India: Abraxene’s Consecutive Rebuttal By Indian Patent Office

Indian Patent office, for the consecutive time rejects the grant of patent for an anti-cancer drug named 'Abraxene' developed by Abraxis Bioscience Inc which is a US-based biotechnology firm. IPO rejected the patent application for the second time, following an order passed by the Intellectual Property Appellate Board (IPAB) on the 20th of January, 2014 for fresh consideration of claims.

FACTS AND BACKGROUND

Abraxene is an injectible formulation of protein bound particles (paclitaxel) primarily used in the treatment of breast cancer, lung cancer and pancreatic cancer. On 29th June 2009 a patent Application titled 'Composition and method for delivery of pharmacological agents' bearing application No: 2899/DELNP/2005 was filed in India by Abraxis Biosciences claiming priority from a US patent application filed on the 9th of December, 20021 . NATCO filed a pre-grant opposition on several grounds including lack of novelty, after the said application was published in the official gazette. On 24th July 2009, IPO rejected the patent based on u/s 2(1)(j), u/s 3(e ) and u/s 10 of the Patents Act, 1970. Aggrieved by the decision of IPO, the Applicant Abraxis filed an appeal numbered 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 of the Controller.

APPLICANT'S ARGUMENTS:

Abraxis argued in their appeal that the order passed by the Controller reflected the violation of principle of natural justice as they were denied an opportunity of being heard. Giving an opportunity to the Applicant to be heard and clarify the objections raised by the IPO is a mandatory requirement as per Section 14 and 15 of the Indian Patents Act 1970. It was further mentioned in the order passed by the Controller that the Applicant has not filed any reply to FER within the prescribed time period which was vehemently denied by the Applicant who reiterated that they had filed the reply to FER within the prescribed time.

Abraxis strongly pointed out that the Assistant Controller of Patents and Designs took the decision based on the ground of insufficiency which was not at all raised by NATCO.

IPAB'S DECISION:

In the order (Order No. 9 of 2014) dated 20th January 2014, the IPAB in its decision 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.

SUBSEQUENT HEARINGS

As per the directions of Hon'ble IPAB, hearing was held on 01/04/2014 and 02/04/2014.Further NATCO 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.

ISSUE OF MAINTAINABILITY OF SECOND REPRESENTATION FILED BY THE APPLICANT

The Controller explained in detail regarding the admissibility of fresh representation by the opponent. It was contended that the second representation is considered as a fresh representation and not a 'serial opposition' as the opponent was unaware of the amended claims 1-12 which claims 1-93 was previously. Owing to the fact that the scope of amended claims is different from that of the original claims, the Controller upheld this contention and the fresh representation were taken on record.

DISMISSAL OF GROUNDS

Ground u/s 25(1)(b)- The claims lack novelty: In respect of the contention on the ground of lack of novelty raised by the opponent it was held by the controller that the prior art document does not disclose each and every element of the instant claimed composition, therefore the invention does not lack any novelty thereby dismissing the contentions u/s 25(1)(b). Ground u/s 25(1)(d)- The claims are in public use/ publicly known: The Controller held that the referred prior art document WO'079 does not disclose the composition as claimed fully, therefore through the said reference the instant claimed composition was not available to the public before the priority date of the instant application. Therefore the contention that the claims are in public use or publicly known under section 25 (1)(d) was also dismissed.

MAINTENANCE OF GROUNDS

Ground u/s 25(1)(e)- The claims lack inventive step: 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):CLAIMS ARE NOT PATENTABLE U/S 3(E) OF THE PATENTS ACT, 1970

The opponent raised contention u/s 25 (1)(f ) that the claims are not patentable u/s 3(e) and 3(d).Hearing the arguments of both parties, the Controller held that the applicant did not provide any comparative data in support of the unforeseen effect. Also, 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.

The applicant had mentioned in the complete specification that by his invention the associated sideeffects of said composition are reduced and enhancing transportation of claimed composition. However, the specification neither indicated any enhance effect of paclitaxel nor demonstrated any significance of such properties with regard to 'therapeutic efficacy' in view of the known substance. Therefore, in absence of any therapeutic efficacy of the composition as claimed, the amended claims 1 to 12 fall u/s 3(d) of the Patents Act, 1970 and make the invention non-patentable.

The contentions raised under section 3(e) , it was held by the Controller 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 falls under section 3(e) of the Patents Act, 1970.Further, in light of the teachings of prior art references, the invention is a product of routine experimentation work of a skilled artisan, therefore the invention falls under the purview of section 3(e) of the Indian Patents Act, 1970 and is non-patentable.

GROUND U/S 25(1)(G)- SPECIFICATION DOES NOT SUFFICIENTLY AND CLEARLY DESCRIBE THE INVENTION

The Controller held that the specification failed to provide a specific working example of the best mode of performing invention and hence amounted to insufficiency of disclosure as provided by applicant.

CONCLUSIONS:

The decision of patent denial to Abraxene would benefit the domestic pharmaceutical companies to launch affordable versions of the drug in the local market. On the other hand, Abraxis can either appeal the order in front of IPAB again, or file a Writ petition. If the order of the IPO is upheld, it is a win for generic drug manufacturers such as Natco and Cipla Natco's version, Albupax, was the first indigenously developed nanotech-based cancer drug. But it landed into problems after a year of launch, being charged with safety concerns by the drug controller. After clearing the hurdles, Natco is yet to launch the drug. Other companies like Cipla launched the drug Paclitax Nab (nano particle albumin bound) for the treatment of metastatic breast cancertion in 2012, at around Rs 11,000 per injection2.

Footnotes

1. http://ipindiaservices.gov.in/decision/2899-DELNP-2005-6374/2899%20DELNP%202005%20Decision.pdf

2. http://m.economictimes.com/industry/healthcare/biotech/pharmaceuticals/us-company-abraxisbiosciences-denied-patent-on-anti-cancer-drug/articleshow/37115731.cms

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