Grounds for Compulsory Patent Licensing in United States, Canada, China, and India

Holding ownership to a patented invention means one has certain exclusive rights: a) the right to decide who may use the invention during the time of protection; b) the right to give licenses to other parties to use the invention on mutually agreed terms; and, c) the right to sell and transfer ownership of the patent to someone else[1]. Once this patent expires, the invention would enter the public domain to be shared freely[2].

However, given certain conditions, a compulsory license can be granted, in which “authorization [is] given by national authority to a person without or against the consent of the titleholder, for the exploitation of a subject matter protected by a patent or other intellectual property rights” [3].

Compulsory licensing has been most contentiously applied for patented pharmaceutical companies who are often looking to recoup research and development costs. Proponents of this instrument are now also growing amongst advocates for climate change mitigation technologies [4]. The Pervasive Technologies: Access to Knowledge in the Marketplace project is broadly assessing access to knowledge through sub-100 dollar devices. The accessibility of these critical technologies, and subsequent access to knowledge, information, and culture through these devices may be implicated by this policy lever[5]

Thus, this paper seeks to answer the following questions:

1. What are the grounds for compulsory licensing set in international treaties?
2. How does Canada, United States (i.e. North America), India, and China (i.e. Asia) provide for compulsory licensing within its national laws?

This will be done through first providing an overview of the relevant international treaties to understand the compulsory licensing framework which signatory nations must follow. Then, utilizing Correa (1999)'s study as a foundation, an analysis of the text within the four aforementioned's codified laws will be assessed to understand all the possible grounds compulsory licensing can be provided. This paper will conclude by summarizing any significant distinctions across the four jurisdictions.

Compulsory Patent Licensing in International Law and Regional Trade Agreements
Paris Convention for the Protection of Industrial Property (1883) [6]
Article 5(2) of the Paris Convention provides each country with the right to "grant compulsory licenses to prevent abuses which might result form the exercise of exclusive rights conferred by the patent… " United States, Canada, China, and India are four of the 175 contracting parties to this convention [7]. This can only be done after 4 years of applying for the patent, or 3 years from the date in which the patent was granted. This means, a sufficient amount of time must have elapsed to allow the rights holder to exploit the invention.

North American Free Trade Agreement (1994)[8]
Article 1704 in NAFTA provides that "appropriate measures" can be taken to control abusive or anticompetitive practices. The United States and Canada have utilized this ground of anti-competition to grant numerous compulsory licenses.

Article 1709 notes that there must not be a discrimination of technology – patents may only be revoked when the grant has not remedied lack of exploitation, and that the use of the patent adheres to certain criteria.

In 1993, Canada repealed the compulsory licensing regulations from its Patent Law to comply with the international TRIPS and NAFTA treaties.

Trade Related Aspects of Intellectual Property Rights (1994) [9]
All members of the World Trade Organization is provided the right to use compulsory licenses via Article 31 Other Use Without Authorization of the Right Holder within the Trade Related Aspects of Intellectual Property Rights (TRIPs) agreement. This Article stipulates 12 procedural provisions: compulsory licensing should be granted on 'individual merits'[10], must have shown prior effort to obtain authorization under reasonable commercial terms [11], must be non-exclusive[12], adequate renumeration must be provided[13], and the license must be terminated as soon as the circumstances for which it was granted cease to exist[14].

Suggested, but not obligatory grounds for which compulsory licensing could be granted under the TRIPs agreement are a) emergency and extreme urgency, b) anticompetitive practices, c) public non-commercial use, and the d) use of dependent patents[15].

Doha Declaration on the TRIPS Agreement and Public Health (2001)
The Doha Declaration is a clarification of the earlier TRIPS agreement in response to some countries' public health concerns due to obstacles to accessing patented medicines.[16]

Paragraph 4 of the Doha Declaration expressly allows Members to take measures to protect public health, while paragraph 5b states that "each Member has the right to grant compulsory licenses and the freedom to determine the grounds upon which such licenses are granted". Freedom of each country to define the terms of their intellectual property rights is also further reiterated.

Grounds for granting compulsory licenses
Correa (1999) in his paper Intellectual Property Rights and the Use of Compulsory License: Options for Developing Countries outlines eight common grounds which provided the framework for this comparative analysis between the jurisdictions of the United States, Canada, India, and China. Through analyzing the codified law on compulsory licensing, a few other grounds were added to the list.

Refusal to deal
In principle, the patent owner has an exclusive right to determine whether or not to issue a license to a third party. However, if under reasonable terms, one still refuses to issue a license, national courts may interpret this as an abuse of patent rights, resulting in lack of availability of the product and commercial development. In the United States, this is often raised as an anticompetitive issue.

Non-working and inadequate supply
The "working obligation" was initially understood as the industrial use of an invention, which according to Article 31 of the TRIPs Agreement required working 'predominantly' for local markets. However, many countries have defined 'working' to include commercial use of the invention, in which importation of a product would suffice[17].

Public interest
The public interest needs to be balanced with individuals' rights, and it is the responsibility of the courts or administration in each respective country to determine this. Thus, what actually constitutes as "public interest" varies depending on time and jurisdiction. For example, countries with limited industrial development could consider a compulsory patent to develop its national industries as for public interest [18]. Accessibility of a product at the lowest price have been argued to be in public interest, but some courts have ruled this to be invalid[19]

Anticompetitive practices
A patent is essentially a temporary monopoly meant to provide an economic reward for the inventor's work, as well as additional incentive to continue producing[20]. However, excessive monopolization through unlawful or unfair practices, such as when a patent is overly broad, acquiring and accumulating patent portfolios, and subsequent patent trolling are some acts that be considered anticompetitive patent practices[21]. Compulsory licenses have also been granted through this ground under anti-monopoly, antitrust, and competition laws.

Governmental use
Each country's government decides what is to be considered as governmental use. Occasionally synonymous to government use has also been public, non-commercial use, or as suggested by the TRIPs agreement, for the purposes of national emergency or urgency. This is assuming the government is acting on behalf of public interest; given its lack of an international standardized definition, this ground can be utilized and interpreted in other ways.

Facilitate use of dependent patents
When a new invention (dependent invention) cannot be developed without infringing on the license of an existing patented invention, (principle invention) a compulsory licensing can be granted to facilitate innovation. This ensures the patents of principle inventions would not block technical progress. The TRIPs agreement expressly allows this, provided reasonable compensation is articulated. In some jurisdictions, cross-licensing, (which involves a licensing agreement between two parties to exploit each other's intellectual property[22]) can be negotiated to resolve this issue.

Compulsory licenses for medicines
Numerous countries have issued licenses for increased accessibility to food and medicine. Prior to the Doha Round, TRIPs prohibited this, as Article 27 states "national laws cannot discriminate in exercise of patent rights on the basis of field of technology". However, the Doha Declaration addressed this, allowing pharmaceuticals to have increased accessibility (via pricing, production, and importation) for the sake of public health.

Exclusive Grant Back or Coercive Package Licensing
A grant back can be agreed upon when there is an expectation of an improvement on the licensed technology through increased superiority or method [23]. This allows the licensee to commercialize an improved product without having to file for another patent[24]. Exclusive grant back provides the licensor the exclusive right to use or sublicense improvements, while licensee retains non-exclusive right to practice the improvements.[25] Grant-backs, particularly exclusive ones are sometimes deemed as anticompetitive.

A package license, otherwise known as patent pools is used when the licensing of more than one patent is necessary to commercialize an invention [26] Coercive package licensing can occur when the licensing of other patents within the package is forceful and unnecessary. The defining and interpretation of 'coercion' ultimately depends on each country's respective authorities.

Hindrance from Importation of Abroad[27]
This ground may fall under non-working, but is unique in that it notes a state's ability to grant compulsory license on behalf of a foreign-owned patent. Yang (2012) cites that this as one of the most controversial aspects of compulsory patent licensing, as countries may feel undermined when another state can grant compulsory licenses that are against their own interests[28].

Jurisdictional comparison of Compulsory Licensing
The following table was developed as an exercise to review compulsory licensing within the jurisdictions of the United States, Canada, India, and China. Utilizing Correa (1999)'s findings as a skeletal framework, the four aforementioned countries' codified patent laws were used to determine the grounds for compulsory licensing. The main compairson was done through analyzing the specific text within the laws of the four jurisdiction – one approach to treaty and law interpretation[29] However, for those countries that were lacking general provisions on compulsory licensing (i.e. United States, and eventually Canada in 1993[30]), there was a need to expand to a more comprehensive approach and look through other codified laws beyond patents and intellectual property, as well as through case law to see if the mentioned grounds have been used to provide for compulsory licenses[31].

Summary of Cross-Jurisdictional Comparison
As mentioned previously, this comparison necessitated an expansion into codified law outside of compulsory licensing and patent law into case law, since the United States had never written a general provision for compulsory licensing, and Canada had repealed theirs in 1993 upon the signing of the NAFTA and TRIPS agreement. For Canada, compulsory licenses (CLs) continued to be granted following the repeal through the Foods and Drugs Act, as well as the Competition Act. Despite United States' lack of general provisions, Knowledge Ecology International claims it is the world's leader in the use of CLs, yet hypocritical to developing countries' requests for affordable patented pharmaceuticals.[39]

In general, India and China both have very extensive compulsory licensing laws. China's State Intellectual Property Office even developed additional Measures to account for the execution of compulsory licensing. Despite comprehensive CL provisions, India has had only one compulsory license ever granted in the case of Natco Pharma Ltd v. Bayer Corporation, for the domestic production of cancer-drug Nexavar. [40] China has yet to grant any compulsory license, but the new Measures may signify an increasing willingness to do so, or even to be used as a bargaining tool. However, given its goal of developing domestic intellectual property (i.e. China's 5-year plan), it is unlikely that China will grant compulsory licenses in the masses.[41]

In regards to the specific grounds themselves, some grounds noted particular differences per country.

Under U.S. Intellectual Property Law, refusal to deal is actually is considered a right, thus does not provide for compulsory licensing; depending on the degree however, it could lead to anti-competition[42]. According to the Paris Convention, one can only request consideration for a CLs 3 years from the granting of a patent, or 4 years from application, allowing said time for provision of dealing. However, India seems to have a more stringent period of not exceeding a period of six months, while China noted specifically not 'without legitimate reasons'.

The non-working and inadequate supply was again not present in U.S. Law, yet Canada did include it in its former compulsory licensing provision prior to repeal. Canada had defined 'working' specifically referring to a commercial scale when compulsory licensing was in effect. India's 'working' means being available at a reasonably affordable price, and supplied or developed, through the establishment of commercial activities, worked to the fullest extent that is fully practicable, while China mentioned non-working 'if without good reason, it is not implemented or fully implemented'.

The United States does not have any provision providing explicitly for public interest. However, under the Bayh-Dole Act, government-funding for research during the economic crisis in the 1970s was granted as long as the inventors agreed to allow petition for 'march-in rights', in which the government or a third party “shall have the right...to require the contractor...to grant a nonexclusive, partially exclusive, or exclusive license” (35 U.S. Code S203(a)) if it meets one of four requirements - one being to “...alleviate health and safety needs which are not reasonably satisfied...” (35 U.S. Code Section 203). Canada's public interest clause had existed, but was repealed. India now states that CLs can be granted to make available to the public “at a reasonably affordable price, to public advantage, and for public non-commercial use”. In China, public interest is provided in conditions of 'national emergency or extraordinary state of affairs, for the purpose of public interest'.

The United States does however strongly uphold and value competition, and have granted CLs to remedy anticompetitive practices under its Antitrust laws, prohibiting any 'attempt to monopolize any part of trade or commerce'. China also uses the language of 'monopolistic actions' and allows compulsory licensing if its “negative impact on competition needs to be eliminated or reduced.” Canada's Competition Act allows for compulsory licensing if one 'limits unduly, the facilities for transporting, producing, manufacturing... restrain or injure unduly, trade or commercial etc..' .preventing fair competition. India also notes the remedying of anticompetitive acts in its patent laws.

Governmental use in the United States have been granted for use by the Department of Defense and as mentioned previously for the Bayh-Dole Act. However, unlike the other countries of focus, there is no way to appeal a CL for the purposes of government-use. The only way to remedy this as a patent owner is compensation. In Canada, the Commissioner may on application by the Government of Canada or province authorize a CL. Indian patent law also allows CLs for the purposes of the Government, with the explicit possibility of being made free of any royalty or renumeration. It also expressly notes within S103 that one can petition to the Government if this occurs. The Chinese Patent Law notes governmental use through the language of 'great significance to national or public interests', and 'national emergency or extraordinary state of affairs. The possibility of appeal is also expressly noted in Article 58.

Neither United States or Canada have formally codified any mention of compulsory licensing for the use of dependent patents, though it does exist in the TRIPs agreement they both comply to. In India patent law, CLs is granted through this ground “only if it involves important technical advancement of considerable economic significance, and... only if it cannot be accomplished without infringing other patents.” In China, the law states that if an “invention/utility model represents major technological advancement...compared with earlier invention or utility model...and the exploitation of former relies on exploitation of the latter...”, a compulsory license may be granted.

Compulsory licensing for medicine in the United States again have never been codified, but have been used to encourage Bayer to reduce their prices under the possibility of being issued compulsory liceninsg. Home to many of the pharmaceutical industries who own patents to medicines, the United States has been called hypocritical due to its common lack of providing affordable pharmaceuticals. Canada allows for CLs under the Food and Drugs Act which points to the World Trade Organization guidelines. Prior to the repeal of its compulsory licensing act, Canada also had specific provisions relating to medicines, and was actually the first country to authorize the compulsory licensing of an AIDS drug for Rwanda for export.[43] In India, the only compulsory license that has ever been granted was for cancer drug Nexavar. In its compulsory licensing provision, it states that CLs are “available for manufacture and export of patented pharmaceutical products...to any country having insufficient or no manufacturing” abilities. Similar to the TRIPs agreement, it also states that none of the principles should impede the protection of public health and nutrition. China's patent laws state that CLs can be used for the benefit of public health. The Measures for Implementation specifies more specifically which countries and regions are allowed, which includes WTO members, or the 'underdeveloped' nations.

Only in the Indian Patent Law does it explicitly allow for CL in the event of exclusive grant backs due to anti-competition and/or not being reasonable to the public. On the contrary, the United States actually had allowed exclusive grant back in the Transparent Wrap Machine Corp v Stokes & Smith Co. case[44]. However, the FTC now strongly recommends against it as it is considered anticompetitive when a grant-back is exclusive[45]. Canada and China does not seem to have this condition in their laws.

Similarly, only in the Indian patent law does coercive package licensing provide for compulsory licensing. This clause may have implications on standard-essential patent pools when attempting to determine which patents are indeed 'essential', and if they comply with fair, reasonable, and non discriminatory regulations[46].

Indian Patent Law also expressly allows for compulsory licensing on the ground that a product is hindered by importation from abroad. It must be proven the lack of accessibility is soley due to the process of it being imported, perhaps affected by natural disasters, socioeconomic reasons, political instability, sanctions, or more – ultimately affecting the cost and availability of this product. [47]

Conclusion and Further Reflections on Compulsory Licensing
Ultimately, there seems to be no correlation between the detail and scope of compulsory licensing (and other codified) law, and the number of compulsory licenses granted. However, it must be noted that the Eastern countries of focus in this review have had much less time developing its intellectual property landscape. In addition, the comprehensiveness of India and China's patent laws also reflect the incorporation of valuable lessons learned from poor implementation of other countries.

The prevalence of broadly defined patents, patent trolling, and the increasing need to navigate patent thickets all act as barriers to innovation and production to a commercial scale in which these technologies can actually be disseminated. The Pervasive Technologies project looks ultimately at bridging the digital divide through providing access to low-cost technology, and subsequently access to information, culture, and knowledge.

Compulsory licenses can be used to decrease the cost burden of production, and reduce barriers to innovation, ultimately providing greater accessibility to these tools for all of society. The Centre for Internet and Society has proposed and continues to advocate the establishment of patent pools for low-access devices through the use of compulsory licenses to achieve this goal[48].