Keywords

1 Introduction

The current global public health crisis caused by the new Coronavirus has revealed a shortage of vaccines, active substances, excipients and other treatments and materials—especially in the context of biotechnological innovations—required to tackle the pandemic’s effects on individual health and on healthcare provision in general. The various vaccines developed since the beginning of January 2020 currently benefit from exceptional manufacturing and marketing authorisations in all Member States of the European Union (and also in non-members).

The flexibilities of the TRIPS Agreement, particularly the right to grant compulsory licences for the use of patented inventions, have been hailed as the panacea for the problem of coronavirus vaccine shortages. The improvement of second generation genetically recombinant vaccines designed to prevent the entry of the viral protein (spike protein) into human cells is currently being studied and developed. However, upstream of this complex legal issue, there are a whole set of constraints in terms of pharmaceutical regulation, access to secret know-how, manufacturing and distribution chains for vaccines and other raw materials.

Most of the Covid-19 vaccines, however, are not yet protected by patent rights. Only those developed in the Russian Federation were granted patent rights in a very short space of time (about 2 months from the filing date), and these patents are thus in force in that country. It is assumed that by the end of the 12-month periodFootnote 1 following the date of filing of the first application, the holders of these patent rights will have filed identical applications for protection at the European Patent Office and the US Patent and Trademark Office, as well as at similar public bodies in Japan, the People’s Republic of China, South Korea, Israel, etc. Meanwhile, other pharmaceutical products used in the fight against this pandemic already enjoy patent rights, and in some other cases the patents have already expired.Footnote 2

2 Biotechnological Inventions and Patent Rights

Patent law protects inventions. Inventions are creations of the human spirit that translate into technical solutions (that are new and involve an inventive step) for multiple technical problems, which imply human manipulation of natural forces (e.g., chemistry, mechanics, thermodynamics, electromagnetism), albeit with the help of machines or computer programs, including those provided with artificial intelligence.

In the legal framework of biotechnological inventions, the European Union legal rules are (to date) the only ones that define the concept of “life” in patent law, along with the legal systems of the Member States that have transposed Directive 98/44/EC into domestic law; in other words, the European Union legal system is the only one on the planet that defines the concept of biological material, for the purposes of patent law. In Art. 2(1)(a) of Directive 98/44/EC, of 6 July 1998, of the European Parliament and of the Council, on the legal protection of biotechnological inventions (in Official Journal of the European Communities, no. L 213, of 07/30/1998, p. 13 ff.), biological matter is defined as “any matter containing genetic information and capable of reproducing itself or being reproduced in a biological system”. The Portuguese Industrial Property Code of 2018 accepted this definition, qua tale, in its Art. 54(4).

It should be noted that this definition avoids the use of the word “life” or “organism” or even “living organism”. This option seems to be justified by the need to ensure that the concept of biological matter is not limited only to materials that produce energy and that grow and divide, which would exclude viruses from the list. A criterion was thus adopted (a criterion of “life”) that highlights the capacity for replication and expression of transmissible genetic information (Marques 2007a, p. 228). As can be seen, this notion of “biological matter”—conceived in the mid-1980s—is now somewhat outdated, as a consequence of the development of scientific knowledge. For example, it only covers (biological) materials that can be replicated or that can self-replicate in a biological system (and not, e.g., viruses, which replicate DNA outside cells and cellular systems equipped with membranes designed to isolate proteins and nucleic acids from the outside environment, with replication of DNA in vitro, in a “test tube”).

The creativity underlying cultural goods protected by copyright—which do not require a constitutive registration system—, unlike the creativity underlying the manipulation of the forces of nature (and, pour cause, of genomes) and the utilitarian approach that emerges from them as necessary to satisfy human needs materialised in products or processes, allows us to understand why the latter subsystem of intellectual property—i.e., patent law and patentable genetic realities—resonates less, in ethical and legal terms, among consumers of products and processes that are protected by this patent law. Despite much national and supranational controversy surrounding the limits placed on access to health care by the rules governing medicine patents, and despite criticism of the specific rules on the patentability of elements detached from the human body (including genes) and animals, and how these affect access to plant reproduction or plant propagation materials—in particular, seeds—, these industrial property rights have not been part of the cultural life of citizens or organisations representing their interests in these areas of human action (Marques 2021, p. 161).

These inventions may have biological materials as their object: e.g., genetic sequences (DNA, RNA), bacteria, viruses, cells, cell lines, and animal and plant parts. And these biotechnological inventions and the patent rights attached to them are at the forefront, domestically and in international trade, of current and future controversies over people’s access to health care and of States’ aspirations to improve their public health systems, in terms of the acquisition and supply of medicines to their citizens.

It is my opinion, however, that the issue of providing patent protection for certain biological realities, and in particular genetic sequences—including the genetic sequences of human beings–, and of protecting pharmacological, preclinical and clinical information transmitted by drugs companies when applying for approval for generic medicines, places the patent right, the legal rules on plant varieties and the exclusive rights over that test data at a new juncture, namely, the economic enjoyment of this type of industrial property rights and economic analysis of the markets created by the presence of the biological realities thus protected, on the one hand, and the cultural and social sense of the use and consumption of the products and processes protected by these rights, on the other. Quite often the same biological reality (e.g., a plant or part of a plant) constitutes the mass where two types of exclusive industrial rights—the biotechnological patent right and the plant variety breeder's right—can converge, with a potential serious conflict regarding their protection, particularly if the holders of those rights are different persons or entities.

Directive 98/44/EC, of the European Parliament and of the Council, of 6 July 1998, on the legal protection of biotechnological inventions, determines, in its Article 5 that: “1. The human body, at the various stages of its formation and development, and the simple discovery of one of its elements, including the sequence or partial sequence of a gene, cannot constitute patentable inventions. 2. An element isolated from the human body or otherwise produced by means of a technical process, including the sequence or partial sequence of a gene, may constitute a patentable invention, even if the structure of that element is identical to that of a natural element”.

Article 4 states that; “1. The following shall not be patentable: (a) plant and animal varieties; (b) essentially biological processes for the production of plants or animals. 2. Inventions which concern plants or animals shall be patentable if the technical feasibility of the invention is not confined to a particular plant or animal variety. 3. Paragraph 1(b) shall be without prejudice to the patentability of inventions which concern a microbiological or other technical process or a product obtained by means of such a process”.

The protection of inventions concerning sequences of genes, cells, animals and plants — including human genetic sequences previously detached from the human body — has provoked immense controversy and concern, and has been the focus of several misunderstandings and some facts that are difficult to refute (Marques 2001, p. 21 et seq.; Burk 2013, p. 747). We may consider the issue of the patentability of cell lines derived from totipotent cells of human embryos: concerning the “bioethical clause” contained in the European Patent Convention (Art. 53(a)), in decision G 0002/06, of 25/11/2008 (use of embryos/Warf), the Enlarged Board of Appeal ruled that such lines were not patentable, since, although totipotent cells had not been claimed, the making of the invention, as described, involved the destruction of embryos. More recently, the Technical Board of Appeal reiterated this decision, in Decision T 2221/10, of 4/2/2014 (Culturing stem cells/ TECHNION).

With regard to plant varieties (which enjoy their own industrial exclusivity through a Plant Variety Right based on the Convention for the Protection of New Plant Varieties of 1961 (Neumeier 1990, p. 13 et seq.; Wuesthoff et al. 1999, pp. 95–112; Mills 2005, p. 139 et seq.; Marques 2007b, pp. 98–134; Metzger and Zech 2021, section 3), in the European Union the legal rules on patent rights allow for the protection of inventions if the technical feasibility of the invention is not confined to a particular plant variety, or in cases that are not essentially biological processes for the production of plants.

3 Patent Rights and Access to Medicines (e.g. Vaccines). Pre-existing Patent Rights and Supplementary Protection Certificates for Medicinal Products; Patent Applications and Patent Rights Not Yet Granted

The vast majority of vaccine-related (product or process) inventions are currently the subject of patent applications. In some cases the patentability procedures for these have already allowed the applications to be published, although the patent rights have not yet been granted. This is because, as a rule, patent applications are published 18 months after the application for protection.Footnote 3 Hence, most of these patent rights applications were only published in the second half of 2021. In the future, this situation will probably be repeated as a result of the successive changes that will need to be made to the vaccines patented in the meantime, due to the mutations that the virus will periodically undergo.

These patent applications generally include claims directed to:

  • vectors containing the nucleic acid of the virus;

  • cells and pharmaceutical compositions containing the virus;

  • antibodies (monoclonal) intended to recognise the viral protein;

  • in vitro viral infection diagnostic methods;

  • modified genetic sequences of the viral protein (in vaccines developed by Moderna and Pfizer);

  • the use of the virus as a vaccine to prevent or treat infection.

On the other hand, some medicines (e.g., vaccines) may be protected by various patent rights (e.g., for chemical intermediates, starting materials, chemical or biotechnological synthesis process(es), pharmaceutical formulation, etc.), which, in compliance with the principle of unity of invention (Article 73 of the Portuguese Industrial Property Code; Article 82 of the European Patent Convention), may be the subject of several patent applications or divisional applications.

There is, however, a set of patent rights that were granted in the recent past concerning other coronaviruses. This is, for example, the case of European Patent (EP) 3 172 319 B1, applied for on 07/23/2015 (also for Portugal) and granted on 11/20/2019, EP 2 898 067 B1, applied for on 23/09/2013 and granted on 15/01/2020 (of the same sort designated to be in force in Portugal), and US patent US 7,220,852 B1, which was filed on 04/12/2004 and granted on 05/22/2007.

It is known that Pfizer and BioNTech, Moderna and AstraZeneca have entered into patent rights (sub)licence agreements concerning several patents—relating to methods of acting on the messenger RNA (mRNA) of segments of the viral protein—that have been held by the University of Pennsylvania since 2005 (Abinader 2020; Le Péchon-Joubert and Carlyne 2021).

4 The Issue of Access to Test and Clinical Data (Pharmacological, Toxicological, Preclinical and Clinical Data) and Generic Medicines. Exceptional Marketing Authorisations (For Reasons of Public Interest) for the Placing of Vaccines Against COVID-19 on the Market

In any case, most of the (product and process) inventions concerning vaccines have already been granted (exceptional) manufacturing and marketing authorisations by administrative health authorities (e.g., the European Medicines Agency; the Hungarian health agency for certain vaccines from China, and the Russian Federation). However, as far as patentability procedures are concerned, these inventions are still in the (formal and substantial) examination phase of protection applications.

In fact, the issue of an administrative authorisation for a medicinal product to be placed on the market for human use does not usually occur prior to the granting of the patent rights underlying the technological innovations that that medicinal product incorporates; indeed, the opposite is almost always the case. However, the public health emergency that States are experiencing has reversed the normal order of things. This has given rise to the unusual situation of granting authorisation to place the medicines on the market before granting patent rights on those medicines, through the issue of exceptional authorisations (for reasons of public interest) for the placing of vaccines against COVID-19 on the Market.Footnote 4

In addition to the above, many medicines are protected (and will be protected) by means of a supplementary protection certificate (SPC).Footnote 5 The SPC—which lasts for a maximum period of five years, and can be extended for an additional period of six months when it concerns medicinal products for paediatric use (including vaccines)—becomes effective from the expiry of the patent rights relating to the reference medicinal product which has previously received authorisation to be placed on the market.

However, the current legal regime on the compulsory licensing of pharmaceuticals protected by patent rights can only affect patent rights and not supplementary protection certificates (that have already been granted or are already in force). Moreover, there are numerous medicines whose patent rights have already expired that benefit from this separate protection right (although it is instrumentally linked to the basic patent right where the active substance or composition of active substances that is part of the medicinal product subject to the Marketing Authorisation is mentioned—i.e., in the claims or description), where the object of that right is the reference drug to which the Marketing Authorisation was granted.

In any case, even if this legal framework is changed—in the sense of expressly enshrining the possibility of granting compulsory licences for pharmaceutical products that are the object of patent applications—the issue of access to data on pharmacological, toxicological, and preclinical tests and trials still remains. This data was generated by the company that obtained the marketing authorisation to place the reference drug on the market, which is, as a rule, the holder or licensee of the patent rights. The method that enables the chemical (biotechnological) and pharmaceutical invention to be produced in a safe and effective way by the beneficiaries of those compulsory licences is indispensable and requires access to such test data.

However, on the one hand, this test data is protected by a sui generis trade secret regime that binds the health authorities that approve such medicines in terms of their safety, efficacy and quality. In the European Union, this legal framework lasts for at least 8 years from the issue of the marketing authorisation. On the other hand, the marketing authorisation of the reference drug—even if the drug is not the object of any patent rights or patent applications, or the potential patent has been judicially invalidated or has been waived by the patent holder—, as previously stated, grants its holder exclusive marketing rights for that medicinal product for a period of 10 to 12 years from the date on which the marketing authorisation is issued.

This situation imposes, de iure condendo, the possibility of providing for a specific legal permission for the competent health authorities to use this test and trial data to approve generic medicines (manufactured under compulsory patent rights licences or compulsory patent application licences); and, in addition, these administrative bodies are authorised to provide such scientific data to the beneficiaries of these compulsory licences under strict confidentiality conditions, in order for them to demonstrate the bioequivalence—et pour cause, the safety and efficacy—of the generic medicines used in the treatment of this viral infection, with the primary aim of being, themselves, generic medicines approved on the basis of a public health emergency.

Access to such test data in these public health emergency situations will need to operate on the basis of a stand-alone compulsory licence or, alternatively, be integrated within the compulsory licence of the product that is the object of a patent application (or of the product subject to patent rights, if these have already been granted). Evidently, in calculating the financial (or other) compensation to be allocated to the patent holder or to the patent applicant that holds the test and clinical data, the economic value of this data will have to be computed (Marques 2008a, pp. 233, 234; Marques 2008c, p. 211; Marques and Fernandes 2013, pp. 547, 548), and the extent of the legal power that a reference medicine marketing authorisation holder has to oppose the marketing, by third parties who are beneficiaries of the compulsory licence, of the corresponding generic medicines within a period of 10 years from the date of issue of that marketing authorisation.

Finally, one important point to remember is that the manufacture and marketing of medicines (in casu, vaccines)—even when partially achieved with the use of subsidies from the European Union and/or its Member States—is highly dependent on the content of the multiple distributions agreements concluded between the Member States (or the European Commission on behalf of the European Union) and pharmaceutical companies (some of them based outside the European Economic Area), namely the timeliness of deliveries, the price per unit, the forms of payment, the penal clauses foreseen in the event of delay or definitive non-compliance, the clauses to be inserted in contracts concluded downstream intended to allow the manufacture and adequate distribution of medicines and other devices, the law applicable to the merits of the case, the international jurisdiction for the competent court award, etc. Moreover, the marketing will also depend on the availability of certain types of biological and non-biological materials used in the manufacture of some vaccines, which are widely known to be in short supply.

5 Compulsory Licensing of Patent Rights and Biotechnological Patented Medicines

The original text of the Paris Convention for the Protection of Industrial Property, adopted in 1883, imposed an obligation on the patent holder to use the patent rights, and the Washington Revision (of 1911) established a sanction for non-compliance. Hence, this provision created a legal duty for the patent holder and failure to comply could give rise to expiry of the patent (Marques 2009, p. 184).

Article 5 of the Paris Convention already provided for the possibility of issuing a compulsory licence due to lack of exploitation of the object of the patent. In fact, after the Hague Review (1925), the Paris Convention began to provide for the possibility of granting compulsory licences and, ultima ratio, for the expiry of the patent if it was not being commercially exploited.

In Portugal, the compulsory licensing of patent rights for reasons of public interest was introduced from the outset in the Industrial Property Code of 1940. In fact, the Portuguese legislator transposed compulsory licensing in Article 30(1) of the Code. The issue of this compulsory licence was possible provided one of the following conditions was met: the patent holder had not exploited the patent, without just cause, directly or through a licensee, for a period of three years following its granting, or, in the case of it having been exploited, such exploitation had then ceased for three consecutive years. Furthermore, the 1940 Code also provided for compulsory licensing in respect of dependent patents (dominant patent versus dependent patent).

Article 30 of the TRIPS Agreement allows Contracting States to “provide limited exceptions to the exclusive rights conferred by a patent, provided that such exceptions do not unreasonably conflict with a normal exploitation of the patent and do not unreasonably prejudice the legitimate interests of the patent owner, taking account of the legitimate interests of third parties”. These exceptions are the free use of patented products or processes beyond the intrinsic limits of the patent right, allowing for a return to the sphere of freedom, previously hindered by the industrial property rules, provided that certain requirements are observed.

Article 31 of the same Agreement establishes, in addition, the minimum legal rules for the issue of compulsory licences and extends the possibility of their use to cases of national emergency—this in addition to public use and cases of dependent patents, which were already included in the Paris Convention. Subparagraph b) of Article 31 also provides for the need to first make efforts to obtain a voluntary licence under reasonable commercial conditions. Compulsory licences will only be issued if such efforts have been unsuccessful within a reasonable timeframe. There is also a requirement to pay adequate remuneration in the circumstances of each case, taking into account the economic value of the licence, as well as a requirement that decisions be subject to judicial or other independent review by a distinct higher authority. The new Article 31bis of the TRIPS Agreement—following the Doha Declaration of November 2011 on the TRIPS Agreement and public health—provides for the possibility of issuing compulsory licences for the manufacture of pharmaceutical products in a Contracting State primarily intended for export to one or more Contracting States with serious public health problems, in other words, to the extent necessary for the purposes of producing a pharmaceutical product and its export to an eligible importing Member in accordance with the terms set out in paragraph 2 of the Annex to the Agreement.

However, the requirement of prior negotiation may be waived by the domestic laws of the Contracting States in the event of a national emergency, in a situation of extreme urgency or in the case of non-commercial public interest. It should be noted, however, that Portugal has not yet amended the Industrial Property Code of 2018, in order to provide for this exemption from the need for prior negotiations for reasons of public interest generated by a situation of extreme urgency (e.g., a public health emergency).

Compulsory (or non-voluntary) licences granted for products subject to patent rights emanate from administrative acts that remove some of the property rights from the rights-holder, embodied in heteronomous constitutive public authorisations, whereby the beneficiary of the compulsory licence (human person, legal entity, public entity or the Government itself) will be able, without the agreement of the holder of the patent rights, to exercise all or some of the legal rights included in the respective document (e.g., offer, import, manufacture, marketing, etc., of the products protected by the patent rights or execution of the processes protected by it), in line with the conditions of exploitation imposed by the said administrative body (Marques 2008b; Fidalgo 2015, p. 61).

Considering the need to adequately fight the SARS-CoV-2 pandemic, as well as the current (and future) mutations that coronaviruses may suffer and the possible epidemics arising therefrom, the possibility of granting a compulsory licence can certainly be justified for reasons of public interest, particularly when the exploitation of the invention is of “primary importance” for public health. This compulsory licence may relate, for example, to the manufacture and distribution (including the import) of diagnostic methods, anti-inflammatory medicines, monoclonal antibodies, syringes, ampoules, excipients and, above all, vaccines. In Portugal, compulsory patent rights licensing based on reasons of public interest is currently provided for in Article 108(1)(c) of the Patent Law. Article 111 of the same law specifies the conditions for granting these licences. One condition for their issue is a reasonable period of prior negotiations between the patent holder and the person interested in commercially exploiting the invention.

The current Industrial Property Code (2018), as previously mentioned, does not expressly enshrine the waiver of prior negotiations in cases of national emergency, in situations of extreme urgency or in cases of public non-commercial use. Furthermore, in Portugal, the compulsory licence is always issued at the request of the interested party. That is to say, there is no such thing as a compulsory licence issued by the Government or the competent minister (e.g., Ministry of Health) of its own motion.

On the other hand, the aforementioned Article 9(2) of Regulation (EC) No. 816/2006, of the European Parliament and of the Council, of 17 May 2006, on compulsory licensing of patents relating to the manufacture of pharmaceutical products for export to countries with public health problems, provides that prior negotiations are waived in national emergency situations or other circumstances of extreme urgency, or in the case of public use for non-commercial purposes.

There is greater justification for discussing the possibility of issuing compulsory licences before granting patent rights—which is already provided for in some (albeit very few) legal systemsFootnote 6—when we are faced with emergency situations (affecting public health), such as the situation affecting us since January 2020 with the SARS-CoV-2 pandemic. Requests could be made either after the patent application has been published or before its publication but after it has been filed. The overwhelming majority of legal systems do not provide for the issue of compulsory licences for products subject to a patent application, but only those subject to patent rights. Let us see.

Article 8(1) of the TRIPS agreement, for example, states, as one of its basic principles, that Contracting States, when formulating or amending their laws and regulations, may adopt measures necessary to protect public health and nutrition and to promote the public interest in sectors of vital importance for their socioeconomic and technological development, provided that those measures are compatible with the provisions of the Agreement. In view of the declared pandemic situation due to COVID-19, Germany was one of the first States to operate this possibility, with the Gesetz aur Verhütung und Bekämpfung von Infektionskrankheiten beim Menschen – Infektionsschutzgesetz – IfSG, at the end of March 2020 (Bundesministerium der Justiz 2000; Musmann 2020).

The same happened in France. Law No. 2020-290, of 23 March 2020, amended Art. 3131-15 of the Code de la Santé Publique. Henceforth, the French Prime Minister may, when a state of health emergency is declared and with the sole purpose of guaranteeing public health, determine the practice of the following acts: “order the requisition of any person and of all the goods and services necessary to combat the health catastrophe”, and “take all measures to make available to patients adequate medicines for the eradication of the health catastrophe”. Likewise, on 14 December 2020, Article L. 5121-12 of the Code de la Santé Publique was amended, in order to allow the use of medicines protected by patent rights or patent applications when these are subject to an ex officio licence in the interest of public health.

6 Alternatives to Patent Law

Current efforts to give effect to the rules provided for in Article 31bis of the TRIPS Agreement—on the possibility of issuing a compulsory licence for the manufacture and export of active substances (and other materials) used in the manufacture of medicines protected by patent rights—seem, for the time being, to be a futile and ineffective exercise to solve the problem of the scarcity of vaccines and other treatments used (or to be used) in the fight against the SARS-CoV-2 pandemic (especially in Africa and some Asian countries) and, in the future, the problem of other variants and other diseases that mobilise the use of biological materials (e.g., RNA).

It is true that the threat of this type of licences being issued by the competent administrative bodies has already been seen to contribute to the voluntary joint cooperation in technology transfer agreements that will enable certain companies to manufacture vaccines in countries heavily affected by this pandemic (e.g., India).

The flexibility provided for in the aforementioned Article 31bis of the TRIPS Agreement—which has already made it possible to waive the requirement that the issue of compulsory licences for patent rights and any related use shall be authorised predominantly for the supply of the domestic market of the Member authorising such use—will likely imply international pressure on some countries (in particular, India) to make better use of their installed industrial capacity. Yet, there appears to be little possibility of breaking the deadlock, given the European Union's opposition based on the claim that the safeguards currently existing in the TRIPS Agreement, regarding compulsory licensing of patent rights, read together with the Doha Declaration (2001), are fully sufficient. It is worth stressing that these provisions, in this approach, are sufficient to deal with the current COVID pandemic.

In other words, there is no lack of voluntary licensing agreements already signed to manufacture and distribute COVID-19 vaccines, the administration of which is destined for countries that have installed industrial capacity to manufacture these vaccines. However, vaccine shortages continue to exist in developing countries (in Africa), presumably because of financing difficulties (e.g. the need to make market commitments in advance, in terms of promissory purchase and sale, distribution or commercial concession agreements, etc.), poor planning (the Indian government, for example, started placing vaccine orders only in January 2021), and regulatory issues of civil law, pharmaceutical law, and tax law (e.g., liability waiver for damages caused in the administration of medicines; exemption from price controls; exemption from provisional testing and exemption from customs duties).

However, it should not be forgotten that there is considerable under-use of vaccine production capacity in these countries, since many manufacturing facilities do not have licences to operate and may only obtain these in the medium term. On the other hand, it is accepted without contention that vaccines already on the market cannot be reverse engineered; in other words, they cannot be manufactured without the active cooperation of the pharmaceutical company(ies) that developed the vaccine. This involves technology transfer activities (along with know-how agreements), which, in themselves, depend on the availability of highly qualified personnel and raw materials (e.g., adjuvants, excipients, intermediate products; biological materials). It is difficult to know the amount of know-how (and confidential information) that can be transferred or communicated if compulsory licensing rules are implemented for the manufacture of vaccines (and other medicines) and their export to countries with serious public health problems in this area of SARS-CoV-2.

In view of the above, within the framework of the State task of pursuing the public interest — given the public health emergency situation that the SARS-CoV-2 pandemic raises, which will probably protract in time as the variants and mutations of this virus emerge and evolve — it seems legitimate to propose the following guidelines as viable alternatives to patent law:

  • Compulsory licensing of patent rights (and supplementary protection certificates) relating to the use of patentable inventions for reasons of public interest in the medical and pharmaceutical field should have as its object the rights arising from the patent application itself, rather than just the patent rights in force in the territory of the State that granted them or where they were validated (this is the case of European patents granted by the European Patent Office).

  • The requirement of prior negotiations between the Public Administration (or an interested person) and the patent holder (or the patent application holder) in national situations of emergency or other circumstances of extreme urgency, or in cases of public use, should be waived for non-commercial purposes. As a way of mitigating the circumstances in the legal sphere of the holder or applicant of the industrial property rights, the Government could publish, with reasonable notice, a list of chemical substances (e.g., active substances, excipients, adjuvants) or other materials for which it is justifiably considering issuing a compulsory licence, in order to be able to negotiate the possible issue of a voluntary licence; Universities, public laboratories, private teaching and research institutions and members of civil society could be consulted in the process of preparing that list.

  • The Government (or the Ministry of Health) should be legally authorised to determine, by means of an Order, under Article 111 of the Portuguese Industrial Property Code, that an invention protected by a patent or a supplementary protection certificate concerning products, processes or uses mentioned in the previous paragraph may be used based on reasons of public interest, establishing the terms of such use and the equitable and adequate remuneration due to the patent applicant or patent holder.

  • There should be an extension of the term of exclusive marketing rights (e.g., adding up to a maximum of 18 months to the terms in force in cases of medicines aimed at treating highly contagious diseases) and the possibility of transferring these exclusive rights from innovative companies (which have obtained these rights for medicines to treat diseases of populations in underdeveloped countries: e.g., AIDS/HIV, malaria, tuberculosis) to drugs companies whose patents are expiring (vouchers);

  • Provisions should be made so that these vouchers can allow their purchasers to benefit from a shorter period of health approval for other medicines;

  • Conditional and temporary tax benefits could be granted to pharmaceutical companies that develop and place on the market certain types of biotechnological medicines with considerable benefits or that develop new biotechnological medicines with significant therapeutic action;

  • Pools could be created of patent rights transferred by pharmaceutical companies and held by non-profit entities whose members are those companies, and which thus have (cross) access to these technologies at a very low cost;

  • -There could be a legal imposition of standard contractual terms (with a vertical effect throughout the research, development and marketing chain) aimed at enabling an easier and less costly use of chemical substances and biological (or biotechnological) raw materials with therapeutic properties in agreements signed between companies that have benefited (at least one of them) from state support/aid in research and development programmes (e.g., chemical or biotechnological synthesis, composition of active substances, methods of use of substances already disclosed), as well as, in some cases, (co)ownership of the patent right or the patent application right.

  • It should be possible to waive patent rights already granted (or to be granted) on chemical and biotechnological inventions in exchange for granting patent rights holders a longer term of protection of test data as a result of the marketing authorisation of medicines given by the competent health authorities (For further developments, cf.Gervais 2019, p. 385).

These legislative changes could be made both in the Portuguese Industrial Property Code (Articles 108(3) and 111) and in Law No. 81/2009, of 21 August (public health surveillance system) (Marques 2020, p. 121).

7 Conclusions

The advent of epidemics and pandemics—especially the COVID-19 virus pandemic—calls for a reflection on the social utility of patent law (and supplementary protection certificates for medicinal products) in stimulating research and development of new therapies over the course of time. These incentives, which belong to the legal subsystem of industrial property rights, are articulated with and compete with incentives for the introduction of innovative biotechnological medicines coming from the legal framework on pharmaceutical regulation, with regard to the manufacture and placing on the market of medicines and medical devices (marketing authorisation procedures).

The threat of imposing compulsory patent rights licensing (limited, however, to the territory of the State whose Government issues them) serves as a deterrent and encourages the conclusion of know-how sharing agreements, as well as agreements aimed at voluntary licensing of patent rights and supplementary protection certificates.

In a more or less distant future, it may be possible to imagine a set of legislative measures aimed at stimulating the scientific and (bio)technological development of medicines outside the framework of patent law and supplementary protection certificates (with a patent extension term). This objective will depend on a global meeting of minds within the World Trade Organization, with a view to amending the TRIPS Agreement.