Artist Bjørn Bjørnholt

Supplementary Protection Certificates Extending the duration of your patent

October 2011

Jan Mondrup Pedersen M.Sc. Chemistry and Physics, Ph.D. Synthetic Organic Chemistry Patent Attorney T +45 33 63 93 43 E jmp@pv.eu

Overview

• Introduction – the purpose of SPC’s and why you should care

• Basic Requirements – what do you need?

• Opportunities and limitations – to file or not to file?

• Deadlines – when do you apply?

• Conclusions – take home messages

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Introduction and Purpose

• The possibility of obtaining an extension of patent protection via Supplementary Protection Certificates for medicinal products and agrochemical products was introduced in Europe in the 1990’s via regulation (EC) No’s 1768/92 (now 469/2009) and 1610/96

• The purpose of the regulations is to compensate for any reduced effective patent duration caused by prolonged clinical development procedures for products subject to regulatory approval

• The regulation allows for up to 5 years of added market exclusivity for a product plus an additional 6 months for products obtaining regulatory approval for paediatric use (since 2007)

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Scope of Protection

• European SPC’s extend the duration of protection for an approved product (API) protected by a patent, it does not extend the duration of the patent as a whole. It is a separate right protecting an active product ingredient only

• However, as an exception, if the approved product is e.g. a specific salt of an API, the SPC still protects all forms protected by the basic patent (Farmitalia C-392/97)

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Patent SPC

Geographical Scope

• The SPC regulation is in force within the European Economic Area (EEA) but the application procedure and interpretation takes place on the national level

• Some non-EEA countries introduced very similar rules (e.g. Switzerland, Russia, Kazakhstan and Belarus)

• Regulations with a similar purpose apply in other key countries including Australia, the US and Japan (“patent term extensions”)

• The following will refer mainly to the EEA regulations

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Why You Should Care

• We intend to license/sell our product IPR prior to regulatory approval – should I forget about SPC’s?

• No

• Knowing the value of your IPR and product portfolio

• 80% of UK revenue for Prozac™ generated during the SPC term!

• Impact on drafting of patent application

• Potential combination products?

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Basic Requirements - Eligible Products (API’s)

• Small molecule drugs

• Peptides

• Biologics (proteins, antibodies, DNA, LNA…)

• Vaccines

• Medical devices ( )

• …and mixtures thereof 7

The Four Basic Regulatory Requirements • For a given country in Europe, you need (Article 3 of the regulation):

• (a) A basic patent protecting the “product” (API) in question

• You must be the patent proprietor

• If you are a licensee simply ask the proprietor to apply

• (b) An authorisation to place the product on the market as a “medicinal product”

• You can use anyone’s marketing authorisation (MA)

• Applies to both human (2001/83/EC) and veterinary (2001/82/EC) authorisations

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The Four Basic Regulatory Requirements

• (c) The product (API) must not already have been subject of an SPC

• A product may be protected by numerous patents

• To avoid SPC “evergreening”

• (d) The marketing authorisation (MA) must be first MA for the product

• Generics are unlikely to obtain an SPC – even if their formulation/drug form is patented (i.e. novel)

• Applies in a given state – i.e. any SPC/MA in another EEA state is irrelevant

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Opportunities and Limitations

• The four basic requirements, although they appear simple enough, are open to interpretation in a wide array of special cases

• The interpretation of the regulation is made at the National Patent Offices and National Courts, however in cases of doubt or different national practices, cases may be referred to the Court of Justice of the European Union (CJEU)

• The regulation is not clear – likelihood of grant must be based on a review of the case law

• A few examples to illustrate this…

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a) A basic patent protecting the “product(s)” (API)

• The question whether a basic patent actually protects the API sought protected by an SPC sometimes arises

• The regulation itself (Article 1c) states that a basic patent may be a patent protecting:

• A product as such

• A process to obtain a product

• An application of a product (e.g. 2nd medical use)

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a) A basic patent protecting the “product(s)” (API)

• Combination products is currently a hotly debated issue

• Your basic patent protects product A

• Your MA is granted for product (A+B)

• Some states have applied an infringement test leading to grant, while others require a disclosure of A+B in the description or claims leading to refusal – referral to the CJEU (Medeva C-322/10 - pending)

• Thus, presently it is recommended to describe all conceivable combination products in a patent application that may lead to an SPC!

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c) The product must not have been subject of an SPC d) The MA must be first MA for the product

• The question often arising is whether the new product is sufficiently different from the product of a previous SPC/MA

• Some important examples (A being approved) SPC grant?

• A+B different from A? YES (salmeterol/fluticasone)

• A+Y different from A, Y being a non-API? NO (MIT/Gliadel C-431/04)

• A towards disease Z, A being approved for disease X? NO (Yissum C-202/05)

• A in a new dosage or administration form? NO (Yissum C-202/05)

• A as a novel salt, ester or polymorph? ? (recital 14 vs case law)

• A as a single enantiomer, e.g. (R)-A? YES ([2009] EWCA Civ 646)

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Deadlines

• The Deadline for filing an SPC application expires:

• A) 6 months after grant of patent, or

• B) 6 months after grant of MA

whichever is later (usually B)

• Late filing may only be remedied at national examiners discretion (Difloxacin SPC/GB/97/080)

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Conclusions

• Unless it is crystal clear that you do not fulfil one or more of the four basic requirements, have an expert assess your possibilities

…do this already at patent drafting stage or IPR/product valuation stage

• As soon as your product enjoys both patent protection and is authorized to be marketed in a European country, *SPC* should pop into your head

…and remember: An external patent advisor is typically blissfully unaware that you received an MA!

• It is possible to have an SPC based on a second medical use patent, but only if the product has not been approved for other uses

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Calculation of SPC Duration

• Take the period elapsed from

• the filing date of the basic patent (usually the PCT filing date)

• to the grant of the first Marketing Authorisation in Europe

• Subtract 5 years from the above period

• If > 5 years, then limit to 5 years

• Add this period to the patent expiry date, and you have your SPC expiry date

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