Highlights of the New patent rules:
The amendment to the Patent Rules 2003, have been bought in with NEW PATENT RULES, 2016 which came into effect on May 2016. Here we look into the major changes with respect to earlier practices.
START-UP:
A “Start-up” is defined with the conditions to be met by an entity to be entitled Start-up status which are:
| >> | The new rules have placed Start-ups in par with the natural person in relation to the fees to be paid as per First schedule for each process at the patent office, which is a major relief to the start-ups compared to earlier, where they had to pay in equivalent to Small entities. |
| >> | Start ups given the privilege of requesting expedited examination by filing Form 18 A with the prescribed fees of Rs. 4000/-. |
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When an application processed by a start-up is fully or partly transferred to anyone other than a natural person or start-up, the difference in fees to be paid by the new applicant. |
| >> | For an application processed already by a start-up, no difference in the fees to be paid even if it ceases to be a start-up due to lapse of 5 yrs or a hike in turn-over. |
| >> | Expedited examination request filed by start-up would not be questioned even if it ceases to be a start-up due to lapse of 5 yrs or a hike in turn-over. |
Address of service:
Everyone is required to submit an e-mail id along with the postal address. In addition to this PA is required to submit a mobile number registered in India.
Leaving and Serving Documents:
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The Controller General of Patents at Indian Patents Office granted Compulsory License to a local company NATCO PHARMA, under section 84 (1) (b) of the Patents Act, 1970 to manufacture the generic version of sorafenib tosylate . This effectively ends the BAYER CORPORATION CORPORATION's monopoly in India on the drug which is used to treat kidney and liver cancer. The case in question is the first of its kind in the Indian Patents Act, 1970 wherein the provisions of Section 84 have been invoked for seeking the grant of compulsory license.
In terms of Section 84 of the Indian Patents Act, at any time after the expiration of three years from the date of grant of a Patent, any person interested may make an application to the Controller for grant of compulsory license on patent on any of the following grounds, namely:
(a) That the reasonable requirements of the public with respect to the patent invention have not been satisfied;
(b) That the patented invention is not available to the public at a reasonably affordable price;
(c) That the patented invention is not worked in the territory of India.
After careful consideration of all the relevant aspects including Statements on Form 27 regarding commercial working of the patented invention in India filed by the patentee, the Controller General came to the conclusion that none of the above requirements have been met by the patentee, BAYER CORPORATION Corporation, which resulted in the grant of the compulsory license to NATCO PHARMA , the Applicant. The Controller General found that BAYER CORPORATION had not only failed to price the drug at a level affordable to the general public but was also unable to ensure that the medicine was made available in India in sufficient quantities.
While passing the Order against BAYER CORPORATION, the Controller General noted that during the last four years the sales of the drug by BAYER CORPORATION at a price of about Rs 2,80,428/- constituted a fraction of the requirements of the public. It stands to reason, therefore, that a patented article like Nexavar was not bought by the public because it was not affordable to them. The drug was being sold by the German giant at a fabulous price of Rs.2,80,428/- per month, whereas NATCO PHARMA has requested BAYER CORPORATION for license to manufacture the generic version of the same at an affordable price of 8,880 per month which BAYER CORPORATION had rejected.
In the Order, the Controller General stipulated that the price of the drug covered by the patent sold by the company shall not exceed Rs 8880 for a pack of 120 tablets which is the requirement for one months treatment. It also directed the company to pay a royalty of 6 per cent of the net sales of the drug on a quarterly basis.
NATCO PHARMA had also argued that even though the patentee imported the patented drug into the country it was not utilized to its fullest extent as provided under section 83 (a) and (b) of the Indian Patents Act due to its high pricing at Rs.2,80,428/-. The Act requires the company to utilize the invention to the fullest extent possible.
The Controller General also wondered why BAYER CORPORATION did not offer differential pricing for different classes and sections of the public in the country so that it could be affordable to all. Most importantly, the Order also requires that the company will have to supply the drug covered by the patent to at least 600 needy patients per year free of cost.
The Controller General found BAYER CORPORATION guilty of absolute neglect and delay, as the company, despite launching the product worldwide in the year 2006, and the patent in India granted in 2008, did not launch it in India till 2009, causing delay in the launch for no convincing reason.
In keeping with an international trade agreement India and other countries signed in 1994, as part of the World Trade Organization, the country in 2005 adopted a new patent law recognizing patents on pharmaceutical products, where previously it had only protected manufacturing processes.
The TRIPS [ TRADE-RELATED ASPECTS OF INTELLECTUAL PROPERTY RIGHTS ] Agreement which governs trade and intellectual property rules, compulsory licenses are a legally recognized means to overcome barriers in accessing affordable medicines. The Indian decision reflects similar moves made in other countries, including the US and Thailand. In February 2011, the US Patent Office decided not to prevent a generic medical device used for skin grafts from being sold, but insisted that its manufacturer pay royalties to the patent holder. Between November 2006 and January 2007, Thailand issued compulsory licenses for two AIDS drugs (efavirnz and the combination of lopinavir+ritonavir) and one antihypertension drug (clopidegrel).
Today's system is one where new medicines are patented, and drug companies relentlessly defend their monopolies at the expense of patients who cannot afford the high prices charged. We should move to a new equitable and rational system where new medicines have multiple producers paying royalty to the patent holders, helping them not only to recoup their development costs but also ensuring access to the developing countries.
This landmark judgement made by the highest authority of the Indian Patent Office marks for the first time that Indian Patent Law has been used to allow generic production when a patent drug is unavailable and unaffordable.
Trade Marks (Amendment) Rules, 2010
There is an amendment to the Indian Trade Mark Rules 2002 effective May 20, 2010. It is the expansion of the Fourth Schedule to include three additional classes of services to the existinglist. The total number of classes now stands at 45, instead of the previous 42. The notification is available at http://ipindia.nic.in/tmr_new.
The added services are as follows:
42. Scientific and technological services and research and design relating thereto; industrial analysis and research services; design and development of computer hardware and software.
43. Services for providing food and drink; temporary accommodation.
44. Medical services, veterinary services, hygienic and beauty care for human beings or animals; agriculture.horticulture and forestry services.
45. Legal services; security services for the protection of property and individuals; personal and social services rendered by others to meet the needs of individuals.
India - New Patents (Amendment) Act
The Government of India has met the December 31 deadline for complying with its obligation to World Trade Organisation (WTO) under TRIPs agreement, by promulgating an Ordinance – The Patent (Amendment) Ordinance, 2004 followed by the Act – Patent (Amendment) Act, 2005.
The most important changes are
Product Patent can be issued in respect of food, drugs and medicines. Provisions of 'process patent' for these goods abolished.
Provisions in respect of EMR (Exclusive Marketing Rights) abolished.
Computer programme per se is not patentable, but its technical application to industry or a combination with hardware is patentable.
Provision of 'acceptance of specification' and its advertisement have been deleted.
Application for patent will be published in Official Journal. At that time opposition can be made on limited grounds but hearing is not mandatory
After grant of patent, opposition can be made within 12 months.
Provisions of sealing of patent omitted.
Suit for infringement of patent cannot commence before date of publication of publication of the application.
Penalties enhanced substantially.
India - New Designs Act
The Designs Act, 2000 has come into force with effect from May 11, 2001. The salient features of the Act are:
The definition of a Design has been widened. Design means and includes composition of lines or colour or combination thereof applied to any article in addition to the visual features of shape, configuration, pattern or ornamentation applied to any article but should not include any Trade mark or property mark or artistic works as defined under the Copyright Act, 1957.
Absolute novelty is essential to register a design under the Act.
International Classification of Industrial Designs according to Locarno Agreement has been introduced.
The right of priority is applicable from an application filed in a convention country.
The period of protection is for ten years extendable for a further period of five years.
India - New Trade Marks Act
India has enacted the new Trade Marks Act substantially amended its existing Trade & erchandise Marks Act 1958. The Act will come into force as soon as the enabling Rules are notified.
The salient features of the new Act are: -
The definition of a mark has been widened to include any sign capable of distinguishing the goods or services of a person in respect of which it is registered from the goods or services of another person and may include any sign capable of being represented graphically, including aspects of packaging, shapes and colors.
Service Marks registration is possible in India.
Multi-class application is possible covering several classes of goods and/or services.
The division between Part A & Part B of the Register has been abolished.
The period of registration has been increased from 7 to 10 years with renewals for the like period.
Statutory protection has been provided to well-known trade marks.
The definition of infringement has been expanded.
Additional provisions have been included for enforcement of rights.
An Appellate Board is to be established to expedite appeals and applications for rectification.
PMG ASSOCIATES
Advocates, Patent & Trademark Attorneys
EF7-10, Vasanth Nagar, Palarivattom
Cochin-682 025, INDIA
Tel:+91484 2337856 / 6457856
Fax :+91 484 2347893 / 2337057
E-Mail : info@pmgip.com