This is an update to our posts on April 8, 2021, March 15, 2021 and March 10, 2021. As readers are aware, the Brazilian Supreme Court was scheduled to decide the constitutional challenge involving Article 40 of the Brazilian Intellectual Property (IP) Statute (ADI 5529), on April 7, 2021; however, the hearing was delayed due to a discussion in another case.
Yesterday, the Brazilian Supreme Court issued its decision, with a majority holding the 10-year patent term unconstitutional (Article 40, sole paragraph). Nine Justices issued opinions stating that 10-year patent term, even in view of the backlog of patent applications waiting to be examined at the Brazilian Patent and Trademark Office (BRPTO), violates the country’s Constitution. The Justices also decided that the general provision of 20 years from the date of filing provides a suitable and sufficient term of protection for patent owners.
The decision was based on 5 reasons that can be summarized as it follows. Specifically, according to the Court, the challenged provision:
- Constitutes a “term extension” that affords disproportionate protection to patent owners;
- Undermines the temporary nature of a patent as provided by the Brazilian Constitution;
- Provides automatic compensation to an applicant without assessing the applicant’s responsibility in contributing to the delay in examination;
- Finds no parallel in any other IP regimes abroad (namely, the fact that patents automatically receive a patent term of 10-years from the date of grant); and
- Raises drug prices in the Brazilian market by creating monopolies thereby impacting society’s access to drugs and public health social policies.
Justice Barroso, followed by Chief Justice Fux, issued dissenting opinions, arguing that pending patent applications do not provide any type of protection for patent owners, therefore, there is no protection prior to grant. Only granted patents provide protection. In their view, if patent owners are not provided a 10-year patent term, they might not have sufficient term to protect their inventions. Additionally, Justice Barroso stated that if the BRPTO is examining applications at a faster rate as a result of the backlog combat plan, the 10-year patent term will soon be unnecessary and would not need to be declared unconstitutional or revoked. Therefore, in his opinion, Congress should focus on improving the BRPTO.
Chief Justice Fux also stated that it was necessary to observe the consequences of the decision and its impact in the economy.
Is the Decision Retroactive?
The Supreme Court will decide next week whether the decision applies retroactively. Justice Toffoli is proposing not to apply the decision retroactively to all patents issued before the publication of the final decision with two notable exceptions. Specifically, under Justice Toffoli’s proposal, the decision would be retroactive for: (i) patents directed to pharmaceuticals (including both products and medical devices); and (ii) in specific cases where the constitutionality of Article 40 was argued in lawsuits already in progress (which would include non-pharma patents). However, several of the Justices expressed concern that the decision should not be retroactive or should be tailored only to pandemic related products (versus all pharmaceutical products).
After some debate, the Justices decided to postpone a final decision on the retroactive effect of its decision until Wednesday, May 12th session.
Please continue to watch BRICS & Beyond for continued updates on the Supreme Court decision.
This post was written by Lisa Mueller and by Rob Rodrigues and Luisa Saraiva from Licks Attorneys
Back on April 2, 2015, the U.S. Patent and Trademark Office (USPTO) published final rules for implementing the Geneva Act of the Hague Agreement Concerning the International Registration of Industrial Designs July 2, 1999 (Final Rules). Implementation of the Hague Agreement was significant because it allowed Applicants to (1) file a single international design application with the USPTO as the “office of indirect filing”; (2) designate multiple Hague Agreement member countries and pay filing fees for each designated country; and (3) benefit from the resulting registration becoming effective and enforceable in each of the designed countries.
Also included in the Final Rules, however, was a change that impacted U.S. utility patent practice, specifically, the filing of a Request for Continued Examination (RCE). Most importantly, the Final Rules clarified that the filing of an RCE under 37 CFR. § 1.114 was not applicable in international design applications and excluded U.S. National Stage Patent Cooperation Treaty (PCT) applications that did not comply with 35 U.S.C. § 371. On page 17930 of its summary of the Final Rules, the USPTO explained that this change to Section § 1.114 was made to “clarify that the request for continued examination practice set forth in § 1.114 added in section 4403 of the AIPA [American Inventors Protection Act of 1999] does not apply to an international application until the international application complies with 35 U.S.C. § 371 (which requires the filing of an inventor’s oath or declaration (or substitute statement) in the international application, as well, as for example, the basic national fee and an English language translation of the international application if filed in another language)”. As a result, the USPTO amended § 1.114 by revising paragraphs (e)(3)-(5) and adding paragraph (e)(6) to currently read as shown below:
§ 1.114 REQUEST FOR CONTINUED EXAMINATION. (a) If prosecution in an application is closed, an applicant may request continued examination of the application by filing a submission and the fee set forth in § 1.17(e) …. ***** (e) The provisions of this section do not apply to: (1) A provisional application (2) An application for a utility or plant patent filed under 35 U.S.C. § 111(a) before June 8, 1995; (3) An international application filed under 35 U.S.C. 363 before June 8, 1995 or an international application that does not comply with 35 U.S.C. § 371; (4) An application for a design patent; (5) An international design application; or (6) A patent under reexamination.
The Final Rules became effective on May 13, 2015. Thus, beginning on this date, a U.S. National Stage PCT application for which an inventor’s oath or declaration (or substitute statement) had not been filed was not eligible for an RCE filing.
Last week, Applicants who filed an RCE in a U.S. National Stage PCT application in which an inventor oath or declaration had not been filed began receiving Notices of Abandonment which stated:
“The Office acknowledges the filing off the Request for Continued Examination (RCE) on January 1, XXXX. However, the RCE provisions of 37 CFR 1.114 do not apply to an international application that does not comply with 35 U.S.C. 371. See 37 CFR 1.114(e)(3). An inventor’s oath or declaration for each named inventor is required for an international application to comply with 35 U.S.C. 371, notwithstanding the changes permitting applicants to postpone filing the inventor’s oath or declaration until the date on which the issue fee is paid. See 37 CFR 1.495(c)(3)(ii). See also Changes To Implement the Hague Agreement Concerning International Registration of Industrial Designs, Final Rule, 80 Fed. Reg. 17918, 17930 (April 2, 2015). The present application, which is a national stage entry of an international application, has not met the requirement of 35 U.S.C. 371(c)(4) in that a compliant inventor’s oath or declaration has not been filed for each named inventor. Accordingly, as a proper reply to the Office Action mailed on June 1, XXXX, has not been timely filed, the application is abandoned.”
The receipt of these Notices of Abandonment came as a complete surprise to many Applicants and has led to the question as to “What do you do if you find yourself in this predicament?”
For abandoned applications:
- Obtain executed inventor oaths or declarations or substitute statements as quickly as possible;
- File an RCE form along with the executed inventor oaths or declarations or substitute statements; and
- File a Petition for Revival of an Application for Patent Abandoned Unintentionally under 37 CFR § 1.137(a) and the petition fee as soon as possible.
For pending U.S. National Stage PCT applications:
- Conduct an audit of your currently pending application and obtain executed inventor oaths or declarations or substitute statements and file them in the USPTO as soon as possible; or
- If the application is under final rejection and executed inventor oaths or declarations cannot be readily obtained or the conditions for filing a substitute statement have not been met, file a continuation application.
Patents issued from U.S. National Stage PCT applications in which an RCE was filed without an inventor oath or declaration:
Consider filing an RCE form with the executed inventor oaths or declarations or substitute statements and a Petition for Revival of an Application for Patent Abandoned Unintentionally under 37 CFR § 1.137(a) (Petition to Revive) and petition fee as soon as possible.
Although it may appear odd to be filing a Petition to Revive on an issued patent, the USPTO has previously granted such petitions. For example, a Petition to Revive was granted in U.S. Patent No. 6,872,198 (the ‘198 patent). U.S. Application No. 10/231,748 (Application), which issued as the ‘198 patent, was filed with a nonpublication request under 35 U.S.C. § 122(b)(2)(B)(i). A PCT application was later filed claiming priority to the Application. During litigation, it was alleged that the Application should have been abandoned under 35 U.S.C. § 122(b)(2)(B)(iii) for failure to notify the U.S. Patent Office of the PCT filing. The Patent Owner filed a Rescission of Previous Nonpublication Request and a Petition to Revive on March 23, 2006. The USPTO granted the petition on August 17, 2006. In its Decision Granting Petition Under 37 CFR § 1.137(b) (Decision), the USPTO noted that “[T]his application matured into Patent No. 6,872,198 on March 29, 2005. Therefore, no further action being required, this patented file is being referred to Files Repository.” Copies of the Petition to Revive and Decision are provided here:
The ‘198 patent was the subject of litigation in Arrow Intern. v. Spire Biomedical, Inc., 443 F.Supp.2d 182 (D. Mass. 2006) and Arrow Intern. v. Spire Biomedical, Inc., 635 F.Supp.2d 46 (D. Mass. 2009).
Additionally from a policy perspective, perhaps a technical correction to the statute should be considered that (1) would be retroactive; and (2) would make RCEs in these applications proper provided that all the requirements under 35 U.S.C. § 371 were satisfied by the time the issue fee is paid. Such a revision of the statute would be consistent with 35 U.S.C. 115(f), which requires the oath or declaration to be filed no later than the date on which the issue fee for the patent is paid.
Considerations for future U.S. National Stage PCT Application filings
One option when filing a U.S. National Stage PCT application is to file the application as a 35 U.S.C. § 120 continuation application, which is also known as a “pass through” or “bypass” continuation. Filing a bypass continuation avoids the need to submit an oath or declaration before the filing of an RCE. Another option is to include inventor signatures as part of the PCT Request (Form PCT/RO/101) by utilizing Box VIII(iv). Alternatively, signatures of the inventors can be included on Form PTO/AIA/01 using the PCT international application number to identify the application to which the declaration is directed and submit the form upon entering the national phase.
We will continue to monitor this situation and provide further updates as they become available.
This post was written by Lisa Mueller and Jeff Childers.
On July 21, 2020, the Parliament of Ukraine introduced several major amendments to Ukrainian patent law. Although the amendments still need to be approved by the President in order to become effective, this is considered a mere formality and is expected to be completed within the next several weeks.
The amendments are particularly relevant for the pharmaceutical industry, and even more so for local generic manufacturers, for which the amendments are very favorable. The amendments are as follows:
Significant limitation in the scope of patent protection
According to the amendments, methods of treatment claims are no longer patentable. Additionally, patent protection for new forms of known substances, such as salts, esters, ethers, complexes, combinations and other derivatives, polymorphs, metabolites, pure form, particle size, isomers, will be difficult to obtain unless the Applicant can demonstrate that the new form of the known substances differs significantly from the original substances with respect to efficacy. This change is very similar to the wording of Section 3(d) of the Indian Patent Act of 1970 (http://ipindia.nic.in/writereaddata/Portal/ev/sections/ps3.html), and is contradictory to Ukraine’s international obligations of harmonizing its law with the European Union’s (EU) legislation.
New rules regarding supplementary protection certificates (SPC)
The amendments also require that a valid Ukrainian marketing authorization (MA) exist when a Patent Owner applies for a SPC. Additionally, there are new timing requirements with respect to the filing for an SPC. Specifically, a Patent Owner can only obtain an SPC in Ukraine if a Ukrainian MA is filed within one year after the filing of the very first MA application for the product in another country. For example, if the very first MA is filed in the United States on May 1, 2018, and a second MA is filed in Russia on June 15, 2019, in order to obtain an SPC for any patent filed in the Ukraine covering the product, the MA in Ukraine would have to be filed before May 1, 2019. Additionally, a request for a SPC must be filed within 6 months after the initial Ukrainian MA is obtained or after a patent (that covers the product encompassed by the MA) is granted, whichever occurs first.
Another change relates to the limits on protection provided by a granted SPC. Specifically, a SPC in Ukraine will not cover the use of a patented product that is solely exported out of the country. Moreover, a SPC will not be deemed to be infringed if a patented drug is used within 6 months prior to the expiration of a SPC for purposes of creating a stockpile of product for sale after patent expiry.
New options with respect to oppositions
The amendments also introduce an opposition procedure into Ukrainian patent law. This is good news as the availability of an opposition procedure provides an alternative to the lengthy and costly litigation previously required to invalidate a patent. The amendments provide two opportunities for an opposition: a pre-grant opposition, which can be filed within 6 months after the patent application publishes, and a post-grant opposition that can filed within 9 months after publication of the grant of the patent. Both oppositions will be conducted by the Ukrainian Patent Office. The grounds for a pre-grant and post-grant opposition will be different. Specifically, the grounds available for a pre-grant opposition will include novelty, inventive step, lack of industrial applicability, lack of subject matter eligibility (i.e., the invention is directed to a method of treatment or plant variety), or that the invention is contrary to moral principles. In contrast, a post-grant opposition will be limited to just novelty, inventive step and lack of industrial applicability.
In summary, the new amendments to Ukrainian patent law will make life more challenging for larger pharmaceutical companies and will require greater expenditure of resources and time in order to obtain, maintain, and enforce patents against generic companies in the country.