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02 Feb 2018

Patent Related Developments in 2017

By: Vidya Bhaskar Singh
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Patent Related Developments in 2017

The year 2017 saw several positive changes to India’s IP landscape. These include the Government’s efforts to promote IP protection and awareness, DIPP’s scheme of Modernization and Strengthening of Intellectual Property Offices[1], steps taken by office of the Controller General of Patents, Designs and Trademarks (CGPDTM) to streamline the process of filing and prosecution, and issuing of revised guidelines for examination of Computer Related Inventions. Further, Indian courts too interpreted patent laws more liberally than before.

This write-up highlights key developments relating to Patents landscape in India in 2017, in addition to summarizing the major Patent-related cases of 2017. The write-up also looks at the likely impact of these changes in the year 2018.

Major developments:

  • Guidelines for Computer Related Inventions were revised by the Indian Patent Office and released on June 30, 2017. The most important amendment in the office order issued by the CGPDTM is the removal of the requirement of a “novel hardware element” in cases where a patent for computer related invention is claimed. This is expected to clear the confusion looming over the patentability of computer related or software-based inventions. This also sends a positive signal to stakeholders operating in the domain of IT and IoT about patenting their inventions.

The Department of Industrial Policy and Promotion (DIPP), India and World Intellectual Property Organization (WIPO) have signed an agreement to establish Technology and Innovation support centers. The WIPO’s Technology and Innovation Support Centers (TISC) program provides innovators in developing countries access to locally-based, high quality technology information and related services, helping them to exploit their innovative potential and to create, protect, and manage their Intellectual Property Rights. TISCs provide a number of services including access to online patent and non-patent resources and IP related publications, assistance in searching and retrieving technology information, training in database search, on demand search, monitoring technology and competitors, basic information on industry laws, property laws, management and strategy, technology commercialization and marketing. This is seen to be a positive step to enable Indian startups becoming better informed about IPR and taking proactive steps to protect and monetize them.

  • At the stakeholders’ meeting on Start-ups Intellectual Property Protection (SIPP)) held on December 7, 2017, a number of issues were raised and suggestions made to resolve them. Some of the important changes accepted by the CGPDTM are as follows:[2]
  1. The reporting of Publication of applications for patent before expiry of 18-months will be automated like FER. Publication information may be sent via email and/or SMS alert over phone.
  2. Maintenance and routine update of email address of the Attorney/Agent in the system made easier, with the portal now allowing attorneys/agents to edit the email address.
  3. Patent Office will send SMS alerts along with emails for reminders relating to last date for request for examination filing, FER, renewal filing, and Form-27.
  4. The delivery of FER through emails to be augmented with a delivery receipt system to confirm that the attorney on record has received the FER. SMS alerts have also been initiated in this regard.
  5. Patent Office to cross check very old patent cases where the FER is not issued yet. Old cases expected to be taken up for disposal on priority.
  6. Timelines to be set for issuance of decision after the hearing is conducted and written submissions are filed.
  • Retired Delhi High Court judge, Justice Manmohan Singh was proposed to be appointed as Chairman of IPAB for a period of 3 years. He took up the position in January 2018. This is a significant development because the IPAB has been without a Chairman for quite some time.
  • In the Global Innovation Index of 2017[3], India is seen as an emerging innovation center in Asia.

 

Major Patent Cases of Year 2017:

Some of the landmark Patent cases for the year 2017 would be:

 

Biocon Ltd & Mylan Pharmaceuticals Pvt Ltd vs. F. Hoffman-La Roche AG & Ors[4]

In this case, the Competition Commission of India has addressed the issue of “abuse of dominant position in market”, thereby paving the way for use of biosimilar in the Indian market. Roche has developed a monoclonal anti-body for treatment of breast cancer called Trastuzumab and filed a patent application in India. Later, Roche withdrew HERCEPTIN from the market and introduced BICELTIS and a low-cost version of Trastuzumab under the brand name HERCLON.

Biocon Limited, in collaboration with Mylan Pharmaceuticals Private Limited, developed a biosimilar for Trastuzumab and based on that introduced two new drugs CANMAb and HERTRAZ which were cheaper than Roche’s low-cost versions.

Biocon faced serious flak from the Roche group and it was alleged that given its dominant position, the Roche Group had implemented or attempted to implement a series of actions (including indulging in frivolous litigations against Biocon and writing to various authorities), to impede the entry and/or growth of Biocon’s biosimilar in India, thus adversely affecting competition in the relevant market.

Based on the facts, the Commission prima facie found that Roche’s practices Group were in contravention of Section 4(2)(c) of the Competition Act. The Commission has directed Director General to carry out a detailed investigation into the matter, in terms of Section 26(1) of the Act, and submit a report to the Commission.

Bayer Intellectual Property GmbH vs. Ajanta Pharma Ltd & Ors[5]

In this case, the Hon’ble Delhi High Court interpreted the rights of a patentee in cases where the patents have not been worked or used in India ever since the grant and the patentee is admitted “non-user in Form-27”. Bayer was awarded an ex-parte ad interim injunction thereby restraining the defendants from making, selling, distributing, advertising, exporting, offering for sale, and in any other manner, directly or indirectly dealing with Bayer’s patent.

In light of the facts, the Court balanced self-interest of the patentee against the larger public interest and modified the ad interim injunction and allowed the defendants to make/manufacture, distribute, and offer for sale or sale of the impugned products for purposes of exports.

Bayer Corporation v Union of India & Ors[6]

The Hon’ble Delhi High Court analyzed the reach of Bolar provisions enshrined in the Patents Act, 1970 under Section 107A which permits export from India of a patented invention, solely for uses reasonably related to the development and submission of information required under any law for the time being in force, in India, or in a country other than India, that regulates the manufacture, construction, use, sale or import of any product. The Court held that Natco and Alembic are entitled to export limited quantity of the patented invention (Active Pharmaceutical Ingredient (API) SORAFENIB) of Bayer to China for the purposes of conducting development / clinical studies and trials falling under Section 107A.

Expectations in 2018

The afore-mentioned changes contribute to ushering in a relatively IP favorable environment in year 2018. It is reasonable to expect that industry/stakeholders will react positively to the release of the revised Guidelines for Computer Related Inventions, inclusion of fast track examination, extension of the SIPP (Startup Intellectual Property Protection scheme up to the year 2020 etc. We expect a greater jump in patent application filings than the 10% growth recorded in 2016 and 2015[7].

All stakeholders must prepare to take advantage of the various IP benefits being rolled out.

[1] http://dipp.nic.in/programmes-and-schemes/intellectual-property-rights/modernisation-and-strengthening-intellectual-property-office-msipo

[2] Patents and Trademarks-Suggestions received from Stakeholders and Action taken by Office of CGPDTM is accessible at http://www.ipindia.nic.in/newsdetail.htm?382

[3] https://www.globalinnovationindex.org/gii-2017-report

[4] Case No. 68 of 2016

[5] MANU/DE/0486/2017

[6] MANU/DE/0316/2010 ; W.P.(C) 1971/2014

[7] http://www.ipindia.nic.in/writereaddata/Portal/IPOAnnualReport/1_71_1_Annual_Report_2015-16_English__2_.pdf

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