Timo Minssen, "Regulatory exclusivities for pharmaceutical innovation in Europe"

Harvard Law School, 19 February 2014

Regulatory exclusivities for pharmaceutical innovation in Europe

Patents Without Patents: Regulatory Incentives for Innovation in the Drug Industry

Wednesday, February 19, Harvard Law School

Assoc. Prof. Dr. Timo Minssen

Centre for Information and Innovation Law (CIIR) Copenhagen Biotech & Pharma Forum (CBPF)

University of Copenhagen

Centre for Information & Innovation Law

http://www.google.dk/imgres?imgurl=http://blog.templebar.ie/wp-content/eu_flag.jpg&imgrefurl=http://blog.templebar.ie/%3Ftag%3Deu-green-paper&usg=__FmyzkeFCWE9tdLZwCRovD6u9nSo=&h=301&w=443&sz=15&hl=da&start=11&zoom=1&tbnid=9uFi7wL903REhM:&tbnh=86&tbnw=127&ei=D5y2TunTBqjh4QTVnrDFAw&prev=/search%3Fq%3Deuropean%2Bunion%26um%3D1%26hl%3Dda%26sa%3DN%26rlz%3D1T4ADRA_enDK371DK371%26tbm%3Disch&um=1&itbs=1


AGENDA

• Focus: non-patent based exclusivities • =No focus on SPCs (Reg. No 1768/92)

1. The EU 8+2+1 formula (generally applicable to both small molecule drugs and biologics despite different competitive environment for biologics)

2. Special EU market exclusivities for orphan drugs

3. EU paediatric exclusivities

4. Future (comparative) challenges & points for discussion



1.

The EU 8+2+1 formula

(generally applicable data & market exclusivities under Dir. 2004/27/EC, amending Art. 10 of Dir. 2001/83/EC )



The ”new” general rules on regulatory exclusivities in the EU


Source: Zaide Frias, EMA Head of Regulatory Affairs, SME Workshop, 26.04.2013, EMA


Important differences between market- & data exclusivity

Market exclusivity • Period of time during which a generic, hybrid or biosimilar cannot be placed on

the market, even if the medicinal product has already received a marketing authorisation.

• more absolute but also more precise reg. generic entry • If only market excl. but no data excl. generics/biosimilars could not enter the

market but they could prepare entry by cross-referencing Data exclusivity • Period of time during which a Company cannot cross-refer to data in support of

another marketing authorisation, i.e.: generics, hybrids, biosimilars cannot be cross-validated by the Agency.

• But generic/biosimilar may still achieve MA by conducting their own studies and submitting their own full dossier incl. all necessary trials and evidence.

• Currently particularly high threshold for biologics • In theory protection not as absolute. But generic entry might de facto be

prolonged more than with market excl. depending on need for cross-referencing and complexity of the field.

• Additional ethical problems: Repetition of animal studies etc.






Provisions on extended market/data exclusivities

+1 year market protection for a new therapeutic indication

which brings significant benefit in comparison with existing therapies (Art. 14(11) Reg. (EC) No 726/2004)

- For initial MAA submitted after 20 November 2005 and authorisation of new indication within 8 years

+ 1 year data exclusivity for a new therapeutic indication for

a well-established substance, provided that significant pre-clinical or clinical studies were carried out in relation to the new indication (Art. 10(5) Dir. 2001/83/EC) (=+1 WEU).

+1 year data exclusivity for a change in classification of a

medicinal product on the basis of significant pre-clinical tests or clinical trials (Art. 74(a) Dir. 2001/83/EC) (=+1 OTC switch)




2.

EU marketing exclusivities for Orphan drugs (Regulation (EC) No 141/2000)


Development of orphan medicines: Rationales & Criteria

Underlying rationale “Patients affected by rare diseases have same rights as fellow citizens.” Orphan designation criteria: 1) Drug must either be (a) diagnose, prevent, or treat a life-threatening/very serious condition afflicting

no more than 5 in 10,000 people in the EU; (rare disease) or (b) diagnose, prevent, or treat a life-threatening or very serious and chronic

condition that, without incentives, would probably not be marketed given low likelihood that marketing generates sufficient return to justify investment (neglected disease) ; and

2) No satisfactory method of diagnosis, prevention, or treatment in EU, or if

method exists, the medicinal product should be of significant benefit to patients.

http://www.ema.europa.eu/htms/human/orphans/intro.htm








3.

New Paediatric Medicines in the EU under Reg. (EC) No 1901/2006.

= SPC extensions & PUMA exclusivities



Development of paediatric medicines

Duty Study of drugs in children for new products or authorised products with new

indication, pharmaceutical form and route of administration Agreed Paed. Invest. Plan (PIP) by Paed. Committee (PDCO) • PIP outlines timing & measures to be undertaken • Deferral or Waiver, if applicable • Compliance check at time of marketing authorisation application Sharpened requirements since 2009

See also: http://www.ema.europa.eu/htms/human/paediatrics/introduction.htm








4. Future challenges & points for discussion

• Data exclusivity for 2nd and further medical uses: Fair to the original innovating company? Wise from policy perspective?

• Risk for non-obviousness/inventive step gaps in patent law??? Could regulatory

exclusivities help? How? Alternatives? More governmental involvement? • Regulatory exclusivities & access debate (Art. 39 TRIPS etc.):

o FTA’s with developing countries o Impact of recent EU/EMA data disclosure developments o Special protection of manufacturing know-how reg. Biologics? o The special exclusivity regime for biologics in the US o Links between regulatory exclusivities, ethics, open innovation & paradigm shift in pharma

• Incentives for orphan drugs & effective pharmacovigilance.

• Comp. EU/US studies important both for practical & academic reasons.

• Importance of sustainable innovation & access perspectives in policy debate: solutions

that help during 6 years might have negative effect later

• What and who drives innovation in pharma? Why?



Questions and Comments?


Thank for your attention ! E-mail: [email protected] Web: www.ciir.dk CPH Summer school in Pharma Law & Policy:

http://copenhagensummeruniversity.ku.dk/en/courses/pharmalawpolicy



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Timo Minssen, "Regulatory exclusivities for pharmaceutical innovation in Europe"