By electronic submission
Mr. Stan McCoy
Assistant USTR for Intellectual Property and Innovation
Office of the U.S. Trade Representative
Re: Section 306 Monitoring of Paraguay: Memorandum of Understanding on Intellectual Property Rights: Request for Public Comment
Dear Mr. McCoy:
The Biotechnology Industry Organization (BIO) appreciates this opportunity to comment on Paraguay’s implementation of the MOU on Intellectual Property Rights and additional actions to improve protection and enforcement of intellectual property rights in Paraguay.
BIO is a non-profit organization with a membership of more than 1,100 biotechnology companies, academic institutions, state biotechnology centers, and related organizations in all 50 States and a number of foreign countries. BIO’s members are involved in the research and development of health care, agricultural, industrial, and environmental biotechnology products. The U.S. life sciences industry, fueled by the strength of the U.S. patent system, supports more than 7.5 million jobs in the United States, and has generated hundreds of drug products, medical diagnostic tests, biotech crops, and other environmentally-beneficial products such as renewable fuels and bio-based plastics.
The majority of BIO’s members are small and medium sized enterprises that currently do not have products on the market. As such, BIO’s members rely heavily on the strength and scope of their patents to generate investment to take their technologies to commercialization. More and more, BIO’s members are looking abroad as they expand their markets and R&D and commercialization efforts.
Paraguay continues to have great deficiencies with respect to its patent system and the protection of data supplied to regulatory agencies in support of product marketing authorizations.
Paraguay’s patent examination system suffers from a large backlog that delays the grant of patent protection for valuable inventions and thereby denies the adequate and effective protection of intellectual property rights for BIO’s members. Paraguay needs to identify measures to reduce its excessive backlog. Further, Paraguay remains outside of the Patent Cooperation Treaty (PCT), which facilitates the filing and examination of patent applications in 142 member countries. Acceding to this widely accepted agreement would be a positive step toward facilitating the procurement of patent protection in Paraguay for BIO’s members.
Paraguay’s patent laws also do not provide for sufficient patent term extensions to fully compensate for unwarranted delays in the patent application process. The patent law in Paraguay also excludes transgenic plants and animals from patent protection, thereby further limiting the availability of meaningful protection for many valuable biotechnology innovations.
Paraguay does not provide adequate protection for the data that must be generated in support of marketing authorization to prove that agricultural chemical products are safe and effective, although the Law states the obligation of safeguarding the scientific or technical information contained in the documents submitted for the registration of phytosanitary or zoosanitary products. Paraguay’s obligations in this regard come from the Annex of the 2008 Memorandum of Understanding (MOU) between Paraguay and the United States, section 1 (c) states:
“improve protection for pharmaceuticals and agricultural chemicals by:
Ensuring that Paraguay fully complies, through relevant laws and regulations, with its obligations under the TRIPS Agreement with respect to the protection of undisclosed test or other data from unfair commercial use and disclosure”
Paraguayan Law 3.519 Article 3 provides 5 years of protection for agrochemical products that contain new chemical entities to Paraguay or any other market. This law is problematic for several reasons. First, the period of protection is significantly lower than peer countries and free trade agreements which provide the international accepted standard of ten years exclusivity (see laws in U.S., EU, Brazil, Chile, Peru, Costa Rica, Guatemala, and U.S. free trade agreements). Second, data protection is measured from the date of submission rather than the date of approval. This incentivizes regulatory delay and often results in no data protection as the protection expires before or soon after product approval.
An additional issue with Law 3.519 Article 3 is that the law only provides protection for a small portion of the regulatory data dossier. Only information in the dossier that is confidential business information is protected and only for a temporary period. Instead of a law allowing other companies to rely on the innovator dossier as is typical in other jurisdictions, this law does not prohibit other companies from accessing the innovator’s confidential business information which we believe is a violation of TRIPS Article 39.
Article 3 of Law 3.519 also states that data protection is only provided if Paraguay is the first country where an innovator submits for approval. Many factors dictate where an innovator files for regulatory approval of their products and this provision effectively punishes American innovators for not filing in Paraguay first. TRIPS Article 39 does not limit the availability of data protection to only that country where you file first and such limitations should not be read into the agreement.
Article 8 of Law 3.519 removes and/or prohibits data protection for information that is in the public domain by any means of publication or disclosure. It also removes data protection if the innovator submits the information voluntarily to the health authority without being required to do so by that authority. Therefore, publications by the EPA or FAO/WHO that cite regulatory data that provide toxicology or environmental data may result in the loss of all data protection in Paraguay.
Data protection is critical to the ability of biotechnology companies to develop and commercialize such pharmaceutical and chemical products in a particular market. It is moreover an obligation of Paraguay under Article 39.3 of the TRIPS Agreement, which requires such data to be protected against “unfair commercial use.”
Persistent deficiencies in the patent and data protection regime in Paraguay raise issues in respect to Paraguay’s bilateral and international obligations and deny adequate and effective protection for the intellectual property rights of BIO’s members. BIO requests that USTR take into consideration these deficiencies.
Global Intellectual Property Policy
Biotechnology Industry Organization