Amendments look good to conduct clinical trials in UK, but provisions may conflict with the provisions of the Unified Patent Court (UPC).
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.
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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 US 661 (1990), the Supreme Court held that the exemption also applies to medical devices. However, the 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. Section 107(a) of the Indian Patents Act reads as follows:
Section 107A – Certain acts not to be considered as infringement
“For the purposes of this Act,—
(a) any act of making, constructing, using, selling or importing a patented invention solely for uses reasonably related to the development and submission of information required under any law for the time being in force, in India, or in a country other than India, that regulates the manufacture, construction, use, sale or import of any product;
(b) importation of patented products by any person from a person who is duly authorised under the law to produce and sell or distribute the product, shall not be considered as a infringement of patent rights.”
In Singapore, Section 66(2)(h) provides for narrow provisions that are limited to clinical testing to meet requirements for marketing approval in Singapore only.
In Japan, provisions are shaped by case law interpretation of statutory traditional experimental use exemption.
Similar exceptions are also prevalent in Hong Kong and China.
Bolar Provisions – Europe
In EU, bolar provisions are primarily governed by Article 10(6) of Directive 2004/27/EC, which states:
“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.”
However, such provisions are uncertain and do not create harmony among all states as they are subjected to varying scope and interpretation across Europe. In some EU states, exemption is limited to activities relating to marketing approval of generic medicines, bioequivalents and biosimilars, whereas other EU countries broadly exempt any act required for marketing approval, along with acts relating to innovative medicines.
In light of above-mentioned developments, companies have more certainty than before to plan and conduct clinical trials in UK using patented products. At the same time, amended UK bolar exemptions sound good at present, but may intersect (or conflict) with Unitary Patent Court scheduled for 2015 as UPC contains its own bolar exemptions that only allow for trials to generate data for generic authorization.