The Mayor Inc. is a company incorporated under the laws of United States of America (U.S.A.) consequent to its Research and Development (R&D) activities the company invented and developed its patented drugs to enable

CS Professional · Intellectual Property Rights - Laws and Practices · PYQS · December 2021
The Mayor Inc. is a company incorporated under the laws of United States of America (U.S.A.) consequent to its Research and Development (R&D) activities the company invented and developed its patented drugs to enable its administration to human beings. On successful invention of the patented drug in 1999, the company applied for a patent in U.S.A. Thereafter, on 12 July, 2000 the company applied for an international patent under the Patent Co-operation Treaty (PCT) and on 5th July, 2001 applied in India for grant of the patent to the patented drug in India. On March, 2008 the office of the Controller granted the company's application dated 5th July, 2001. This patent granted in India on 3rd March, 2007 corresponded to the patent granted to this patented drug in over 45 countries of the world. The patented drug is used in the treatment of patients sufferintg from Kidney cancer i.e. Renal Cell Carcinoma (RCC). The aforesaid patented drugs acts more as palliative i.e. relieves patients from the pain and to an extent also slows down the spread of cancer by restricting the speed with which the cancer cells grow. As a consequence of being granted a patent, the company had exclusive right to make, manufacture, use and sell the patented drug either by itself or through its licensee to the exclusion of others for a period of 20 years from the date of its application. Thus, the company had exclusive right to prevent third parties from making/manufacturing, using, selling or importing the patented drug in India without the company's permission/license. The company Mayor Inc. sells this drug under a brand KCWIN which is registered Trademark in India USA, Europe, China, Russia, Japan and New Zealand. Mayor Inc. through its subsidiary Mayor India Ltd. sells the drug in India. The drug was found to be very effective and the doctors worldwide appreciated the result of the drug. M/s. Kipla Pharmaceuticals established in the year 1930, located in Mumbai, Maharashtra, India is a manufacturer of various generic drugs. Owing to the huge demand for the drug, which was nearly about 20 lakh units and the failure of Mayor Inc. to meet the growing demand due to the import restrictions since their manufacturing units is in Washington, Kipla Pharmaceuticals approached Mayor Inc., for technical assistance and license manufacturing of their patented drug KCWIN in India on 20th January, 2012. However, Mayor Inc. declined to grant the license of manufacture for reasons best known to them. As per the records available, Mayor Inc. had supplied only 2 lakh units against the huge demand in India at the rate of ₹ 2.4 lakhs per month. Kipla on other hand manufacturing the same drug at ₹ 10,000 per month. In the 2012, the Mayor India came to know that exact copies of their product KCWIN is being manufactured by M/s Kipla Pharmaceuticals. Immediately, thereafter, a Cease and Desist notice was issued by Mayor Inc. to Kipla Pharmaceuticals for infringing the Patent of Mayor Inc. Taking the plea that pharmaceutical companies spend billions of dollars on research. It is estimated that, of every thousand potential drugs screened, only 4-5 reach clinical trials and only one is actually approved for marketing. Pharmaceutical companies patent the drugs that they develop and thereby obtain exclusive marketing rights. Further at the time of expiry of its Patent on KCWIN the The Mayor Inc. came with a minor change in the effectiveness and quality of KCWIN and de-novo applied for Patent before the controller of Patents, who rejected to grant the patent on the ground that it 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. Based on the above facts, answer the following: (a) The rights of the Mayor Inc. are not absolute. Discuss.

Answer & Explanation:

The patent right is not an absolute right. It is a fettered right and is subjected to certain specific prescribed constraints. The Patents Act balances well between individual rights of patentee and the interest of general public. A patent does not grant absolute monopoly. The rights of Mayor Inc. (Patentee) are directly subjected to certain conditions under Section 47 of the Patents Act, 1970 that reads as under: Grant of patents of be subject to certain conditions -- The grant of a patent under this Act shall be subject to the condition that - any machine, apparatus or other article in respect of which the patent is granted or any article made by using a process in respect of which the patent is granted, may be imported or made by or on behalf of the Government for the purpose merely of its own use; any process in respect of which the patent is granted may be used by or on behalf of the Government for the purpose merely of its own use; any machine, apparatus or other article in respect of which the patent is granted or any article made by the use of the process in respect of which the patent is granted, may be made or used, and any process in respect of which the patent is granted may be used, by any person, for the purpose merely of experiment or research including the imparting of instructions to pupils; and in the case of a patent in respect of any medicine or drug, the medicine or drug may be imported by the Government for the purpose merely of its own use or for distribution in any dispensary, hospital or other medical institution maintained by or on behalf of the Government or any other dispensary, hospital or other medical institution which the Central Government may, having regard to the public service that such dispensary, hospital or medical institution renders, specify in this behalf by notification in the Official Gazette. The four exclusive clauses are limitations and conditions. These limitation and conditions may be divided into two kinds. The first two clauses of the above Section are of first kind of the limitations and conditions that are general in character and applicable to the every patent. The last two clauses are of second kind of the limitations and conditions; those are limited to the pharmaceutical patents only. Section 47 (1), (2), and (4) deal with governmental use, and Section 47 (3) deals with experimentation/research of the granted patents. Section 47 provides a statutory exemption from patent infringement liability to the government. Section 47 (1) and (2) states that the government may import, make, or have made on its behalf any patented product or product made by a patented process "merely for its own use." Section 47 (4) allows the government to make, use, vend, or even import any medicine or drug, medical equipment, or other equipment for use or distribution in public health centers owned by the government or notified by the government for that purpose. The scope of Section 47 is narrow in comparison with other sections of the Act dealing with the governmental use of a patented invention like Sections 100 and 101. Two landmark cases are determining the scope of Section 47. In the case Garware Wall Ropes Ltd. v. Al. Chopra and Konkan Railway Corp. Ltd. , the Bombay High Court, brought out the differences between Sections 47 and 100. The plaintiff (appellant), in this case, Garware Wall Ropes Ltd. (patentee), filed an injunction against the defendant to put an end to the manufacturing and selling of their patented products. The defendant was A.I Chopra, who was making these products and selling them to Konkan Railways under a contract. The defendant contended that since they were manufacturing and selling the patented products only for the Konkan Railways, a Central Government department, and that their contract had been signed on behalf of the President of India, it would fall within the scope of Government use. The Bombay HC stated that a government agency (third party) could use the patented invention on behalf of the government on the payment of royalty/remuneration to the patentee based on a contract or a license between the patentee and the third party under Section 100. However, under Section 47, the use of the patented invention by the government is restricted merely to its own use only. Therefore, a third party is not allowed to use the patented invention under this section. Further, no royalty fee or other remuneration had to be paid to the patentee by the government when it is using the patented invention for a sovereign purpose. The Bombay HC opined that the government exemption under Section 47 would only be applicable to departments of the government and government servants and agents only. The Delhi High Court in Chemtura Corporation v. Union of India provided a different interpretation of Section 47. The defendants, in this case, were the government of India and a consortium of third parties who supplied products based on drawings provided to them by the Railway Ministry on the basis of a contract. The plaintiff contended that Section 47 would not be applicable to the consortium, and it would be liable for infringement as it was not a government agency. The Delhi HC rejected this contention and stated the consortium (third party) was strictly following the instructions and drawings provided by the Ministry and had no autonomy concerning the product. Therefore, it opined that the consortium would fall within the scope of the government exemption. These are the views that can be observed in the two landmark cases concerning the government exemption in Section 47. Section 47 (3) deals with another instance where a patented invention may be used without attracting liability - for the purpose of research/experimentation and imparting instructions to pupils for educational purposes. Article 47 (3) reads "any machine, apparatus or other article in respect of which the patent is granted or any article made by the use of the process in respect of which the patent is granted, may be made or used, and any process in respect of which the patent is granted may be used, by any person, for the purpose merely of experiment or research including the imparting of instructions to pupils."

Topics: Patents

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