IP-Academy

Public health and pharmaceutical patents

Public Health and Pharmaceutical Patents

Author: Danielle Carvey

It is safe to say that we all know the importance of innovation and its place in society. Pharmaceutical inventions, for example, have saved countless lives, with vaccines being one of the most discussed topics of 2020. They are vital to public health, and policy makers must weigh up the factors of pharmaceutical patent rights compared to the accessibility of the inventions to the public, but what is a pharmaceutical patent?

A pharmaceutical patent, much like a regular patent, grants exclusive right over the use of an invention to the patent owner, however there are a few differences in terms of validity periods and licensing. In addition to the basic validity period of 20 years from the filing date, a Supplementary Protection Certificate (SPC) may be granted in respect of pharmaceutical patents in more than 20 countries, including the US, UK and some countries of the EEA (European Economic Area), for example. The latter issues the SPC, which allows for an extension providing either an overall maximum of 15 years of exclusivity from the date of the first marketing authorisation (MA), or 5 supplemental years after the expiry of the patent, and is designed to compensate the inventor(s) for any time lost between the granting of the patent and the MA of the same.

In the UK an SPC will not extend the term of a patent, but gives similar protection, which enters into force when the patent expires and can last for up to 5 years. An SPC for a medicinal active ingredient may also be extended for a further six months if it has undergone the appropriate pediatric testing. It is worth noting that this may be subject to change after Brexit is finalised.

A similar system applies in the US, however, the Certificate Extending Patent Term applies to the entire patent in this jurisdiction. Furthermore, the term of a patent eligible for extension shall be extended by the time equal to the regulatory review period for the approved product. Such period occurs after the date the patent is issued, whereas in the EEA the scope is narrower, applying only to the active ingredient(s) of the patented product.

The duration of the certificate can also be limited in certain instances, for example, when a patent term has already been extended under a specific national law.

Although patent protection contributes to greater pharmaceutical research funding, which is a strong incentive to continued development of life-saving inventions, it can also hinder individuals from obtaining the treatment they need due to monopolization of patented treatments and corresponding increases in costs. A possible remedy to this is compulsory licensing, a mechanism which allows another party to produce a patented product or process without the express consent of the owner of the pharmaceutical patent itself. Safeguards such as this ensure that the pharmaceutical industry can be compensated for its scientific advances and contribution to the public health, while also preventing monopolization. On the flip side, however, critics have argued that licensing may create incentive issues, with companies purchasing licenses and increasing treatment costs as opposed to researching and developing new ones.

The socio-ethical implications of pharmaceutical patent rights on the wider public health are contentious, and require a collective approach of resolution. A combination of policy reform, standardised pharmaceutical state funding, company obligations, and a collaborative commitment to the stabilisation of pharmaceutical treatment costs may be the key to fairness and accessibility for the good of public health.

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According to Article 115 of the European Patent Convention, any person can submit their observations regarding a European patent application, or a European patent pending before the European Patent Office (EPO), in order to contribute relevant information to the examiners at the EPO. Such submissions are called third-party observations (TPOs) and serve as a valuable tool in the patenting process.

TPOs have an accelerating effect on a patent application. Submitting non-anonymous, well-supported observations pursuant to Article 115 and Rule 114 EPC substantiating a lack of patentability during examination can expedite the next Office Action from the EPO. This mechanism differs from the submission of a PACE request, as it only accelerates the next substantive communication from the EPO.

TPOs, which are sent to both the examiner and to the applicant for consideration and comment, not only help to prevent a patent from being wrongly granted, but can also lead to the amendment of patent claims. s Alongside the possibility of amendments to the patent claims, a TPO may also result in the granting of a patent with a lesser scope of protection.

Third-party observations can relate to patentability, novelty, inventive step, sufficiency of disclosure, lack of clarity, or amendments that are not allowed as per the rules. Observations must be filed while the proceedings are still ongoing to effectively influence the examination. TPOs filed after a patent has already been granted will be neither considered nor made available for file inspection.

TPOs are typically submitted using an online form via the EPO website, with no official fee required to be paid for the submission. They must be filed in one of the official languages of the EPO (English, German or French) and explain the grounds on which they are based. The supporting documents may be filed in any language, although the EPO may request the translation within a prescribed time period.

TPOs may be submitted anonymously, yet it is important to note that the submitting party mustn't already be a part of the proceedings and are not permitted to join the proceedings following the filing of the TPO. The EPO will not directly inform the filing party of any further action that was taken in response to their TPO, however the outcome will be confirmed in the office actions and published by the EPO.

Third-party observations are important in ensuring that the patent examination process is strong and accurate. By welcoming contributions from external parties, the EPO gains diverse knowledge and expertise, enhancing the examination process and making sure that granted patents meet high standards within the European Union.

The Eurasian Patent Organization and Office (EAPO) is an intergovernmental organization founded in 1995 with the aim of promoting the development and protection of intellectual property across the region, in accordance with the Eurasian Patent Convention (EPC). The EPC was first signed on September 9, 1994 and entered into force on August 12 of the following year, formally establishing the EAPO.

Member states to the EAPO include countries from both the Commonwealth of Independent States (CIS) and non-CIS countries, fostering international collaboration in the field of IP. These Member States in 2024 include Armenia, Azerbaijan, Belarus, Kazakhstan, Kyrgyzstan, Russia, Tajikistan, and Turkmenistan. The EAPO headquarters are located in Russia with the official language of the Office being Russian.

The EAPO's main aim is to facilitate intellectual property protection for inventions and industrial designs via one Eurasian application that is valid throughout all 8 Member States. As such, the Office plays an important role in streamlining the IP application process throughout Eurasia, providing a unified platform for inventors and businesses to seek protection for their ideas in multiple member states simultaneously. The EAPO system therefore simplifies procedures for patent and design protection, reduces costs, and enhances efficiency, contributing to the growth of innovation and technology within the region.

The Office has provided protection for Eurasian patents since its origin, and began to accept applications for regional industrial design protection in June 2021 following the adoption of the Protocol on the Protection of Industrial Designs to the Eurasian Patent Convention in 2019.

In order to obtain a Eurasian patent valid in all EAPO Member States, an applicant should file just one application to the EAPO which can be submitted in any language so long as it is followed by a Russian translation within a 2 month period, or within 4 months if the corresponding fee is paid. A Eurasian patent may also be obtained on the basis of a PCT application by entering the Eurasian regional phase within 31 months from the earliest priority date. Eurasian patent applications are subject to substantive examination with an applicant required to submit a request for the same within 6 months from the date of publication of the search report for conventional applications. For PCT based applications the substantive examination should be requested upon regional phase entry.

Once a Eurasian patent is granted, the patent holder is able to decide which Member States they wish for the patent to be maintained, as well as restore lapsed Eurasian patents due to unpaid maintenance fees. Applicants may also extend the term of validity of Eurasian patents in certain invention areas. During the period of time between the publication of the Eurasian patent and the payment of the first annual maintenance fee, the patent holder has the exclusive right to their invention in all Eurasian countries.

All fees in relation to Eurasian patents or industrial designs are paid to the EAPO directly, as opposed to each respective EAPO Member State individually. The filing fee for Eurasian patents may be reduced by 25% if the application contains an already produced international search report or PCT search report by another ISA, and by 40% if such reports were produced by the Rospatent.

As of 2022, the EAPO also acts as an international search authority (ISA) and an international preliminary examination authority (IPEA) in accordance with the PCT.

The EAPO has participated in multiple international collaborations, including the signing of Memorandums of Understanding (MoU's) with the African Intellectual Property Organization (OAPI), the African Regional Intellectual Property Organization (ARIPO), the European Union Intellectual Property Office (EUIPO), the European Patent Office (EPO) and the World Intellectual Property Organization (WIPO).

Moreover, the EAPO also engages in Patent Prosecution Highway programmes with several IPO's worldwide inclusive of the Japanese Patent Office (JPO), the Korean Intellectual Property Office (KIPO), the Finnish Patent and Registration Office (PRH) and the EPO, facilitating an expedited patent processing time through the sharing of examination findings with the respective IPO's of the PPH agreements.

The EAPO's commitment to intellectual property rights underscores its significance in fostering a conducive environment for research, development, and economic growth in the region. If you would like to find out more information on how to file for IP protection in Eurasia or via the EAPO, please contact us via our social media platforms or here!

The European Union Intellectual Property Office (EUIPO) is a regional IP office and European Union Agency founded in 1994, located and headquartered in Alicante, Spain. As such, the EUIPO facilitates the protection of European Union trademarks (EUTM), formerly a "community trade mark", as well as Registered Community Designs (RCD). An alternative name for the EUIPO is in the French language, namely “Office de l'Union européenne pour la propriété intellectuelle”.

The office was founded and operates on the basis of Regulation (EU) 2017/1001 of the European Parliament and of the Council of 14 June 2017 on the European Union trade mark. As an international hub for intellectual property matters, the office operates in five working languages, namely English, French, German, Italian and Spanish. Applications received by the EUIPO can be processed in the twenty-three official languages of the EU.

Registered Community Designs, as well as EU trademarks registered through the EUIPO, benefit from unitary protection effect across all EU Member States. Registered trademarks and designs with the EUIPO are published and the information made publicly available in the corresponding IP registers managed by the office. The Register of European Union trademarks, for example, contains particulars of all EU trademark applications and registrations, whilst the Community Design Register contains information pertaining to registered EU designs. Both of these registers are continually updated to track any amendments to EUTM's or RCD's such as ownership information and licencing.

The EUIPO also publishes the EU Trade Marks Bulletin and Community Designs Bulletin containing said registrations, as well as other relevant information available to the public.

In addition to facilitating the registration of RCD's and EUTM's, the EUIPO also maintains the Orphan Works Database, providing access to information relating to orphan works contained in the collections of publicly accessible forms such as educational establishments and archives in Member States.

Furthermore, the office oversees the Observatory on Infringements of Intellectual Property Rights, aiming to assist in the fight against counterfeiting and piracy by raising public awareness through the encouragement of best practices and cooperation. The EUIPO has overseen both Orphan Works and the Observatory of Infringements since 2012.

The EUIPO is a vital IP office for the facilitation of intellectual property throughout the European Union, with the office examining over 150,000 EUTM applications and 90,000 RCD applications every year. Moreover, the office allows for a multitude of international cooperations and initiatives spanning across the globe, aligning with the European Commission external actions policy priorities. As such, the EUIPO aims to create awareness on the benefits of IP protection and registration, encouraging innovation as a source of economic development across the EU.

Furthermore, the office supports the development of the administration of IP and enforcement services by modernizing legislation and promoting participation in international IP Treaties. Through Memoranda of Understanding (MoU), the EUIPO forges collaborations with other IP offices directly, identifying actions that can benefit the IP field in EU Member States and the IP sphere on a global level.

The EUIPO also engages in the TM5, consisting of five major IP offices for trademarks, and the ID5, comprising five major IP offices for industrial designs. These five offices include the CNIPA, EUIPO, JPO, KIPO and USPTO in close collaboration with the World Intellectual Property Organization (WIPO).

The EUIPO serves as a focal point for not only the European IP sphere, but for IP protection on a multi-regional level too.

The European Patent Office (EPO) is a regional intellectual property office which contributes to a unified patent system across member states, streamlining the process for the protection of patents across the region. It is headquartered in Munich, Germany, with several other branch offices present in cities across Europe.

The EPO is the executive arm of the European Patent Organisation, an intergovernmental structure established on October 7, 1977, on the basis of the European Patent Convention (EPC) signed in 1973. The organization has grown to include all 27 member states of the European Union, alongside other non-EU states, bringing the total number of EPO member states to 39 inclusive of 44 respective countries.

The EPO operates alongside the EPC, a treaty which provides a legal framework for the granting of European patents by way of a single, harmonized procedure before the EPO. This mechanism allows the EPO to function as a centralized patent office for European member states, allowing applicants to file for protection of their inventions via a more simplified route when compared with filing for patent protection separately in each respective country. As such, the EPO plays a pivotal role in the intellectual property field of the region.

The EPO operates in three official languages, namely English, French and German, and patent applications may be filed in any of the three official languages.

One of the core functions of the EPO is to provide for the examination and granting of patents for inventions, with examiners from the Office assessing applications as per the necessary criteria such as a patent possessing novelty, industrial applicability and an inventive step.

Further establishing its role in the international IP landscape, the EPO is also actively involved in multiple international patent co-operations, with the office notably constituting one of the members of the Patent Cooperation Treaty (PCT). The PCT streamlines the process for the filing of international patent applications and facilitates the exchange of information and prior art. Moreover, the EPO has forged further collaborations with approximately 75 IP offices and regional IP organizations across the globe.

The Office has also formed cooperative validation agreements with five non-member states, namely Cambodia, Georgia, Moldova, Morocco and Tunisia. These agreements allow applicants to file for patent protection via the harmonized procedure before the EPO as they would when seeking patent protection in member states (either directly or via the Euro-PCT route), however applicants may request patent validation in the 5 aforementioned states despite them being non EPC members. The validation of a European patent in such states will have the same effect as a national patent would in each state respectively, and is available upon paying the corresponding fee.

Applications for patents in validation states are subject to the national laws of each respective state, however the state itself will not conduct examination, with the examination results conducted by the EPO being utilized instead.

The EPO plays an important role in the IP sphere on both an European regional level, and on an international level. Beyond its patent granting function, the EPO supports innovation by providing access to extensive patent databases and resources. As well as applicants and inventors, others such as researchers and policymakers can utilize data produced by the EPO to analyze and monitor patterns and trends in the field of technology to make informed decisions with respect to their patent portfolio, prospective applications, and future innovation.

Further, the work produced by the EPO and the quality of examination of patents has a direct impact on economic development and innovation in Europe. The EPO therefore aids in facilitating the encouragement of investment in research and development, fostering economic growth and technological advancement in the European region.

If you are interested in filing for patent protection by way of the EPO or Euro-PCT, or simply would like to learn more, contact us via our website or social media platforms.