Proceedings before the Office and Procedural Rules

This chapter discusses the Basic Regulation and the Proceedings Regulation that contain a diversity of provisions on procedures, which relate to application procedures, objection procedures, or appeal procedures. It describes the Community plant variety rights system that opens the possibility for breeders to apply for Community plant variety rights. It also explains the specific procedure of framework of the Community system, which complies with fundamental principles on legitimate expectations and the right to a fair hearing. This chapter deals with the ancillary procedures relating to variety denominations, the objection procedure, and the procedure on access to documents. It highlights specific procedures to be followed concerning the application for a compulsory licence and requests for nullity and cancellation.

Die Nichtangriffsverpflichtung im deutschen und europäischen Kartellrecht

Subject of this dissertation is the assessment of non-challenge clauses between a patent holder and a licensee as well as possible exceptions for free licences, obsolete technology and settlement agreements against the background of German and EU competition law. In addition, the author assesses non-challenge obligations based on the principle of good faith as well as termination rights of the patent holder in case of challenge. Finally, the author analyses whether recent German and EU case law on the compulsory licence defence results in contradictions to the assessment of non-challenge obligations. The author graduated from the University of Heidelberg and works as an attorney in the field of German and EU competition law.

Requirements for Granting a Compulsory Licence for a Medicinal Product

Alirocumab

The compliance of South Africa's patents compulsory licensing regime to the TRIPs Agreement

In South Africa, patents compulsory licences can be issued under the Patents Act or Competition Act although the latter is not explicit. Whereas there has not been a single compulsory licence issued through the Patents Act, there is however a growing interest to obtain compulsory licences of drugs using the competition law regime. Focusing specifically on the standard of compensation, the objectives of this paper are two-fold: first, it seeks to determine why there is a growing interest in resorting to the competition route as opposed to the Patents Act. Secondly, the paper aims to determine the extent to which the South African compulsory licensing regime complies with the TRIPs Agreement. It is found herein that the standard of compensation under patents law is higher than that found in the competition law cases. Further, it is found however that compulsory licences issued through the competition law do not take into account the procedural safeguards that are found in the Patents Act as well as the TRIPs Agreement; as such, they undoubtedly infringe the rights of the patentees. The article recommends that the South African Competition Act should be reviewed with a view to aligning its compulsory licensing scheme with that of the Patents Act and the TRIPs Agreement, thereby establishing a nexus between competition law and patents law. This paper comes at an opportune moment in which South Africa and China are urging other WTO members to share their national experiences on the use of competition law to ensure access to health, and it shall therefore shed some light on how South Africa does it and the obstacles therein.

23. Exploitation

This chapter looks at the many different ways in which patents may be exploited and some limits to exploitation. It first explains how patentees themselves can exploit the patent and considers two of the more common forms of voluntary uses: assignment and licence. It then describes situations in which compulsory licences are available and the compensation payable where the patent is used via a compulsory licence or by an employer or the Crown. Mortgages, testamentary dispositions, and registration of interests and transactions are also discussed, along with patent law in the UK and British and European competition law. The chapter concludes by assessing compulsory licences under section 48 of the Patents Act 1977, the licensing and cross-licensing of biotechnological inventions, and compulsory licences for public health.

THE LEGAL IMPLICATION OF COMPULSORY LICENCE PHARMACEUTICAL PRODUCTS IN THE TRIPs AGREEMENT TO THE PROTECTION OF THE RIGHT TO HEALTH IN DEVELOPING COUNTRIES

Compulsory license of pharmaceutical products in the Trade Related Aspects of Intellectual Property Rights (TRIPs) Agreement attempts to balance the interest of patent holders and The right to health. The access of medicines in developing countries for the epidemic diseases, such as, HIV/AIDS medicine is crucial to protect The right to health. The objective of the research is to analyze comprehensively the legal implication of compulsory license for the pharmaceutical product to the protection of The right to health in developing countries. It is a normative juridical research by applying conceptual and comparative approaches. The results of the research shows that: first, the implementation of compulsory licence is in accordance with the international human right law: second, the legal implication of the compulsory license causes the adoption of policy and regulations regarding the protection of the right to health in developing countries, such as Indonesia, Malaysia, Brazil, India and South Africa. Keywords : Compulsory license, pharmaceutical products, legal implication and The right to health

Compulsory Licensing under India’s New Model Bilateral Investment Treaty

The traditional lack of patent protection for pharmaceutical products allowed India’s generic sector to expand and become ‘the pharmacy of the world’ supplying affordable medicines to both developed and developing countries. With the entry into force of the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement in 2005, the mechanism of compulsory licensing was incorporated as a flexibility to ensure that the protection of intellectual property (IP) rights does not undermine the public access to affordable medicine. Following the issuance of the first compulsory licence by the India’s patent office to Natco for Nexavar in 2012, various domestic companies requested a licence for production of generic copies of patented drugs. The recourses and litigation over the compulsory licensing provisions under India’s Patent Act 1970 indicate the importance of the institution of compulsory licensing for ‘Indian pharma’ and its desire to rely on it in the future. This article attempts to assess the legal consequences of the new India’s Model Bilateral Investment Treaty providing investment tribunals with the jurisdiction to examine the compliance of domestic decision to grant compulsory licence with the World Trade Organization (WTO) TRIPS Agreement. JEL: K33, P45, F21, O34, O53, O19

Compulsory licences on pharmaceutical patents in India: A short article

Over the last few years, multiple media reports have commented on compulsory licensing of pharmaceutical patents in India. A majority of these reports painted a doomsday scenario and were devoid of facts. The grant of India’s sole compulsory licence in March 2012 (to Natco for Bayer’s patented drug – Sorafenib) spawned a series of media reports theorising that the grant of this compulsory license was ‘… a major blow to global pharmaceutical firms’ and speculating a beginning of compulsory licensing era for pharmaceuticals patents. However, this simply has happened and India till date has rejected all subsequent compulsory licence applications filed after the Natco/Sorafenib compulsory license application. The purpose of the present article is to collate the present information around the various compulsory licences in India and provide some historical background at a time when even developed countries are beginning to issue compulsory licences for pharmaceutical products.