Mundipharma and Sandoz: The undisclosed disclaimer
On April 7, 2010, the Dutch Court of The Hague gave a provisional judgment in the patent case between Mundipharma and Sandoz in which it made some interesting considerations about the ‘undisclosed disclaimer’: when a disclaimer must be seen as ‘undisclosed’ and whether there is an undisclosed disclaimer in this instance.
The conflict regards a Mundipharma painkiller containing a controlled release formulation, for which it owns the Dutch part of European Patent 0722730 (EP 730). The original application is international patent WO 93/10765 (WO 765). In its counterclaim, Sandoz states that the disclaimer in EP 730 is undisclosed in WO 765 and considers EP 370 invalid.
EP 730 concerns a formulation for a regulated release of oxycodon or an oxycodon salt, which is established by the use of a controlled release matrix. In an opposition against EP 370, the patent was altered but maintained. This decision was appealed by Mundipharma and the opposing party, Sandoz.
The decision on appeal was suspended, awaiting the decision on Mundipharma’s auxiliary requests. Mundipharma put the painkiller on the market under the name OxyContin. Sandoz was granted three permits by the Medicines Evaluation Board to sell a generic formulation for controlled release of oxycodon hydrochloride in dosages of 5, 10 and 20 milligrams.
"The court considered whether the disclaimer changed the technical teaching of the patent, but foud that it did not. It considered that the disclaimer had a solely legal implication."
Sandoz used the shortened registration procedure for generic products and pointed to OxyContin as the referential preparation, stating that its formulation is bioequivalent to OxyContin. Mundipharma analysed the Sandoz products and found out that they contain a matrix with particles of oxycodon hydrochloride, that the in vitro release pattern of the Sandox products matches the release profile in EP 730 and that they have a pH-independent release pattern as meant in EP 730.
Mundipharma states that Sandoz has infringed its patent, since the products fall under its scope of protection. In a counterclaim, under the condition that the pending opposition does not revoke the conclusions of EP 730, Sandox claimed the nullity of EP 730 based on inter alia added material regarding an undisclosed disclaimer.
Sandoz stated that the added material is covered by the disclaimer “other than an acrylic resin matrix”, which was not disclaimed in WO 765 and does not meet the requirements for undisclosed disclaimers set out in the decision of the Grand Chamber of Appeal (G1/03). This would be in conflict with the requirements following from G1/03; therefore, conclusion 1 of EP 730 should be invalid.
According to the court, G1/03 only concerns the permissibility of disclaimers that are not disclosed in the original application. ‘Undisclosed disclaimers’ means that only those that are neither positively nor negatively disclosed in the original application.
In this case, the court considered that the disclaimer contained material that was not literally found in WO 765, but deductible from it by the average skilled person. Therefore, the court considered that the disclaimer was not ‘undisclosed’ as meant in G1/03. Sandoz also states that the disclaimer has a technical meaning.
The court therefore considered whether the disclaimer changed the technical teaching of the patent, but found that it did not. It considered that the disclaimer had a solely legal implication. It prevents double patenting in relation to WO 765, which had already led to EP 643 from which EP 730 is a divisional.
The disclaimer covers a limited group of substances for a controlled release matrix, so it only alters the scope of protection of the patent, but not its technical teaching. Sandoz’s other nullity claims—scope for further development, lack of inventive step and novelty—were also denied by the court.
The court considered conclusion 1 of EP 370 to be valid and therefore that the 10 and 20 mg formulations of Sandoz infringed the patent. The 5 mg dosage did not infringe the patent since it is out of the range mentioned in conclusion 1 of EP 370. The court also suspended the decision in the principal action until a decision is made in the pending opposition and awarded Mundipharma a provisional injunction.
Michiel Rijsdijk is a partner at Arnold + Siedsma. He can be contacted at: mrijsdijk@arnold-siedsma.com
