Friday, 15 July 2011

The United States of America et al. V/s Lupin Ltd

July 14, 2011: A lawsuit against Lupin Ltd (Defendant) for patent infringement has been filed in the district court of New Jersey by the United States of America and the Board of Trustees of the University of Illinois (Plaintiffs). Lupin is a pharmaceutical company having a principal place of business in Mumbai, India. Lupin is involved in the marketing and selling of generics and entered the US generic pharmaceutical market in 2003 with the Abbreviated New Drug Application (ANDA) approval for cefuroxime axetil. An ANDA is an application for an approval of a generic version of a licensed medication or an approved drug. If an ANDA application is approved, then the manufacturing company can manufacture and sell the generic version of the drug for lower cost to the general public. Currently, there are close to 14 ANDA approvals granted to Lupin by the US FDA.

It is brought to the notice of the readers that an application for ANDA can be made through paragraphs I, II, III and IV certifications. Lupin has filed Paragraph IV certification for ANDA no 202-073. Typically, an ANDA applicant filing a paragraph IV certification must notify the owner of the patent about the application. In return, the patent owner may bring a patent infringement suit within 45 days of receiving such notification. The plaintiffs have filed the complaint (lawsuit) within the 45 day interval.

The patent-in-suit is US7470506 (the '506 patent) entitled "Fitness Assay and Associated Methods" and was issued to the United States of America as represented by the Secretary, Department of Health and Human Services on December 30, 2008. An analysis of the '506 patent reveals that the '506 patent is focused towards a biochemical fitness assay and covers method of using Prezista. Prezista is a kind of protease inhibitor and is used as one of the treatment options for people suffering from HIV. Pharmaceutical companies are required to list patents that cover certain drugs and medication in the FDA publication (Orange Book) for public access. The Orange Book includes information about Approved Drug products with Therapeutics Equivalents Evaluations. A search in the Orange Book for the '506 patent revealed that the '506 patent covers methods for using Prezista.

According to details provided in the complaint filed by the plaintiffs, the government of United States, as authorized by an agreement with University of Illinois, has granted a non-exclusive license of the '506 patent to Tibotec (A pharmaceutical company having primary place of business in Ireland). Tibotec holds approved New Drug Application (NDA) (Non. 21-976) for Duranavir Ethanolate Tablets, 75mg, 150mg, 400mg, and 600mg dosage strengths sold under the trade name Prezista.

The complaint also mentions that Lupin submitted ANDA no. 202-073 to the FDA seeking approval to commercially manufacture, use, and sell Darunavir Ethanolate Tablets 75mg, 150mg, and 300mg. It is asserted in the lawsuit that Lupin's ANDA is based on Prezista NDA and, according to Lupin, demonstrates the bioequivalence of Lupin's product to Prezista. The complaint also goes on to disclose that Lupin had sent letters to the government of United States and University of Illinois on June 3, 2011 and notified them that Lupin had included certifications in its ANDA that the '506 patent is invalid. Consequently, Lupin believes that the '506 patent is unenforceable and Lupin is not infringing on the '506 patent by manufacturing, using and selling its products in the market.

The plaintiffs, on the other hand, have alleged that Lupin is intentionally, and deliberately seeking approval of a drug that will infringe the claims of the '506 patent. Consequently, the plaintiffs believe that Lupin is liable for inducement of infringement as well contributory infringement of the '506 patent. As a result, the plaintiffs have requested for monetary compensation and royalty for the patent infringement by Lupin. The plaintiffs have also requested that effective date of any approval of ANDA no. 202-073  in the future should not be any earlier than expiration date of the '506 patent.

Further Information about Paragraph IV certification*:

An ANDA applicant filing a paragraph IV certification must notify the proprietor of the patent. The patent holder may bring a patent infringement suit within 45 days of receiving such notification. If the patent owner timely brings a patent infringement charge against the ANDA applicant, then the US FDA suspends the approval of the ANDA until: 
>> the date of the court’s decision that the listed drug patent is either invalid or not infringed;  
>> the date on which the listed drug patent expires, if the court finds the listed drug’s patent is infringed; or  
>> the date that is 30 months from the date the owner of the listed drug’s patent received  notice  of  the  filing  of  a  Paragraph IV certification. (Subject to modification by the court).  This  means  that  for  30  months  from  the  date  of  receipt  of  notice  of Para VI filing, no ANDA can be approved.

In other words, once the branded drug company indicates its intent to begin a patent infringement suit against the generic company as a result of the paragraph IV filing, the US FDA is prohibited from approving the drug in question for thirty months or until such time that the patent is found to be invalid or not infringed. If, prior to the expiration of thirty months, the court holds that the patent is invalid or would not be infringed, then the US FDA approves the ANDA when that decision occurs. Conversely, if the court holds that the patent is valid and would be infringed by the product proposed in the ANDA prior to the expiration of thirty months, then the US FDA does not approve the ANDA until the patent expires.

*Source: IPpro

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