Overview
An Opinion drafted by the Brazilian Patent and Trademark Office (BPTO) legal department regarding the patent term for pharmaceutical products or chemical products for agriculture filed between January 1
st, 1995 and May 14
th, 1997, the so called “mailbox” patents, was published in the official patent gazette on September 10
th, 2013. On September 11
th, 2013, the BPTO legal department filed 37 lawsuits at the Federal Courts to correct the term of about 247 “mailbox” patents
1. The conclusion in this Opinion is that said “mailbox” patents may not benefit from the 10 years term counted from the date of granting, but rather are limited to the 20 years term counted from the filing date, which would significantly reduce the term of these patents.
Upon the creation of the World Trade Organization (WTO) on January 1
st, 1995, which deals with the rules of trade between nations, one of the agreements that came into effect was the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement. The TRIPS Agreement, which is the most important multilateral instrument for the globalization of intellectual property laws, was negotiated at the end of the Uruguay Round of the General Agreement on Tariffs and Trade (GATT) in 1994
2.
The TRIPS Agreement established that patents shall be available for any invention, whether a product or process, in all fields of technology without discrimination, where those inventions meet the standard substantive criteria for patentability, namely, novelty, inventive step and industrial applicability. Most members have agreed to apply the TRIPS Agreement at the moment they become a member of the WTO. However, some transition provisions, which gave WTO Members a larger period of time to adapt their legislation and practices to the TRIPS obligations, were foreseen.
3 According to Article 65.4 of the TRIPS Agreement, developing countries, that did not provide product patent protection in a particular area of technology when the TRIPS Agreement came into force (on January 1
st, 1995), has up to 10 years to introduce the protection (until January 1
st, 2005). Therefore, during such transitional period, the developing countries had the obligation of providing a system whereby applications for said inventions could be filed, even if a decision on such patent applications is delayed up until January 1
st, 2005 (referred to as “mailbox” system). Particularly in Brazil, the referred transitional period occurred from January 1
st, 1995 (the effective date of the TRIPS Agreement) to May 14
th, 1997 (the effective date of the current Brazilian IP Law #9279/96).
4
Mailbox patents according to the Brazilian IP Law
According to Sole Paragraph of Article 229 of the Brazilian IP Law #9279/96
5, the term of a “mailbox” patent is defined as follows:
“Article 229…Sole Paragraph – The criteria of patentability in this Law, on the effective date of filing the application in Brazil, or of the priority, if any, shall apply to applications related to pharmaceutical products and chemical products for agriculture filed between January 1st, 1995 and May 14th, 1997, thus ensuring protection as of the date of grant of the patent, for the remaining term as from the date of filing in Brazil, limited to the term provided for in the heading of Article 40.”
Article 40 provides that the term of a patent is 20 years from its filing date but not less than 10 years from the date of grant. Specifically, Article 40 states the following:
“Article 40 – An invention patent shall be in force for a 20 (twenty) year term, and a utility model patent for a 15 (fifteen) year term, as from the date of filing.
Sole Paragraph – The term shall not be less than 10 (ten) years for patents of invention and 7 (seven) years for utility model patent, as from the date of grant, except if BPTO is unable to proceed with the examination on the merits of the application, due to a proven pending litigation or for reasons of force majeure.”
Additionally, according to the provisions of Article 229-B of Brazilian IP Law #9279/96, patent applications for pharmaceutical products or chemical products for agriculture filed between January 1st, 1995 and May 14th, 1997, shall be decided upon until December 31
st, 2004, in order to comply with the deadline established on Article 65.4 of the TRIPS Agreement (that is, January 1
st, 2005). Specifically, Article 229-B states the following:
“Article 229-B – applications for product patents filed between January 1st, 1995 and May 14, 1997, which enjoyed no protection under Article 9 items “b” and “c” of Law # 5.772 of December 21, 1971, and whose applicants have not exercised the ability set forth in Articles 230 and 231, shall be decided upon until December 31, 2004 in accordance with this Law.”
As can be seen, those “mailbox” patents could not obtain the benefits of sole paragraph of Article 40 of the Brazilian IP Law, but only the heading of such Article. Therefore, the sole paragraph of Article 229 would limit the term of the “mailbox” patents to 20 years from the filing date.
However, contrarily to the provisions of sole paragraph of Article 229 and Article 229B, the BPTO had issued several “mailbox” patents beyond the deadline of December 31st, 2004, with a term of 10 years from the granting date, apparently considering those patents as “regular patents”, no longer being examined in the “mailbox” system, since the BPTO failed to comply with the rule of Article 229-B.
Court actions filed against the Mailbox Patents
The federal attorneys of the BPTO submitted on September 5th, 2013 an Opinion to the President of BPTO arguing that the term of the “mailbox” patents should be of 20 years counted from their filing date and that the patent term of 10 years counted from the grant, established in the sole paragraph of Article 40, should not apply to these patents.
In sum, according to the federal attorneys of the BPTO’s understanding, the provisions of Article 40 (sole paragraph) would not be applicable to the “mailbox” patents, concluding that these patents granted with a 10 years term would violate the law, therefore entailing nullity actions according to Article 46 of the Brazilian IP Law, which states that:
“a patent that is granted contrary to the provisions of this law shall be null and void.”. However, the obligation of issuing a decision granting or denying “mailbox” applications by December 31
st, 2004 established on Article 229-B was completely omitted from the Opinion.
After being signed by the president of the BPTO, the Opinion was published on September 10
th, 2013 in the Industrial Property Gazette and after that 37 lawsuits were filed by the BPTO at the Federal Courts requesting (1) a preliminary injunction to suspend the effects of the patents after its expiration date with the 20-year term from the filing; (2) the nullity of the patent, since it was granted with the incorrect validity term, being contrary to the provisions of Article 229 of the Brazilian IP Law, or (3) the partial nullity of the patent to correct its term from 10 years from the granting date to 20 years from the filing date
6. Regarding the item (1), the Circuit Judge, at a Trial level, has rejected in most of the lawsuits the preliminary injunction requested by the BPTO to suspend the effects of the patents after their claimed expiration date of 20 years counted from the filing date.
Although the BPTO filed lawsuits contesting an act executed by itself, the Patentee needs to submit a defense response in the present litigation. If such response is not submitted, the lawsuit would proceed, the patent would probably be considered null and the patentee might be condemned to pay attorney fees to the BPTO in the end of the litigation. In this regard, when executing such decision, in order to compensate this amount, the BPTO may request the Court transference of any other IP right in the name of the patentee to the payment of these attorney fees. Moreover, this debt may be also included in the Brazilian government’s debtor list, which means that the debtor company may be restricted from participating in public biddings
6.
In the event the patentee has already lost interest in the “mailbox” patent under litigation, an option would be to file an administrative petition at the BPTO requesting the waiver of rights of the patent and then informing to the court that the lawsuit should be dismissed in relation to this specific patent. This would be the less expensive way to handle the matter. On the other hand, if the “mailbox” patent is of interest of the patentee, thus, a full defence should be submitted to the courts.
Notwithstanding the above, based on the provisions of a new Resolution #113/2013
7, published on October 29, 2013, which normalize the procedures regarding the payment of annual fees and the corresponding restoration/shelving of patent/patent applications, the BPTO notified the final extinction of several “mailbox” patents under litigation for having more than one annual fee overdue.
In the cases where an administrative petition requesting the waiver of rights was not filed yet and a decision finally extinguishing the “mailbox” patent was notified, according to the new Resolution #113/2013
7, the simple submission to the court of a response informing the issuance of such decision by the BPTO itself would be enough to request the closure of the litigation against this specific patent.
The present scenario may be considered unjustified and unfair for the owner of the “mailbox” patent under litigation, however a response to the lawsuit is necessary in view of the several negative consequences that can be reflected in the patentee’s business. Therefore, the value of the “mailbox” patents should be evaluated in order to choose the best strategy to follow.
Reference List
1. M. J, Zanon,
Brazilian Patent and Trademark Office – INPI files Lawsuit to correct the patent term of 247 medicines and agrochemicals patents, M.J. Zanon (Nov. 25, 2013), available at <http://www.mjzanon.com/brazilian-ip-news/brazilian-patent-office-and-trademark-%E2%80%93-inpi-files-lawsuit-to-correct-the-patent-term-of-247-medicines-and-agrochemicals-patents/>.
2. World Trade Organization (WTO),
Pharmaceutical patents and the TRIPS Agreement, (Nov. 25, 2013), available at <
http://www.wto.org/english/tratop_e/trips_e/pharma_ato186_e.htm#fntext2>.
3. World Trade Organization (WTO),
Intellectual property: protection and enforcement, (Nov. 24, 2013), available at <
http://www.wto.org/english/thewto_e/whatis_e/tif_e/agrm7_e.htm>.
4. World Trade Organization (WTO),
Developing countries’ transition periods, (Nov. 26, 2013), available at <
http://www.wto.org/english/tratop_e/trips_e/factsheet_pharm04_e.htm>.
5. INSTITUTO DANNEMANN SIEMSEN DE ESTUDOS DE PROPRIEDADE INTELECTUAL (IDS), Comentários à Lei da propriedade industrial p.492-493 (Renovar 2nd ed. 2005).
6. Lisa Mueller, Gustavo de Freitas Morais and Justin Duarte Piné,
The Problem of Mailbox Patents and Patent Term in Brazil, Bric wall blog (Nov. 25, 2013),
available at <
http://bricwallblog.wordpress.com/2013/10/01/the-problem-of-mailbox-patents-and-patent-term-in-brazil/>.
7. MINISTÉRIO DO DESENVOLVIMENTO, INDÚSTRIA E COMÉRCIO EXTERIOR, Instituto Nacional Da Propriedade Industrial,
Resolution #113 /2013, Industrial Property Journal # 2233, October 22, 2013.
Authors
Silvia Moreira Taketsuma Costa
Patent Attorney
Dannemann Siemsen
Marques de Olinda Street, 70
CEP: 22251-040
Rio de Janeiro, RJ
Brazil
Telephone.: +55 21 2237 8712
Fax: +55 21 2237 8922
[email protected]
Biography:
Graduated in Industrial Pharmacy, worked in the area of analytical chemistry and quality control in the pharmaceutical industry, since 2007 works as patent attorney at Dannemann, Siemsen, Bigler & Ipanema Moreira in the field of chemical-pharmaceutical, cosmetic and biotech patents and is currently concluding the Master studies in Intellectual Property and Innovation at Brazilian PTO.
Rafaella de Souza Oliveira Azevedo
Patent Attorney
Dannemann Siemsen
Marques de Olinda Street, 70
CEP: 22251-040
Rio de Janeiro, RJ
Brazil
Telephone.: +55 21 2237 8974
Fax: +55 21 2237 8922
[email protected]
Biography:
Graduated in Industrial Chemistry, worked in the area of environmental analytical chemistry and since 2009 works as patent attorney at Dannemann, Siemsen, Bigler & Ipanema Moreira in the field of chemical-pharmaceutical, cosmetic and biotech patents.
Related Event
When: Tuesday, January 28 to Wednesday, January 29, 2014
Where: Radisson Blu Hotel, Amsterdam
Tags: Biotch Patent, patent litigation, Pharma Patent