Monthly Archives: May 2015

CIPLA & BMS may settle patent dispute over Entecavir in India

US based pharma major Bristol-Myers Squibb (BMS) and Indian pharma company Cipla Ltd. are heading towards an amicable settlement on a long-stretched patent dispute concerning BMS’ hepatitis B drug Entecavir, a leading anti-viral drug for Hepatitis B patients that brings in more than a billion dollars each year globally for BMS.

Entecavir, being a pre-1995 molecule, was not patented in India as the Indian patent law did not provide patent protection for “products” till 1995. However, BMS filed a patent application for its once daily composition comprising Entecavir and got a patent in India for the same. The patent application (IN/PCT/2002/00891/MUM) was filed at Mumbai patent office by BMS in 2001 and it was granted (IN213457) in the year 2008.

Claim 1 of IN ‘457 read as:

  1. A pharmaceutical composition effective for once a day oral administration to treat Hepatitis B virus infection in a human adult patient comprising up to 1 % of entecavir, adhered to a carrier substrate of kind such as herein described, and pharmaceutically acceptable excipients such as herein described in an amount as herein described, wherein the said percentage is based on a total composition weight of 100 mg.

Claim 12 of IN ‘457 read as:

  1. A method of preparing a pharmaceutical composition of entecavir as claimed in claim 1 comprising (a) dissolving said entecavir and an adhesive substance in a solvent wherein said solvent is water or water having an acidic or basic pH, (b) spraying said solution obtained in step (a) onto a carrier substrate while said carrier substrate is in motion, (c) drying said coated carrier substrate from step (b) to remove said solvent, and (d) combining said dried coated carrier substrate from step (c) with other excepients as claimed herein above to form said pharmaceutical composition.

In 2010, Cipla, had filed a revocation application with the India’s Intellectual Property Appellate Board (IPAB) against BMS’ patent IN ‘457 covering a pharmaceutical composition comprising up to 1% of Entecavir effective for once a day oral administration to treat Hepatitis B virus infection in a human adult patient.

When the case came up before the IPAB, the counsel representing Bristol-Myers Squibb informed the patent tribunal that both the drug makers are in negotiations to settle the patent dispute. The IPAB bench comprising chairman justice KN Basha and DPS Parmar, technical member, patents, adjourned the matter since both the parties were exploring the possibilities of an amicable settlement.

BMS previously reached a settlement with Indian generic firm Natco Pharma concerning the drug. Natco and BMS had entered into a similar settlement over the Entecavir composition patent, after Natco had applied for revocation of the patent at the IPAB.

Generic drug producers such as Dr. Reddy’s and Cadila launched their generic versions of Entecavir (Baraclude) in India earlier in 2010 by designing around the once daily composition patent. Ranbaxy had also launched a generic product of the drug earlier in the Indian market.

US scenario of Entecavir: (Patent dispute between BMS & Teva)

Entecavir is protected by two patents in United States viz. US 5206244, product patent which covers the Entecavir molecule and US 6627224 which covers Entecavir compositions effective for once a day oral administration. Teva Pharmaceutical, an Isreal based generics major, challenged the Entecavir product patent in a US court and launched its generic version of Entecavir in US market. Teva successfully invalidated the Entecavir product patent based on obviousness ground and an appeal by BMS was denied by the US Court of Appeals for the Federal Circuit, in 2014.

About the Author: Antony David, Senior Patent Associate at Khurana & Khurana, Advocates and IP Attorneys and can be reached at: antony@khuranaandkhurana.com

Part 3 of 3: Patent Term Extension laws for Europe and the United States of America: compared and contrasted

This is third and last part of the three part series dedicated to the discussion on the comparison of the Patent Term Extension laws of Europe and the United States of America (USA). While part one of three, which discussed the comparison of terms used for the extension of patent term in Europe and the USA, relevant regulations, effective date of the regulations, authority to grant extension, and provisions of negative or zero extension, was more a kind of introductory one, second part took care of comparison on the basis of statutory requirements for the grant of extension along with possible interpretations of the relevant terms, scope of protection during the extended period of term, maximum number of extensions per product, maximum number of extensions per patent, calculation of period of extension, and this part is giving comparison of the total combined duration of market exclusivity of a general patent and extension, further extension of ‘extension of patent term’, patent term adjustment (PTA), period within which request for extension should be made, interim extension, application fees/ renewal fees, combination product, provision which may reduce the period of extension, terminal disclaimer and extension of patent term.

This table is continuation of the table 1 from part 1 and part 2

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About the Author: Swapnil Patil, Patent Associate at Khurana & Khurana, Advocates and IP Attorneys and can be reached at: swapnil@khuranaandkhurana.com

Part 2 of 3: Patent Term Extension laws for Europe and the United States of America: compared and contrasted

This is second part of the three part series dedicated to the discussion on the comparison of the Patent Term Extension laws of Europe and the United States of America (USA). While part one of three, which discussed the comparison of terms used for the extension of patent term in Europe and the USA, relevant regulations, effective date of the regulations, authority to grant extension, and provisions of negative or zero extension, was more a kind of introductory one, this part takes care of comparison on the basis of statutory requirements for the grant of extension along with possible interpretations of the relevant terms, scope of protection during the extended period of term, maximum number of extensions per product, maximum number of extensions per patent, calculation of period of extension, and third and last part of the series will give comparison of the total combined duration of market exclusivity of a general patent and extension, further extension of ‘extension of patent term’, patent term adjustment (PTA), period within which request for extension should be made, interim extension, application fees/ renewal fees, combination product, provision which may reduce the period of extension, terminal disclaimer and extension of patent term.

This table is continuation of the table 1 from part 1

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About the Author: Swapnil Patil, Patent Associate at Khurana & Khurana, Advocates and IP Attorneys and can be reached at: swapnil@khuranaandkhurana.com

Part 1 of 3: Patent Term Extension laws for Europe and the United States of America: compared and contrasted

Many people love comparing and contrasting and I am one of those (at least for study purposes). This time, I am comparing Patent Term Extension laws for Europe and the United States of America (USA). Though there are other provisions that may extend the life of patent such as patent term adjustment to compensate the delays due to patent offices, and paediatric exclusivity, I am specifically focusing on the patent term extension intended when the patent owner loses patent term during the early years of the patent because the product cannot be commercially marketed without approval from a regulatory agencies. Though Patent Term Extension laws in both the USA and Europe serve the same purpose, you will agree with me when I say that there are notable differences in the provisions of both. Products eligible for extension of patent term are not limited to human drug products, but this blog focuses more on them, somewhere references may also be found to medical devices, food additives, or color additives, animal drug products, and plant protection products. Unless otherwise specified, details discussed in this blog are related to human drug products/medicine products.  In the table 1, the Patent Term Extension laws for Europe and the USA are compared for easy understanding. Table 2 is for regulations governing Supplementary Protection Certificate and Table 3 is for calculation of extension period for the USA. As the discussion of this topic is quite lengthy one, I thought it fit to post it in series of three. While part one of three, which discusses the comparison of terms used for the extension of patent term in Europe and the USA, relevant regulations, effective date of the regulations, authority to grant extension, and provisions of negative or zero extension, is more a kind of introductory one, part two will take care of comparison on the basis of statutory requirements for the grant of extension along with possible interpretations of the relevant terms, scope of protection during the extended period of term, maximum number of extensions per product, maximum number of extensions per patent, calculation of period of extension, and third and last part of the series will give comparison of the total combined duration of market exclusivity of a general patent and extension, further extension of ‘extension of patent term’, patent term adjustment (PTA), period within which request for extension should be made, interim extension, application fees/ renewal fees, combination product, provision which may reduce the period of extension, terminal disclaimer and extension of patent term.

Table 1: Comparison Patent Term Extension laws for Europe and the USA

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Table 2: Regulations governing Supplementary Protection Certificate
 

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Table 3*: Calculation of extension period for the USA
 

*This table is for other than animal drug or veterinary biological products. Term of the patent shall be extended from the original expiration date of the patent, which shall include any patent term adjustment (PTA) granted under section 154 (b)

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The patent term extension of a patents that were issued before September 24, 1984, where the regulatory review period began and ended before September 24, 1984, were only function of the regulatory review period could be extended for more than five years.

About the Author: Swapnil Patil, Patent Associate at Khurana & Khurana, Advocates and IP Attorneys and can be reached at: swapnil@khuranaandkhurana.com