies looking to register innovative drugs or medical devices will need to provide clinical trial data related to any racial divergence relevant to the Chinese market.  Regardless, this change is significant and should considerably shorten the time period for approval of future drugs by several years.  However, one concern is that the guideline did not set a timetable for implementation.

The guideline also includes other measures to speed up approvals for clinically needed drugs and equipment, establish a compulsory licensing system and to make it easier for research institutions to conduct clinical trials.  Additionally, the Chinese government has said that it is also exploring a new system linking drug approvals to patent status (a patent linkage system). 

This announcement comes as China aims to boost its drug industry and shift from generic drugs towards more innovative medicines and medical equipment.  China has the second largest drug market next to the U.S.  The changes proposed by the guideline are intended to make China’s industry more competitive and help meet the clinical needs of its nearly 1.4 billion people, for whom high costs and access to health care are significant issues.

This post was written by Lisa Mueller.

Understanding Bolar and Bolar-Like Exceptions in the U.S. and Abroad – Part 3– Mexico

This is part 3 in our multiple part series examining Bolar and Bolar-like exemptions in U.S. as well as in a number of foreign jurisdictions.   Part 1, the Bolar Exemption in the U.S., can be found here.  In Part 2, the Bolar Exemption in Canada can be found here.


In Mexico, no medicinal product for human use can be placed on the market unless it has been approved by the Federal Commission for Protection against Sanitary Risks (COFEPRIS).  Like the U.S., Mexico has a linkage system.  However, in Mexico, not only do the linkage regulations prevent medicinal product approvals in violation of patent rights but the regulations also establish a Bolar-like exemption for generic and biologic follow-on products (biocomparables). Accordingly, under certain conditions, the Bolar-like exemption allows pilot production and tests to be performed.  However, as will discussed in more detail below, the recent importation of considerably large amounts of active pharmaceutical ingredients (APIs) covered by Mexican patents for the purpose of conducting clinical trials has tested not only the scope of the exemption but also COFEPRIS and the Mexican Patent Office (which is known as the Mexican Institute of Industrial Property (IMPI)).

Exclusivity rights and the Bolar exemption

The Mexican Health Law and its Regulations set forth an abridged procedure for generics, as well as a recently enacted hybrid-procedure for biologic follow-on products (biocomparables). The Regulations establish a Bolar-like exemption for these products.  In Mexico, applications for approval of a generic or biocomparable product can be submitted at a certain time point prior to expiration of any innovator patents covering the product.  Specifically, this time period is three years prior to expiration for generic products and eight years prior for biologic follow-on products.  Under certain conditions, the exemption allows pilot production and tests to be performed.

Nevertheless, in contrast to European Law, Mexican domestic law is silent about providing a research and development exemption (RDE) for patent infringement.  As will be discussed further below, although COFEPRIS considers formulation patents when deciding whether to grant an application for marketing authorization, it recently approved the importation of a large (4 kg) quantity of API by a non-authorized party.

Regulatory Data Exclusivity

Prior to 2008, Mexico’s domestic law was silent regarding Data Package Exclusivity (DPE) rights. However, in January 2008, the Mexican Health Regulations were amended with respect to generic medications.  Specifically, the amendments eliminated the requirement that a generic applicant prove the safety and efficacy of its products.  However, this provision was replaced with the requirement that a generic applicant prove the interchangeability of its products with those of the innovator in order for a marketing authorization (MA) to be granted.

Additionally in 2008, the Regulations were further amended to implement an abbreviated approval procedure for generic drugs based solely on bioequivalence and bioavailability studies.  However, these Regulations did not provide any provisions regarding non-reliance by a generic applicant on the MA holder’s data during the data exclusivity period as established in the international treaties such as NAFTA and TRIPS.

In Mexico, no specific legislation exists regarding regulatory exclusivity.  However, there are some provisions applicable to this issue in  the intellectual property (IP) law (IP Law), the Health Law Regulations, New Molecules Regulations and International Treaties enacted and/or ratified Mexico (e.g., such as NAFTA and TRIPS).  In fact, in 2012, COFEPRIS published an internal memorandum on its website providing guidelines on regulatory data exclusivity (RDE)  According to these guidelines (as well as a minimum term set by NAFTA), a MA holder has a five year exclusivity period during which its information cannot benefit or be used to support a third party application for registration of a generic drug.  It is important to note that the guidelines do not preclude generics from conducting their own clinical trials to obtain MA.

Although these guidelines show COFEPRIS’ willingness to protect RDE according to NAFTA and TRIPS, several concerns exist.  Some of these examples include: (i) the uncertainty regarding the legal status of an internal memorandum published on a website rather than in the Official Gazette; and (ii) the wording of the guidelines do not clearly address either RDE for biological products, registration of new formulations and indications, nor proceedings and measures to enforce and observe RDE.

Linkage System

The linkage system in Mexico is a system in place between COFEPRIS and IMPI.  The purpose of the linkage system is to prevent the granting of MAs to non-authorized third parties for products that would fall within the scope of the patents listed in the Linkage Gazette (Gazette).  The Gazette is a document published periodically (e.g., about every six months) by IMPI listing the patents covering medicinal products.

For many years, IMPI listed only patents covering small molecules.  However, in 2012, IMPI began listing patents covering pharmaceutical formulations.  The inclusion of formulation patents in the Gazette eliminated the need for patentees to spend time and money in legal challenges to include these patents in the Gazette while also expanding the application of the linkage system to more than just compound patents prevent.

Interestingly, the excitement of the inclusion of formulation patents in the Gazette was short lived because practically speaking, COFEPRIS only recognizes compound patents.  As a result, COFEPRIS has paid very little attention to formulation patents listed in the Gazette during the approval of follow-own products  Unfortunately, this has undermined the preventive aim of the system and as a result, presented issues for patentees monitoring their competitors for potential infringing activities and increased the number of linkage litigation cases.

The Importation of APIs

COFEPRIS is in charge of granting approval of imports of APIs, which is mandatory before Mexican Customs. However, neither the wording of the Bolar-like exemption nor the rules governing the importation of APIs clearly address the amount of API that can be imported by an applicant of a follow-ons product for the purposes of conducting the tests needed to obtain marketing approval.  IMPI nor COFEPRIS have published their opinion of whether the exemption allows for the importation of only small quantities of APIs for purposes of conducting the tests and trials necessary obtain a MA.  This has led to circumstances where unauthorized parties received approval from COFEPRIS to import large amounts (e.g., 4 kilograms) of patented APIs which were far beyond the small amounts necessary to conduct pilot production and testing.

In most instances, the approvals by COFEPRIS for importation of large amounts of patented APIs are for those APIs where the patents are close to expiry.  However, during the last four years, this trend has increased because parties manufacturing medicinal products in Mexico no longer have to have a facility physically located within Mexico.  The removal of this requirement has significantly changed the pharmaceutical business in Mexico.  Now, many small and medium foreign companies start their business in Mexico by:  (1) entering into partnerships with pharmaceutical companies already established in Mexico; and (2) introducing their products via brokers and distributors.

On July 1, 2013, COFEPRIS published amendments to their guidelines in the Official Gazette, regarding the importation of APIs.  Specifically, the amendments stated that with respect the importation of Tadalafil, Sildenafil, Raloxifeno and Clembuterol, applicants had to provide the details of the clients being supplied these APIs as well as justify the total amount of API being imported based on the number of clients.

Patent Enforcement

The IP Law entitles a patentee to prevent the importation and manufacture of patented subject matter by non-authorized parties.  Although the IP Law provides an experimental exemption, this exemption applies only to scientific research that has absolutely no commercial purposes whatsoever.  Therefore, the experimental exemption would not apply for a generic company seeking to apply for a MA.

The IP Law also provides for interim injunctions for alleged patent infringement.  Additionally, at the border, a database managed by Mexican Customs in coordination with IMPI has been created.  This database is populated with the registered trademarks of owners that are interested in the surveillance of their IP rights throughout the forty-nine customs checkpoints that are distributed in boundaries, seaports, bus and train stations and airports.

With respect to medicines, pharmaceutical substances, chemicals and APIs, the activities and efforts of the Customs Office are primarily focused and limited to detecting prohibited drugs and narcotics.  After detecting any such prohibited drugs and narcotics, the next step involves enforcing the IP protection with the borders for patents, particularly those that protection pharmaceutical products.  Since June 2012, Mexican Customs has collaborated to detect and seize APIs grounded in border measures granted by IMPI to IP right holders.

Current Situation

IMPI has applied the Bolar-like exception with some flaws in its interpretation and scope (Note:  In Mexico, patent enforcement occurs before IMPI at the first stage).  For example, IMPI adopted the criteria that if the importation of patented products was conducted by brokers or third parties different from the manufacturer of the drugs in Mexico, the Bolar-like exemption does not apply (as a defense) and thus, ther will be a finding of patent infringement.  In contrast, if the importation is conducted by the manufacturer, the Bolar-like exemption applies and there will be no finding of patent infringement.  In both situations, the amount of the imported product is disregarded by IMPI.  As a result, this gives more weight to the activity of the importer rather than the final destination of the imported product.  Currently, these cases are under debate at the Mexican Supreme Court (assuming that the Mexican Supreme Court affirms their discretion to review the case).

In conclusion, there have not been any changes in the regulations involving the Bolar-like exemption in Mexico.  The few cases in which the Bolar-like exemption has been litigated have some flaws in terms of the understanding of the facts and applicable procedural rules (for example, IMPI determined that the burden was on the plaintiff in a patent infringement action to prove that the amount of patented product exceeded amount needed to obtain regulatory approval.  Such a determination is clearly contrary to the procedural rule that the Bolar-like exception is a defense, and as such, must be proven by the defendant and not the plaintiff.  It will be interesting to see how the Mexican Supreme Court decides this issue.

Conclusions and Recommendations

There are several areas that can be improved in the Mexican legal framework to grant legal certainty to both innovators and applicants of follow-on products.  These include, for example:

  • That COFEPRIS use and observe the patent Linkage Gazette when it is deciding whether or not to approve the importation of APIs. .
  • That COFEPRIS establish standards for small amounts of APIs need to adequately comply with the regulatory tests needed for a MA for follow-on products, and deny imports for quantities outside these amounts.
  • That COFEPRIS require importers to declare the destination of the eventual imported products.
  • That IMPI clearly establish as appropriate, the differences between the experimental use and the Bolar-like exception.
  • That IMPI be careful when, on a case-by-case basis, it reviews whether there is an adequate amount of API being imported for tests necessary to support a generic MA application. In some instances, even a small amount of an API may represent the manufacturing of thousands of infringing products (which may end in the grey and black market.).
  • That Customs take advantage of the information contained in the Gazette to detect and stop substances that could enter the country in violation of any patents.
  • Renegotiations of NAFTA will likely impact the IP and regulatory legal frame in Mexico. It is expected that the new NAFTA will raise the IP protection available in Mexico and will cause Mexico to review it entire IP system thus impacting patentability subject matter, linkage regulation, the Bolar-like exception and data package exclusivity for chemicals and biologics.

Please continue to watch the BRIC Wall Blog for updates on the Bolar-like exemption in Mexico.

This post was written by Lisa Mueller and Alejandro Luna of Olivares.

After Years of Waiting, Your or Your Competitor’s Patent Application May Quickly Issue in Brazil. Are You Ready?

The Instituto Nacional da Propriedade Industrial (INPI), also known as the Brazilian Patent and Trademark Office (BRPTO), may soon automatically grant approximately 231,000 currently pending patent applications in an effort to reduce the backlog of unexamined patent applications that have plagued the office for years.  As many of our readers know, the backlog of unexamined applications has resulted in pendency periods on average of at least ten (10) years.  Although expedited examination is available for green technologies, oil and gas technologies (under the patent prosecution highway (PPH), limited pharmaceutical applications, and when an Applicant can demonstrate clear infringement, these measures have failed to put a significant dent in the existing backlog.

In July 2017, the Brazilian government stated that it was considering an emergency measure authorizing INPI to automatically grant approximately 231,000 pending patent applications by 2020.  More information on this measure can be found at the following links:  here, here and here.  Although the announcement of this “automatic” grant has been highly controversial, INPI has implied that it has few, if any other options for dealing with the current backlog. Interestingly, some examiners are threatening to go on strike against the measure.

The emergency measure involves a simplified examination procedure in which INPI would automatically grant any unexamined applications that do not have any outstanding annuity payments due and do not have pre-grant submissions filed by parties against the granting of the patent.  Pharmaceutical applications or divisional applications where the parent application has not yet been examined, are excluded from the measure.

Proposed rules for implementing the new measure were available for public comment until August 31, 2017.  Interestingly, during recent meetings, INPI has suggested that proposals made by local associations that add complexity to the process, such as the possibility of amending claims prior to grant or requesting substantive examination after grant, will likely be disregarded.

While the exact details and the timing of implementation of the measure are unknown, now is the time for Applicants with pending non-pharmaceutical or (certain) divisional applications to be developing a strategy to take advantage of the measure while minimizing any potential risks.  For example, Applicants with products having a short product life span should consider taking full advantage of this emergency measure.

The measure as currently drafted contains an “opt-out” clause in which an Applicant may, within 90 days, request that an application not be automatically granted but instead be subject to regular, substantive examination.  Applicants should strongly consider using the “opt-out” option for applications covering very important inventions and/or if the claims as originally filed do not provide the desired coverage (especially since INPI is likely to disregard any amendments made after the application was filed).  Moreover, Applicants should examine applications of competitors since the measure provides the opportunity for third parties to prevent the automatic granting of an application by the submission of pre-grant submissions with briefs and accompanying prior art.  These pre-grant submissions must be filed before the emergency measure comes into effect.  Moreover, there is no cost for filing the brief before INPI.  .

Please continue to watch the BRIC Wall Blog for updates on the emergency measure for eliminating the backlog of patent applications in INPI.

This post was written by Lisa Mueller and Roberto Rodrigues of Licks Attorneys