As an international medical humanitarian organisation, Médecins Sans Frontières/Doctors Without Borders (MSF) has repeatedly witnessed the lack of timely and sufficient access to medicines, tests and vaccines for people in our care. From the HIV epidemics of the 1990s and 2000s to the COVID pandemic, intellectual property (IP) monopolies have stood in the way of lifesaving access to medical tools, particularly in developing countries.
But what is IP, and how does it work to restrict access to medical tools? How are patents granted, and when and how can they be overcome? Answers to these questions inevitably involve jargon and dense legalese, which can serve to further distance discussions of IP from people who are directly affected by it. This glossary seeks to bridge this distance by providing accessible definitions and illustrations of common and not-so-common IP terms. In so doing, it draws on nearly 25 years of MSF Access Campaign’s advocacy for more affordable and accessible medical tools.
Active pharmaceutical ingredients (API)
The main component of a drug that produces its intended effects.
A provision that prevents a voluntary license holder (licensee) or its subsidiaries from re-selling or exporting the licensed products to a country outside of the geographic scope of the license agreement. Anti-diversion clauses may include specific obligations for the licensee or its subsidiaries to use special packaging or identification for the products produced and supplied under the license, and to adapt special enforcement measures to prevent “diversion” of the product.
Article 31bis of the TRIPS Agreement
To remedy the challenges faced by WTO members with no or insufficient manufacturing capacity to effectively use a compulsory license under Article 31(f) of the TRIPS Agreement, Paragraph 6 of the Doha Declaration mandated the TRIPS Council to work out an ‘expeditious solution’ to ease the use of compulsory licenses for exportation and importation.
Following the substance of the Declaration, Article 31bis was incorporated into the TRIPS Agreement. It allows an importing WTO member with “insufficient or no manufacturing capacities in the pharmaceutical sector” to import patented “pharmaceutical products” under a compulsory license granted by another exporting WTO member.
However, Article 31bis comes with complex and burdensome procedural requirements for WTO members to use and has been considered as not providing an expeditious solution as envisaged by the Doha Declaration.
The Bayh-Dole Act or Patent and Trademark Law Amendments Act is a piece of US legislation that standardised rules for patenting and licensing of inventions resulting from US federal funding. The Act allows for the transfer of exclusive control over government funded inventions to universities and other federal contractors. These universities and businesses are then allowed to exclusively license the invention to other third parties.
The Act, however, provides the government with the ability to “march in” and grant licenses for patents that resulted from publicly funded R&D.
When two medicines release the same active ingredient into the body at the same rate and to the same extent under similar conditions. The regulatory approval of a generic medicine is based on the demonstration of its bioequivalence to the originator medicine.
Also see, ‘Reference product’
While generic manufacturers can enter the market after the expiry of a patent on an innovator product, it can take them up to a few years to secure the necessary authorisation. As a result, the owner of the expired patent can enjoy a de facto monopoly for as long as it takes for the generic product to secure regulatory approval.
A Bolar exception/exemption allows generic manufacturers to make preparations during the term of the patent, including for the purpose of seeking regulatory approval of their products so they may enter the market soon after the expiry of the patent. Such activities prior to the patent expiry for the purposes of research and regulatory approval do not amount to infringement.
It was first established in 1984 under the Hatch-Waxman Act in the US, and later became widely accepted in other national laws as an important public health safeguard.
The brand name of a drug is its proprietary name, under which a company sells it in the market. For example, Advil and Motrin are brand names of drugs which contain the same active pharmaceutical ingredient (API)—ibuprofen. A generic drug can also have a brand name under which it is marketed.
A legal measure enabling a government to grant a permit allowing alternative production or importation of a generic version of a patented medical product without the prior consent of the patent holder.
A copyright is a type of IP which gives the owner/author of literary or artistic works the rights to authorise or prevent the use of their works by other entities. A copyright normally contains economic rights related to reproduction, public performance, recording, broadcasting, translating or adapting the copyright-protected work. It also contains moral rights such as being identified as an author. There are exceptions and limitations under copyright laws to allow fair use and promote public interest of access to knowledge.
There is a series of international treaties governing the protection of copyrights, under the auspices of WIPO and WTO.
Source: WIPO, Copyright; and WTO, Agreement on TRIPS as Amended by the 2005 Protocol
Cost of goods sold (COGS)
The direct costs of producing the goods sold, including the cost of the materials and labour directly used to create the good. As this is usually not revealed by the manufacturer, it is sometimes estimated through different methodologies.
Drug regulatory agencies rely on test data generated by originator corporations to approve generic versions of medicines. This practice is fully compliant with requirements set out in the TRIPS Agreement, which only prohibit disclosure of such data.
Data exclusivity is a TRIPS-plus requirement that also prohibits regulatory agencies from relying on test data submitted by the originator corporation to assess and approve generic medicines for a certain duration. Therefore, under data exclusivity, generic manufacturers need to wait out the period of exclusivity or conduct clinical trials anew in order to seek authorisation for their product. This delays and can even block the market entry of more affordable medicines even when patent monopolies have expired.
The Doha Declaration on the TRIPS Agreement and Public Health was adopted by governments at the World Trade Organization (WTO) Ministerial Conference in Doha, Qatar, in 2001. It reaffirms all WTO members’ right to use public health safeguards enshrined in the TRIPS Agreement, such as compulsory licences to overcome IP barriers ‘to promote access to medicines for all,’ and guides countries in their use.
Where corporations file for additional patents on small changes, such as ‘new use,’ new forms or formulations, etc. to existing drugs in order to extend a drug's market monopoly period beyond the expiry of the primary patents on the chemical compound, and blocking or delaying generic competition that can support more affordable prices.
Falsified medical products
Medical products that deliberately/fraudulently misrepresent their identity, composition or source.
Fill and Finish
In vaccine production, "fill and finish" refers to the final stages of the manufacturing process where the vaccine is prepared in its final container (such as vials, ampoules, or syringes) and packaged for distribution. This step involves filling the containers with the vaccine formulation and then performing various operations to ensure the product's quality, sterility, and stability.
Free trade agreement (FTA)
An FTA is an agreement between two or more countries where they agree on certain obligations that affect trade in goods and services. These agreements can include elements such as IP and protections for investors, among other topics, which could have an impact on people’s access to affordable medical products.
Entry into the market of generic versions of pharmaceuticals can enhance competition in the drug market by offering more choice and by lowering drug prices, often improving peoples’ access to medicines.
Competition concerns arise when originator companies use their IP rights to delay or prevent generics from entering, including through evergreening.
Generic medicines (also see, ‘Bioequivalence’)
A generic medicine contains the same API as its originator medicine. Generic medicines can be produced and sold after the patents on the original drugs expire, or under a voluntary or compulsory license. They undergo a regulatory authorisation process before being brought to market.
Good Manufacturing Practices (GMP, also referred to as 'cGMP' or 'current Good Manufacturing Practice')
GMP is the aspect of quality assurance that ensures that medicinal products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the product specification.
A provision in a voluntary license agreement that requires the licensee to transfer or license back or allow use of all improvements made to the licensed product by the licensor during the period of the license.
International non-proprietary name (INN)
INNs facilitate the identification of pharmaceutical substances or active pharmaceutical ingredients. Each INN is a unique name that is globally recognised and is public property. A non-proprietary name is also known as a generic name.
Intellectual property (IP) rights
IP rights are the rights given to persons over the creations of their minds. They usually give the creator an exclusive right over the use of their creation for a certain period of time.
The purchase of a product in a country for use in the same country. The product could be locally produced or imported by a third party.
Products supplied in-country for use in the same country. Can also be obtained by loan, donation or from an external partner in the same country.
The period of time after the marketing authorisation of a medicine when similar/generic medicines for the same indication cannot be placed on the market.
Marketing authorisation holder
Entity holding the authorisation to place a medical product in a given market.
In the context of medical products, a monopoly is a situation where a corporation has complete control of the product and excludes viable competition from providing the same product through various strategies, including IP.
A declaration where a right holder commits not to enforce their patents in certain stated countries, allowing generic manufacturers to produce or supply the medicine in those countries without the fear of an infringement suit. Immunity from a suit is an alternative agreement to a non-assert declaration, whereby the patent holder waives the right to sue, subject to certain terms and conditions.
In a non-exclusive license there can be one or more licensees. The licensor grants the licensee the right to use the IP but is also free to exploit it further by allowing multiple other licensees.
The drug that received the first marketing authorisation in a particular jurisdiction.
Orphan drug designation
The US Food and Drug Administration (FDA)’s Orphan Drug Designation programme awards corporations with a tax credit on qualifying clinical R&D expenditures; a seven-year period of market exclusivity upon FDA approval; and a waiver of the FDA user fee. Orphan drugs are for rare diseases.
'Paragraph 6 system’ (also see ‘Article 31bis’ above)
Rules outlined in the TRIPS Agreement originally restricted compulsory licences to serve mainly the domestic market, unless they were issued to deal with anti-competitive behaviour.
The Doha Declaration recognised that this restriction on compulsory licensing could hamper its effective use by countries with insufficient or no pharmaceutical manufacturing capacity. The amendment of the TRIPS Agreement aims at removing this difficulty by creating an additional form of compulsory licence that had not existed before: a compulsory licence especially tailored for the export of medicines to countries in need – in effect, a 'trade-related' compulsory licence. This mechanism was sometimes termed the 'paragraph 6 system,' from its origins in the Doha Declaration.
The new Article 31bis of the TRIPS Agreement gives full legal effect to this system and allows low-cost generic medicines to be produced and exported under a compulsory licence exclusively for the purpose of serving the needs of countries that cannot manufacture those products themselves.
However, Article 31bis comes with complex and burdensome procedural requirements for WTO members to use, and has been considered to not provide an expeditious solution as envisaged by the Doha Declaration.
A flexibility enshrined in the TRIPS Agreement that allows anyone to import a medical product patented in a given country from another country, from a person or entity authorised under the law to produce, sell or distribute the product, without the consent of the patent-holder.
A government-granted exclusive right on inventions concerning a product, a process or other technologies, that enables the patent holder to prevent any other entities to use, make, sell, offer to sell, import or export the patented invention without the consent of the patent holder. In return, the patent holder discloses the invention to the public.
Patents are often granted upon the fulfilment of certain criteria defined by national laws. There are usually three requirements for patentability: novelty (new characteristics which are not prior art); inventive step or non-obviousness (knowledge not obvious to someone skilled in the field); and industrial applicability or utility.
The exclusive rights last for a minimum of 20 years starting from the date of filing of the patent application, according to WTO rules.
Patent term extension (or supplementary protection)
Extension of patent protection beyond the 20-year term required under the TRIPS Agreement.
The practice by corporations of surrounding their drugs with many patents to strengthen their monopoly position over the drug and keep competitors out of the market.
These thickets deter competitors as they would need to conduct detailed analyses to identify the patents that block them from developing alternative versions and then challenge them individually.
A mechanism by which the validity of a patent can be challenged after it has been granted, within a certain time frame. A post-grant opposition may lead to the revocation of a patent.
The mechanism by which some countries allow any person, including patients and health organisations, to provide information to the patent office to aid the examination of a patent application once it is published. The information provided can lead to the rejection of unmerited patent applications and prevent evergreening of pharmaceutical monopolies.
Primary patent (on pharmaceuticals)
Patent on an active ingredient/chemical compound, which usually prevents the introduction of generic alternatives during the term of the patent.
Publications or other public disclosures made before the filing (or priority date) of a patent application against which the novelty and inventiveness of the invention in the patent application is judged.
The date that the first patent application for a specific invention was filed.
Priority review voucher (PRV)
The FDA’s PRV programme grants clinical trial sponsors that successfully register an eligible medicine or vaccine a ‘voucher’ (or a PRV) for priority review of another product that would not qualify for an accelerated review on its own merit.
Pro-public health laws
Laws that work in favour of strengthening public health systems, including by promoting people’s health and access to medicines over pharmaceutical profits and profiteering.
An example is India’s patent law which says that a new form of a known medicine can only be patented if it shows significantly improved therapeutic efficacy over existing compounds [Section 3(d)]; this is a provision to stop the common industry practice of extending, or ‘evergreening,’ their patent monopolies for routine modifications of known compounds.
Public health safeguards
Legal measures taken to safeguard public health in the context of IP protections, including but not limited to compulsory licenses, ‘pre-grant’ oppositions, ‘post-grant’ oppositions, Bolar exceptions, research and experimental exceptions, and strict patentability and examination standards to prevent evergreening.
See 'WHO prequalification'
The totality of the arrangements made to ensure that pharmaceutical products are of the quality required for the intended use. Quality assurance covers all the steps to ensure the level of quality of medical products complies with relevant international standards of quality, safety, and efficacy throughout the entire supply chain, from raw materials to the manufacturer, to the patient.
All measures taken, including the setting of specifications, sampling, testing and analytical clearance, to ensure that raw materials, intermediates, packaging materials and finished pharmaceutical products conform with established specifications for identity, strength, purity and other characteristics.
In bioequivalence studies, a reference or comparator drug/product is the one against which the generic or biosimilar product is assessed.
Research and development (R&D)
Studies and tests that are done to design new or improved products.
Secondary patents on chemical pharmaceutical products often refer to additional patents filed and granted beyond the primary patent covering the base chemical compound of a medicine.
Secondary patents can cover a wide range of aspects around the base compound, including various derivative forms of the base compound, combinations, formulations, compositions, and methods of use. Pharmaceutical corporations often use secondary patents to secure a longer market monopoly even after the expiry of the base compound patent.
Many secondary patents on pharmaceuticals are a result of lower standards of patentability criteria and examination.
Also see, ‘Evergreening’
Substandard medical products
Medical products which are authorised but fail to meet their quality standards or specifications.
Supplementary protection (or patent term extension)
See, ‘Patent term extension’
Sharing the knowledge and expertise needed for production of medical tools, like medicines, vaccines and diagnostics, with other manufacturers in a systematic way.
Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement)
The TRIPS Agreement, under the auspices of the WTO, provides minimum standards in the international rules governing IP, including patents on medicines. It came into force on 1 January 1995 and applies to all members of the WTO.
These standards include, amongst others, that patents be granted for a minimum of 20 years; that patents be granted both for products and processes; and that undisclosed pharmaceutical test data be protected against ‘unfair commercial use’.
A trade secret is a type of IP consisting of information that is not generally known to the public, contains commercial value due to its secrecy, and that has been kept secret via reasonable steps taken by the person/entity with lawful control over it.
Information related to methods and technology used to manufacture a drug are a common example of trade secrets.
A trademark is a type of IP whereby a sign, symbol, word or phrase or a combination of these elements is used to identify and differentiate goods and services by one corporation/entity from another’s.
Transferable exclusivity vouchers (TEVs)
A voucher that applies a certain number of years of exclusive protection on the regulatory data of a medical product of a developer’s portfolio, which may be sold/passed on to another company. In practice, TEVs often function as additional years of market monopoly on the TEV holder’s bestselling products, yielding high levels of revenue for the company but delaying generic competition that could bring prices down to more affordable levels for people and healthcare systems.
The policy space available for governments to interpret the TRIPS Agreement as per their domestic situation, such as to address public health needs, as reaffirmed in the Doha Declaration, including but not limited to compulsory licenses.
Provisions in bilateral or multilateral trade agreements/negotiations, investment treaties and national laws that go beyond the minimum requirements contained in the TRIPS Agreement.
In the context of access to medicines, ‘TRIPS-plus' often refers to those provisions that have detrimental effects on access to medicines through longer and more exclusive protection over the originator products.
Examples include extension of patent terms beyond 20 years, introduction of data exclusivity, loosening criteria for patentability, and limiting the use of compulsory licensing.
A proposal brought forward to the WTO by India and South Africa in October 2020 to temporarily waive patents, trade secrets and other IP on all COVID-19 medical tools.
The proposal was supported by over 100 governments, but the final agreement did not adequately waive IP on all essential COVID medical tools, and it did not apply to all countries.
Contractual agreements through which patent-holding entities (licensors) set out the terms under which a generic version of a patented medicine can be used, produced or marketed by other entities (licensees). Through license terms and conditions, pharmaceutical corporations can set limitations on where and to whom a product can be sold, control the supply of API and impose other restrictions on licensees.
Prequalification is a WHO programme to assess the quality, safety and efficacy of medical products to help ensure that medicines, diagnostics and vaccines supplied by procurement agencies meet acceptable standards of quality, safety and efficacy.
Source: WHO, Prequalification of medicines