bolar provisions amendment in uk patent laws – to affect clinical trials and medicinal assessments
DESCRIPTION
Key takeaway Amendments look good to conduct clinical trials in UK, but provisions may conflict with the provisions of the Unified Patent Court (UPC). Introduction Recently, UK Patents Act was amended that can boost clinical trials in UK by providing greater certainty to companies using patented products. Specifically, section 60 of the Patents Act has been amended that will affect clinical trials and medicinal assessments. The effective date of said amendments is October 1, 2014. UK Bolar Provisions Amendment What are the amendments? The amendment will allow the companies to use patented products as amended section 60 relates to experimental use exceptions, which after consultation with the stakeholders, extended the “Bolar exemption” to include clinical trials conducted on innovative medicinal products as well as on generic medicinal products. Specifically, new Sections 60(6D) to 60(6G) have been added to the UK Patents Act. The new provisions are aimed at broadening the scope of the existing exemption in Section 60(5)(b) of the Patents Act for acts “done for experimental purposes relating to the subject matter of the invention.” Activities Covered under New Exemption Following activities will be covered: Activities carried out to Provide data on new medicines to UK or non-UK regulatory authorities. Activities to 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. Activities carried out to amend a UK or non-UK authorization for a medicine. Activities to obtain a UK or non-UK authorization for a new indication of an existing drug. Activities to obtain full authorization in the EU of a generic drug or biosimilar. Health technology assessment of a generic or biosimilar product. Activities to provide data for obtaining regulatory approval outside of the EU for a generic or biosimilar product. Scope of New Exemptions The new exemptions do not extend to commercial activities (sale, commercial supply, or manufacture in preparation for sale or supply) as these only include use of patented medicine as comparator in medicinal product assessment [as defined]. In addition, the exemptions also include medicinal product assessment on combination where patented drug is part of combination. History of Bolar Provisions Bolar Provisions are named after a US law that was enacted to overturn a prior court ruling holding that the US did not provide for a research exemption – Roche Products, Inc. v. Bolar Pharmaceutical Co., Inc., 733 F.2d 858 (1984). In said ruling, the court held that exception for experimental use must be construed narrowly, and that experimentation for pure speculative research was not infringement. Bolar Provisions – USA In United States, provisions are provided under the Hatch-Waxman Act to encourage marketing of generic pharmaceuticals. In the case of Eli Lilly and Co. v. Medtronic, 496 USTRANSCRIPT
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
