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UNITARY PATENT

In 2012 Member States and the European Parliament agreed on the "patent package" - a legislative initiative consisting of two...

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Humira patent rights shot by "Fujifilm declaration"

By Dr. Janet Strath


In our Spring 2017 edition issues we wrote about "Arrow" declarations and how they are a defence against submarine divisional patent applications. An "Arrow" declaration is a court declaration that a certain that a certain product was known or obivous at a particular date - i.e that a party is free to make and sell its product notwithstanding a certain pending patent application, because any claims that might validly be granted would not be infringed. The remedy is named after the case of Arrow Generics v Merck, in which the High Court declared that a certain generic pharmaceutical was known or obvious at the priority date of certain divisional patent applications.

Now, in Fujifilm v Abbvie Biotechnology 1), Mr Justice Henry Carr has granted a similar declaration for particular dosage regimens for biosimilar adalimumab products that Fujifilm intend to launch in Europe. A twist in this case, however, is that there was np pending UK patent applicaton in existence. Abbvie had withdrawn the UK designation for their EU patent fpr the dosage regime (presumably to try to avoid UK jurisdiction and avoid any Arrow declaration).

Explaining that the circumstances relied on in the present case were not the same as those in Arrow Generics v Merck, and were not the same as originally pleased, Carr J went on to state that "describing these declarations as Arrow declarations is a potentially misleading shorthand, as the purpose of the declarations is different". The main purpose of an Arrow declaration was to provide a "Gilette defence" to allegations of infringement in the UK. However, in this particular case, Abbvie argued that it had "taken steps leading to the revocation of all patents which are or might have been in issue in these proceedings" and had "also given clear and unambiguous undertakings to the Court which are just as useful as the relief sought by the Claimants in the declarations." As a result, Abbvie contended, there was no need for a Gillette defence in the UK since there would never by any UK patent claism to the dosage regimens in question and, therefore, the declarations sought should not be granted because they did not serve a useful purpose.

However, Carr J found that the declarations would serve a useful purpose by:

- providing commercial certainty for FKB and SB/Biogen regarding the intended launch of their biosimilar adalimumab products;

- dispelling commercial uncertainty in the UK (and European) market, created by Abbvie's threats to enforce its patents against biosimilar competition anywhere in the world;

- providing clarity for third parties in the UK, which the judge considered to be necessary, given AbbVie's conduct to date, and was not provided by Abbvie's undertakings;

- protecting the FKB and SB/Biogen's supply chain for the UK market, and

- promoting settlement on a European or even a worldwide basis, in that it would change the parties' negotiating positions because AbbVie would need to take account of the fact that the court had declared that it could not prevent the marketing of FKB and SB/Biogen's products, in spite of AbbVie's public statements to the contrary, which had extended to Europe in general.

Also, Carr J noted that the "Fujifilm declaration" was based on the facts of the present case and therefore may not be appropriate for generalisation.

1 Fujifilm v Abbvie Biotechnology Ltd (2017) EWHO 395


For questions about this matter or related issues, please contact our paralegal Dr.Janet Strath (janet.strath@maucherjenkins.com)

 






Tuesday, August 15, 2017