Intellectual Property Rights with Special Reference to Health

A presentation on "Intellectual Property Rights with Special Reference to Health" by Jasvir Kaur after having a research paper on 'Intellectual Property Rights with Special Reference to Health' from Sardar Patel University of Police, Security & Criminal Justice, Jodhpur.

1. PRESENTATION ON INTELLECTUAL PROPERTY RIGHTS WITH SPECIAL REFERENCE TO HEALTH SUBMITTED BY: JASVIR KAUR ROLLNO.- 1089

2. Intellectual Property Rights with Special Reference to Health

3. CONTENTS INTRODUCTION THE ISSUE OF RESEARCH IP PROTECTION CONTRIBUTING IN R&D NATIONAL POLICY OPTIONS PATENT REGIME IN INDIA CONCLUSION

4. INTRODUCTION: Intellectual property is a form of knowledge which societies have decided can be assigned specific property Rights. what is intellectual property? Intellectual property refers to creation of mind,inventions,litrary and artistic works,and symbols,names, images, and designs used in commerce. CREATION:-(Creation of the mind) Think / come with new idea Design new “inventions” Produce “works of Art” Solve problems in new ways , or develop a new idea based on an “original knowledge”

5. WHAT ARE INTELLECTUAL PROPERTY RIGHTS? Intellectual property (IP) rights are the rights awarded by society to individuals or organisations principally over creative works: inventions, literary and artistic works, and symbols, names, images, and designs used in commerce. They give the creator the right to prevent others from making unauthorised use of their property for a limited period. IP is categorised as Industrial Property (functional commercial innovations), and Artistic and Literary Property (cultural creations). Current technological developments are blurring, to some extent, this distinction, and some hybrid sui generis systems are emerging.

6. KINDS OF IPR: Patents Industrial designs Trademarks Geographical indications Trade secrets Copyrights Integrated computer circuits Plant breeder’s rights Database protection

7. PATENTS: A patent is an exclusive right awarded to an inventor to prevent others from making, selling, distributing, importing or using their invention, without license or authorisation, for a fixed period of time (TRIPS stipulates 20 years minimum from filing date). Right to exclude others from using your invention. owner has a qualified right to use the invention. Patent is:- - A conditional grant. -Balance of rights and obligations. - Subject to the other law of land. -Granted to the owner of invention/assignee

8. THE ISSUE OF RESEARCH The impact of intellectual property rules and practices on the health of poor people in developing countries has generated substantial controversy in recent years. The predated TRIPS, and featured prominently in the TRIPS negotiations, impetus has been added by the coming into force of TRIPS, and the dramatic rise in the incidence of HIV/AIDS, particularly in developing countries. For the developed countries, the pharmaceutical industry was one of the main lobbyists for the global extension of IP rights. For developing countries, a major concern was how the adoption of intellectual property regimes would affect their efforts to improve public health, and economic and technological development more generally, particularly if the effect of introducing patent protection was to increase the price and decrease the choice of sources of pharmaceuticals.

9. We are aware of the importance of effective patent protection for the industry most directly involved in discovering and developing new pharmaceuticals. without the incentive of patents it is doubtful the private sector would have invested so much in the discovery or development of medicines, many of which are currently in use both in developed and developing countries. The pharmaceutical industry in developed countries is more strongly dependent on the patent system than most other industrial sectors to recoup its past R&D costs, to generate profits, and to fund R&D for future products. Successive surveys have shown that the pharmaceutical companies, more than any other sector, think patent protection to be very important in maintaining their R&D expenditures and technological innovation. The industry understandably takes a close interest in the global application of IPRs, and generally resists the contention that they constitute a major barrier to access or a deterrent to development in developing countries.

10. IP PROTECTION CONTRIBUTING IN R&D: Total pharmaceutical R&D in the private sector has more than doubled in the last decade to an estimated $44 billion in 2000.  Total global pharmaceutical research and development (R&D) spending from 2008-2022 in billion U.S. dollars. In 2012, the pharmaceutical industry spent some 137 billion U.S. dollars on research and development. This increase in investment in research and development is because of TRIPS compliance developing countries which are framing their policy of IPR in such manner which benefits the both sides of coin the producer and consumer.

11. NATIONAL POLICY OPTIONS: These type of principles or features can be part of a national policy that will benefit both the developed and developing countries. Differential Pricing Parallel Imports Compulsory Licensing

12. DIFFERENTIAL PRICING: It is a method in which a product has different prices based on the type of customer, quantity ordered, delivery time, payment terms,etc. It is also called as discriminatory pricing,or multiple pricing. D ifferential pricing in principle should be an economically rational way for global companies to maximise their profits on products that are sold in both low and high income markets. It should also be a way of ensuring that poorer people obtain less expensive products.

13. Markets with different price levels must be segmented so that low priced medicines cannot enter higher priced markets. This means controlling exports and imports of relevant products. Pricing decisions in higher priced markets, where these are set or influenced by government policy, must not be made by reference to prices in the low priced mar ket. T he tools of the IP system, including parallel imports and compulsory licensing, are likely to play an essential part in underpinning differential pricing and market segmentation. In order to ensure an effective operation of a differential pricing system, national laws in developing countries should retain the right for the government to admit parallel imports and to issue compulsory licences.

14. PARALLEL IMPORTS: Parallel imports refers to the branded goods that are imported into a market and sold there without the consent of the owner of the trademark. The goods have been manufactured by or under license by the brand owner and therefore are not counter however ,they may have been formulated or packaged for a particular justification,from that intented by the brand owner. T he purpose of ensuring that lower priced products can be supplied to, and only to, those who need the lower prices, it may be necessary to derogate from that general principle. Therefore an important component in establishing a system of differential pricing is that markets need to be segmented to prevent low priced products undermining high priced markets. For that purpose, it is essential that developed countries put in place effective mechanisms that prevent parallel importing of medicines .

15. COMPULSORY LICENSING: The result of implementing TRIPS will be to curtail the supply of generic copies of patented products. This will remove an important element in restraining and reducing the prices of patented products in developing countries. Providing effective legislation and procedures for compulsory licensing may have an important role to play in maintaining a pro-competitive IPR policy in the new environment. We do not regard compulsory licensing as a panacea, but rather as an essential insurance policy to prevent abuses of the IP system. In other words, Compulsory licensing is when a government allows someone else to produce the patented product or process without the consent of the patent owner.

16. PATENT REGIME IN INDIA: The Patent (Amendment) Act 2005 (hereinafter referred to as the 2005 Amendment) was passed by the Parliament in its budget session of 2005 to amend The Patent Act, 1970 hereinafter referred to as The Act) and meet its obligation under TRIPS Agreement of WTO. The Act was effective from 1st January 2005. T he Act makes wide ranging changes to India's patent regime, the most controversial provision is the one introducing product patents in the area of pharmaceuticals.

17. SOME CHANGES INTRODUCED IN 2005 AMENDMENT: Extension of product patent protection to all fields of technology Section 3 (D) Of Patents Act Software Patentability Deletion Of The Provisions Relating To Exclusive Marketing Rights Compulsory Licensing Regime Ever-Greening of Patents

18. IMPLICATIONS ON INDIAN ECONOMY: Price rise and access to medicine : It is feared that the 2005 Amendment would spur a steep rise in drug prices and an adverse impact on “ access” to important and life saving drugs. From a completely objective point of view two categories of drugs will be affected— first , medicines that will be invented after January 1, 2005. If a medicine is patentable, the patent holder will be granted a 20 year monopoly from the date of filing as a result of the new rules. Without a compulsory license, generic versions will not be permitted on the market for the life of the patent. In other developing countries that have begun protecting patents on medicines in accordance with WTO rules, the vast majority of medicines patent filers in developing countries are multinational drug companies based in industrialized countries.

19. THE REALITY :GENERIC V/S.BRANDED The reality of generic drug is that it’s manufacturing cost is cheaper than the branded drug but in most cases it’s maximum retail price is often higher than the branded drug because in India you cannot produce a medicine simply by its salt composition if you are producing generic drug then also you have to name your product and this result into creation of new concept generic branding and this leads to the benefit of wholesaler ,retailer and producer not the patient because he has the access to generic medicine which is costlier than branded and less reliable.

20. Generic Drug- Branded Drug-

21. In the previous slide when a doctor would prescribe the patient aceclofenac & paracetamol tablets the choice of giving or generic drug or branded will be on retailer and he will give the patient generic drug because he has more margin in it than the branded but the patient will have to suffer as it would be costly for him and at the same time less reliable than the branded. The previous slide depicts that generic drug is costly than the branded drug which shows that the concept of generic branding benefits the producer, wholesaler and retailer and the patient does not get the benefit and to avail this benefit to patient or consumer a new policy should be made and incorporated.

22. CONCLUSION: The developing countries should adopt a policy in compliance with trips and adopt necessary provisions depending upon the manufacturing capacity and financial stability of the country to provide access of essential drugs to the people . The developed countries should also cooperate with developing countries and do a agreement with them in such a manner that should benefit both sides of coin that is research and development company and access of medicines to poor people.

23. In context of India ,considering the present situation to solve the problem of access of medicines to poor people at low cost .The government should make a policy which creates uniform MRP(maximum retail price) of the drug meaning fix the price of drugs by including the drug in first schedule of the DPCO(drug price control order) so, that there is no difference between the MRP of generic drug or whether it is branded which will benefit to the public .Otherwise, if we continue the concept of promoting generic medicine it will only favour or fill the pockets of retailer and wholesaler because the manufacturing cost of generic drug is low compared to branded drug but its MRP varies very less or sometimes even more than the branded drug . Hence, to benefit the consumer uniformity of MRP should be ensured by the government.

24. Another solution to the problem in India the government can allow or permit manufacturing of the generic drug be simple salt name which will help consumer to identify which is generic and branded but this can only be done when all the loopholes of implementation machinery that is the executive is resolved.

25. THANK YOU