Correct Interpretation of section 107A of the Indian Patents Act: Judgement in Bayer Vs. Natco & Alembic

In a recent decision, the Divisional bench of Delhi high court has dealt with correct interpretation of Section 107A of the Patents Act, 1970, commonly known as the Bolar provision.The ruling came as a result of two appeals made by Bayer Corp. Ltd.  against the Natco Pharma and Alembic Pharmaceuticals for infringement of its patents for its drugs Nexavar and Xarelto. Both the appeals dealt with the identical issue.

Background of the Case:

Bayer had approached Delhi high court to stop Alembic Pharmaceuticals from exporting Rivaroxaban, the active ingredient of its patented drug ‘Xarelto’ and Natco Pharmaceutical from exporting Sorafenib, the active ingredient of its patented drug Nexavar. Both the Indian drug manufacturers were granted compulsory licenses for manufacturing respective drugs. According to records, both the patents for the drugs ‘Xarelto’ and ‘Nexavar’ granted to Bayer would cease to be in force from 2020.

On March 8, 2017, a single-judge Bench of the Delhi high court lead by Justice Rajiv Sahai Endlaw had allowed Natco Pharma and Alembic to export the active pharmaceutical ingredient (API) Sorafenib and Rivaroxaban for research and development of information for regulatory submissions.

Natco pharma and Alembic pharmaceuticals affirmed that they will export Bayer’s patented drugs only for the purposes allowed as per section 107A of the Patent Act, 1970.

Some of the findings of the single- judge bench were as follows: –

  • Sale by a non-patentee (even if the non-Patentee is a compulsory Licensee) of a pharmaceutical product solely for the purposes prescribed in Section 107A would also not be infringement;
  • Use of the word selling in section 107A refers to selling within India, and also exports;
  • Merely because no provisions are stated to exist in laws relating to export of pharmaceutical products, for ensuring that API exported is used in the destination country for the purposes for which it has been exported, does not allow Court to interpret Section 107A as not permitting export;
  • Natco and Alembic can export the patented invention for purposes specified in Section 107A of the Patents Act, and for no other purposes.

Aggrieved by the judgement, Bayer Corp. Ltd. Appealed to the Division bench of the Delhi high court for correct interpretation of Section 107A.On 22nd of April 2019, the divisional bench gave its final verdict in both the cases.

Bolar provision-Interpretation:

The decision of the divisional bench of the Delhi high court dealing with the issue of correct interpretationof Section 107A(a) of the Patent Act, 1970 relating to “Bolar Provision” concluded that:

The Bolar exemption is the global community’s thought out design to ensure that –

the enclosure of intellectual property rights, granted to inventions, does not last beyond the term assured and that

the general public is afforded with the end of the bargain which every society guarantees while sealing a patent i.e. access to the technology or invention for generations to come.

But for a Bolar exemption, a third party manufacturer would not be able to start experimentation and ready a product, for its availability to the general public after the expiry of the patent term.

Final Judgement of the Divisional bench of the Delhi high court:

On 22nd April 2019, the division bench of Justice S. Ravindra Bhat and Justice Sanjeev Sachdeva affirmed the findings of the single bench Judge Rajiv SahaiEndlaw.

The decision of the divisional bench confirmed that the sale, use, construction of patented products (by individuals and entities that do not hold patents) in terms of Section 107A of the Act for purposes both within the country and abroad is authorized and legal provided the seller ensures that the end use and purpose of sale/export is reasonably related to research and development of information in compliance with regulations or laws of India (or the importing country), for its submission in accordance with such laws.

The divisional bench held that any dispute over the end use or purpose of the export, whether it is reasonably for research or regulatory submissions will be the subject matter of a civil suit, where the relief can be granted based on circumstances and the evidence.

The divisional Bench directed that the court trying the suit would decide the case in accordance with law taking into account discussion and factors indicated in this judgment.

Author: Ms. Mita Sheikh – Associate Director  and Co- Author- Dhanada Deshpande , Intern at Khurana & Khurana, Advocates and IP Attorneys. In case of any queries please contact/write back to us at mita@iiprd.com .

Leave a Reply

Archives

  • October 2021
  • September 2021
  • August 2021
  • July 2021
  • June 2021
  • May 2021
  • April 2021
  • March 2021
  • February 2021
  • January 2021
  • December 2020
  • November 2020
  • October 2020
  • September 2020
  • August 2020
  • July 2020
  • June 2020
  • May 2020
  • April 2020
  • March 2020
  • February 2020
  • January 2020
  • December 2019
  • November 2019
  • October 2019
  • September 2019
  • August 2019
  • July 2019
  • June 2019
  • May 2019
  • April 2019
  • March 2019
  • February 2019
  • January 2019
  • December 2018
  • November 2018
  • October 2018
  • September 2018
  • August 2018
  • July 2018
  • June 2018
  • May 2018
  • April 2018
  • March 2018
  • February 2018
  • January 2018
  • December 2017
  • November 2017
  • September 2017
  • August 2017
  • July 2017
  • June 2017
  • May 2017
  • April 2017
  • March 2017
  • February 2017
  • January 2017
  • December 2016
  • November 2016
  • October 2016
  • September 2016
  • August 2016
  • July 2016
  • June 2016
  • May 2016
  • April 2016
  • March 2016
  • February 2016
  • January 2016
  • December 2015
  • November 2015
  • October 2015
  • September 2015
  • August 2015
  • July 2015
  • June 2015
  • May 2015
  • April 2015
  • March 2015
  • February 2015
  • January 2015
  • December 2014
  • November 2014
  • October 2014
  • September 2014
  • August 2014
  • July 2014
  • June 2014
  • May 2014
  • April 2014
  • March 2014
  • February 2014
  • January 2014
  • December 2013
  • November 2013
  • October 2013
  • September 2013
  • August 2013
  • July 2013
  • June 2013
  • May 2013
  • April 2013
  • March 2013
  • February 2013
  • January 2013
  • December 2012
  • November 2012
  • September 2012
  • August 2012
  • July 2012
  • June 2012
  • May 2012
  • April 2012
  • March 2012
  • February 2012
  • January 2012
  • December 2011
  • November 2011
  • October 2011
  • September 2011
  • August 2011
  • July 2011
  • June 2011
  • May 2011
  • April 2011
  • March 2011
  • February 2011
  • January 2011
  • December 2010
  • September 2010
  • July 2010
  • June 2010
  • May 2010
  • April 2010