Intellectual Property Rights in Pharmaceuticals

By Amitav Singh, National University of Advanced Legal Studies, Kochi

Editor’s Note: With the rapid advancement of science and technology, the pharmaceutical industry has been flourishing the market with life saving drugs. Intellectual property rights of pharmaceuticals is governed by patent law. India being a signatory of the GATT is governed by TRIPS, apart from having its own national IPR laws. Moreover, with the introduction of compulsory licensing and ever-greening strategies, patent laws have become more sound and comprehensive. This paper discusses the patent law in the light of the pharmaceutical industry in India.

Introduction

Indian Pharma Industry has grown very rapidly in recent times. We have witnessed various suits and landmark judgments in India. After independence the non-availability or non-accessibility of important life-saving medicines led the government to appoint two committees[i] to bring some viable changes in the pre-existing patent laws in India. The recommendations eventually led to the introduction of a new patent act of 1970. It covered only process patent in pharmaceuticals. The term of these process patents was only 7 years. This new law made Indian Pharmaceutical Companies quite enthusiastic and they started producing generic versions of expensive foreign medicines. This made Indian companies expert in ‘reverse-engineering’. They started developing new drugs and this proved to be a boon for Indian pharmaceuticals field. The share of Indian sector of pharmaceuticals industry recorded a growth from 15% to near 18%. It made India self-sufficient in manufacturing of medicines and it became the exporter of bulk/active ingredients. India became net exporter of pharmaceuticals obtaining the 3rd largest position in terms of volume and 14th largest in terms of values.[ii] However, there are some views that Indian Patent Act, 1970 discouraged foreign drug companies to invest in India because they feared that the existing patent laws would not provide them enough protection leading to less profits. But the act was important because India was still developing in pharmaceutical fields and any act in favour of foreign companies would have proved fatal for the poor population for it would have been difficult for it to purchase expensive medicines.

Change came after India signed  the GATT  on  15  April  1994,  thereby  making  it  mandatory to  comply  with  the  requirements  of GATT, including the agreement on TRIPS because it faced the threat for being kicked out of WTO if it failed to do so. It became necessary for India to meet the minimum standards under the TRIPS agreement in relation to patent and pharmaceuticals industry. This made India to introduce patent not only for process but also for product. The term was also to be increased to 20 years. However, India got the benefit of developing country and took some time to introduce these terms. In this regard there were three amendments that were brought-  Patents  (Amendment)  Act,  1999  (“First  Amendment”),  the  Patents (Amendment)  Act,  2002  (“Second  Amendment”)  and  Patents (Amendment) Act, 2005 (“Third Amendment”).

TRIPS and Amendments in Patent Law in India

There is a general perception that re-introduction of the product patent regime in India was the single most significant contribution of TRIPS Agreement. However, on a closer look abrogation/deletion of the licence of right provision from the Patents Act, 1970, could be viewed as the major factor in taking India to the global patent arena, where the protection of the patentee’s rights are truly and deservedly made available without dilution. India took a longer period to inculcate the provisions of TRIPS, however, it came with a set of conditions elaborated in Articles 70.8 and 70.9 of the agreement.

The above-mentioned Articles are included in the “Transitional Arrangements”, which required India to introduce two provisions in its Patents Act. According to art. 70.8 of the TRIPS agreement India had to provide ‘a means’ by which product patent can be filed from 1995 and if any country member of WTO has granted patent to the product and it had obtained marketing approval in any of the WTO member counties then it had to be granted by India as well. The first amendment of the Patents Act, 1970 introducedthe requirements under the “transitional arrangements through Section 5(2), which allowed product patent applications to be filed, while Chapter IVA provided for the grant of EMRs. [iii]

Basically, major bulk amendments to the Patent Act was brought in the second amendment on January 1, 2000. The key issues included in the Second Amendment were, re-defining patentable subject matter, extension of the term of patent protection to 20 years and amending the compulsory licensing system.[iv]

A third amendment was introduced in 2005 and it introduced product patent regime in areas, including pharmaceuticals that were hitherto covered by process patents.[v]Indian Government abolished the EMR provision in this amendment and included new definition for drugs and provision for patenting of new use and embedded use.[vi] It has also revamped the fees structure, penalty provision, qualification of patent agent, and filing and publication procedure. But it has been silent on ever-greening strategies and online filing procedures. It also allows for pre-grant opposition in addition to postgrant opposition (within one year of grant of patent). It stresses that provisional specifications should be updated with complete specification within 12 months with no provision for further grace period.[vii]Article 27 of the TRIPS Agreement harmonizes the subject matter of patent in a broad manner.[viii]

Effect of Product Patent

The discontinuation of the “process-patent-alone” regime in case of chemicals has been a crucial change as regards patentable subject matter. ‘Process patent’ means that only the procedure or the method used to develop a particular drug would be patented and not the drug itself. Others could use different method to produce that drug. This gave rise to ‘generic medicines’. In product patent now the product or the drug developed can be patented. Companies can no longer develop the same drug once it is patented. This involved removal of Section 5(1) of Patents Act, 1970 which provided for process patents in this field. This has meant that from January 1, 2005 product patent applications are being accepted and examined. Included in these product patent applications would be those applications that were made since 1995 using the “mailbox”[ix] provisions.[x] It was feared that this might be detrimental to the system of medical care in the country. Their contention was that it might make certain life-saving drugs out of reach of the common man. Before third amendment took place Indian company freely manufactured expensive drugs by using different procedure and this made them experts in ‘reverse engineering’. But post-TRIPS situation, Indian generic companies have the following basic option:[xi]

 For non-patented or patent-expired drugs:

  • To continue to cater to domestic and export markets

For patented drugs:

  • Undertake R&D for development of new drugs
  • Collaborate with innovator companies for manufacturing, marketing and R&D
  • Manufacture patented drugs through compulsory or voluntary licensing

Several studies have found that Indian companies adopted this new change very fast. They started investing in R&D. In fact, what is more fascinating is the dominance of Indian companies in retail market post-TRIPS. For 2007/08, of the 468 companies considered by orG-IMS5, only 46 are controlled by foreign companies accounting for 20 percent of the market. This is a distinctive feature of the situation in India. Of the 20 largest companies, 16 are Indian controlled (including cipla, Ranbaxy, Dr. Reddy’s, Lupin, Sun pharmaceuticals, Piramal Healthcare and cadila Healthcare) and only four are MNCs.[xii] In contrast to the situation in the early 1970s, 39 of the top 50 companies today are Indian companies. The market share of MNCs has declined over the years, even after the introduction of product patent protection in January 2005 — from 23 percent in December 2004, to 22 percent in March 2006 and 20 percent in March 2008.[xiii]. In some cases it gave scope for foreign companies to open a subsidiary in India which will be managed by Indian company to sell their drugs. It also opened the scope of contract research. MNCs are now very extensively investing in India. MNCs have also started buying up Indian companies — the most notable being the acquisition of India’s largest pharmaceutical company, Ranbaxy by the Japanese MNC, daiichi Sankyo in June 2008. Other acquisitions of Indian companies include dabur by Fresenius, Matrix by Mylan and Shanta Biotechnics by Sanofi-Aventis.[xiv]

India is favoured the most because of its low cost in R&D. This strong performance of the generic industry in the global markets resulted from a number of its inherent advantages. It has been argued that Indian firms have lower costs – estimated to be one-eighth in R&D activities and one-fifth in manufacturing – as compared to the Western firms. The cost advantages are most pronounced in respect of lower fixed asset costs and labour costs, where the costs in India can be one-eighth of the cost in the US.[xv]

Therefore, what was feared previously didn’t happen. Indian companies used this new change in their favour and became one of the most prominent parties in the manufacturing and distributing of drugs in the world.

What can be Patented?

Complying verbatim with Article 27, Section 2(1)(j) of the Act provides that ‘invention means a new product or process involving inventive step and capable of industrial application’[xvi]If  the  invention  was known or used by any other person or used or sold  by the  applicant to  any person in  India  and/or outside India,  then  the  applicant  would  not  be  entitled  to  the  grant  of  a patent.[xvii]  Already having the knowledge of any such product makes its exclusivity void and thus it will affect the validity of an application in India. The patent application must be filed prior to any publicity or prior knowledge. There  is  a  12-month  grace  period  permitted  in  India,  when  a  person  has  made  an application for  a patent in  a convention country, and if  that  person or his legal representative (or his assignee) makes an application with respect to the same invention in India.[xviii] The word “new” in the patent sense means new on a worldwide basis. Any earlier patent, earlier  publication,  document  published  in  any  country,  earlier product  showing  the  same  invention,  or  earlier  disclosure  or  use by the  inventor  will  prevent  the  granting  of  a  patent  in  India.[xix]

However, there are several innovations that cannot be classified as inventions. Section  3  of  the  Patents  Act  enlists  the  innovations  that  are  not classified as inventions  within the meaning of the Act. These are as follows:

  • a method  of  agriculture  or  horticulture;
  • a  process  for  the  medicinal or  other  treatment  of  human  beings and  animals;
  • a mere discovery of any new property, or new use for a known substance, or  a  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);
  • 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 
  • an invention  which  is  frivolous  or  which  claims  anything obviously  contrary  to  well  established  natural  laws;
  • an invention which, in  effect, is  traditional  knowledge or which is  an  aggregation  or  duplication  of  known  properties  of traditionally  known  component  or  [xx]

Patent Ever-Greening Strategies

With the introduction of patent acts some companies to protect their financial gains came up with a strategy called, ‘ever-greening’. It has been in practice since the passage of the Waxman-Hatch legislation (Drug price competition and Patent term restoration act) in USA in 1984, in which the pioneer drug can receive an extension term equal to one-half the time of the Investigational New Drug (IND) period, running from the start of the human clinical trial to the time till the New Drug Application (NDA) is submitted.[xxi]

Ever-greening is basically a strategy adopted by the companies by which they bring some minor changes in such as adding new mixtures of isomers, using same molecular formula but with different structure. Some MNCs buy out or frustrate competitors, thus increasing the price of the medicine. Frivolous patent infringement suits are  filed which result in activation of an automatic 24-30 months freezing or delay in processing of generic product claim, especially in Canada and USA.[xxii] For example, Bristol Meyers filed baseless patent infringement suits for several years to prevent competition to their anti-cancer drugs, Taxol and Platinol and also to the anti-anxiety drug, BuSpar. By this procedure, they could protect more than $ 2 billion sales annually.[xxiii] Various studies have found that this ever-greening strategies increase the cost of drug and make it unaffordable to many needy patients.[xxiv]

In India concerns were raised by the MNCs when Supreme Court in its recent judgment in Novartis case[xxv], rejected the grant of patent. Novartis is a foreign drug company which filed its application for getting patent for the beta-crystalline of imatinib mesylate, brand name Glivec (Gleevec) in 1996. It was kept in mailbox. Meanwhile it was granted Exclusive Marketing Rights (EMR). After 2005, when the Patent Act recognized product patent, Novartis’ application was viewed. Some Indian generic companies registered their objection regarding the product which was to be patented. Since it was previously patented, it lacked innovation. However, the company contended that there are certain changes in imatinib. Still, the grant of patent was rejected by patent controller in Chennai. The new product failed to pass the test laid down by Sec. 3 (d) of Indian Patent Act, 2005. This particular section was made to tackle ever-greening strategies of MNCs. It states:

“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.;”

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 substances  are to  be considered  to  be  the  same  substances,  unless  they  differ significantly in properties with regard to efficacy.[xxvi]

The validity of sec. 3 (d) was upheld by the Supreme Court and it was also found that the term ‘efficacy’ is not vague. It said that mere changes in the structure of any chemical formula would not make it an invention. The decision of Supreme Court was applauded in many countries for it gave a strong message against the practice of ever-greening in pharmaceutical field. Many said that this would make these MNCs to invest more in R&D to develop more effective cure rather than presenting same old medicine with some minor changes.

Compulsory Licensing

In the context of the on-going debate on the patent law reforms, a key issue, which is often glossed over, is that the compulsory licensing system is one of the essential pillars of the patent system.[xxvii]It has been well recognised that compulsory licences are expected to play an important role in preventing abuse ofpatent rights that may arise when the patent holder tries to pre-empt entry of competitors using his statutory rights.[xxviii]The context for this issue has been provided by the Paris Convention. Article 5A of the Stockholm Act of the Paris Convention clarifies that “failure to work” or “insufficient working” of a patent constitutes an “abuse” of patent rights.[xxix] Indian Patent Act in sec. 84 provides that, compulsory licencing can be granted only after expiry of three years from the grant of a patent in following cases:

  • Reasonable requirements  of  the  public  with  respect  to  the patented  invention  have  not  been  satisfied;  or,
  • The patented  invention  is  not  available  to  the  public  at  a reasonably  affordable  price;  or,
  • The patented invention is not worked in  the  territory  of 

While granting compulsory licences, authority has to take some additional factors into consideration:

  • The nature of the invention, the time which has elapsed since the sealing of the patent and the measures already taken by the patentee or any licensees to make full use of the invention;
  • the ability of the applicant to work the invention to the public advantage;
  • the capacity of the applicant to undertake the risk in providing capital and working the invention, and
  • The efforts made by the applicant to obtain licence from patentee on reasonable terms and conditions and that such efforts were not successful within a reasonable period.[xxx]

The first compulsory licencing in India was granted in Bayer v. Natco[xxxi] case in the year 2012. In this the company filing the application for the compulsory licencing gets the right to develop drug and sell it in lower price. Like in the above mentioned case the original drug cost Rs. 2.8 lakhs but the company filing application would sell it for Rs. 8800. But Natco will have to pay some 6% royalty to Bayer. Since more than 90% of MNC drugs are imported into India, this order may pave the way for wholesale compulsory licenses to be issued against a wide spectrum of drugs in the near future.[xxxii] It sets the tone for future cases and will spur many other generics to resort to this route. To this extent, it will certainly be music to the ears of several patient groups and NGO’s that have been battling pharmaceutical patents and excessive prices for many years now.[xxxiii] The amendment seeks to implement the  agreement on Para 6[xxxiv] of Doha  Declaration  on  TRIPS  and  public  health.  The amended provision will allow Indian companies to produce and export AIDS drugs  to  African  and  South  East  Asian  countries.[xxxv] In para 4 the freedom is given to the members to take“measures to protect public health.” The Agreement should be “interpreted and implemented in a manner supportive of WTO Members’ right to protect public health and, in particular, to promote access to medicines for all”. Compulsory licencing has actually made India a big exporter of medicines in many countries, namely in Africa, where the medical system is poor and medicines are out of reach of the poor.

Although, compulsory licencing can be used as an effective tool to combat anti-competitive practices, due diligence should be exercised while granting the same. This can discourage R&D by foreign pharmaceutical companies and thus, can have adverse effect on FDI. It should be granted in limited number of cases which were in desperate measures for the protection of public interest in large.

Types of Patent Application

To get the patent right there are several procedure that the applicant has to follow. Some are as follows:

  • Regular/Ordinary Application – The first application for patent filed in the Patent Office without claiming priority from any application or without any reference to any other application under process in the Patent office is called an ordinary application.[xxxvi]
  • Convention Application -When an applicant files a patent application, claiming a priority date based on the same or substantially similar application filed in one or more of the convention countries, it is called a convention application.[xxxvii]India has  published  a  list  of  convention  countries  under  Section  133 of the  Patents Act and is  also a member of the  Paris Convention. The  convention  application  has to  be  filed  within one  year  from  the date  of  priority  and  has  to  specify  the  date  on  which,  and  the convention  country  in  which  the  application  for  protection  (first application) was made.[xxxviii]
  • PCT (Patent Cooperation Treaty) International Application -A PCT Application is an international application governed by the Patent Cooperation Treaty, and can be validated in upto 142 countries.[xxxix] However, it does not provide for the grant of an international patent, it simply provides a streamlined process for the patent application process in many countries at the same time.[xl]
  • PCT National Application -When an international application is made according to PCT designating India, an applicant can file the national phase application in India within 31 months from the international filing date or the priority date (whichever is earlier).[xli]
  • Patent of addition – Applicant can file a patent of addition in respect of any improvement or modification of an invention described or disclosed in the complete specification already applied for or has a patent.[xlii] However, it has to be proved that it was an invention and not a mere workshop modification. The major benefit is the exemption of renewal fee so long as the main patent is renewed. A patent of addition lapses with the cessation of the main patent.[xliii]

Competition Law and Indian Patent Act for Pharmaceuticals

Ever since the changes where brought in the Patent Act it has become important to struck the balance between IP protection and the competitive law angle, such that an incentive may be provided for further development, and protection is given to the exploitation of this technology or product, such costs of development may be recovered by the entity in question.[xliv] Yet this has to be balanced against the fact that this situation may lead to a monopoly, especially in view of the new patent regime that has been implemented in India in 2005.[xlv] Before product patent was introduced generic companies gave stiff competition to the major companies by producing low cost medicines which made big companies to decrease their cost by substantial percentage. However, now the position is different and the product patent is a huge set back to the generic companies. Competition law, therefore, is now going to play a vital role, in the pharmaceutical industry, with heightening of intellectual property protection in India.[xlvi] As mentioned above, India is one of the most favourable venues to invest and carry trade in pharmaceutical industry. MNCs over Indian entities, at every stage of the pharmaceutical industry, can abuse their dominant position. Indian Companies lack resources and capital to invest in R&D as compared to the foreign companies. Foreign companies invest heavily and extensively in R&D, clinical trials, and then in advertising which in effect is seen in the final price of the medicine when it comes to market. It has been seen that these MNCs collaborate with local companies to act as their subsidiary. In USA it has been seen that many such big companies pay some money to prevent the local companies from producing generic version. Competition Act, 2002 aims at targeting and preventing monopolization in any field.

There are mainly three types of competition issues that may potentially arise in the pharmaceutical industry in India, in the form of collusions, horizontal or vertical mergers and acquisitions, and abuse of dominant position.[xlvii] The first issue is with regard to activities amounting to collusions, though among Indian manufacturers, this situation has not yet emerged, though existence of such tendencies in certain segments with few competing manufacturers cannot be denied.[xlviii] It increases price of the medicine and make it out of the reach of many poor patients. Secondly, through mergers and acquisitions, anti-competitive practices can take place. The Competition Act, 2002 provides for mergers review beyond a threshold level.[xlix] Thirdly, there is abuse of dominant position. Since the pharmaceutical industry is knowledge-intensive, intellectual property gives monopoly status to companies, often abused to the detriment of consumers.[l]

Therefore, in order to promote public good it is very important to strike a balance between IPR and Competition Act. There are many stringent provision present in Competition Act which can be used to combat anti-competitive strategies. Many companies say that only through competition can the prices be regulated. Thus, it becomes important to make sure that competitiveness remains in pharmaceutical industry so that the consumers can be benefited.

Conclusion

The Indian Pharmaceutical Industry is by far one of the most diverse, knowledge driven, technology intensive growth area, where fast track advancements can surely generate significant resources.[li]When TRIPS was signed many apprehended that it would be detrimental for the Indian Pharmaceutical Industry. But patent act became important if India wanted to increase its pharmaceutical industry by encouraging big foreign companies to invest in India. It is a known fact that it takes a lot of expenditure before a new drug is introduced in market, and the company which produces it aims at getting profit. If the patent act of any country doesn’t provide it enough support for that, it will never invest in that country. This will stagnate the growth of pharmaceuticals industry because, as mentioned above, it is a knowledge intensive sector. It requires huge capital to invest in R&D and then in further stages to produce more enhanced medicine. However, to make sure that the general public of a country can get easy access to medicines, it is very important to have enough safeguards as well. Fortunately, India has made its Patent Act quite efficient in this regard. By introducing, compulsory licencing and provisions to tackle ever-greening strategies, it can stop monopolization which will help India grow its pharmaceutical industry.

Edited by Sinjini Majumdar

[i] Two Committes are: Tek Chand Patents Enquiry Committee (1948-50) & Ayyangar Committee (1959).

[ii] Gopakumar G Nair, Imapct of TRIPS in Indian Pharmaceuticals Industry, Journal of IPRs, Vol. 13, Sep. 2008.

[iii]Biswajit Dhar&KM Gopakumar, Effect of Product Patents on theIndian Pharmaceutical Industry available at http://wtocentre.iift.ac.in/Papers/3.pdf (last visited on 18-9-2013)

[iv] Ibid.

[v] Ibid.

[vi] Sajeev Chandran, Archna Roy and Lokesh Jain, Implications of New Patent Regime on Indian Pharmaceutical

Industry: Challenges and Opportunities, Journal of Intellectual Property Rights, Vol. 10, July 2005, pp. 269-280.

[vii] Ibid

[viii] Manisha Singh Nair, India: Product Patent Regime & Pharmaceutical Industry In India – The Challenges Ahead, available at http://www.mondaq.com/india/x/30303/Patent/Product+Patent+Regime+Pharmaceutical+Industry+In+India+The+Challenges+Ahead (last visited 20-9-2013)

[ix] Mailbox was introduced in the 2nd amendment relying on the provision (70.8) of TRIPS to provide the opportunity to the inventors to get their product patented once the product patent provision is included in the Patent Act, during the transition period.

[x] Supra note 4

[xi]Sudip Chaudhuri, Chan Park and K. M. Gopakumar, FIVE YEARS INTO THE PRODUCT PATENT REGIME: INDIA’S RESPONSE, available at http://www.undp.org/content/dam/india/docs/five_years_into_the_product_patent_regime_india%E2%80%99s_response.pdf (last visited on 14-9-2013)

[xii] Ibid

[xiii] Ibid.

[xiv] Ibid.

[xv] Supra note 4

[xvi] Manisha Singh Nair, India: Product Patent Regime & Pharmaceutical Industry In India – The Challenges Ahead, available at http://www.mondaq.com/india/x/30303/Patent/Product+Patent+Regime+Pharmaceutical+Industry+In+India+The+Challenges+Ahead (last visited 20-9-2013)

[xvii]Gowree Gokhale & Dr. Milind Antani, Indian Legal and Regulatory environment: The Pharmaceutical Industry, available at http://www.ipproinc.com/admin/files/upload/09e84b64ad31880686136a2b5bf05dcf.pdf (last seen 19-9-2013)

[xviii] Ibid

[xix] Ibid

[xx] Ibid

[xxi] MMS Holdings Inc., Drug Patent Evergreening: An Overview, available at http://blog.mmsholdings.com/blog/bid/86991/Drug-Patent-Evergreening-An-Overview (last visited 23-9-2013)

[xxii] Supra note 7

[xxiii] Ibid

[xxiv] See, Nathalie Vernaz mail, Guy Haller, François Girardin, Benedikt Huttner, Christophe Combescure, Pierre Dayer, Daniel Muscionico, Jean-Luc Salomon, Pascal Bonnabry, Patented Drug Extension Strategies on Healthcare Spending: A Cost-Evaluation Analysis, available at http://www.plosmedicine.org/article/authors/info%3Adoi%2F10.1371%2Fjournal.pmed.1001460;jsessionid=1F22D17E0D00F1163CD3F42051F437EE (last visited 22-9-2013)

[xxv] Novartis AG v. Union of India (2007) 4 MLJ 1153

[xxvi] Supra note 17

[xxvii] Supra note 4

[xxviii] Ibid

[xxix] Ibid

[xxx] Ibid

[xxxi] C.L.A. No 1 of 2011

[xxxii] Spicy IP, Breaking News: India’s First Compulsory License Granted!, available at http://spicyipindia.blogspot.in/2012/03/breaking-news-indias-first-compulsory.html (last visited 22-9-2013)

[xxxiii] Ibid

[xxxiv] It was recognized that WTO Members with insufficient or no manufacturing capacities in the pharmaceutical sector could face difficulties in making effective use of compulsory licensing under the TRIPS Agreement. They instructed the Council for TRIPS to find an expeditious solution to this problem and to report to the General Council before the end of 2002

[xxxv] Supra note 17

[xxxvi] Intellectual Property Cell, Types of Patent Application, available at http://www.ipcell.iisc.ernet.in/ip/patenttypes.html (last visited 22-9-2013)

[xxxvii] Ibid

[xxxviii] Supra note 17

[xxxix] L.R. Swami Co., Types of patent applications, available at http://www.lrswami.com/page/types-of-patent-applications (last visited 22-9-2013)

[xl] Supra note 35

[xli] Supra note 38

[xlii] Supra note 35

[xliii] Ibid

[xliv] Pricing and competition in the pharmaceutical market, How increased competition from generic drugs has affected prices and returns in the pharmaceuticals industry, July 1998, available at http://www.cbo.gov/ftpdoc.cfm?index=655&type=1 (last visited 23 sep 2006), as quoted in Abhimanyu Ghosh & Kabir, Balance of Competition and Intellectual Property Laws in the Indian Pharmaceutical Sector, Journal of Intellectual Rights, Vol. 12, May 2007, pp. 293-302

[xlv]Abhimanyu Ghosh & Kabir, Balance of Competition and Intellectual Property Laws in the Indian Pharmaceutical Sector, Journal of Intellectual Rights, Vol. 12, May 2007, pp. 293-302

[xlvi] Chaudhuri Sudip, The WTO and India’s pharmaceuticals Industry (Oxford University Press, New Delhi), 2005

[xlvii] Nanda nitya, Khan Amri ullah, Competiiton policy for the pharmaceuticals sector in India, in Mehta pradeep S (ed), Towards a Functional Competition policy for India- An Overview (CUTS International, Academic Foundation, New Delhi), 2005, p. 171

[xlviii] Supra note 45

[xlix] Ibid

[l] Ibid

[li][li] Prof. Anup Mukherjee and Debashis Bhattacharya, “Pharma Industry in West Bengal-The Road Ahead”,

Express Pharma (2007), available at http://www.expresspharmaonline.com/20071015/westbengalpharmaview01.shtml (last visited 19-9-2013)

One Reply to “Intellectual Property Rights in Pharmaceuticals”

Leave a Reply

Your email address will not be published. Required fields are marked *