One-minute read |
With major backlogs at patent offices, lack of specialisation on the part of the judiciary and enforcement officials and political unrest in some countries, prosecuting and enforcing patent rights in Latin America can be risky. But many nations are taking key steps to improve their systems, and the introduction of the WIPO-administered Patent Cooperation Treaty, often through accession to Free Trade Agreements with the US and Europe, has greatly improved the landscape for patent owners in the region. However, it is crucial to stay on top of recent developments in administrative and judicial proceedings and to obtain advice from local counsel in order to be successful in prosecuting and enforcing patent rights throughout Latin America. |
What are the chief obstacles for companies seeking to obtain patent protection in your respective countries?
CN: I am afraid to say that, in Brazil, it's the National Institute of Industrial Property's (INPI/BR) slow-paced examination process. On average, examiners take six years to analyse a patent application. In the pharmaceutical sector, Article 229-C of Industrial Property Law 9,279 (1996) requires prior approval by ANVISA (National Agency of Sanitary Surveillance) for the concession of patents, a step that is a great obstacle to the processing of patents in this sector. Most IP practitioners and patent holders agree that the best alternative would be to revoke Article 229-C.
DZ/OM: Applicants also face serious delays at the Argentine Patent Office (INPI/AR). INPI/AR faces a major backlog of patent filings, given the lack of economic resources and personnel. Innovations in the field of electronics are the least backlogged and are often examined two to three years after the substantive examination request. Inventions in most other classes are examined within approximately three to five years after the substantive examination request, while applications in the field of chemistry and biotech are examined approximately six to seven years after the substantive examination request.
Once the patent is granted, patent owners face problems obtaining adequate remedies in cases of infringement. During 2000-2003, the Argentine federal courts applied the remedies provided in TRIPS. However, the Argentine patent law was amended and the application of legal remedies relating to patent infringements became more complex beginning in 2004.
AL: There are three major obstacles in Mexico: 1) a lack of examination guidelines at the Mexican Patent Office (IMPI); 2) difficulties in enforcement, specifically with respect to recovering damages; and 3) strict application of formal rules by IMPI during prosecution.
Enrique, what are the obstacles from an in-house perspective?
EC: In general, IP laws and regulations are pretty reasonable and in line with international standards. The main obstacle is that timings are too delayed. Most patent and trade mark offices move very slowly and have a huge backlog of unresolved cases. Obtaining a patent takes five to eight years on average and a trade mark one to three years. You have exceptionally good timings in a few places like Mexico or Peru (six months for trade marks) but the regional average is too high.
Has the Patent Cooperation Treaty helped with the delays at all? Is your country a member?
CN: I would say no, the PCT has not helped with the delays. Brazil signed the PCT in 1978. In September 2008, INPI was accepted by WIPO in the capacity of Searching and International Preliminary Examining Authority (ISA/IPEA). It is expected that the country will start activities in this capacity by the end of April. In the event this phase is successfully implemented, one would expect that international patent applications filed in Brazil will become more reasonably priced and more expedient.
AL: Mexico has been a party to the PCT since 1995. The PCT has benefited patent owners by extending the timeframe for filing national phase applications and it has shortened the application study period, since examiners are able to rely on previous search reports and examination on the merits.
DZ/OM: No, Argentina is not a member of the PCT, but it would simplify and expedite the patent filing process.
Enrique, do you think it would help companies if more countries in Latin America acceded to the Patent Cooperation Treaty?
EC: Absolutely. This would help reduce administrative red tape, costs and timings, thus improving the competitiveness of the region. I was very glad to see that Perú ratified the PCT in January 2009. I hope that, as we see more countries sign Free Trade Agreements (FTAs) with the US, there will be more adherence to the PCT, since this is part of the basic IP clause that these FTAs include. This was the case with Peru and hopefully will be the case soon with others, such as Panama and Colombia.
Participants |
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Matthew Bryan Geneva Director, Patent Cooperation Treaty Legal Division, WIPO |
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Enrique Cavero Venezuela Intellectual property manager, Latin America, Procter & Gamble |
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Carlos Vicente da S Nogueira Brazil Partner, Vicente Nogueira Advogados |
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Alejandro Luna Mexico Partner, Olivares & Cía |
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Daniel Zuccherino Argentina Partner, Obligado & Cia |
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Octavio Mitelman Argentina Partner, Obligado & Cia |
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Eileen McDermott United States Americas editor, Managing IP |
Matt, how does the PCT benefit Latin American countries?
MB: By joining the PCT, the companies and individuals in that country gain access to the PCT system: the ability to file PCT applications based on their nationality or residence. And the PCT itself provides those companies and individuals with more time and more information on which to base their international patenting decisions. Many individual applicants from Latin American countries can benefit from low cost access to the PCT system through significant fee reductions available to them. Latin American patent offices can be more secure in their patent granting decisions when a PCT application comes to them in the national phase. They can take advantage of the international search and the patentability analysis which has been done on the PCT application by a PCT International Searching Authority. WIPO establishes special cooperation plans with its PCT member states, covering issues such as investment in automation of the office, assistance with training and capacity building of the office staff, and support in awareness building about the PCT and IP generally in the private sector.
What are the biggest obstacles to getting Latin American countries to join the PCT?
MB: First, I would say an understanding of what the PCT is and what it is not. Some government officials and users of the patent system in non-member countries have preconceived notions about the PCT or its consequences, which may not always be based in fact.
Second, historically there has been a significant amount of fear on the part of the patent profession in non-PCT countries that the PCT will result in a loss of business for them. As a related matter, some national companies believe that with the introduction of the PCT, more international companies will come into the national market, thus restricting the patent landscape for them.
Third, getting the PCT to be a priority for the government is difficult. Quite understandably, the patent system and the PCT are not at the top of the agenda for every country. But with patience and persistence, we are often able to make progress on this.
Carlos, Luis, Daniel – is there a perception that the PCT might take work away from patent prosecution attorneys?
CN: I do not think so. As a matter of fact I would say that the work has increased, since to file international applications and/or to proceed with national-phase applications, legal guidance and the actual presence of an attorney is indispensable, due to the fact that the PCT system requires compliance with formal procedures and the legal domestic legislation of a given country.
AL: This was a concern for IP firms before the PCT was ratified by Mexico, but the workload and filing volume has actually increased with national-phase applications.
DZ/OM: No. On the contrary, in the middle and long terms, we consider that the adhesion to PCT may definitively increase work for patent prosecution attorneys.
Matt, what is being done to address the needs of countries whose IP offices are not equipped to handle PCT applications?
MB: The PCT International Cooperation Division and other sectors within WIPO, such as the Technical Assistance and Capacity Building Bureau for Latin America/Caribbean, implement plans to assist IP offices in preparing for functioning under the PCT, of course in collaboration with those offices. This assistance can take the form of training for the Office staff on their various roles and functions under the PCT, support for automation of the Office's processes, and integration of WIPO-developed tools to help offices more efficiently process applications and transmit the necessary data to WIPO and the applicants. In addition, WIPO makes available PCT experts who can train the patent professionals in the country in how to correctly file and prosecute PCT applications before the national office. Lastly, WIPO colleagues serve as points of contact and trouble shooters, to answer PCT-related questions, and assist the Office in resolving problem cases. The Offices are not trained once and turned loose-they can turn to WIPO for help and guidance on their PCT responsibilities at any time.
What is WIPO doing to entice governments to participate in the PCT and what strides have been made so far?
MB: We don't do much enticing. We simply try to inform all interested governments about the advantages and implications of joining the PCT, and are available to them as a resource. In many cases, it is the potential user community – large and small companies, and individual inventors – that go to the government and make the request for accession, so that they can benefit from the PCT. But each country must decide for itself when such Treaty accession would be best for it and its citizens.
Enrique, what recent developments in Latin American IP law or practice most affect your company's IP rights?
EC: I have mentioned the case of Peru adopting the PCT and making other improvements, such as passing new legislation on border measures – as a consequence of entering the Free Trade Agreement with the US. Panama and Colombia have similar FTAs waiting to be approved by the US Congress. Argentina created the Customs registry to facilitate border measures approximately a year ago and in Uruguay there is a bill in Congress also on border measures. In Colombia, they are discussing the possibility of joining the Madrid Protocol and the need to pass a law on Liability of Internet Hosts and Service Providers. On the other hand, there is the case of Venezuela going back to outdated legislation as a consequence of their withdrawal from the Andean Community.
Brazil and the PCT |
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The table below shows the significant increase in the number of Brazilian patent applications filed abroad through the PCT(source: WIPO data):
The chart below shows the number of patents applications filed in Brazil. In 2006 less than 25% of the patents were filed by Brazilian-based individuals.
Note: The share of non-resident filings in France is very low which is partly due to the fact that the PCT national phase route is closed for France. A PCT applicant seeking protection in France must therefore enter the PCT regional phase at the EPO. Source: WIPO Statistics Database |
Can you explain this? What are the implications for IP practitioners and companies?
EC: Venezuela recently withdrew from the Andean Community, so the Andean IP legislation that once applied is no longer in force. Instead of passing new, similar legislation to replace it, the government decided to go back to an old law that dates from 1956. As a result, IP protection has been significantly lowered. For example, certain types of patents, including pharmaceutical, food and beverages, and certain IP institutions, such as geographical indications and appellations of origin, are no longer recognised. The system in general has become much more problematic. For example, the Nice Agreement is no longer applicable and (although this is more an official position by the Trademark and Patent Office than an actual change in the law) neither are the TRIPs or the Paris Agreement.
Have there been any significant recent developments that affect IP rights in other countries?
CN: The Law on Innovation and Technology, signed by president Luiz Inácio Lula da Silva on October 11 2005, sets forth in its first article "incentive measures for innovation, and scientific and technological research within the production segment, with views to achieve technological autonomy and industrial development of the country".
This new Law has three underlying aspects: 1) creation of an adequate environment to establish strategic partnerships among universities, technological institutes and companies; 2) fostering the participation of science and technological institutes in the process of innovation; and 3) encouraging innovation in companies.
Also, the ever-growing number of patent applications related to new polymorphic forms of drugs, in addition to the political, economic and technical concern, have motivated INPI to make special efforts to help review and evaluate this matter through the publication of the recent Guidelines of Patent Application Examination. However, the Interministerial Group for Intellectual Property (GIPI) also recently published an adverse opinion contrary to extending patent protection to new polymorphic forms of drugs.
There are also about a dozen bills being considered by Congress that propose amendments to the Law on Industrial Property.
AL: The most significant trends in patent law for this year will most likely have to do with a set of criteria on the publication of formulation and use patents in the Linkage Gazette. IMPI has also suggested that the examination on the merits before granting a pharmaceutical patent will be stricter.
Additionally, IMPI has been summarily denying all pending applications directed to business method-related inventions. However, IMPI has been granting many patents directed to computer related inventions.
In patent validity and patent infringement cases, the litigation department at IMPI has requested the patents department to issue an internal so-called technical report related to the evidence and arguments offered by the contesting parties. This report is not set forth in the IP Law, but is being used as the technical basis before issuing decisions.
Finally, in January 2009 a specialised IP section at the Federal Court for Tax and Administrative Affairs (FCTAA) began operating. This section has jurisdiction to review all cases based on the IP Law, the Federal Copyright Act, the Federal Law of Plant Varieties and other IP-related provisions. The creation of this section should help to generally improve the applicable criteria to IP cases.
How have Free Trade Agreements had an impact on IP protection in Latin America?
AL: Mexico is party to several agreements, including TRIPs, NAFTA and a Free Trade Agreement with the European Union, all of which have had substantial impact on IP protection in Mexico. According to certain judicial interpretations of the Mexican Constitution, these treaties can be invoked as applicable law in Mexico both before the administrative authorities and the courts.
CN: Brazil has only signed a Regional Trade Agreement among South American countries called MERCOSUR (Southern Common Market). Despite proposed efforts to integrate regional trade mark and patent applications of MERCOSUR member countries, the system is still under study. Additionally, a project to establish a common databank is presently under study, which would expedite trade mark and patent searches and enable more comprehensive results in local offices. Also, the exchange of technical information would be improved, with the intent of more harmonised internal procedures of MERCOSUR's local institutes.
DZ/OM: Argentina is not party to or considering entering into any Free Trade Agreements with other countries. In view of the current political environment in Argentina, the chances are low that the country will enter into any Agreements in the short term.
Which industries experience the most difficulty in asserting patent rights in your country?
CN: The pharmaceutical industry seems to face the most extreme difficulties, since, in addition to economic interests, concerns about the population's access to medication and public health are also at stake. Furthermore, in the case of pharmaceutical products and processes there is still the mandatory compliance with the provisions set forth in Article 229-C of the Law on Industrial Property, which requires prior approval by ANVISA.
DZ/OM: The chemical-pharmaceutical and chemical-agricultural industries also experience the most difficulties in Argentina.
Do Customs offices have authority to stop the import/export of infringing products?
CN: Yes. However, titleholders should be proactive and inform Customs authorities as soon as they suspect any entry into the country of products that may eventually be infringing patent rights.
WIPO’s 2009 PCT goals |
In the course of 2009, WIPO would like to see – and is making efforts in the direction of – the PCT being more fully used as it was intended by its founders, to more effectively reduce duplication and reduce cost for its users. WIPO will be working with the Offices of PCT contracting states to try to ensure that PCT work products are of highest possible quality, that practices and fee structures encourage work-sharing and duplication reduction, that national law inconsistencies with PCT are reduced, and all with the goal that the PCT can and should be used more effectively which will in turn enable the PCT to contribute more fully to solutions to the problems facing the international patent system. |
Last year, for example, the Ministry of Justice and the Ministry of Health implemented some actions to combat drug piracy. These included intensifying the repression and traceability of products; establishing a direct channel with pharmaceutical industries so that they may benefit from a detailed databank; developing and carrying out educational campaigns; and educating public agents.
Since the National Council to Fight Piracy was created in 2004, Brazil has established records on the apprehension of pirated products. This number, to the best of my knowledge, is about R$1.5 billion in seized products.
AL: In Mexico, Customs offices require an order from IMPI to stop the import/export of infringing products.
DZ/OM: Law 25,946 was enacted on December 29 2004, introducing several changes in the Customs Code. This law introduced the border measures provided in Article 51 of TRIPs. Moreover, it has raised TRIPs standards by not only protecting against counterfeit trade marked products or copyrighted goods, but it has broadened the protection of IP rights at borders to all intellectual and industrial property rights provided in the Argentine legislation.
By virtue of this legislation, the Customs agents are now empowered to determine actual or potential infringements to IP rights and may block entry of any goods into the country. The legislation sets out that merchandise may be stopped at Customs while the authorities conduct investigations relating to potential infringements. This is the first time Argentine legislation has afforded such authority to Customs.
Unfortunately for patent owners, Law 25,986 was amended by Law 26,458 on December 10 2008, which restricted the application of Article 46 to counterfeit trade marks and pirated copies.
Which agencies or courts are responsible for patent enforcement procedures?
CN: Within the administrative sphere, INPI is the entity responsible for processing and evaluating patent applications. However, ANVISA also assists in approving patent applications relating to pharmaceutical products and processes, as I mentioned earlier.
In the judicial sphere, the federal courts can judge the validity of administrative actions issued by INPI. As far as cases in which infringement actions are initiated by third parties, the state courts are responsible.
AL: IMPI is the first authority in charge of granting and enforcing patents, including studying and deciding proceedings on validity and infringement. However, as a result of recent court precedents, the decisions issued by IMPI can be challenged either before the federal district courts, which normally review constitutionality issues, or the new specialised IP section of the FCTAA. Decisions by either court can be appealed in a final stage before federal circuit courts.
After an infringement has been declared and can no longer be appealed, the plaintiff may pursue a civil action for damages. The plaintiff must choose a federal or state court, unless the patent infringement affects government interests, in which case jurisdiction will be granted to a federal court. The plaintiff will have to follow the rules established in the Code of Civil Procedure to determine the judge with proper jurisdiction.
DZ/OM: The civil and commercial federal courts are responsible for patent enforcement procedures in Argentina. Although these courts are involved in other legal matters as well, they are the only ones with jurisdiction related to civil remedies in connection with patent infringements.
How effective are these agencies or courts?
CN: Unfortunately, despite substantial efforts, INPI still has an extensive backlog for both patent and trade mark applications. This situation generates an environment of complete insecurity among users of the system, who are deprived of the power to fully execute rights while they are waiting to be granted by the Institute, often at times when faced with hostile acts against such rights.
On the other hand, the judicial branch, based on the prerogative set forth in Article 24 of the Law on Industrial Property, carries out a fundamental role in protecting and enforcing industrial property rights, in particular in the State and Federal Courts of Rio de Janeiro.
Since 2002, the State Court of Rio de Janeiro established jurisdiction boundaries of 12 commercial districts in connection with litigation trials involving industrial property issues. The Judicial District of Rio de Janeiro is the only court in Brazil that since 2000 has had a trial court with four circuits specialised in industrial property matters. By the same token, the Second District of the Federal Regional Court, an Appellate Court, whose jurisdiction covers the states of Rio de Janeiro and Espírito Santo, created 2 specialised panels in 2005 to judge matters related to industrial property.
The São Paulo Superior Courts, which answer for approximately 50% of the suits filed in Federal Courts, still do not have panels specialised on industrial property issues. This situation often results in cases being transferred to the Rio de Janeiro courts.
Specialisation has represented a large step in judging conflicts involving industrial property matters and made it possible to expedite procedures, in line with the interests of the judicial branch, as well as those of lawyers and IP owners.
AL: One of the major problems that patent holders face in Mexico is the extended timeframe before damages generated from an infringement can be recovered, due to the need to obtain a declaration of infringement with no chance of appeal before a claim for damages can be started. Additionally, even though IMPI is effective in imposing preliminary injunctions, these can be easily lifted by the alleged infringer by filing a counter claim.
Latin American PCT members |
The following Latin American countries are PCT contracting states, among the 139 total number of States:
Argentina, Bolivia, Chile, Panama, Paraguay, Peru, Uruguay, and Venezuela are expected to accede to the PCT soon. According to Bryan, in both Chile and Peru, the PCT has been approved by the necessary government authorities and WIPO is awaiting the deposit of the instrument of accession. |
The specialised IP section of the FCTAA just began operating in January 2009 and it is yet to be determined how effective it will be in its duties.
DZ/OM: The amendment incorporated into the Argentine Patent Law by Act Nº 25.859 in December 2003 has made the achievement of preliminary injunctions envisaged by TRIPs more complex and difficult for patent holders. Prior to this amendment, the Argentine Federal Courts clearly showed their willingness to protect patent owners through the application of the civil remedies provided in Articles 50 and 51 of TRIPs.
EC: In the substantive aspect, specialised agencies and courts like IMPI in Mexico, INDECOPI in Peru and the specialised IP judges of Panama are usually very technical and proficient. And generally speaking in the region, although there is a great lack of knowledge and understanding of IP matters – especially in the lower courts – I would say that the final decisions are for the most part reasonable. The problem is that any judicial proceeding will easily take two to five years to reach a final decision. This is a major problem.
How can patent owners maximise their chances of success in the courts?
CN: The only way to maximise the chances of success in the courts is to be sure to validate the rights allegedly infringed, obtain concrete evidence of infringement and preserve evidence that leads to infringements. Actions against infringers may be brought on either civil or criminal grounds. In many cases, serving a cease and desist letter is enough to stop the infringement. The implementation of this procedure, however, should be evaluated on a case by case basis, since it could later jeopardise actions that the patent holder may eventually file against the infringing party.
Also, in the administrative sphere, it is possible for a patent owner who is seeking to invalidate a patent to voluntarily submit supporting documents to prove to the examiner that the technology at issue lacks novelty or inventive step.
AL: The ideal way to ensure success is by presenting a very strong case at the initial stage before IMPI. Higher courts do not generally review the cases de novo, but analyse instead the legality of IMPI's decisions. For pharmaceutical patents, the recent enactment of linkage regulations have helped patent holders to reduce the burden of proof before IMPI concerning the scope of patents.
EC: The final decision, whether favourable or not, will normally be delayed. So, in practical terms, success implies obtaining a judicial injunction or making an administrative injunction hold up in the courts. This is possible only if you have the best case and evidence at hand, for which you need the best possible protection in terms of registered trade marks, patents or copyrights. This requires the best possible advice regarding what to build, what to protect and how. So the short answer is "get the best advice and have it all along", because partial or last minute solutions will not help.
What is being done to improve the patent system in your countries?
CN: INPI has made important efforts to hire and organise new patent examination teams. By the end of 2008, there will be a total of 238 new examiners. Expectations are that all applications filed as of 2010 will be analysed within 4 years maximum, in line with international practices.
Also, this year INPI intends to implement an electronic system for patent application management. The idea is to adapt the system already used internationally to reduce pendency.
INPI is also carrying out studies that would lead to greater efficiency of patent application filings and examinations in the biotechnology area.
INPI is sponsoring debates on patentability criteria and facilitating courses for Brazilian citizens to make them more knowledgeable of the system. As part of this, the Institute is taking part in the formulation of governmental policies to promote the development of national industries, the protection of new inventions and to combat counterfeiting.
However, it is crucial that the government clearly adopts a concrete incentive policy regarding innovation and research. Figures up until the end of first semester of 2008 showed a significant decrease in the number of patents filed in Brazil (see chart), and this may eventually reflect negatively on the country's patent system abroad.
AL: IMPI has requested a thorough reform of the IP law, and there are some projects under review for this purpose. The work by the specialised IP section of the FCTAA should also improve litigation time frames and criteria.
DZ/OM: Senators Riofrío and Gioja have drafted a bill aimed at amending the Argentine Patent Law in order to conform our patent system to regulations that recognise adequate protection to innovators. The bill provides for the right to claim reasonable damages from the date of publication of an application against any third party who, between the publication date and the date the patent is granted, has used the invention in an infringing manner. This protection can also apply prior to the publication date of the patent application in cases where parties have been notified by the applicant of the filing and relevant subject matter. The bill points out that, during the prosecution process, the reach of the protection is determined by the claims included in the relevant patent application at the time of the publication. However, the patent grant will definitively determine with retroactive effects the provisional protection, always provided that the reach of the claims has not been broadened during prosecution. In this case, the protection will not be extended to the amendments incorporated during patent prosecution. This protection is not effective in the event the patent application is withdrawn or rejected by the Patent Office.
Additionally, we are proposing another bill to regulate the provision of Supplemental Protection Certificates (SPC) in Argentina. The purpose is to extend the life protection of the exclusive rights derived from a granted patent in order to recover the time which demanded the registration proceeding.
Has the economic downturn impacted patent filings or practice for any of you?
EC: Not the strategy, which as I said before consists in being efficient. It has perhaps put a bit more pressure on the cost side of the equation though.
CN: As far as I can ascertain, there has indeed been a downturn in patent filings. But we still do not have precise information on the numbers.
AL: Yes. To some extent patent filing volume has been reduced in the last few months.
DZ/OM: Yes, but only slightly so far.
What key strategies do you recommend patent holders use to enforce their rights in Latin America?
DZ/OM: 1) Coordinate legal actions throughout Latin America; 2) in the field of pharmaceuticals, coordinate IP legal actions with regulatory actions; and (3) hire specialised attorneys and technical experts.
CN: I would recommend five key strategies: 1) Develop and maintain a surveillance program to monitor the market; 2) Follow-up the launching of similar products by other companies and determine the possibility of eventual infractions; 3) Notify, as promptly as possible, Customs' authorities in case of suspicious import/distribution/sale of products manufactured due to patent infractions; 4) Send a cease and desist letter, provided safeguards mentioned above are complied with to the alleged infringing party on the responsibilities resulting from the use of a patent protected object, and 5) Send a warning letter, as a cautionary measure, to the titleholder of patent application that may allegedly be considered an infringement of his patent or a previous patent application.
The more aggressive patent titleholders are vis-à-vis their rights, the safer their rights will be.
Protecting pharmaceutical patents in Latin America – Q&A |
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EM: What are the biggest obstacles to obtaining patent protection for your company in Latin America?MD: The failure to recognise secondary patents, such as new methods of use, polymorphs and formulations. EM: Do you often file applications using the Patent Cooperation Treaty?MD: Yes, our applications are filed via the PCT. For those countries that are not members of the PCT, we must make decisions about whether or not to file well before we know if the patent application in question will realise value. As a result, some of our more important products, for which we may have otherwise entered the national phase via the PCT, may lack patent protection in non-PCT countries. EM: What are the major obstacles to enforcement?MD: Lack of patent linkage, resulting in approval of copy products without regard to our existing patent rights. This is combined with difficulty in obtaining injunctions in a timely manner, extensive litigation delays, and minimal damage awards that do very little to deter infringers. EM: How often are you involved in litigation in Latin America?MD: Eli Lilly is routinely involved in litigation matters in Latin America, and as noted above, significant delays in the litigation and decision-making process result in some of these cases extending over months to years. EM: What key strategies do you employ to enforce your company's patent rights in Latin America?MD: Our strategy is to obtain meaningful patent protection for compounds and, where possible, for the label indication. We enforce these patents as necessary through infringement actions. EM: Has the economic downturn affected your company's patent strategy in Latin America in any way?MD: No, at this time, the patent strategy in Latin America has not changed. However, decisions regarding patent filing strategy are routinely reviewed, and are based on the certainty of obtaining meaningful patent protection, and ability to enforce our rights. EM: What most needs to be done to improve the patent system in Mexico and other Latin American countries for the pharmaceutical industry?MD: The biggest obstacle for the pharmaceutical industry is the lack of meaningful data exclusivity, including a prohibition on reliance on innovator data for approval of copy products. Existing data exclusivity laws provide loopholes by which data exclusivity is denied if all data are not confidential. However, in regulated industries, such as pharmaceuticals, ethical obligations and the need for transparency require that some data must be made public prior to submission of the regulatory data package to health authorities. Data exclusivity would provide a period of certainty to innovator companies that submit confidential data to regulatory agencies without undergoing unnecessary litigation. |
