This articles addresses issues related to the protection of the rights of brand-name drug patent holders in connection with generic drugs registration by other manufacturers.
The way drugs have to make from a laboratory to a pharmacy is known to be very long and, in addition to research activities, involves certain legal procedures such as obtaining patents, registering brands as intellectual property and drug registration with special healthcare and certification bodies.
Fast-growing economies and large population make CIS countries, such as Uzbekistan and Kazakhstan, high-potential emerging markets both for pharmaceutical giants and smaller drug manufacturers.
Most drugs marketed in these countries are either brand-name or generic (i.e. identical to the original formulations).
Having reviewed our efforts in the sphere of patent protection in the pharmaceutical industry over the last years, we conclude that there is a need for certain improvements to the existing laws to protect the rights of holders of patents to brand-name drugs and to create good faith competition among generics manufacturers.
Our understanding of the pressing issues and possible solutions suggested in this article are based on many months of work of an Almaty (Kazakhstan) based task force consisting of Legalmax specialists, representatives of the leading global pharmaceutical companies, our colleagues from international law firms, and patent attorneys. Officials from the Ministry of Justice and the Ministry of Healthcare and Social Development as well as other stakeholders also contributed to the discussion.
The approach to streamlining the marketing of brand-name drugs and generics boils down to the necessity of harmonizing administrative regulations in the area of drugs registration and approval and laws governing registration and protection of intellectual property rights, including, without limitation, patents which are typically hold by developers of innovator drugs.
The term "innovator (brand-name) drugs" means original drugs first developed/manufactured and protected under valid patents, including, without limitation, entitled to legal protection in a certain country. A "generic drug" is, in turn, a non-patented drug identical to the original brand-name one due to the use of the same active pharmaceutical ingredient for which the term of legal protection has expired.
The lack of legal tools and legal provisions prohibiting registration and market launch of generics during the term of the patent for invention containing the same active ingredient is the source of most legal disputes and, therefore, leads to the infringement of patent holders' rights in relation to original drugs and formulations used in them.
As a result of legal loopholes in this area, generics are approved for market launch during the term of the validity of patents for active ingredients used in such generics which, in most cases, creates grounds for patent disputes.
Many of the above problems can be avoided and the interests of patent holders and those of the generics manufacturers may be balanced if healthcare authorities and generics manufacturers are under obligation to take certain actions aimed at excluding the possibility of entering into the national register of pharmaceuticals or medical goods for as long as the patent for their active ingredient remains valid.
This recommendation is not news and has been implemented on a global scale in the form of the Patent Linkage system that has proven itself as one of the most efficient tools in the area of protection of lawful patent holders' rights.
Patent Linkage principles have been built into the laws of most developed countries, and their implementation in the laws of Kazakhstan and Uzbekistan is a pressing issue for the professional business community and end consumers of pharmaceuticals.
The importance and necessity of this system are due primarily to the fact that it offers protection to inventions made by national and foreign research centers thus promoting their innovative efforts and research in the area of improving existing and creating new drugs. Secondly, guarantees of foreign patent holders' rights protection and observance will lure the most advanced treatments and disease prevention methods into the consumer market.
Patent Linkage may be made a part of national legislation through introduction of simple yet efficient instruments to control and prevent the infringement of valid patents:
- All drug registration applications filed by interested companies shall be published in specialized bulletins or on the official website of the Ministry of Healthcare or its divisions; thus, the brand-name drug patent holders and manufacturers will be able to identify by themselves any potential infringements of their intellectual property rights.
- The patent holders must be entitled to file a request with the registration authorities (based on information obtained from the above open sources) to suspend registration subject to the provision of reasonable and sufficient evidence that the patent holder's rights may be infringed if the generic is registered and allowed into the market.
- In addition to declaring that no third party rights are infringed, the person applying for generic registration shall support such declaration with documents obtained from the national patent authorities (Kazpatent and Intellectual Property Agency of the Republic of Uzbekistan) through the official procedure of obtaining information about patent search of the key components of drugs to be registered, and their manufacture and use procedure.
- The application for generic drug
registration shall, in a manner excluding any double interpretation
or ambiguity, specify whether there is any legal impairment to the
drug components. In particular, one of the below conclusions must
be made in the application:
- the drug to be registered does not contain any inventions or any other patented objects that are under legal protection in the country; or
- the drug to be registered contains elements of an invention with valid legal protection, the expiry date of the patent to be specified.
If the generic to be registered contains any patented components, its registration is to be suspended until the patent expires, or until a respective court decision comes into effect if the applicant files a court complaint in connection with the patent holder's actions.
The proposed way of Patent Linkage introduction into the national legal system will undoubtedly involve further work; however, we believe that using it will allow us in the nearest future to materially reduce the possibility of patent holders' right infringement, to strike the right balance among interests of all pharmaceutical market participants, and to create conditions for good faith competitive environment.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.