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Patent Intelligence Briefings

Pharmaceutical Patents

Supplementary Protection Certificates (SPCs)

Paediatric Extensions

Data & Marketing Exclusivity

Exclusivity vs. Patent Cover

Paediatric Use Marketing Authorisations

The Specific Mechanism

Patents, Trademarks, Copyrights

Product, Process & Formulation Patents

Key Patent Definitions



Singulair - Sigma Pharmaceuticals Plc vs Merck Sharpe & Dohme

Specific Mechanism – Ambiguity, Confusion and Conflict

Medeva and Georgetown - Combination Drugs and SPCs



Abilify - Aripiprazole - Rejection of Paediatric Application by UK Patent Office

After some considerable deliberation the United Kingdom Intellectual Property Office (UKIPO) decided on 4th March 2015 to reject Otsuka‚Äôs application for a paediatric extension to the SPC on their product patent EP367141. This is very much in line with most other EU member states, so did not come as a surprise. Read more...

Singulair - Sigma Pharmaceuticals Plc vs Merck Sharpe & Dohme

The Sigma vs. MSD case is a landmark ruling in relation to The Specific Mechanism and parallel importation of branded medicinal products from new EU member states. It sets out the importance of correctly identifying the patents and SPCs that are significant to parallel imported, branded medicinces. Read more...

Pharmaceutical Drug Shortages

Recently reported in the press (see Times, 27/02/2011) of a current shortage of drugs in the UK. This apparently has been brought about by the UK being one of the cheapest in Europe and subject to exporting of certain medicines to countries where the price is higher and thereby claim higher reimbursement in countries of destination. Read more...

Specific Mechanism – Ambiguity, Confusion and Unspoken Conflict

The Accession Treaty of 2003 sought to protect pharmaceutical IP rights in an expanding EU, but in so doing has created a legacy of confusion and unaddressed conflict in parallel trade. Read more...

The Medeva and Georgetown Cases - Combination Drugs and SPCs

On 24th November 2011, the European Court of Justice announced its judgements on two cases, Medeva (Case C-322/10) and Georgetown et al. (Case C-422/10). Both related to combination drugs, supplementary protection certificates (SPCs) and the interpreation of SPC regulations. Read a simple explanation of the issues and implications. Read more...

Following Successful Rivastigmine SPC Challenge Mylan Launches First Exelon Generic in the UK

Following the the recent revocation of Novartis' related Rivastigmine SPC, PITTSBURGH and POTTERS BAR, England, Mylan Inc. (Nasdaq: MYL) today announced that its U.K.-based subsidiary has launched Rivastigmine Capsules POM, 1.5 mg, 3 mg, 4.5 mg and 6 mg. This product is the generic version of Novartis' Exelon® Capsules, a treatment for dementia in people with Alzheimer's disease. Mylan is the first company to launch a generic Rivastigmine formulation in the U.K. Read more...

MPA Guide to Data Exclusivity

EU data exclusivity provides originators of medicines a degree of marketing protection. Outside of the defined period of exclusivity, applicants are able to refer to the originator’s documentation and file for an abridged licence, citing the originators work and having to prove that their product is the same as that of the originator. The costs and complexity associated with filing an abridged application for a marketing authorisation are significantly lower than those for a full application. Read more...

Tibotec grants HIV licenses to generics

Tibotec Pharmaceuticals of Cork, Ireland has granted multiple non-exclusive licences to generic manufacturers including Hetero Drugs Limited, Matrix Laboratories Limited (a Mylan company) of India and Aspen Pharmacare of South Africa to manufacture, market and distribute the investigational non-nucleoside reverse transcriptase inhibitor rilpivirine hydrochloride (TMC278), pending its approval for use with other antiretroviral agents in the treatment of treatment-naive HIV-1 infected adults. Read more...

Viral Genetics settles HIV/AIDS products

Viral Genetics Inc of San Marino, California, and its President Haig Keledjian, have entered into a binding Release and Settlement Agreement with Timothy and Thomas LLC (T&T) and its principals. The Agreement received the approval of the Court, ending the lawsuit that had started in March 2006 and which was before the United States District Court for the Northern District of Illinois (Case No. 06 C 1813). The Court dismissed all claims without admission of liability by any party. Viral Genetics has also paid or settled all legal fees incurred as a result of this litigation during the last several years. Read more...

Aircraft Medical wins litigation against Verathon

Aircraft Medical Ltd of Edinburgh, Scotland, has been told that judgment has been passed in its favour in the long running patent infringement litigation between it and US rival Verathon Medical Inc, a subsidiary of Roper Industries Inc.

The case was heard in the UK at the Scottish Court of Session, where Verathon unsuccessfully claimed that the McGrath(R) Series 5 video laryngoscope infringed its UK EP '131 patent, the "Glidescope" patent. In a comprehensive judgment, Lord Hodge ruled that Verathon's patent does not prevent UK-based Aircraft's production activities and global exports of the McGrath(R) Series 5. Read more...

EU SUPPLEMENTARY PROTECTION CERTIFICATES (SPCs) - The most important of pharmaceutical patent expiry

Over 13 years ago, on 2nd January 1993, the EC regulation came into effect, six months after it was published in the Official Journal of the European Communities entitled, "..the creation of a supplementary certificate for medicinal products." (EC Council Regulation No. 1768/92)

The need was perceived to create "fair" legislation to allow a "reasonable" period of marketing exclusivity and this is the culmination of years of debate between the pharmaceutical industry and the governments of the EC member states. Read more...

Global Generic Medicines Summit

This year Health Network Communications ran its first conference on this subject. It was held at the Kensington Hilton, London and spanned two days.

This was a well attended conference where around 70 delegates listened to and watched some very well presented papers by some well known speakers.

This was a truly international event with speakers and delegates from all over the world reporting on various aspects relating to their countries generic activity. Read more...

Pharmaceutical Patent Term Extensions

All those concerned with the manufacture and sale of generic pharmaceuticals know that one of the most important pieces of information is the knowledge of when the targeted product will be free of its exclusivity…when will the patent expire.

Until not very long ago all that the generic producer had to know was the patent expiry. However, over the past decade or so we have seen the creation of the Pharmaceutical Patent Term Extension. In the USA, it has emerged under the Waxman-Hatch legislation; in Europe, in the form of EU Supplementary Protection Certificate (SPC). Subsequently, many countries throughout the world are following one of these forms to extend cover on their pharmaceutical products. Although this does not apply to all marketed products, most new products will qualify for these extensions. Read more...

Pharmaceutical Patent Intelligence

This subject is a vital aspect of any pharmaceutical company’s knowledge contributing towards the development of marketing strategy. With the implementation of the EC Regulation covering the Supplementary Protection Certificate (SPC) on the 2nd January 1993 the perceived need to be aware has become paramount. As a marketing research consultancy we have been involved in the supply of patent intelligence since the mid 1970’s; MPA has become acutely aware of its significance over the years and believes it has evolved a comprehensive service to cope with all needs in this area. Read more...

French Generics Market

For sometime now French generics have been considered, by all concerned, as the market sector containing the most potential in all of the European Union (EU). France represents one of the highest per capita consumers of pharmaceuticals in the world. Its pharmaceutical market is also one of the world’s largest with estimated total spending valued in the region of € 30 billions in 2004. Read more...

UK Parallel Imports and Pharmacuetical Patents

One of the most important elements of UK parallel importation is the identification of suitable products. For this it is imperative to identify source of the product where the price is lower than in the United Kingdom. Read more...

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EC Regulation 469/2009 Article 20 EU Supplementary Protection Certificates | Pharmaceutical Patent Term Extensions
Pharmaceutical Patent Intelligence | French Generics Market | UK Parallel Imports and Pharmaceutical Patents
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