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Fordham IP Conference 2011
Supplementary Protection Certificates
Recap and Current Status
29 April 2011
Brian CorderyBristowsLondon
Agenda
• Reminder of some basic concepts and definitions
• Current References to the Court of Justice
SPCs – Basic Concepts and Definitions
• SPC regime introduced in Europe in 1992 to provide partial compensation to patent holders in the pharmaceutical field for the patent life lost in obtaining regulatory approval
• The SPC regime was deemed necessary to encourage pharmaceutical research and development in Europe; and to keep up with the USA and Japan which introduced similar regimes in the 1980s
• Original Regulation 1768/92 was codified and consolidated into Regulation 469/2009
• A “uniform solution” is contemplated...
SPCs – Basic Concepts and Definitions
Three key definitions:
Basic patent: a patent protecting: (i) a product as such; (ii) a process or (iii) an application
for a product
Product: the active ingredient or combination of active ingredients of a medicinal product
Medicinal Product: the substance presented for treating or preventing desease in humans
“Protected” is not defined: “a matter of national law” (CJEU Farmitalia [1997])
SPCs Conditions for Obtaining a Certificate (Article 3)
(a) the product is protected by a basic patent in force;
(b) a valid authorisation to place the product on the market as a
medicinal product has been granted in accordance with Directive
2001/83/EC or Directive 2001/82/EC, as appropriate;
(c) the product has not already been the subject of a certificate;
(d) the authorisation referred to in point (b) is the first authorisation to
place the product on the market as a medicinal product.”
(Emphasis added)
What does “Protected by a Basic Patent” mean?
Infringement test
A product is protected if it would infringe the designated basic patent
e.g. a patent for X would be infringed by X+Y and therefore X+Y is protected by a basic patent for X
“Subject matter”; “Identifiable”; “Disclosure”; “Clear Pointer”; “Inventive Concept” tests
To be protected, the product must be disclosed/claimed in a specific/class/generic/not limited way
A uniform landscape?
Apply the infringement test
Strict (combination must be disclosed)
Less strict (any reference to a combination will suffice)
Uncertain / changing
Very strict ( must be specifically claimed)
References to the Court of Justice
Patent claims
MA SPC sought
Outcome
Medeva (1)Queensland (1)
A A+B A+B Denied – Art 3(a)Referred
Medeva (2)GeorgetownQueensland (2)
A A+B A Denied – Art 3(b)Referred
Daiichi A A+B A+B Denied – Art 3(a)Referred
Yeda A+B A A Denied – Art 3(a)Referred
• Medeva / Georgetown hearing is set for 12 May 2011
Other Issues
• Reference to the CJ on Article 3(d) in Neurim [8 March 2011] – does a patent and MA for the use of melatonin to advance the breeding season of sheep count as the first authorisation to place the product on the market, thus depriving a later invention for use of melatonin in the treatment of sleep disorders in humans from the opportunity to obtain an SPC?
• Synthon v Merck; Generics v Synaptech – Questions to the CJ on the meaning of “first authorisation to place the product on the market”: opinion of AG Mengozzi delivered on 31 March 2011.
• Further reference on negative SPCs in the Sitagliptin case
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