A patent is a statutory right granted by the government subject to fulfilling certain criteria. Though the subject matter of protection differs depending on the industry, the common rules for all inventions are that they should be novel, non-obvious and applicable to the industry. A patent also provides the legal basis for monopoly in the commercialization of a product or process.
Technology-based industries such as chemical, pharmaceutical, and biotechnology include a wide variety of invention – from recombinant engineering to therapies for humans, animals and agriculture.
Drug development, for example, requires heavy investment in research and development of a new molecule and clinical trials before launching the products in the market. Clinical trials are necessary to establish the efficacy and tolerance factors of the new drugs in front of the regulatory authorities and they require a lot of documentation.
Developing a new molecule and successfully launching it is a time-consuming, risky and costly venture due to the high research cost, multiple lab trials, and long research duration for optimization of the processes and finally to get regulatory approval. As a general principle, of the 5000 molecules that a pharmaceutical company starts testing, only one will be successful after going through all the phases of clinical trials. Therefore, patent rights for pharmaceutical companies are essential in ensuring research for new medicines continues, this is in the public interest.
However, patent protection is open to vulnerabilities in the pharmaceutical sector as the manufacturing process has often seen infringement due to competition among generic drug makers. Therefore, in drug development, it is necessary to make sure that all efforts are taken to avoid wastage of resources in the form of money or time.
Patent portfolio has substantial value in the pharmaceutical industry and companies need strong patents to protect their products or processes from any kind of infringement. To achieve the desired results, companies should have a patent strategy from the conception to commercialization.
An effective patent search before starting research activities is an important step in saving time and ensuring optimum use of resources. Patent searching is a pre-requisite tool that helps in providing visibility for the research and, in turn, for commercialization and reducing infringement risk.
An effective approach to search can be extremely useful in planning and implementing patent strategy, ensuring that the research and development are in the right direction. Searching is also an effective tool to find both patents and general literature.
A patent search is usually performed by a technical person or a subject domain expert and is done in various steps to identify the key features of the invention.
It starts with the identification of the keywords, including synonyms, and various sub-tools such as IUPAC (International Union of Pure and Applied Chemistry) name, International Patent Classification etc., which varies based on the requirement and the area of
technology being studied.
Usually, the primary focus of a search is to identify the work that has already been done to avoid duplication and to identify the gaps. It is also helpful in proceedings in case a patent is opposed or revoked.
Prior art searches such as patentability or novelty searches to judge the patentability of the invention is helpful if performed before starting work on any proposed project.
Freedom-to-operate opinion is another safety tool that can be used to ensure that the proposed technology or substance is not infringing any patents. Although the opinion requires in-depth analysis, it is limited to specific jurisdictions and in-force patents. Validity or invalidity search is another method to determine the validity of an invention in view of prior arts.
Further, a technology landscape search can be performed for an effective understanding of the advancement in technology, major players in the market, current and upcoming competitors. This search can be expanded with state of the art searches, the broadest of all available patent search tools, which gives an overview of the market trends and helps get a close look at the domain.
Pankaj Musyuni is a managing associate at LexOrbis.
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