Indian Patent office rejects Patent claim over Abraxane

In a major setback, the Indian Patent Office denied a patent to an anti cancer drug Abraxane manufactured by US-Based Abraxis BioSciences. Here we will discuss the decision given by IPO at the back drop of the arguments advanced by the respective parties.

 Background

In a brief, Patent application no. 2899/DELNP/2005 filed by Abraxis Biosciences was earlier rejected by Indian patent office on 24th July 2009, based on u/s 2(1)(j), u/s 3(e ) and u/s 10 of the Patents Act, 1970. Being aggrieved by the decision of Controller General of Patents, the applicant filed an appeal (M.P.NO. 57/2010 IN OA/3/2010/PT/DEL and OA/3/2010/PT/DEL) in ‘Intellectual Property Appellate Board’ (IPAB) against said decision. The Honorable IPAB vide its decision dated 20/01/2014 (Order No. 9 of 2014) set aside the said controller’s order and remanded the matter to the Assistant Controller for a fresh consideration by affording opportunity to both sides based on the Principle of natural justice. The detailed article is already discussed on IIPRD blog here.

Pursuant to that order, fresh consideration was given to Abraxis and hearing was held on 01/04/2014 and 02/04/2014. Further, the opponent NATCO Pharmaceuticals filed a fresh representation u/s 25(1) on 28/03/2014 under the grounds of section 25(1)(g) and 25(1)(f) limited to section 3(d). The said representation was forwarded to the applicant. The applicant filed reply statement on 15/04/2014. The hearing on the fresh representation was held on 17/04/2014.

 Decision made by Controller

On the issue of admissibility of fresh representation by the opponent, it was contended that the opponent was unaware about the amended claims 1-12 which were previously 1-93 and hence, the fresh representation by the opponent must be taken on record. The Controller upheld this contention and the fresh representation were taken on record.

Moreover in respect of the contention on the ground of lack of novelty raised by the opponent it was held by the controller that the invention does not lack any novelty and thus the contention u/s 25 (1) (b) is dismissed.  Therefore the contention that the claims are in public use or publicly known under section 25 (1)(d)  was also dismissed. However, the Controller maintained the contentions raised by the opponent on three grounds which are as follows.

Ground u/s 25 (1)(e)

The contention raised by the opponent u/s 25 (1)(e) that the claims lack inventive steps was upheld by the Controller as the applicant failed to provide any substantial evidence regarding the improved unexpected properties in the claimed composition as contended by the applicant. Moreover, the teaching of cited reference reveals that a person having ordinary skill in the art would have sufficient teaching/ suggestion and motivation to reach at every element of the claimed composition.

 Ground u/s 25 (1)(f)

The opponent raised contention u/s 25 (1)(f) that the claims are not patentable u/s 3(e) and 3(d). It was observed by the Controller that the applicant failed to provide any comparative data supporting the claimed unforeseen effect. Further, the examples given in the specification are more of routine pharmacological study of the composition to analyze therapeutic and toxicological effect on the body on the administration of claimed composition. It was claimed by the applicant that by this invention the associated side-effects of said composition are reduced and enhancing transportation of claimed composition. However, it was further observed by the controller that the specification as provided neither indicates any enhanced effect nor provides any significant properties relating to therapeutic efficacy as claimed. Hence, the application falls under the purview of section 3(d) of Indian Patent act, 1970 which makes the invention non patentable (Relied on the decision by Honorable Supreme Court in the case of Novartis vs. Union of India).

Further in relation to the contention raised under section 3(e), it was held that the claimed composition is considered as a mere admixture resulting only in the aggregation of the properties and therefore, the instant amended claims 1 to 12 fall u/s 3(e) of the Patents Act, 1970. The rationale behind this is that the claims by the applicant is routine experimentation work for a person with ordinary skill in the art as inferred from the prior art references. Hence, the contention u/s 25(1)(f) is maintained and the application also fails under the purview of section 3(e) of Indian Patent act, 1970 which makes the invention non patentable.

Ground u/s 25 (1)(g)

The Controller upheld the contention u/s 25 (1)(g) as raised by opponent that there exists insufficiency of disclosure as provided by applicant. It was observed that the specification lacks disclosing any working demonstration or any example regarding claimed invention.

 Conclusion

By this judgment the Controller strengthen the rational and provisions of the patent act to be followed stringently by the applicants so that the application shall not fall under the purview of the provisions that makes the invention not patentable on the grounds of insufficiency, lack of inventive step and the category of invention which are not patentable under the patent act. The decision given by Controller General of Patents is another safeguards against evergreening of pharmaceutical drug patents as provided under section 3 (d) of the Indian Patent act, 1970.

About the Author: Mr Sitanshu singh, Patent Associate at Khurana & Khurana and can be reached at:  sitanshu@khuranaandkhurana.com

Leave a Reply

Categories

Archives

  • March 2024
  • February 2024
  • January 2024
  • December 2023
  • November 2023
  • October 2023
  • September 2023
  • August 2023
  • July 2023
  • June 2023
  • May 2023
  • April 2023
  • March 2023
  • February 2023
  • January 2023
  • December 2022
  • November 2022
  • October 2022
  • September 2022
  • August 2022
  • July 2022
  • June 2022
  • May 2022
  • April 2022
  • March 2022
  • February 2022
  • January 2022
  • December 2021
  • November 2021
  • 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