Non-standard abbreviations used in SPCs -- a new list

This month the European Medicines Agency (EMEA) published some new QRD documents updates. These included a List of frequently used non-standard abbreviations to be used in SPC and labelling. This is version 9 of the original list: it runs for three pages and contains around 30 terms and their non-standard abbreviations in 23 languages. There are warnings that some terms have abbreviations in some languages only, while in others the full term must be used (eg there is no Portuguese abbreviation for "percutaneous transluminal coronary angioplasty". The notice contains no indication as to the list's legal status.

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.

70 positives for PDCO in first year of operation

Writing in Pharma Times Peter Mansell reports that, in its first year of operation, the European Medicines Agency’s Paediatric Committee (PDCO) received 233 applications (covering 420 indications), adopting 70 positive opinions on paediatric investigation plans (PIPs) and waivers from these requirements, but only one negative one. 61% of these decisions were for as-yet unlicensed products.

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.

Significant date ahead for EU Paediatric Regulation

The Medicines for Children Research Network has produced a handy summary of developments regarding the the EU Paediatric Regulation. In short, while over 100 million people in the EU -- around 22% of its population -- are under 19 years old, more than half the medicines they take have not been tested or authorised specifically for their use. The dangers are obvious and need not be spelled out here. In 2006 the EU Paediatric Regulation was adopted. This provided for the establishment of the Paediatric Committee (PDCO), allowing drug manufacturers to apply for Paediatric Investigation Plans (PIPs) or requests for waivers.

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.

Recent publication

The most recent issue of the Bio-Science Law Review (BSLR, published six times a year by Lawtext Publishing) carries a short note by Taylor Wessing Associate Catherine Drew. This note, "Patents -- SPC Regulations", discusses the recent decision of the UK IPO in Merck & Co. Inc, BL O/108/08, on whether a SPC can have a negative or zero term.

Details of the BSLR here, and of Lawtext here.

E-notice regarding codification exercise

The European Commission has published a proposal for a codified version of the Council Regulation concerning supplementary protection certificate for medicinal products. The objective is not to improve or amend the law, but merely to reduce the volume of Community law. The proposal will involve the numbering of several articles and recitals of the existing legislation.

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.

EU expands as Pipeline Scope announces latest data offering

A press release from eMediawire has announced that

"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".

Double-patenting and terminal disclaimer still can't stop generic Mirapex

Following a trial held in March, the US District Court for the District of Delaware held that Boehringer Ingelheim's patent for Mirapex (pramipexole dihydrochloride) was invalid for "obviousness-type double patenting". This product, which is indicated for the treatment of Parkinson's disease and Restless Leg Syndrome, has enjoyed annual sales in the US of approximately $380 million.

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.

New Communication on clinical trials databases

This morning the Official Journal of the European Union published the Communication from the Commission regarding the guideline on the data fields contained in the clinical trials database provided for in Article 11 of Directive 2001/20/EC to be included in the database on medicinal products provided for in Article 57 of Regulation 726/2004.

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.

Teva challenge to Seroquel fails; paediatric extension granted

Citing an item in Forbes, Fiercepharma reports that drugs giant AstraZeneca has avoided a full-blown trial to protect its antipsychotic medication for bipolar disorder Seroquel. Teva Pharmaceutical hoped to market a generic version of this medication, which has a current US patent expiration date in September 2011, and commenced legal proceedings against AstraZeneca based on a "no inequitable conduct" challenge, but it has been reported that a federal court in New Jersey has given summary judgment in AstraZeneca's favour. A patent extension for specifically for paediatric use will extend AstraZeneca's protection to March 2012. Teva is believed to be considering an appeal against the court's ruling.