Raloxifene Monopoly Is Maintained In The US Thanks To ‘Method Of Use’ Patents

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GenericsWeb, the leader in established pharmaceutical patent analysis and searching, recently published an article based on its proprietary Pipeline Patent Intelligence that analyses opportunities in launching a generic Raloxifene product for Eli Lilly’s blockbuster selective oestrogen receptor modulator (SERM) Evista®. Global sales of Evista® declined 6% in Q1 2013 generating US$240.6 million.

GenericsWeb, the leader in established pharmaceutical patent analysis and searching, recently published an article based on its proprietary Pipeline Patent Intelligence that analyses opportunities in launching a generic Raloxifene product for Eli Lilly’s blockbuster selective oestrogen receptor modulator (SERM) Evista®. Global sales of Evista® declined 6% in Q1 2013 generating US$240.6 million.

The article by GenericsWeb highlights the following observations in relation to generic Raloxifene:

  •     Raloxifene was developed and marketed by Elli Lilly (Lilly) who, in July 2006, entered into a marketing and distribution agreement with Daiichi Sankyo for major European markets.
  •     Patents which protect the Raloxifene molecule and its hydrochloride salt have expired in all major markets.
  •     Patent protection conveyed by patent families US92093392A and US20501294A protecting methods of use and the dosage regimen for Evista® are considered to constrain generic entry beyond the expiry of patents in the molecule family.
  •     While the US members of the family expired in December 2012, the protective term of the European member has been extended by SPC in France, Germany, Spain and the UK, expiring in early August 2013.
  •     Teva launched their Raloxifene products in Spain ‘at risk’ prior to the conclusion of revocation proceedings, triggering Lilly to file an injunction which was ultimately dismissed.
  •     The patent protecting the dosing regimen of administering 60 mg/day Raloxifene hydrochloride in the treatment and prevention of osteoporosis is considered to further constrain generic entry until March 2014.
  •     Remaining patent families protecting technologies are generally not considered to be a constraint to generic competition as they are likely to be circumvented.
  •     NCE data exclusivity is generally not considered to be a constraint to generic competition as it has expired, however in the US, Lilly was awarded seven years of orphan data exclusivity.
  •     Extensive patent litigation has been identified in the US for patents in the families that relate to authorised uses and administration of Raloxifene.
  •     In regard to patents US6458811, US6797719 and US6894064 from the family US1416796P, which expire in March 2017, claiming Raloxifene hydrochloride having defined particle size and its use, the District Court found them to be invalid for lack of obviousness and lack of enablement.
  •     In Australia, Lilly filed a patent infringement suit against Apotex in May 2012. This resulted in Apotex agreeing not to manufacturer, market and sell their Raloxifene product.
  •     Of note are the families with priorities US28017380A and US3002887A, both included as 'Key' due to patent infringement litigation brought against Lilly for its manufacture and sale of Evista®

GenericsWeb notes that: “patents protecting the Raloxifene molecule and its hydrochloride salt have expired in all major markets. However, patents protecting the main indicated use of Raloxifene in the treatment and prevention of postmenopausal osteoporosis and its dosage regimen have provided some constraint to generic competition beyond the expiry of molecule patents. In the US, these patents have proved to be a barrier to generic competition, after being upheld after paragraph IV challenges by Teva, preventing final FDA approval until March 2014. In Europe declaration of invalidity has allowed generic entry in some markets, but not all. This demonstrates the benefits of ‘method of use’ patents in maintaining the innovators monopoly beyond molecule patent protection and data exclusivity provisions. In addition to constraining generic entry, it can be costly to generic companies having to delay the launch of their generic products until the conclusion of revocation proceedings, receiving injunction orders restraining them from the manufacture, marketing and/or sale of their generic equivalents, and other penalties awarded for patent infringement. Orphan data exclusivity in the US will prevent approval of ANDAs having the indicated use of Raloxifene in the reduction of invasive breast cancer until September 2014, again demonstrating the validity of life-cycle management strategies based on therapeutic use.”

You can read the entire article here at: http://www.genericsweb.com/druginfocus/Raloxifene

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Yoann Bretonnet
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