A niche blog dedicated to the issues that arise when supplementary protection certificates (SPCs) extend patents beyond their normal life -- and to the respective positions of patent owners, investors, competitors and consumers. The blog also addresses wider issues that may be of interest or use to those involved in the extension of patent rights. You can email The SPC Blog here
Thursday, 31 July 2008
STOP PRESS: it now seems that the "SPCs" mentioned here are themselves a non-standard abbreviation for "Summaries of Product Characteristics", referred to as SmPCs by those who like to distinguish them from supplemtary-protection-certificate-type SPCs . Thanks, Trevor Cook (Bird & Bird) for pointing this out.
Wednesday, 30 July 2008
Under Regulation 1901/2006 companies seeking approval for a new medicinal product, a new indication, route of administration or pharmaceutical form of an existing patent-protected drug must submit a PIP which spells out how they they propose to develop the drug for the various subsets of the paediatric population. If the proposal is approved, the drug's supplementary protection certificate will secure a six-month extension.
Friday, 25 July 2008
This is very topical since tomorrow, 26 July 2008, is the date from which there is imposed an obligation to submit results of studies according to an agreed PIP with applications for (new) marketing authorisations (see Article 7) or a decision granting a waiver or deferral.
The new requirements apply to most products, but not to generics, hybrid applications, biosimilars and well-established medicinal products, or to homeopathic and traditional herbal medicinal products. Different rules govern patented and off-patented medicines, as well as both rewards and incentives for compliance.
For products still under patent, a PIP must be submitted and agreed with the PDCO. If the agreed programme is conducted and the obligations are fulfilled there is the possibility of gaining a 6 months extension of the Supplementary Patent Certificate.
Wednesday, 23 July 2008
Details of the BSLR here, and of Lawtext here.
Sunday, 20 July 2008
Remarkably, the claim is made that the volume of European Union legislation stands at around 85,000 pages. Anyone who regularly reads the Official Journal would be likely to guess that the real figure stood at many times that number.
Readers can review the proposed codified site here.
Wednesday, 9 July 2008
"Finally, the generics industry has fast access to reliable key patent, SPC and data protection expiry information".This access is provided by Pipeline Scope, the latest release from GenericsWeb, which also claims to provide accurate and complete data for over 1,400 international non-proprietary names, across 37 countries, delivered through a user-friendly interface. According to Leighton Howard, Managing Director of GenericsWeb:
"SPC and data exclusivity are critical drivers for generic pharmaceutical development. Existing products lack a logical interface for researching and viewing this information in a way that quickly answers the questions being asked. Scope is developed from the ground up with a perspective of both the patent specialist and the business development executive in mind, allowing fast access to reliable key patent, SPC and data protection expiry information."The SPC-related information concerns protection "in 30 EU states" [at the date of the press release, the number still stood at just 27] plus extensions of term for non-EU countries".
Monday, 7 July 2008
Both Barr Labs and, a little later, Mylan filed abbreviated new drug applications (ANDA) to manufacture a generic version of Mirapex in 2005, with paragraph IV certifications against the validity of Boehringer's US patents 4,843,086 and 4,886,812. Boehringer responded by filing suit against Barr and Mylan, and the cases were consolidated for trial.
The district court affirmed the principle that the same invention can't be patented twice. In this case the '086 patent -- which expired during the course of the litigation -- claimed methods of treating certain diseases by administering tetrahydrobenzthiazoles, while the '812 patent claimed the tetrahydrobenzthiazole compounds themselves, including pramipexole dihydrochloride. Said the court:
"Although there are differences between the '812 patent and the '086 patent, . . . those differences are insufficient to support the patentability of the '812 patent in light of the '086 patent".Double-patenting may be avoided by making a terminal disclaimer. During the trial Boehringer terminally disclaimed
"...only the terminal part of the statutory term of the '812 patent which would extend beyond the 1,564 days after the full statutory term of the '086 patent as that term is defined in 35 U.S.C. § 154, so that by virtue of this disclaimer, the '812 patent will expire on October 8, 2010".Boehringer received a 1,564 day extension under 35 USC § 156 due to FDA regulatory review of Boehringer's New Drug Application for Mirapex. As a result of this patent term extension, the original expiration date of the '812 patent, 12 December 2006, was extended to 25 March 2011. Thus, by its terminal disclaimer, Boehringer disclaimed five and a half months of patent term (the period of time between the expiration date of the '086 patent and the original expiration date of the '112 patent). According to Boehringer, its terminal disclaimer blocked Barr and Mylan's double-patenting argument. The court disagreed:
"A dual problem is presented in that the terminal disclaimer was not only filed at or near the conclusion of trial in this action, but it was also filed after the expiration of the earlier '086 patent. ...[F]or a terminal disclaimer to be effective, the earlier filed patent must not have expired at the time of the filing of the disclaimer"Source: iStockAnalyst.
Thursday, 3 July 2008
Article 57 provides for the European Medicines Agency to establish the EudraPharm database on medicinal products authorised in the Community to be accessible to the general public. Where appropriate, EudraPharm should also include references to data on clinical trials currently being carried out or already completed, contained in the clinical trials database provided for in Article 11 of Directive 2001/20 — the EudraCT database).
The purpose of this guideline is to identify the data elements from the EudraCT database corresponding to the information to be included in EudraPharm, to identify the trials which will be included and to set out the criteria for the update of this data. The idea is to provide relevant information in the interests of public health. EudraCT data fields are mainly consistent with international initiatives relating to clinical trial registries such as the WHO International Clinical Trials Registry Platform and the International Committee of Medical Journal Editors (ICMJE). Although EudraCT may have additional fields, the convergence of the information to be made public with the WHO ICTRP facilitates the work of sponsors and researchers submitting information to different registries for different purposes, and facilitates the access of patients, health professionals and citizens in general to this information.