Pharma Sector in India is caught in the debate over the enforcement of Intellectual Property Rights (IPR) and access to affordable medicines. Affordable drugs are necessary and is a matter of great concern for the healthcare system. There is a need to refine the Drug policy in India in the light of growing concerns about patent filing in the pharma sector and access to cheap medicines.
Enforcement of Intellectual Property Rights encourages companies to invest in research and development. Most companies invest in research and development so that they can reap profits from the product developed. Patenting the product or process ensures that others do not replicate the concerned product to gain a share of the potential profits. But the critics of enforcement of intellectual property rights in the pharma sector argue that patents encourage monopolies. The pharmaceutical companies who patent drugs can sell those drugs at quite high prices because of no competition involved in the marketing of the drug.
The incomplete understanding of intellectual property rights (IPRs) is the real issue that India’s drug industry is facing. Currently, only 5% of medicines used in India are said to be patent-protected. Breakthrough therapies are being developed in the world but why these therapies are not made available to India but are being introduced in other countries?
It is observed that the new drugs and therapies encounter delay in marketing approval in India despite their global launch. Moreover the new drugs that are launched in India are produced and sold as generic versions by Indian manufacturers within one year of their introduction. Generic medicines are the copies of brand name counterparts of drugs originally developed by other companies. The rapid appearance of generic versions of medicines and delays in marketing approval display a lack of faith in the patent regime.
Patents are important in innovative sectors like pharmaceutical industry as they provide incentives for companies to invest in those sectors. Investment in innovation, research and development is an essential component of supporting an innovative and enterprising economy.
In order to link medical innovation with affordable treatment a supportive role by the Government is required. The government should design a price-control mechanism without tampering the grant of patents. The government should deploy tools to reduce uncertainty in Intellectual Property Rights and to build an ecosystem that promotes medical innovation. We must achieve a balance between the current and future needs of patients and the timely introduction of existing and new pharmaceutical drugs.
Mediation is a potentially efficient and cost-effective alternative to traditional litigation and arbitration. The use of mediation has become increasingly popular in several areas of dispute resolution and one such area is that of intellectual property (IP).
As the field of Intellectual property is vast, here the importance of mediation as an alternative to both litigation and arbitration in patent infringement disputes is discussed.
A patent can be defined as a set of exclusive rights granted by a sovereign state to an inventor or assignee for a limited period of time in exchange for detailed public disclosure of an invention typically for 20 years during which the product or process cannot be exploited by others.
Patent disputes typically arise when patent rights are breached i.e Patent infringement occurs when a third party makes, uses, sells, offers to sell a patented invention without the patent owner’s permission. The scope of the patented invention or the extent of protection is defined in the claims of the granted patent. Therefore, patent infringement disputes involve courts interpreting and evaluating the claims of a patent on which the protection is sought. This is a complex procedure and the litigation process often become expensive and complicated. In the defense of infringement party allegedly responds with a counterclaim of patent invalidity and a defendant involved in patent litigation may ask to reexamine the patent being litigated. During re-examination the court will reconsider the validity of original patent and whether it meets the statutory requirements of novelty, inventiveness and non-obviousness. If a defendant successfully pleads the defence of a patent the patent owner will lose not only the case but also the patent itself.
Alternatively, mediation in patent infringement disputes can save time and money by avoiding the interpretation and reinterpretation of patent claims. Also, mediation removes the risk of patent invalidation and promotes creative solution in patent disputes. Moreover, unlike litigation, mediation process is confidential.
For example- A company holding patent rights for a technology founds that its competing company is selling the same technology without any license. The concerned company threatens to file patent infringement case in all jurisdictions in which the company is holding patent rights. But the mounting cost of legal action would take a toll on the company and the litigation process is very time consuming. In such a situation, mediation is instrumental in transforming a hostile situation in which the parties were preparing to engage in prolonged and expensive litigation into one in which they were able to conclude an arrangement which suits the business interests of both parties and ensures the profitable use of the technology in the service of those interests.
Mediation is a great idea and can offer people a way of working things out without spending lots of money which could be better spent elsewhere to grow a business.
The primary goal of “Make in India” initiative was to make India a “Global Manufacturing Hub”. With both multinational companies and domestic companies manufacturing their products within the country, the significance of exports and the manufacturing sector in India has increased considerably. Several measures have been taken to ensure continuous and unending improvement of the Indian IP ecosystem in the country due to the need to extend such to exports for its proper commercialization.
Just as other Intellectual Property Rights, Trade Secrets are extremely valuable and sometimes even critical for a company’s growth and survival. Trade secret is a formula, process, device, method, technique or other business information having commercial value. This information is kept confidential and exclusive. Reasonable steps have been taken to maintain its secrecy to get competitive advantage over the competitors.
For example, Trade secrets like Coca-Cola’s formula for its aerated drinks have been preserved for many decades and is not in the public domain.
India has no specific law for the protection of trade secrets. But, Article 39 of Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement to which India is a signatory provides for the specific provision for the protection of undisclosed information.
Article 39 of the TRIPS Agreement states that:
In the course of ensuring effective protection against unfair competition as provided in Article 10b is of the Paris Convention (1967), Members shall protect undisclosed information in accordance with paragraph 2 and data submitted to governments or governmental agencies in accordance with paragraph 3.
Natural and legal persons shall have the possibility of preventing information lawfully within their control from being disclosed to, acquired by, or used by others without their consent in a manner contrary to honest commercial practices (10) so long as such information: (a) is secret in the sense that it is not, as a body or in the precise configuration and assembly of its components, generally known among or readily accessible to persons within the circles that normally deal with the kind of information in question (b) has commercial value because it is secret; and (c)
has been subject to reasonable steps under the circumstances, by the person lawfully in control of the information, to keep it secret.
Members, when requiring, as a condition of approving the marketing of pharmaceutical or of agricultural chemical products which utilize new chemical entities, the submission of undisclosed test or other data, the origination of which involves a considerable effort, shall protect such data against unfair commercial use. In addition, Members shall protect such data against disclosure, except where necessary to protect the public, or unless steps are taken to ensure that the data are protected against unfair commercial use.
Unlike Patents and Copyrights which can be protected for about 20 years and 100 years respectively, trade secrets can potentially last much longer. A trade secret continues to remain a trade secret as long as any other person does not independently discover the information.Due to the absence of law for the protection of trade secrets, Indian courts have approached trade secrets protection on the basis of principles of equity, action of breach of confidence and contractual obligations.
In India, a person can be contractually bound to not disclose any information which is told to him in confidence and if the person discloses the information, he/she can be sued for violating the Non-Disclosure Agreement.
Companies can include a non-disclosure agreement in their employment contracts which prevents the employees to disclose any sensitive and confidential information regarding the company during their term of employment with the company or afterwards so that the secret is not spilled out. In cases where the trade secret is in a physical form like blueprints, files etc. a strict Security System should be in place so that this confidential information remains confidential.
If your business relies on sensitive information that you would consider to be a trade secret, we encourage you to consult with a legal practitioner for advice on maximizing its protection.