Supreme Court Suspends the Rule that Determines Minimum Expiry Date for Patents on Medicines and Pharmaceutical Products
Minister Dias Toffoli, of the Federal Supreme Court (STF), suspended today (7) the validity of a rule that extends patents on medicines and pharmaceutical products. In a preliminary decision, he suspended Article 40, sole paragraph, of the Industrial Property Law (Law 9.279 / 1996).
With the health crisis caused by the pandemic, the Attorney General filed a preliminary injunction requesting that the rule has a direct impact on the fundamental right to health, since, while the patents of large laboratories have not expired, the pharmaceutical industry will be prevented from producing generic drugs against the new coronavirus and its current and future variants. He pointed out that there were drugs whose patent would have expired, had the rule not been questioned.
Prosecuting a patent may take several years in many emerging markets but among the measures to tackle this problem, many jurisdictions have provided supplementary periods of protection for certain delays occurring during prosecution.
Mexico has entered some International Treaties containing provisions related to patent term extensions particularly in the first and second versions of its Free Trade Agreements with Canada and the US (NAFTA/USMCA) but it has been only recently that such remedy was obtained through successful strategic litigation in the local courts.
In this live and free event, we (lawyers and patent experts from Moeller IP) are going to cover this topic including the judicial case decided in October 2020 by the Supreme Court extending the term of a patent claiming a pharmaceutical product, which had been prosecuted for over 5 years.
To register just use this link https://www.surveymonkey.com/r/G7QN86B
If you have any question contact us at email@example.comRead More
During the fourth quarter of last year, the Mexican Supreme Court of Justice (SCJN), the highest court of the Mexican judiciary, decided on extending Mexican patent No. 238942 because of the administrative delays incurred during its prosecution.
Extension of patent: A patent may be extended to compensate for the delays
In summary, the plaintiff requested the extension of patent No. 238942 at the Mexican Institute of Industrial Property (IMPI) based on article 1709 of the North American Free Trade Agreement (NAFTA) which establishes that a patent may be extended to compensate for the delays caused during its approval process. Accordingly, it took the IMPI around 6 and a half years to grant the corresponding patent, from January 12, 2000, to July 26, 2006.
IMPI denied the request arguing that, according to article 23 of the Mexican Industrial Property Law (IPL), the applicable law at the moment of the granting, term of protection of a patent cannot extend beyond 20 years, starting from the filing date of the patent application. Furthermore, that the application of article 1709 of NAFTA was discretionary; thus, no damage was caused.
The term of protection may never be less than 17 years starting from the date of the grant.
The plaintiff appealed IMPI’s decision through the Mexican judiciary eventually reaching the SCJN. Herein, the SCJN decided that IMPI and previous courts of the Mexican judiciary performed a wrongful interpretation of the applicable law which affected the rights of the plaintiff. Further, the SCJN interpreted that the term of protection may never be less than 17 years starting from the date of the grant.
The recent decision will have important repercussions on the extension of Mexican patents; specifically, those granted before NAFTA was updated to the Agreement between the United States of America, the United Mexican States, and Canada (USMCA).
On December 10th, 2020 the Congress of Uruguay modified article 99 of its Patent Law Number 17164, which had been modified in 2013, to implement protection against patent infringement occurring between the time that goes between the publication of the application, and it’s granting.
Article 289 of Budget Law approved by the Congress set forth the new article 99 of the Patent Law, which has entered in force on January 1st, 2021, and reads:
“The owner of a patent may take the corresponding actions against anyone who infringes the rights arising thereof and may even claim compensation for the acts carried out between the publication of the application and the granting of the patent.
When the right belongs to numerous owners, any of them may take the corresponding actions.
The possibility of claiming compensation for the acts carried out between the publication of the application and the granting of the patent shall not apply in the case of patenting of pharmaceutical products, except in the cases where it has been irrefutably proven that a substantial part of its development has actually taken place in the country (Uruguay)”
Defining when the development of a “substantial part” of pharmaceutical products has taken place in Uruguay seems a vague legal standard so local judges and tribunals will have to clarify it in the future.Read More
As announced by the Argentine authorities, the country has been chosen by some international laboratories, in order to test the effectiveness of vaccines against the coronavirus, which causes the disease known as COVID-19, by carrying out a series of tests on a sample of people, taking as parameters issues such as age, sex, previous disease conditions, among other factors.
In Argentina, there is a specific regulatory framework for conducting tests on the human body, which includes not only common law – civil law – but also specific rules and even provisions of public bodies that regulate issues related to said tests.
The main rules applicable to the development of this type of activities – going from the most general to the most specific – will be succinctly developed, in which are immersed questions about the disposition of the body itself, informed consent, transfer of personal data, sensitive data processing
a) Law 26,994. Civil and Commercial Code.
The civil and commercial code is applicable to the case of informed consent, regulating the acts of disposition that a person can carry out on the body itself, including investigations in human beings.
Article 58 establishes the requirements that need to be carried out when a person is a study subject or participant in medical research in humans through interventions, such as treatments, prevention methods, diagnostic or predictive tests, whose efficacy or safety are not scientifically proven.
Article 59 for its part, regulates informed consent regarding medical acts and health research.
b) Law 25326. Protection of Personal Data.
The conduct of clinical trials also involves sensitive personal data, by relating such trials to very personal and fundamental issues related to the dignity of the person, which have the status of human rights.
In Argentina, the law that regulates the protection of personal data in general, and sensitive data in particular is Law 25326.
This law establishes that sensitive data is “… Personal data that reveals the racial and ethnic origin, political opinions, religious, philosophical or moral convictions, affiliation, and information regarding health or sexual life.”
Likewise, in its article 7, when dealing with the category of data, and when referring to sensitive data, the law prescribes the following: “ARTICLE 7 – (Category of data). 1. No person can be forced to provide sensitive data. 2. Sensitive data can only be collected and processed when there are reasons of general interest authorized by law. They may also be treated for statistical or scientific purposes when their holders cannot be identified. ”
In section 2, the law refers to the process of data anonymization that consists of dissociating the data itself in relation to the determined or determinable person, holder of that data, through a certain process.
Article 8 of the law also mandates that, regarding health-related data, “Public or private healthcare establishments and professionals linked to the health sciences may collect and process personal data related to the physical or mental health of patients who come to them or who are or have been under treatment by them, respecting the principles of professional secrecy. “
Regarding the consent of the owner of personal data, Article 5 of the Data Protection Law prescribes that “(…) the free, express and informed consent will be required, which must be in writing, or by any other means that allows match it, according to the circumstances. The aforementioned consent given with other declarations must appear expressly and prominently, prior notification to the requested data, of the information described in article 6 of this law. “
Specifically speaking of international personal data transfer –sensitive data in particular-, article 12 exceptionally authorizes the transfer of said type of data only in an epidemiological investigation, as long as it is carried out under the terms of subsection e) of Article 6 –only when an anonymization procedure is applicable to the data collected-.
c) Resolution 1480/2011 and Disposition 6677/2010 from the Health Regulatory Authority –ANMAT-
c.1) Res. 1480/2011, Point A3. provides a definition of what informed consent has to be considered when a clinical trial is being carried out. The rule establishes that “As a general principle, consent must be obtained for all research involving human beings or carried out with biological samples or personal data.” In connection with this, the test subject will have to be informed the measures that will be taken to protect the confidentiality of personal data.
Regarding the confidentiality of the information obtained from the test subjects, point A6 prescribes that personally identifiable data should not be used when a study can be done without it. When it is necessary to record personal identification data, researchers must justify that need. For this purpose the consent has to be obtained. Furthermore, point A8. Regarding the management of the data and the results, prescribes the obligation for the researches to secure the personal data.
c.2) Disposition 6677/2010 from the Argentinean Health Regulatory Authority. Regime of Good Clinical Practices for Clinical Pharmacology Studies.
This provision states:
- a) That researchers must ensure the confidentiality of the information in the stages of preparation, execution and completion of the study, as well as the identity of the people incorporated into it;
- b) That the protocols contain confidentiality considerations;
- c) That it is an indispensable requirement for the approval of a clinical trial, the presentation of an informed consent form in which the person is informed: objectives, methods, advantages, therapeutic alternatives and possible risks inherent in the study and that it is free to withdraw their consent to participate, at any time, without explaining the causes.
As a corollary of this report, in order to carry out clinical trials in Argentina on people, the following aspects must be taken into account:
a) Minimum consent requirements.
- The confidential nature of the information related to the study, and the personal data of the patient.
- The objectives, methods, and potential benefits provided in the study.
- Therapeutic alternatives.
- The possible risks inherent in the trial, and the damages that may be caused to the patient.
- The freedom of the participant to withdraw their consent at any time, without explaining the causes or resulting in harm to them.
- That the researcher will provide the medication free of charge in the study.
- That if the patient / healthy volunteer cannot provide consent on their own, it must be obtained from their legal representative.
- That the researcher will bear the costs arising from the clinical investigation, both the expenses of the procedures used for the study and the damages caused to the patient as a consequence of their participation.
- That the signing of the informed consent does not imply the resignation of the patient to any of the rights provided in the current legal regulations.
b) Data Protection Principles that have to be complied with during Clinical Trials:
- The obtention of the informed consent;
- The rights that the subject has regarding his personal and sensitive data;
- The informed consent has to include the right of professional secrecy;
- Indicate the pseudonymization and anonymization procedures;
- The right of the person to access, control, rectify and erase their personal data from the database;
- Respect the principle of data quality and the purpose of its collection
Considering the current sanitary emergency, to extend the suspension of terms determined by the Resolutions N 16-2020, 22-2020, 34-2020, 37-2020, 42-2020, 47-2020, 51-2020, 69-2020, 78-2020, and 116-2020 until September 20th, 2020, inclusive.
We will continue to provide legal updates as needed and requested, to our clients and colleagues worldwide, and wish you to stay healthy and safe.
Please do not hesitate to contact us at any time with any doubt or questions you may have.
Free live Webinar on Computer Implemented Inventions (CII) in Latin America on Wednesday July 8th at 12;00 EDT.
Join Jose Santacroce, Head of Moeller’s Patent Department, and Mariano Municoy, Head of our Legal Department in this live webinar where they will analyze the most important issues when filing, prosecuting and enforcing patents protecting CII in Latin America, particularly in Argentina, Brazil and Mexico
Mr. Santacroce retired as Director at the European Patent Office in the field of Computers (Human-Computer Interaction) after working there for 30 years and since early 2018 has led Moeller Patent Department.
Mr. Municoy has 20 years of legal experience and teaches regularly IP courses both in the US at Chicago-Kent as well as in Argentina at Austral and San Andres Universities.
Even though in absolute terms the number of CII patent applications in Latin America is still very low when compared to those of developed countries/regions, relatively speaking they have been growing faster than applications in other fields of technology, which very likely will accelerate in the near future as we all adapt to the new ways of living and working in an-after-COVID 19-world
During the webinar, they will present both a general picture and some particular insights about the best ways to achieve the optimal legal patent protection for CII inventions in Latin America.
At the end, there will be some time available for live Q&ARead More
Brazilian PTO and CAS Establish Technical Cooperation Agreement to Strengthen the Fight Against Patent Backlog
BRPTO and CAS, a non-profit division of the American Chemical Society, signed a technical cooperation agreement (ACT) to expedite the examination of patents. ACT was published in the Federal Official Gazette this Wednesday (06/10). The agreement establishes INPI’s participation in a CAS Search Report pilot, with the objective of improving the patent workflow at the Institute.
The technology, which will be tested and optimized, is able to assess similarities with the state of the art from parameters of a patent application important for the examiner’s analysis. In addition, the system combines machine learning and data selected by humans, which improves the results offered.Read More
By Moeller IP.
The latest update about the suspension of deadlines in the American Region Patent and Trademark Office.
The Enlarged Board of Appeal of the European Patent Office issued opinion G 3/19 (Pepper) on 14.05.20 and concluded that plants and animals exclusively obtained by essentially biological processes are not patentable.
The key concepts of opinion G 3/19
The Enlarged Board of Appeal of the European Patent Office adopted a dynamic interpretation of the exception to patentability under Article 53(b) of the European Patent Convention (EPC) and held that the non-patentability of essentially biological processes for the production of plants or animals also extends to plant or animal products that are exclusively obtained by means of an essentially biological process.
The Enlarged Board of Appeal is the highest judicial authority under the EPC, which provides for an autonomous legal system that is separate from the European Union. The Enlarged Board’s main task is to ensure the uniform application of the EPC.
Under Article 53(b) EPC, European patents shall not be granted in respect of plant or animal varieties or essentially biological processes for the production of plants or animals. Rule 28(2) EPC provides that under Article 53(b) EPC, European patents shall not be granted in respect of plants or animals exclusively obtained by means of an essentially biological process.
Rule 28(2) EPC was introduced by the decision of the Administrative Council of the European Patent Organisation and came into force on 1 July 2017.
In 2015, the Enlarged Board had concluded in its decisions G 2/12 and G 2/13 within the then applicable legal framework, i.e. before the introduction of Rule 28(2) EPC, that the non‑patentability of essentially biological processes for the production of plants or animals under Article 53(b) EPC did not extend to products that are exclusively obtained by means of an essentially biological process.
In 2018, a Technical Board of Appeal held in decision T 1063/18 that new Rule 28(2) EPC had no impact on the interpretation of Article 53(b) EPC, and followed the Enlarged Board’s earlier decisions G 2/12 and G 2/13.
In 2019, the President of the European Patent Office referred a point of law to the Enlarged Board of Appeal under Article 112(1)(b) EPC concerning the interpretation of Article 53(b) EPC in view of legal and other developments occurring after decisions G 2/12 and G 2/13, and in particular in view of new Rule 28(2) EPC.
In its opinion issued today, the Enlarged Board of Appeal held the referral by the President of the European Patent Office to be admissible within the terms of a re‑phrased question. On the merits of the referral, the Enlarged Board endorsed its earlier findings on the scope of Article 53(b) EPC, which were based on the classical (i.e. the grammatical, systematic, teleological and historical) methods of interpretation. However, the Enlarged Board found that a particular interpretation which has been given to a legal provision can never be taken as carved in stone, because the meaning of the provision may change or evolve over time. This meant that decisions G 2/12 and G 2/13 did not settle the meaning of Article 53(b) EPC once and for all.
Taking account of the Administrative Council’s decision to introduce Rule 28(2) EPC, the preparatory work on this provision and the circumstances of its adoption, as well as legislative developments in the EPC contracting states, the Enlarged Board concluded that new Rule 28(2) EPC allowed and indeed called for a dynamic interpretation of Article 53(b) EPC.
In adopting this dynamic interpretation, the Enlarged Board abandoned its earlier interpretation of Article 53(b) EPC in decisions G 2/12 and G 2/13. It held that, after the introduction of new Rule 28(2) EPC, Article 53(b) EPC was to be interpreted to exclude from patentability plants, plant material or animals, if the claimed product is exclusively obtained by means of an essentially biological process or if the claimed process features define an essentially biological process.
In order to ensure legal certainty and to protect the legitimate interests of patent proprietors and applicants, the Enlarged Board ruled that the new interpretation of Article 53(b) EPC given in G 3/19 had no retroactive effect on European patents containing such claims which were granted before 1 July 2017, or on pending European patent applications seeking protection for such claims which were filed before that date.
Source: www.epo.orgRead More