IP Academy

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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Industrial design protection is widely utilised across the globe, with a registered design right preventing others from appropriating or imitating the appearance of a product. However, the obtainment of a design right, alongside a certificate of registration, is often not the final step of design protection.

Once granted, it is important to ensure that a design right is maintained in each jurisdiction in which the owner utilises the design. In order to uphold and maintain such rights, many countries require the filing of a request for design renewal and the payment of annuity/renewal fees.

The renewal process varies between countries and even between regional IP systems. As an example, some of the largest IP offices worldwide include the US, South Korea and China, and they all have different procedures in relation to the renewal of design rights and annuities.

In South Korea, for example, the validity term for an industrial design right consists of 20 years counted from the date of filing. The legislation in the country outlines that once the right has been granted, the registration fee for an industrial design should be paid within 3 months from receipt of the Notice of Allowance.

The registration fee in South Korea is inclusive of the payment for the first 3 years of the design right lifecycle, meaning that further annuity payments should be made in respect of the 4th years onwards. The payment of each annuity fee thereafter is due prior to the anniversary of the registration date for each respective year.

Whilst it is recommended that the payment of an annuity fee is made within the prescribed time, a grace period of 6 months exists in South Korea, allowing for the late payment of said fee when accompanied by payment of a surcharge.

In China, industrial designs with a filing date on or after June 1, 2021 are in force for 15 years from the date of filing, whilst those with a filing date occurring on or before May 31, 2021 are in force for 10 years from the date of filing.

Once granted, the official grant fee should be paid within two months from the date of receipt of the notification to grant a certificate, however, unlike South Korea, this fee is not inclusive of the first annuity. Instead, the first renewal payment, as well as a stamp tax for the design certificate in China, are to be paid separately upon registration of a design.

Further annual fees are to be paid in advance, during the month preceding the anniversary of the filing date. Late payment is possible within a six-month grace period by paying a corresponding surcharge.

In the US, design patents with an application filing date occurring on or after May 13, 2015 are valid for 15 years from the date of issuance, whilst those filed prior to May 13, 2015 have a term of 14 years from the date of issuance.

Unlike the aforementioned countries, as well as many other jurisdictions, design patents in the US are not subject to maintenance fees or annuities.

For those who wish to file for and obtain design rights in multiple jurisdictions, international and regional systems exist which allow applicants to obtain protection in several countries in an often more efficient and cost effective way than filing in individual states separately. As with each jurisdiction, these design right systems possess their own procedures for renewal fees and payment.

An industrial design right applied for via the Hague System, for example, has the same effect in each designated state as it would if it were filed directly in that jurisdiction. They are valid for an initial period of five years from the date of the international registration, which is defined as the date of filing of the international application.

International industrial design rights may be renewed for two initial further 5-year periods, prolonging the validity term for up to 15 years. Thereafter, a right can be renewed up to the limit of years prescribed in the national or regional law of each designated state in which the design is granted. The WIPO will remind the right holder to renew a design six months prior to the due date of the renewal.

A Community Design is a design right registered via the regional system of the European Union Intellectual Property Office (EUIPO). Once a community design has been granted, it is valid for a period of 5 years counted from the date of filing.

It is possible for rights owners to renew the design a further four times for periods of 5 years respectively, meaning a EUIPO registered community design can be valid for a full term of 25 years in total.

The renewal fees are due during the last 6 months of any given 5 year protection period, and late renewal is possible within a six-month grace period by paying a corresponding surcharge.

Industrial designs filed and granted through the African Regional Intellectual Property Organization (ARIPO) have a validity term of 10 years from the filing date. The annuity fees are due on each anniversary of the filing date and are payable in respect of each designated state. They can also be paid within 6 months after the due date on the condition that the corresponding surcharge is paid.

As industrial design renewal procedures are subject to variation from country to country, applicants should take note of any annuity payment deadlines and fees in each jurisdiction they wish to maintain design rights. If you require advice on the renewal of design rights, or simply further information, please contact us.

What’s priority right?

Priority right, which is activated by the first filing, shows that you’ve been the first to apply for an invention, industrial design or trademark. To make use of it, you need to claim your priority right when filing abroad.

What’s the time limit for claiming priority?

Applicants have “twelve months for patents and utility models, and six months for industrial designs and trademarks” (Paris Convention, Art.4) from the filing date of the initial application to take further actions.

Why shall I claim priority?

The Patent Office will decide on the novelty of your invention (check out our post on novelty) based on the priority date. If you filed without priority, all the information that became known in the world (including your first application, if published) would be a part of the state of the art, and your invention would no longer be considered new or novel.

All in all, priority claim preserves the rights of the applicants who want to obtain protection for their intellectual property in more than one country.

Today, we again discuss the three “pillars” of patent law and explore industrial application or applicability, which is one of the patentability requirements. The invention is considered to be industrially applicable if subject matter experts can reproduce and make use of it based on their general knowledge.

The definition is more or less the same in many European countries: the possibility to be “made or used in any kind of industry, including agriculture” (Art. 57, the EPC).

Until recently, interpretation of the industrial application was limited to what is stated above, but in 2005 the Boards of Appeal of the EPO ruled that the requirement of industrial application is only fulfilled if there is commercial benefit from the practical application of the invention.

Fun fact: this requirement excludes a range of absurd inventions from being considered as patentable. For example, if an invention contradicts the laws of physics, it cannot be industrially applicable and is, therefore, not patentable.

The first step on the way to securing your rights is filing of an application. However, there is one issue to consider before launching the process – can you make your first filing abroad?

In many countries, there is a foreign filing license requirement obliging inventors to file first in the country where they created an invention OR obliging nationals of the country to file in their home country before seeking protection abroad.

For example, India and Kenya apply this requirement to their nationals or residents only, while Russia, China, and the USA require first filing of applications for the inventions made in the country regardless of the inventor’s nationality.

If you are not sure where to file first, seek legal advice or feel free to contact us for support.