India: Intellectual Property And Pharmaceuticals (October 2016 - December 2016)

Restriction on The Monopoly Of Indian Performing Rights Society Limited And Phonographic Performance

The Department of Industrial Policy and Promotion (DIPP) vide its office memorandum 06-04/2016-CRB/LU dated 06.10.2016 has issued a clarification regarding the current status of Indian Performing Rights Society Limited (IPRS) and Phonographic Performance Limited (PPL). Earlier both the societies were registered under the pre amended Copyright Act, 1957 for carrying out Copyright business in the field of musical & literary works and sound notification works respectively. The registration of both the societies expired on 21.06.2013, pursuant to which both of the organizations have applied for re-registrations under section 33 of the Copyright (Amendment) Act, 2012. Despite lapse of registrations, both IPRS and PPL continued to issue licenses for copyright works. While the DIPP notified of having constituted an enquiry against IPRS in view of certain allegation of malpractices against it, the IPRS and PPL now has been restrained from issuing any fresh licenses. The restraining order was passed by the Delhi High Court on 23.12.2016 while hearing the writ petition filed by Event And Entertainment Management Association . Alleging that in-spite of lapse of registrations of both IPRS and PPL on 21.06.2013 and furthermore, there being no registration in favor of Novex Communications Private Limited and therefore is not a copyright society, licenses for copyrighted work, are being been issued and granted by the said IPRS, PPL and Novex Communications Private Limited, for which they do not even have copyright and thus, in violation of Section 33 of the new Copyright (Amendment) Act, 2012.

The Petitioner in the present case approached the Hon'ble Court seeking a writ of mandamus against Indian Performing Rights Society Limited (IPRS), Phonographic Performance Limited (PPL) and Novex Communications. The petitioners further submitted before the court that is not even a copyright society but is still operating as one. The Respondent No.1 in the present case being Union of India accepted the notice in the Court and even submitted that they have been receiving complaints against the IPRS and PPL and that they have even initiated a enquiry against them. In view of admission by the Union of India that applications for registration as copyright societies are still pending and that an office memorandum to this effect has already been uploaded on the website of DIPP, the Hon'ble Court restrained IPRS, PPL and Novex Communication Private Limited from acting in contravention of section 33 of the Copyright Act, 1986. Subsequently, on a fresh application having been filed by the erstwhile copyright societies for modification and clarification of the order dated 23.12.2016, the Hon'ble Court on 29.12.2016 held that rights of copyright owners cannot be held to be obliterated in the absence of copyright societies. Since erstwhile copyright societies, as well as, Novex Communication Private Limited claim to be assignees/agents of the copyrighted works, the Hon'ble Court as an interim measure amongst others, has allowed the erstwhile copyright societies, as well as, Novex Communication Private Limited to collect royalty for the copyrighted works subject to providing an invoice to the event management association and confirming that it is the owner/assignee/ authorized agents of the copyrighted works, apart from uploading on its websites the assignment deeds of the copyrighted works and provide the same when demanded by the event management association and putting up a search engine on its website to identify the owner of the copyrighted works.

India Signs Mou With Singapore On Industrial Property Cooperation

On 4th October, 2016 the Singapore Prime Minister on his visit to the Capital, along with the Indian Prime Minister Mr. Narendra Kumar Modi, witnessed the signing of a crucial Memorandum of Understanding (MOU) between the Intellectual Property Office of Singapore (IPOS) and the Department of Industrial Policy & Promotion (DIPP). This is one first bilateral MOU signed between both the countries on the aspect of Industrial Property Protection. As per the MOU signed, a Joint Coordination Committee will be established, which will facilitate bilateral exchanges and cooperation to foster innovation, and support Indian companies in tapping on Singapore as a regional intellectual property hub for their innovation-related activities.

The priority initiatives under the pact would be exchange of best practices, experiences and knowledge on intellectual property awareness among the public, businesses and educational institutions of both countries. Both sides would also exchange experts in the field of intellectual property; spreading of best practices, experiences and knowledge on intellectual property with the industry and universities. The MOU will enable India to exchange experiences in the innovation and intellectual property space that will substantially benefit entrepreneurs, investors and businesses on both sides.

CSIR Urges Laboratories From Indulging Into The Malpractice Of Filing Unwantend Patents

The Director General of the Council of Scientific and Industrial Research (CSIR), has reprimanded 38 laboratories affiliated to it to refrain from seeking patent protection for their inventions without considering the benefits and advantages of such applications. Accusing the laboratories of filing applications for patent registrations without carrying out any technical, commercial or legal evaluation, by such an action, the CSIR aims at curbing the indiscriminate number of applications seeking patent registrations.

The step comes in light of several pitfalls which hoards the intent of filing such applications. Apart from huge amounts of finances which are involved for filing patent applications abroad leading to loses to CSIR, the Director General also cited that the intent behind filing unnecessary applications by the individual scientist is for getting promotions and the labs are simply doing so for increasing the number of applications filed. The reason cited by the Direct General is not unfounded and it has been witnessed by the CSIR is several cases that there is no mechanisim or system to find any prospective licensee for the patent and upon retirement of the scientist who filed patent application, neither the scientist nor the lab bothers about it.

In view of the growing need to strike a chord between unnecessary filing of patent applications and promote development of relevant and important inventions, the CSIR has now cleared the roadmap that from here on 25% of the cost of domestic patent filings and 50% of the cost of foreign patent filings will be borne by the concerned laboratory.

Introduction Of The New Medical Devices Rules In Drugs And Cosmetics Act, 1940

The Ministry of Health and Family Welfare has published in India's Official Gazette on October 17, 2016, the new Medical Devices Rules in Drugs And Cosmetics Act, 1940. The said rules will be applicable in respect of substances covered under sub-clause (i) of clause (b) of section 3 used for in vitro diagnosis; substances that are in the nature of mechanical devices covered under sub-clause (ii) of clause (b) of section 3; and devices specified from time to time by the Central Government by notification in the Official Gazette under sub-clause (iv) of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940.

By introducing the new Rules the Centre has focused on creating a separate registration and oversight system for medical devices and drugs. Also, theses new rules will be defining the duties and functions of the Centre Licensing Authority and State Licensing Authority.

Under the new rules, the Drug Controller of India shall be the Centre Licensing Authoring and shall be the competent authority for the enforcement of the new rules with function related to issuance of license for manufactures who intends to manufacture class C and class D medical devices along with class A and class B medical devices. This will be a relief for medical devices manufacturers as no separate license from the state licensing authority will be required separately for the manufacturing of Class A and Class B medical devices.

The State Drug Controller shall be the State Licensing Authority and shall be competent authority for enforcement of these rules in matters related to manufacture of Class A and Class B medical Devices. However, people who are engaged in the manufacturing predicate medical devices will require a separate approval from Centre Licensing Authority before applying to the State Licensing Authority.

These new rules have introduced four new classes for medical devices on the basis of their functions and impact. The medical devices which will have low risk will fall under Class A; medical devices having low moderate risk will fall under Class B; medical devices having moderate high risk will fall under Class C and medical devices having high risk will fall under Class D.

Notification Issued By Central Government Banning 344 Fixed Dose Combination Drugs Quashed By Delhi High Court

On 01.12.2016, the Delhi High Court decided several writ petitions which the Hon'ble Court was hearing under Pfizer Limited & Ors. Vs. Union of India &Ors W.P.(C)-2212/2016 along with Federation Of Pharma Enterpreneurs & Anr vs. Union of India & Anr. W.P.(C)-2500/2016

In the present case the Government of India on 10th of March, 2016 issued 344 notifications in exercise of its powers conferred under Section 26 A of the Drugs and Cosmetic Act, 1940 ("Act") banning the manufacture of 344 fixed dose combination drugs. The Petitioners filed 454 petitions against the impugned notifications, alleging that the Central Government while issuing the said notifications failed to follow the statutory procedure prescribed under the law.

The Central Government in its defense submitted that the licenses for manufacture of Fixed Drug Combination (FDC) were issued by the State Licensing Authority without the prior approval of the Drug Controller in view of which the manufacturers were asked to apply for licenses to the Drug Controller. The Hon'ble Court while adjudicating the 454 petitions held that firstly, the Central Government should have cancelled the licenses of the manufactures which as per the Central Government were wrongly issued. Secondly, the applications which were received were not considered by the Drug Controller and the same were transferred to ten committees which were instituted by the Central Government for consideration of the said applications. Thirdly, the ten committees formed by the Central Government failed sustainably to execute the purpose for which they were formed and further the Central Government formed another committee which instead of considering the applications went into the aspect of risk to consumers and therapeutic value and therapeutic justification on basis of which the impugned notifications were issued.

The Hon'ble Court further observed that even though it is the responsibility of the Central Government to look after the welfare of public, however in light of the facts it appears that the Central Government has performed its function in haphazard manner and there was no time given to the manufacturers before issuing notification under Section 26 A of the Act. As a consequence thereto, all the impugned notifications were quashed by the Hon'ble Court.

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