Tag Archives: USA

United States district court upholds the validity of two Horizon Pharma patents covering VIMOVO®

Horizon Pharma plc, an Irish specialty biopharmaceutical company, on 27 June 2017, reported that the United States district court for the district of New Jersey upheld the validity of two Horizon Pharma patents covering VIMOVO®, a pain relief treatment for arthritis patients, and that the ANDA applicants viz. Lupin Limited, Dr. Reddy’s Laboratories and Mylan Inc. would infringe at least one of the two patents with their proposed generic version of VIMOVO®.

What is VIMOVO®?

            VIMOVO® is a fixed dose combination of naproxen, a nonsteroidal anti-inflammatory drug (NSAID), and esomeprazole magnesium, a proton pump inhibitor (PPI). VIMOVO is used to relieve signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis and to decrease the risk of developing stomach (gastric) ulcers in people who are at risk of developing gastric ulcers with NSAIDs.

            The two Horizon Pharma patents which cover VIMOVO® and have now been upheld as valid by the US district court are:

  1. US6926907B2 – expires in February 2023. The US’907 patent claims a pharmaceutical composition in unit dosage form comprising therapeutically effective amounts of an acid inhibitor and a non-steroidal anti-inflammatory drug (NSAID), which unit dosage form provides for coordinated release of the acid inhibitor and the NSAID.
  2. US8557285B2 – expires in May 2022. The US’285 patent claims a pharmaceutical composition in unit dosage form comprising therapeutically effective amounts of: (a) esomeprazole, wherein at least a portion of said esomeprazole is not surrounded by an enteric coating; and (b) naproxen surrounded by a coating that inhibits its release from said unit dosage form unless said dosage form is in a medium with a pH of 3.5 or higher; wherein said unit dosage form provides for release of said esomeprazole such that upon introduction of said unit dosage form into a medium, at least a portion of said esomeprazole is released regardless of the pH of the medium.

            On April 21, 2011, July 25, 2011, and June 28, 2013, Horizon Pharma filed patent infringement lawsuits at the New Jersey District Court against Lupin Limited, Dr. Reddy’s Laboratories and Mylan Inc., seeking adjudication for patent infringement by these companies of one or more claims of the US‘907 and US’285 Patents. The infringement lawsuit came after these companies filed an Abbreviated New Drug Application (“ANDA”) with the U.S. Food and Drug Administration (FDA) seeking regulatory approval to market a generic version of VIMOVO before the expiration of the US‘907 patent in February 2023 and the US’285 patent in May 2022. At trial, the ANDA applicants alleged that the claims of the US‘907 and US’285 patents, listed in the Orange Book for VIMOVO were invalid.

            The announcement from Horizon Pharma came on the same day the U.S. district court for the district of New Jersey ruled in favor of Horizon Pharma and upheld the validity and enforceability of the patents at issue. Horizon Pharma says the outcome of the infringement lawsuit will prevent the launch of generic VIMOVO, which is being developed by Indian drug makers Lupin Limited and Dr. Reddy’s Laboratories as well as American generic drug maker Mylan Inc., in the United States.

Advertisements

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

blog3
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

blog-2
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

blog 1
Table 2: Regulations governing Supplementary Protection Certificate
 

blog1-1
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)

blog1-2

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