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

Thank you for your attention

Bristows

100 Victoria Embankment

London EC4Y 0DH

T +44(0)20 7400 8000

F +44(0)20 7400 8050

brian.cordery@bristows.com

www.bristows.com

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