Explicilty mentioning the effect won't help

The Decision Human papillomavirus vaccines/GLAXOSMITHKLINE T 1493/09 available here deals with a vaccine composition having various complicated names. No surprise so far.

The main request was rejected as being obvious over the art and the auxiliary request. The obviousness of the auxiliary request is discussed in points 20 - 22 as below (emphasis added):

Claim 1 of [the auxiliary request] differed from claim 1 of the main request in that it is directed to the second medical use of the vaccine composition, i.e. it is directed to a vaccine composition for use in the prevention or treatment of a disorder related to HPV infection, as opposed to the product as such. The appellant stated that this claim type set a higher bar with respect to evidence on the efficacy as a vaccine, in particular requiring evidence of effective protection in humans.

Claim 1 of auxiliary request 1 includes the therapeutic effect ("prevention or treatment of a disorder related to HPV infection") as an explicit feature, while claim 1 of the main request does not. In other words, claim 1 of auxiliary request 1 is directed to a “vaccine composition” characterised in that it comprises VLPs containing HPV-derived proteins which is capable of generating a protective immune response for each HPV L1 protein present in the VLPs in the composition. In the board’s view, the wording of claim 1 of the main request already implies that the claimed composition is an effective vaccine for the treatment of HPV-related disorders. In fact, this effect (the same as the one as explicitly recited in claim 1 of the auxiliary request) was already taken into account by the board when evaluating the inventive step of the subject-matter of claim 1 of the main request (see in particular points 4 to 10 above). Hence, the board considers that the assessment of inventive step for the subject-matter of claim 1 of the main request according to the problem and solution approach set out at point 2 to 19 above
applies to the subject-matter of claim 1 of the auxiliary request without any change in the reasoning.  

The subject-matter of claim 1 of auxiliary request 1 therefore lacks an inventive step for the same reasons as the subject-matter of claim 1 of the main request. The requirements of Article 56 EPC are not fulfilled.

In other words, mentioning the therapeutic effect makes life more complicated in that evidence for its existence may be required but did not help in this case.

Priority and indirect infringement of second medical use claims: when the Sun shines in the Netherlands

Last month, at the International Trademark Association (INTA) Meeting in Hong Kong, this blogger had the pleasure of an encounter with Jaap J.E. Bremer and his colleague Marleen van den Horst (both of the Dutch firm of BarentsKrans N.V.). There, in that undoubtedly trade mark-friendly environment, we discussed a case that Jaap and Marleen were involved in before the Provisions Judge of the District Court, The Hague, regarding indirect infringement of a second medical use patent and the validity of priority claims (among other things). The decision in this action has since been handed down and Marleen and Jaap have kindly treated PatLit readers to the tale of its outcome. As Jaap explains:

Zoledronate

"The case concerns Novartis’ patent EP 1 296 689 for a “Method of administering bisphosphonates”. It claims, inter alia, a dosage regime (2-10 mg once yearly) of the active substance zoledronic acid / zoledronate, administered intravenously for the treatment of osteoporosis. The Dutch litigation between Novartis and Sun Pharmaceuticals runs parallel to the case in England and Wales between Hospira & Generics UK (Mylan)/Novartis that was reported here on the IPKat weblog not too long ago. Marleen and I represented Sun.

Sun had obtained a marketing authorisation for generic zoledronate for the treatment of Paget’s disease and osteoporosis. The use of zoledronate for the treatment of Paget’s disease was not patent-protected. Sun had requested that the indication osteoporosis be removed ("carved out") from the Summary of Product Characteristics and patient leaflet of its product. In October 2013, Sun participated in a public tender by Dutch health insurance company VGZ, which it won. VGZ's tender conditions did not allow specification of the indication.

Novartis alleged that Sun's generic product (in)directly infringed EP 689. It started preliminary injunction proceedings against Sun, seeking an order (a) to stop it selling generic zoledronic acid to the extent that Sun knew or had reasonable grounds to suspect that its product would also be used to treat osteoporosis, and (b) to stop Sun participating in tenders, unless those tenders would allow designation of the product for Paget's disease only.

Sun disputed the allegations of (in)direct infringement and the orders requested by Novartis. In addition, Sun argued that EP 689 was invalid for lack of novelty over the Reid publication as Sun contested that Novartis was entitled to its priority claims. The PI judge of the District Court in The Hague held that the priority right was most likely invalid, since the priority document US 689 did not directly and unambiguously disclose the combination of intravenous use and the dosage range of "2 up to about 10 mg". The PI judge referred to the decision of the courts of England and Wales. The PI judge found that there was a serious, non-negligible chance that the patent would not survive invalidity proceedings on the merits (the validity test in Dutch preliminary injunction cases), rejected Novartis’ claims and ordered Novartis to pay Sun's costs The PI judge did not rule on the other grounds of invalidity, as presented by Sun, nor on the issue of (in)direct infringement".

Thanks to Marleen and Jaap, we also have an unofficial English translation of the Dutch decision of 12 May 2014. You can read it online here or download it here.