Recent Amendment to UKPatent LawsBOOST TO CLINICAL TRIALS
Summary
Section 60 ofUK PatentsAct Amended
EffectiveDate ofAmendment:Oct 1, 2014
To AffectClinical Trials& MedicinalAssessments
Changes in UK Patents Act
Experimentaluse exceptionin section 60of the PatentsAct changed
Changes to allowcompanies to use apatented product,when carrying outtesting or otheractivity to provideinformation to theregulatoryauthorities
Companies alsoallowed to use apatented productin testing or otheractivity carriedout to supplyinformation forhealth technologyassessments
Activities Covered under New Exemption
Provide data on new medicines to UK or non-UK regulatory
authorities.
Provide data on new medicines to UK or non-UK bodies carrying out
health technology assessments.
Post approval studies to comply with UK or non-UK regulatory
requirements.
Amend a UK or non-UK authorisation for a medicine.
Obtain a UK or non-UK authorisation for a new indication of an
existing drug.
Obtain full authorisation in the EU of a generic drug or biosimilar.
Health technology assessment of a generic or biosimilar product.
Provide data for obtaining regulatory approval outside of the EU for
a generic or biosimilar product.
New Exemption – Scope
Do not extend to commercial activities (sale,
commercial supply, or manufacture in
preparation for sale or supply).
Covers use of patented medicine as
comparator in medicinal product assessment
[as defined]
Covers medicinal product assessment on
combination where patented drug is part of
combination.
Bolar Provisions – History
Do not extend to commercial activities (sale,
commercial supply, or manufacture in
preparation for sale or supply).
Covers use of patented medicine as
comparator in medicinal product assessment
[as defined]
Covers medicinal product assessment on
combination where patented drug is part of
combination.
Bolar Provisions – USA
Provisions provided under the Hatch-Waxman
Act to encourage marketing of generic
pharmaceuticals
In Eli Lilly and Co. v. Medtronic, 496 US 661
(1990), the Supreme Court held that the
exemption also applies to medical devices.
Exact scope of US exemption remains highly
fact-specific
Bolar Provisions – Asia
In India, section 107(a) broadly provides exemption for acts
relating to development & submission of information
required by law in India or other country.
Narrow provisions in Singapore (Section 66(2)(h)) are
limited to clinical testing to meet requirements for
marketing approval in Singapore only
Japan – provisions are shaped by case law interpretation of
statutory traditional experimental use exemption
Exceptions – Hong Kong, China
Bolar Provisions – Europe
Governed by Article 10(6) of Directive 2004/27/EC.
"10(6) Conducting the necessary studies and trials
with a view to the application of paragraphs 1, 2, 3
and 4 and the consequential practical requirements
shall not be regarded as contrary to patent rights or
to supplementary protection certificates for
medicinal products."
Bolar Provisions – Europe
Uncertain and do not create harmony among allstates.Varying scope and interpretation across EuropeIn some EU states, exemption is limited toactivities relating to marketing approval ofgeneric medicines, bioequivalents andbiosimilarsOther EU countries broadly exempt any actrequired for marketing approval, along with actsrelating to innovative medicines
Conclusion
Uncertain and do not create harmony among allstates.Varying scope and interpretation across EuropeIn some EU states, exemption is limited toactivities relating to marketing approval ofgeneric medicines, bioequivalents andbiosimilarsOther EU countries broadly exempt any actrequired for marketing approval, along with actsrelating to innovative medicines
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