INTELLECTUAL PROPERTY IN HEALTHCARE

Studies in medical research and technical developments require a huge investment which can only be possible when there is a possibility of commercial venture. Such commercial venture always craves a good return on the huge investment. A good return can only be possible when there is any monopolistic right which predominates the market. With this view, the patent protection is needed when there is any invention related to surgical tools, stents, implants, wound dressings, diagnostic instruments and the like. Companies who are developing such inventions may envision to sell products in the domestic market as well as in the global markets. Thus, the patent protection is essentially needed for the country of origin at the first instance and thereafter, across the globe where the business possibility prevails. Depending on the nature of the invention, the patent right can be created in multiple jurisdictions if the patent laws allow to do so in that respective country. An invention can cover the process or method of producing the improved products and also the product itself under the purview of patent protection. But the method of treating human being or any species is not patentable in many countries including India. To create patent protection for methods of using medical devices may be difficult in certain jurisdictions, like India, Canada and many countries where the methods of medical treatment are not considered patentable.

Medical devices such as surgical tools, artificial limbs, and diagnostic tools stents are qualified for patent protection. As a general concept, an inventive product can be patented when it meets the criterion of new, non-obvious and usefulness. Thus the medical devices are no different.

In India, under the regime of Patents Act, 1970, it was allowed to produce generic versions of medicines that were patented elsewhere. That created an orbit of low cost medicines within the country which was overpriced in other countries. The Indian pharma-companies were following the practice of re-engineering the process for manufacturing generic drugs which resulted in lowering the market price, increasing competition, availability as well as affordability. This practice was safeguarded by the Patents Act, 1970, when there was no product patent but only the process. Thus, many companies reaped the profits with the help of liberal patent protection and creating sequential and overlapping patents on a single invention through minor changes, which further extended their monopoly for the pricing and availability of drugs. This created unavailability of adequate low-cost generic drugs for public. In the year 2005, a major amendment brought the changes towards product patent in the arena of medicines which made the Indian patent law TRIPS-compliant. But various restrictions have been imposed through Sections 3, which recites as under:

    • An invention which is frivolous or which claims anything obviously contrary to well established natural laws;
    • An invention, the primary or intended use or commercial exploitation of which could be contrary to public order or morality or which causes serious prejudice to human, animal or plant life or health or to the environment;
    • The mere discovery of a scientific principle or the formulation of an abstract theory or discovery of any living thing or non-living substance occurring in nature;
    • The mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant.

Explanation.—For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy;

  • A substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance
  • The mere arrangement or re-arrangement or duplication of known devices each functioning independently of one another in a known way;
  • Omitted by the Patents (Amendment) Act, 2002
  • A method of agriculture or horticulture;
  • Any process for the medicinal, surgical, curative, prophylactic diagnostic, therapeutic or other treatment of human beings or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products. /li>
  • Plants and animals in whole or any part thereof other than micro-organisms but including seeds, varieties and species and essentially biological processes for production or propagation of plants and animals;
  • A mathematical or business method or a computer program per se or algorithms;
  • A literary, dramatic, musical or artistic work or any other aesthetic creation whatsoever including cinematographic works and television productions;
  • mere scheme or rule or method of performing mental act or method of playing game;
  • A presentation of information;
  • Topography of integrated circuits;
  • An invention which in effect, is traditional knowledge or which is an aggregation or duplication of known properties of traditionally known component or components.

The grounds of non-patentability by Section 3, the scope of compulsory licensing under Section 84 to 94 and oppositions (pre-grant and post-grant) under Section 25 provide stringent tests for pharmaceutical patents which are ultimately helping the Indian generic industry to grow. During the last decade, the Government of India took a strong move to protect the traditional knowledge, to control monopoly in the market and also to make healthcare products affordable. Several patents have been refused on the grounds of patentability. The government has taken a firm step against the falsified activities of the industry but side by side encouraging the companies to develop new research and developments, applying for the patent of an invention related to a product. The present IPR protection system in India ensures a broad spectrum of protection of new inventions which will result in constant growth of the pharmaceutical industries.

In the United States, interestingly the inventions related to medical devices and the methods of medical treatment are accepted for patent. Thus, patent claim for a new device as well as methods of using such a device in a medical treatment such as dressing of a wound is allowed in U.S.A.

For example, a dressing comprises the essential feature as applying dressing includes pharmaceutically active compound for creating layer over the wound , lowering the risk of infection of the wound can be set as first claim.

The claim set can cover an additional product claim which can be a feature.

For example, the dressing of first claim, further comprises a coating layer on a wound-facing surface of the dressing, said coating layer comprises the compound X.

The subsequent claims might also include the function of the pharmaceutically active compound. On the way the method of reducing infection of a wound area can be covered.

In Canada, the methods of medical treatment are not considered as patentable item. Thus, the improved method of treatment or improved relief to the patients during treatment is not a subject matter of patent claim. But during the treatment, if any new product which is adopted, the product can be brought under the patent protection.

The method claims can be converted as user claims and also as product-for-use claims. In the true sense, the user claims protect a specific purpose for which a medical device or product is being used without referring any method steps. Thus, the following patent claims should be permissible in Canada.

The product-in-use and the user claims can be presented in Canada for patent protection , wherein the method can be included as additional claim, such as , use of a dressing for reducing infection of a wound site, the wound dressing comprises etc.

In Europe, the methods of medical treatment are not allowed for patenting. The European patent law allows the products used in medical treatments for patent rights provide if it is new and non-obvious, although the methods of treatment are not. Therefore, claims related to any new device are accepted for patent protection. The product-in - medical use can be protected by European patent law if the claims are only related to substances and compositions.

As the Europe patent law does not consider the medical treatment methods as patentable subject matter which may be less of a concern for methods of using new devices, as the protection can be obtained for the new device itself. Furthermore, the methods that relate to new and non-obvious medical uses of a previously known medical device, the patent protection may not be allowed in Europe.

PATENT PROTECTION

A patent can be obtained to protect any new invention for a product or any new manufacturing process but in the case of the method of medical treatment, when the patent protection is a possibility, rather even the discussions at an early stage of development of product, then the patent application must be filed before the product is made in public.

Choosing the appropriate time to file a patent application is also important and consultation with an experienced patent attorney is needed. The attorney can help you to prepare the provisional specification as well as filing the patent application on that basis, an invention can be protected from third party developing and seeking protection for a similar invention in the meantime. The invention may not be at final but the filing of provisional is always advisable. When the invention is at final stage, with the help of an attorney, the patent application should be filed along with the complete specification. The drafting of a patent specification is very crucial work and an expert in this field can only help to it make it perfect for avoiding several objections from patent office at the time of examination.

DESIGN PROTECTION

In introducing any new instrument in the medical treatment of health care activities, the design registration can take a prime for creating exclusive rights on that new device if there are no inventive steps involved. The appearance of the device is the main consideration for the design registration. To secure the registration, the design should be new and novel. Thus, the appearance should qualify the criterion of novelty as prescribed by the Indian Design Act, 2000. Precisely, a design can be protected where the new development is not sufficiently innovative which can justify an application for patent protection, but the appearance of the product is original.

A cancellation proceeding can be initiated against the registered design, if it is found to be known to public at the time of registration. The registration of design process is comparatively quick, providing fast protection, but their protection life is only for 15 years in India.

TRADE MARK PROTECTION

For the commercial exploitation of pharmaceutical products, trade mark takes a prime role for production identification as well as referring the source of origin. Similarly, the devices are also identified by a trade mark which can help the business to grow and for creating good will in the market. To secure the monopoly rights in the business, the adoption of a distinctive trade mark and its application with the products or devices should be legally founded. Thus, the guideline from an experienced IP Attorney should be followed. For any medical product, there might be a number of competing companies in the market, but trade mark can only ensure the monopoly among the large section of customers. By registration of a trade mark, a legal measure can be followed against third party duplication of a brand name. It is to be remembered that the respective trade mark should be able to differentiate the products from a particular business house from those of the other competitors. A distinctive trade mark can only be successful to do so.

An application for registration of a trade mark may be filed at any point of time during the business, but there are certain restrictions e.g. the trade mark should not be descriptive of the product. But it is highly advisable to follow the search procedure for finding that the respective trade mark is not conflicting with any pre-existing trade mark in the trade. A trade mark registration can be opposed when there is any legal issue involving a trade mark which is visually, phonetically or deceptively similar in nature. Such may be overcome through a prolong legal process before the registering body or in the court of law.