Circadin patent extended in Israel despite opposition

Neurim's conduct was found, on the facts,
not to be a "baa" to patent extension

"Unipharm Challenges Validity of Patent Term Extension for Neurim’s Circadin in Israel" is the title of this blogpost by Israeli patent attorney Michael Factor on his eponymous blog The IP Factor ("Opinionated Intellectual Property News Blog with an Israel Slant").

To cut a long story short (the full tale is there for all to read on Michael's weblog), Unipharm opposed the patent term extension of Neurim's Circadin patent and Commissioner King was required to consider three issues:

• Whether an extension could lawfully be granted on account of Neurim's inequitable behaviour 
• Whether the patent in question was to be considered the “basic patent” under Section 64a of Israel's Patent Law 
• Whether Circadin was the first drug containing the active ingredient as required by 64d of the Israel Law

The Commissioner rejected the opposition and extended the patent till 22 April 2017.  A large part of the IP Factor report deals with inequitable conduct, in particular the allegation that, in its ex parte application for patent extension, the company had behaved improperly and withheld or suppressed relevant information.  The Commissioner confirmed that an applicant was required to behave in an equitable manner, but did not consider that any breach by Neurim of that requirement was sufficient to prevent the extension.

Circadin appeal now published in the RPC

Back in May The SPC Blog reported briefly that Mr Justice Arnold (Patents Court, England and Wales) dismissed an appeal against the Intellectual Property Office's refusal to grant a supplementary protection certificate for Circadin.

The judge's decision has now been reported in full, together with a helpful headnote, in volume 127, issue 9, of the Reports of Patent, Design and Trade Mark Cases (RPC), published by Oxford University Press on behalf of the Intellectual Property Office.

High Court upholds IPO's decision on Circadin

In December 2009, we reported that the Intellectual Property Office refused an SPC application for Circadin on the grounds that the application did not comply with Article 3(d) of the SPC Regulation.

The High Court has upheld the IPO's decision. Following a review of the provisions of Regulation 469/2009 and case law of the Court of Justice (Pharmacia, MIT and Yissum), Arnold J. held that "Yissum is fatal to Neurim's case on this appeal". He also considered that the interpretation of Article 3(d) is acte claire.

You can read the decision here.

IPO refuses SPC for Circadin

In the recent UK Intellectual Property Office decision of Neurim Pharmaceuticals (1991) Ltd's application, BL O/384/09, hearing officer Dr C Davies rejected an application to an SPC because it did not comply with Article 3(d) of Regulation (EC) 469/2009.

The facts of the case are as follows: Neurim Pharmaceuticals filed an application for the product melatonin (Ciracadin) based on EP 0518468 (concerning the use of melatonin to correct a distortion or deficiency in the plasma melatonin profile of a human subject) and authorisation EU/1/07/392/001 as the first authorisation to place the product on the market.

The examiner observed that the cited marketing authorisation was not the first authorisation to place melatonin on the market as a medicinal product because there was an earlier authorisation to another company for a composition comprising melatonin for use in sheep to initiate an early breeding season.

The applicants disagreed arguing that the Regulation should be interpreted teleologically and on such an interpretation the SPC should be granted and that the application does meet the requirements of Article 3(d).

The hearing officer held that, although the applicant was correct in arguing that the SPC Regulation had to be given a teleological interpretation, the case could not be distinguished from the ECJ decision in Pharmacia and the case law was clear that the intended use of the medicinal product could not be taken into account when considering the relevance of an earlier marketing authorisation.