Raloxifene - Comprehensive patent search

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Raloxifene - Comprehensive patent search
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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."

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Pipeline Developer is a regularly updated, professional patent search performed by our expert team, which not only identifies relevant patents, but delivers categorisation and interpretation, all delivered by a convenient online interface.

The Pipeline Developer report covers Raloxifene
Raloxifene indications: Postmenopausal osteoporosis
Raloxifene innovator: Lilly (Evista)

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Used by the worlds leading generic pharmaceutical companies and legal teams, Pipeline Developer minimises the risk of wasted developments or legal action, by providing you with nothing less than the very best in comprehensive patent information. Searched and analysed by highly trained, dedicated staff using sophisticated searching techniques, Pipeline Developer delivers results you can rely on. And that means your staff can concentrate on how the patent landscape affects your business, rather than trying to source reliable patent information.
Pipeline Developer features:
# Comprehensive patent searching, covering the world's key territories (see 'search coverage' below)
# Identifies patents covering molecule, formulation, process, use, combination and assay techniques (see 'Patent Categories Identified'below)
# Patent identification, categorisation and interpretation
# Grouped by patent family and assigned to development categories based on Interpretation of key aspects of the patent claims
# Manual filtration of patents not relevant to generic development
# Updated on a monthly basis, including changes to patent families, statuses, and litigation
# Enables fast analysis and verification by hyper-linking to crucial patent documents and national registers

Patent Categories Identified:
1. Molecular Form
a) Molecule Patents
b) Salts, Hydrates & Solvates
c) Polymorphic Forms
d) Other Molecular Forms
2. Active Ingredient Preparation
a) Intermediates & Preparation Thereof
b) Final Synthetic Stages
c) Complete Synthesis
d) Purification Methods
e) Fermentation Methods
f) Biotechnology
3. Formulations & Methods Thereof
a) General Formulations & Methods
b) Injectable Formulations
c) Oral Formulations
d) Other Administration-Specific Formulations
e) Excipients, Kits & Packaging
4. Related Medical Use & Administration
a) New Use Related to Main Indication
b) Dosing Regimen/Administration Conditions
5. Active Ingredient Combinations
a) Novel Combinations
b) Use of Combinations
c) Dosing Regimen & Administration Conditions for Combinations
6. Analytical Methods
a) Assaying Methods
b) Methods of Determining Patient Suitability

Search coverage:
Clicking on a patent family displays detailed information on the 'Core' and 'Non-Core' 'Patent Family Equivalents'. 'Core Patent Family Equivalents' are equivalent patents from territories that are individually verified and monitored for changes, including British, German, Spanish, French, US, Canadian, Australian, European, and PCT patents. Statuses are also monitored and updated. 'Extended Patent Family Equivalents' are equivalent patents found through the INPADOC database, increasing the search coverage to 70 countries.

Patent and national register access:
Clicking on a listed patent/application number or text or image link will launch a pop-up window containing an image of the patent, enabling easy analysis of the patent documents. Clicking on a register link launches a pop-up window with the patent office register extract for that patent. This allows investigation into the examination status of a pending patent, opposition of a granted patent and/or payment of maintenance fees. Please note that no extra charges apply to accessing or downloading documents of any kind.

Litigation alerts:
Informing you of developments in court, litigation alerts can also be accessed by clicking on the litigation symbol next to the status, with links to judgements where available.

Updating:
To take the time and hassle out of monitoring and updating a large number of patents, all Pipeline Developer reporting is updated on a monthly basis. Convenient change flags identify new patent families, new patent family members, changes in statuses and litigation alerts.

Legal status and transaction history:
You can also find legal status and transaction history for 'Extended Patent Family Equivalents' by clicking on the INPADOC Family/Legal Status button for 65 additional territories.

Reporting and access:
All data can be exported into Microsoft Excel and print friendly versions for ease of data manipulation and reporting. Company details are confidential and all data is SSL secure. Five users per company are permitted and access levels are controlled by a nominated 'company administrator'.

Pipeline Developer is just one of the benchmark products from GenericsWeb's Pipeline Patent Intelligence product suite.

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Generic Drug Industry: Raloxifene - Comprehensive patent search

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