United States - Mexico - Canada Agreement (USMCA) (2018) - Electronic Database of Investment Treaties (EDIT)

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United States - Mexico - Canada Agreement (USMCA) (2018)

Subsection B. Measures Relating to Agricultural Chemical Products

Article 20.45. Protection of Undisclosed Test or other Data for Agricultural Chemical Products

1. If a Party requires, as a condition for granting marketing approval (35) for a new agricultural chemical product, the submission of undisclosed test or other data concerning the safety and efficacy of the product, (36) that Party shall not permit third persons, without the consent of the person that previously submitted that information, to market the same or a similar (37) product on the basis of that information or the marketing approval granted to the person that submitted that test or other data for at least 10 years (38) from the date of marketing approval of the new agricultural chemical product in the territory of the Party.

2. If a Party permits, as a condition of granting marketing approval for a new agricultural chemical product, the submission of evidence of a prior marketing approval of the product in another territory, that Party shall not permit third persons, without the consent of the person that previously submitted undisclosed test or other data concerning the safety and efficacy of the product in support of that prior marketing approval, to market the same or a similar product based on that undisclosed test or other data, or other evidence of the prior marketing approval in the other territory, for at least 10 years from the date of marketing approval of the new agricultural chemical product in the territory of the Party.

3. For the purposes of this Article, a new agricultural chemical product is one that contains a chemical entity that has not been previously approved in the territory of the Party for use in an agricultural chemical product.

(35) For the purposes of this Chapter, the term "marketing approval" is synonymous with "sanitary approval" under a Party's law.

(36) Each Party confirms that the obligations of this Article apply to cases in which the Party requires the submission of undisclosed test or other data concerning: (a) only the safety of the product, (b) only the efficacy of the product, or (c) both.

(37) For greater certainty, for the purposes of this Section, an agricultural chemical product is "similar" to a previously approved agricultural chemical product if the marketing approval, or, in the alternative, the applicant's request for that approval, of that similar agricultural chemical product is based upon the undisclosed test or other data concerning the safety and efficacy of the previously approved agricultural chemical product, or the prior approval of that previously approved product.

(38) For greater certainty, a Party may limit the period of protection under this Article to 10 years.

Subsection C. Measures Relating to Pharmaceutical Products

Article 20.46. Patent Term Adjustment for Unreasonable Curtailment

1. Each Party shall make best efforts to process applications for marketing approval of pharmaceutical products in an efficient and timely manner, with a view to avoiding unreasonable or unnecessary delays.

2. With respect to a pharmaceutical product that is subject to a patent, each Party shall make available an adjustment (39) of the patent term to compensate the patent owner for unreasonable curtailment of the effective patent term as a result of the marketing approval process.

3. For greater certainty, in implementing the obligations of this Article, each Party may provide for conditions and limitations, provided that the Party continues to give effect to this Article. (40)

4. With the objective of avoiding unreasonable curtailment of the effective patent term, a Party may adopt or maintain procedures that expedite the processing of marketing approval applications.

(39) For greater certainty, a Party may alternatively make available a period of additional sui generis protection to compensate for unreasonable curtailment of the effective patent term as a result of the marketing approval process. The sui generis protection must confer the rights conferred by the patent, subject to any conditions and limitations pursuant to paragraph 3.

(40) Such conditions and limitations with respect to paragraph 3 may include, among other things: (i) limiting the applicability of paragraph 2 to a single patent term adjustment for each pharmaceutical product that has been granted marketing approval; (ii) requiring the adjustment to be based on the first marketing approval granted to the pharmaceutical product in that Party; (iii) limiting the period of the adjustment to a maximum of 5 years; and (iv) if a Party makes available a period of additional sui generis protection, limiting the period of the additional sui generis protection to a maximum of 2 years.

Article 20.47. Regulatory Review Exception

Without prejudice to the scope of, and consistent with, Article 20.39 (Exceptions), each Party shall adopt or maintain a regulatory review exception for pharmaceutical products that permits a third person to make, use, sell, offer to sell, or import in the territory of that Party a product covered by a subsisting patent solely for purposes related to generating information to meet requirements for marketing approval for the product.

Article 20.48. Protection of Undisclosed Test or other Data

1. (a) If a Party requires, as a condition for granting marketing approval for a new pharmaceutical product, the submission of undisclosed test or other data concerning the safety and efficacy of the product, (41) that Party shall not permit third persons, without the consent of the person that previously submitted that information, (42) to market the same or a similar (43) product on the basis of:

(i) that information, or

(ii) the marketing approval granted to the person that submitted that information,

for at least five years (44) from the date of marketing approval of the new pharmaceutical product in the territory of the Party;

(b) If a Party permits, as a condition of granting marketing approval for a new pharmaceutical product, the submission of evidence of prior marketing approval of the product in another territory, that Party shall not permit third persons, without the consent of a person that previously submitted the information concerning the safety and efficacy of the product, to market a same or a similar product based on evidence relating to prior marketing approval in the other territory for at least five years from the date of marketing approval of the new pharmaceutical product in the territory of that Party.

2. Each Party shallapply paragraph 1, mutatis mutandis, (46) for a period of at least five years to new pharmaceutical products that contain a chemical entity that has not been previously approved in that Party. (47)

3. Notwithstanding paragraphs 1 and 2, a Party may take measures to protect public health in accordance with:

(a) the Declaration on TRIPS and Public Health;

(b) any waiver of a provision of the TRIPS Agreement granted by WTO Members in accordance with the WTO Agreement to implement the Declaration on TRIPS and Public Health and that is in force between the Parties; or

(c) any amendment of the TRIPS Agreement to implement the Declaration on TRIPS and Public Health that enters into force with respect to the Parties.

(41) Each Party confirms that the obligations of this Article apply to cases in which the Party requires the submission of undisclosed test or other data concerning: (i) only the safety of the product, (ii) only the efficacy of the product, or ii) both.

(42) For greater certainty, a Party may deem that such person has provided consent if, after that person is directly notified by a third person that an unexpired applicable patent claiming the approved product or its approved method of use is invalid or is not infringed by the product for which the third person is seeking marketing approval, an infringement action is not initiated against the third person with respect to the patent within 45 days of the notification.

(43) For greater certainty, for the purposes of this Section, a pharmaceutical product is "similar" to a previously approved pharmaceutical product if the marketing approval, or, in the alternative, the applicant's request for that approval, of that similar pharmaceutical product is based upon the undisclosed test or other data concerning the safety and efficacy of the previously approved pharmaceutical product, or the prior approval of that previously approved product.

(44) For greater certainty, a Party may limit the period of protection under paragraph 1 to five years.

(45) For greater certainty, the Parties understand that the United States may comply with the obligations in subparagraph (a) with respect to "the same or a similar product" through 21 U.S.C. §§ 355(c)(3)(E)Gi) and 355(j)(5)(F)Gi), 42 U.S.C. § 262(k)(7), and the regulations implemented at 21 C.F. R. 314.

(46) A Party that provides a period of at least eight years of protection under paragraph 1 is not required to apply paragraph 2.

(47) For the purposes of paragraph 2, a Party may choose to protect only the undisclosed test or other data concerning the safety and efficacy relating to the chemical entity that has not been previously approved.

Article 20.49. Definition of New Pharmaceutical Product

For the purposes of Article 20.48.1 (Protection of Undisclosed Test or Other Data), a new pharmaceutical product means a pharmaceutical product that does not contain a chemical entity that has been previously approved in that Party.

Article 20.50. Measures Relating to the Marketing of Certain Pharmaceutical Products (48)

1. If a Party permits, as a condition of approving the marketing of a pharmaceutical product, persons, other than the person originally submitting the safety and efficacy information, to rely on evidence or information concerning the safety and efficacy of a product that was previously approved, such as evidence of prior marketing approval by the Party or in another territory, that Party shall provide:

(a) a system to provide notice to a patent holder (49) or to allow for a patent holder to be notified prior to the marketing of such a pharmaceutical product, that such other person is seeking to market that product during the term of an applicable patent claiming the approved product or its approved method of use;

(b) adequate time and sufficient opportunity for such a patent holder to seek, prior to the marketing of an allegedly infringing product, available remedies in subparagraph (c); and

(c) procedures, such as judicial or administrative proceedings, and expeditious remedies, such as preliminary injunctions or equivalent effective provisional measures, for the timely resolution of disputes concerning the validity or infringement of an applicable patent claiming an approved pharmaceutical product or its approved method of use.

2. Further to paragraph 1, that Party may also provide:

(a) effective rewards for a successful assertion of the invalidity or non-infringement of the applicable patent; (50) and

(b) procedures, consistent with its obligations under this Chapter, to promote transparency by providing information regarding applicable patents and relevant periods of exclusivity for pharmaceutical products that have been approved in that Party.

(48) Annex 20-A applies to this Article.

(49) For greater certainty, for the purposes of this Article, a Party may provide that a "patent holder" includes a patent licensee or the authorized holder of marketing approval.

(50) Effective rewards may include providing a period of marketing exclusivity to the first applicant that successfully asserts the invalidity or non-infringement of the patent in accordance with the Party's marketing approval process.

Article 20.51. Alteration of Period of Protection

Subject to Article 20.48.3 (Protection of Undisclosed Test or Other Data), if a product is subject to a system of marketing approval in the territory of a Party pursuant to Article 20.45 (Protection of Undisclosed Test or Other Data for Agricultural Chemical Products) or Article 20.48 and is also covered by a patent in the territory of that Party, that Party shall not alter the period of protection that it provides pursuant to Article 20.45 or Article 20.48 in the event that the patent protection terminates on a date earlier than the end of the period of protection specified in Article 20.45 or Article 20.48.

Section G. Industrial Designs

Article 20.52. Protection

1. Each Party shall ensure adequate and effective protection of industrial designs consistent with Articles 25 and 26 of the TRIPS Agreement.

2. Consistent with paragraph 1, each Party confirms that protection is available for designs embodied in a part of an article.

Article 20.53. Non-Prejudicial Disclosures/Grace Period (51)

Each Party shall disregard at least information contained in public disclosures used to determine if an industrial design is new, original, or, where applicable, non-obvious, if the public disclosure: (52)

(a) was made by the design applicant or by a person that obtained the information directly or indirectly from the design applicant; and

(b) occurred within 12 months prior to the filing date in the territory of the Party.

(51) Articles 20.53 (Non-Prejudicial Disclosures/Grace Period) and 20.54 (Electronic Industrial Design System) apply with respect to industrial design patent systems or industrial design registration systems.

(52) For greater certainty, a Party may limit the application of this Article to disclosures made by, or obtained directly or indirectly from, the creator or co-creator and provide that, for the purposes of this Article, information obtained directly or indirectly from the design applicant may be information contained in the public disclosure that was authorized by, or derived from, the design applicant.

Article 20.54. Electronic Industrial Design System

Each Party shall provide a:

(a) system for the electronic application for industrial design rights; and

(b) publicly available electronic information system, which must include an online database of protected industrial designs.

Article 20.55. Term of Protection

Each Party shall provide a term of protection for industrial designs of at least 15 years from either: (a) the date of filing, or (b) the date of grant or registration.

Section H. Copyright and Related Rights

Article 20.56. Definitions

For the purposes of Article 20.57 (Right of Reproduction) and Article 20.59 (Right of Distribution) through Article 20.68 (Collective Management), the following definitions apply with respect to performers and producers of phonograms:

broadcasting means the transmission by wireless means for public reception of sounds or of images and sounds or of the representations thereof; such transmission by satellite is also "broadcasting"; transmission of encrypted signals is "broadcasting" if the means for decrypting are provided to the public by the broadcasting organization or with its consent; "broadcasting" does not include transmission over computer networks or any transmissions where the time and place of reception may be individually chosen by members of the public;

communication to the public of a performance or a phonogram means the transmission to the public by any medium, other than by broadcasting, of sounds of a performance or the sounds or the representations of sounds fixed in a phonogram;

fixation means the embodiment of sounds, or of the representations thereof, from which they can be perceived, reproduced, or communicated through a device;

performers means actors, singers, musicians, dancers, and other persons who act, sing, deliver, declaim, play in, interpret, or otherwise perform literary or artistic works or expressions of folklore;

phonogram means the fixation of the sounds of a performance or of other sounds, or of a representation of sounds, other than in the form of a fixation incorporated in a cinematographic or other audio-visual work;

producer of a phonogram means a person that takes the initiative and has the responsibility for the first fixation of the sounds of a performance or other sounds, or the representations of sounds; and

publication of a performance or phonogram means the offering of copies of the performance or the phonogram to the public, with the consent of the right holder, and provided that copies are offered to the public in reasonable quantity.

Article 20.57. Right of Reproduction

Each Party shall provide (53) to authors, performers, and producers of phonograms (54) the exclusive right to authorize or prohibit all reproduction of their works, performances, or phonograms in any manner or form, including in electronic form.

(53) For greater certainty, the Parties understand that it is a matter for each Party's law to prescribe that works, performances, or phonograms in general or any specified categories of works, performances and phonograms are not protected by copyright or related rights unless the work, performance, or phonogram has been fixed in some material form.

(54) References to "authors, performers, and producers of phonograms" refer also to any of their successors in interest.

Article 20.58. Right of Communication to the Public

Without prejudice to Article 11(1)(ii), Article 11bis(1)(i) and (ii), Article 11ter(1)(ii), Article 14(1)(i), and Article 14bis(1) of the Berne Convention, each Party shall provide to authors the exclusive right to authorize or prohibit the communication to the public of their works, by wire or wireless means, including the making available to the public of their works in such a way that members of the public may access these works from a place and at a time individually chosen by them. (55)

(55) The Parties understand that the mere provision of physical facilities for enabling or making a communication does not in itself amount to communication within the meaning of this Chapter or the Berne Convention. The Parties further understand that nothing in this Article precludes a Party from applying Article 11bis(2) of the Berne Convention.

Article 20.59. Right of Distribution

Each Party shall provide to authors, performers, and producers of phonograms the exclusive right to authorize or prohibit the making available to the public of the original and copies (56) of their works, performances, and phonograms through sale or other transfer of ownership.

(56) The expressions "copies" and "original and copies", that are subject to the right of distribution in this Article, refer exclusively to fixed copies that can be put into circulation as tangible objects.

Article 20.60. No Hierarchy

Each Party shall provide that, in cases in which authorization is needed from both the author of a work embodied in a phonogram and a performer or producer that owns rights in the phonogram, the need for the authorization of the:

(a) author does not cease to exist because the authorization of the performer or producer is also required; and

(b) performer or producer does not cease to exist because the authorization of the author is also required.

Article 20.61. Related Rights

1. Further to the protection afforded to performers and producers of phonograms as "nationals" under Article 20.8 (National Treatment), each Party shall accord the rights provided for in this Chapter to performances and phonograms first published or first fixed (57) in the territory of another Party. (58) A performance or phonogram is considered first published in the territory of a Party if it is published in the territory of that Party within 30 days of its original publication.

2. Each Party shall provide to performers the exclusive right to authorize or prohibit:

(a) the broadcasting and communication to the public of their unfixed performances, unless the performance is already a broadcast performance; and

(b) the fixation of their unfixed performances.

3. (a) Each Party shall provide to performers and producers of phonograms the exclusive right to authorize or prohibit the broadcasting or any communication to the public of their performances or phonograms, by wire or wireless means (59) and the making available to the public of those performances or phonograms in such a way that members of the public may access them from a place and at a time individually chosen by them.

(b) Notwithstanding subparagraph (a) and Article 20.64 (Limitations and Exceptions), the application of the right referred to in subparagraph (a) to analog transmissions and non-interactive free over-the-air broadcasts, and exceptions or limitations to this right for those activities, is a matter of each Party's law. (60)

(c) Each Party may adopt limitations to this right in respect of other non-interactive transmissions in accordance with Article 20.64.1 (Limitations and Exceptions), provided that the limitations do not prejudice the right of the performer or producer of phonograms to obtain equitable remuneration.

(57) For the purposes of this Article, fixation means the finalization of the master tape or its equivalent.

(58) For greater certainty, consistent with Article 20.8 (National Treatment), each Party shall accord to performances and phonograms first published or first fixed in the territory of another Party treatment no less favorable than it accords to performances or phonograms first published or first fixed in its own territory.

(59) For greater certainty, the obligation under this paragraph does not include broadcasting or communication to the public, by wire or wireless means, of the sounds or representations of sounds fixed in a phonogram that are incorporated in a cinematographic or other audio-visual work.

(60) For the purposes of this subparagraph the Parties understand that a Party may provide for the retransmission of non-interactive, free over-the-air broadcasts, provided that these retransmissions are lawfully permitted by that Party's government communications authority; any entity engaging in these retransmissions complies with the relevant rules, orders, or regulations of that authority; and these retransmissions do not include those delivered and accessed over the Internet. For greater certainty this footnote does not limit a Party's ability to avail itself of this subparagraph.

Article 20.62. Term of Protection for Copyright and Related Rights

Each Party shall provide that in cases in which the term of protection of a work, performance, or phonogram is to be calculated:

(a) on the basis of the life of a natural person, the term shall be not less than the life of the author and 70 years after the author's death; (61) and

(b) on a basis other than the life of a natural person, the term shall be:

(i) not less than 75 years from the end of the calendar year of the first authorized publication (62) of the work, performance, or phonogram, or

(ii) failing such authorized publication within 25 years from the creation of the work, performance, or phonogram, not less than 70 years from the end of the calendar year of the creation of the work, performance, or phonogram.

(61) The Parties understand that if a Party provides its nationals a term of copyright protection that exceeds life of the author plus 70 years, nothing in this Article or Article 20.8 (National Treatment) precludes that Party from applying Article 7(8) of the Berne Convention with respect to the term in excess of the term provided in this subparagraph of protection for works of another Party.

(62) For greater certainty, for the purposes of subparagraph (b), if a Party's law provides for the calculation of term from fixation rather than from the first authorized publication that Party may continue to calculate the term from fixation.

Article 20.63. Application of Article 18 of the Berne Convention and Article 14.6 of the TRIPS Agreement

Each Party shall apply Article 18 of the Berne Convention and Article 14.6 of the TRIPS Agreement, mutatis mutandis, to works, performances, and phonograms, and the rights in and protections afforded to that subject matter as required by this Section.

Article 20.64. Limitations and Exceptions

1. With respect to this Section, each Party shall confine limitations or exceptions to exclusive tights to certain special cases that do not conflict with a normal exploitation of the work, performance, or phonogram, and do not unreasonably prejudice the legitimate interests of the right holder.

2. This Article does not reduce or extend the scope of applicability of the limitations and exceptions permitted by the TRIPS Agreement, the Berne Convention, the WCT, or the WPPT.

Article 20.65. Contractual Transfers

Each Party shall provide that for copyright and related rights, any person acquiring or holding an economic right (63) in a work, performance, or phonogram:

(a) may freely and separately transfer that right by contract; and

(b) by virtue of contract, including contracts of employment underlying the creation of works, performances, or phonograms, must be able to exercise that right in that person's own name and enjoy fully the benefits derived from that right. (64)

(63) For greater certainty, this Article does not affect the exercise of moral rights.

(64) Nothing in this Article affects a Party's ability to establish: (i) which specific contracts underlying the creation of works, performances, or phonograms shall, in the absence of a written agreement, result in a transfer of economic tights by operation of law; and (ii) reasonable limits to protect the interests of the original right holders, taking into account the legitimate interests of the transferees.

Article 20.66. Technological Protection Measures (65)

1. In order to provide adequate legal protection and effective legal remedies against the circumvention of effective technological measures that authors, performers, and producers of phonograms use in connection with the exercise of their rights and that restrict unauthorized acts in respect of their works, performances, and phonograms, each Party shall provide (66) that a person who:

(a) knowingly, or having reasonable grounds to know, (67) circumvents without authority an effective technological measure that controls access to a protected work, performance, or phonogram; (68) or

(b) manufactures, imports, distributes, offers for sale or rental to the public, or otherwise provides devices, products, or components, or offers to the public or provides services, that:

(i) are promoted, advertised, or otherwise marketed by that person for the purpose of circumventing any effective technological measure,

(ii) have only a limited commercially significant purpose or use other than to circumvent any effective technological measure, or

(iii) are primarily designed, produced, or performed for the purpose of circumventing any effective technological measure,

is liable and subject to the remedies provided for in Article 20.81.18 (Civil and Administrative Procedures and Remedies). (69)

Each Party shall provide for criminal procedures and penalties to be applied when a person, other than a non-profit library, archive, (70) educational institution, or public non-commercial broadcasting entity, is found to have engaged willfully and for the purposes of commercial advantage or financial gain in any of the foregoing activities.

Criminal procedures and penalties listed in subparagraphs (a), (c), and (f) of Article 20.84.6 (Criminal Procedures and Penalties) shall apply, as applicable to infringements mutatis mutandis, to the activities described in subparagraphs (a) and (b) of this paragraph.

2. In implementing paragraph 1, no Party shall be obligated to require that the design of, or the design and selection of parts and components for, a consumer electronics, telecommunications, or computing product provide for a response to any particular technological measure, so long as the product does not otherwise violate any measure implementing paragraph 1.

3. Each Party shall provide that a violation of a measure implementing this Article is a separate cause of action, independent of any infringement that might occur under the Party's law on copyright and related rights.

4. Each Party shall confine exceptions and limitations to measures implementing paragraph 1 to the following activities, which shall be applied to relevant measures in accordance with paragraph 5: (71)

(a) non-infringing reverse engineering activities with regard to a lawfully obtained copy of a computer program, carried out in good faith with respect to particular elements of that computer program that have not been readily available to the person engaged in those activities, for the sole purpose of achieving interoperability of an independently created computer program with other programs;

(65) Nothing in this Agreement requires a Party to restrict the importation or domestic sale of a device that does not tender effective a technological measure the only purpose of which is to control market segmentation for legitimate physical copies of a cinematographic film, and is not otherwise a violation of its law.

(66) A Party that, prior to the date of entry into force of this Agreement, maintains legal protections for technological protection measures consistent with Article 20.66.1 (Technological Protection Measures), may maintain its current scope of limitations, exceptions, and regulations regarding circumvention.

(67) For greater certainty, for the purposes of this subparagraph, a Party may provide that reasonable grounds to know may be demonstrated through reasonable evidence, taking into account the facts and circumstances surrounding the alleged illegal act.

(68) For greater certainty, no Party is required to impose civil or criminal liability under this subparagraph for a person that circumvents any effective technological measure that protects any of the exclusive rights of copyright or related tights in a protected work, performance, or phonogram, but does not control access to that work, performance, or phonogram.

(69) or greater certainty, no Party is required to impose liability under this Article and Article 20.67 (Rights Management Information) for actions taken by that Party or a third person acting with authorization or consent of the Party.

(70) For greater certainty, a Party may treat a non-profit museum as a non-profit archive.

(71) A Party may request consultations with the other Parties to consider how to address, under paragraph 4, activities of a similar nature that a Party identifies after the date this Agreement enters into force.

(b) non-infringing good faith activities, carried out by an appropriately qualified researcher who has lawfully obtained a copy, unfixed performance, or display of a work, performance, or phonogram and who has made a good faith effort to obtain authorization for those activities, to the extent necessary for the sole purpose of research consisting of identifying and analyzing flaws and vulnerabilities of technologies for scrambling and descrambling of information;

(c) the inclusion of a component or part for the sole purpose of preventing the access of minors to inappropriate online content in a technology, product, service, or device that itself is not prohibited under the measures implementing paragraph (1)(b);

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Document

Name: United States - Mexico - Canada Agreement (USMCA) (2018)
Treaty type: Other International Investment Agreements
Origin language: en,es,fr

Dates and parties

Signed: 30 Nov 2018
Revision signed: 10-12-2019
Entry into force: 1 Jul 2020
Party ISO codes: USAMEXCAN

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