EPLAW Patent Blog

NL - Mylan v. Janssen Pharmaceuticals

Mylan B.V. v. Janssen Pharmaceuticals Inc., District Court The Hague, 11 December 2013, Case No. C/09143 1145 / HA ZA 12-1336

The District Court of the Hague invalidated Janssen’s tramadol-acetaminophen combination SPC on account of a lack of inventive step. The claims of the base patent required the presence of a combination between a tramadol compound and acetaminophen as sole active compounds, in a particular range of weight ratios. This was said to have a beneficial additive effect.

The Court held that a prior art document disclosed a combination between a tramadol compound and acetaminophen in the specified range of weight ratios, albeit in the presence of two more active ingredients. However, as the base patent did not disclose that the additive effect was due to a combination of only tramadol and acetaminophen, the court held that there was no reason to assume that the additive effect would not also occur when making use of the prior art combination. It therefore defined the objective technical problem as finding an alternative formulation of the one disclosed in the prior art.

UK - Eli Lilly v Janssen Alzheimer Immunotherapy

Eli Lilly v Janssen Alzheimer Immunotherapy, 25 June 2013, Patents Court, UK, Case No. HC11C03400

The UK High Court has held Janssen Alzheimer Immunotherapy’s patent relating to a pharmaceutical composition comprising an antibody for the treatment of Alzheimer’s Disease to be invalid.  The two principal issues before the Court were added matter and insufficiency. 

On added matter, the Court rejected the argument that, because claim 1 had been amended to a form that was not limited to antibodies which induced an immune response, matter had been added.  First, the Court held that the administration of the claimed antibody would in fact produce an immune response.  Second, even if the claim did cover antibodies that did not produce an immune response, it did not disclose such antibodes.  There was therefore no added matter.  The Court further held that the limitation in the granted claims to antibodies of the human IgG1 isotype was simply a restriction of the scope of the claim, not one that added matter.

However, the Court held the patent to be invalid on two grounds of insufficiency.  First of all, a Phase 3 trial had demonstrated that the patent was “classically insufficient”: despite much effort and expediture, the patentee has not succeeded in making an antibody that was suitable for the methods of treatment covered by the claims in issue.  The Court further held that it was not possible for a skilled addressee to perform the invention across the whole breadth of the claim without undue burden.  The patent did no more than invite the skilled team to perform a major research project.
Had the patent been valid, it would have been infringed by Eli Lilly’s product.

Read the judgment (in English) here.

Head note: Graham Burnett-Hall and Rajesh Sagar

NL - Janssen Pharmaceutica v. Pharmachemie and Mosadex

District Court The Hague, 22 December 2010, case- /docketno. 346123 / HA ZA 09-2871, Janssen Pharmaceutica N.V. v Pharmachemie B.V. and Mosadex C.V. (Interim judgment)

This case concerns the patent of Janssen for a pharmaceutical composition comprising a compound of a specified formula and a blood pressure reducing agent (claim 4 of the patent). Pharmachemie markets a product containing nebivolol. Nebivolol consists of l-nebivolol (or: RSSS) which is the specified compound, and d-nebivolol, which is the other compound (or: SRRR) and is specified in claim 6 (dependent on claim 4) of the patent.

ES - Janssen v. Teva - Galantamine / Interim Injunction Appeal

Janssen Pharmaceutica NV & Janssen-Cilag, S.A. v.Teva Genéricos Española, S.L., Court of Appeal (28th Section), Madrid, Spain, 16 November 2009, Docket No. 184/09

Section 28 of the Court of Appeal of Madrid has recently confirmed the first instance decision ordering Teva Genéricos Española (Teva) to temporarily refrain from commercializing in Spain generic drugs with the active compound galantamine for the treatment of Alzheimer and related diseases.

Janssen had brought legal actions against Teva for the infringement of the SPC no. C 20010009, which, expiring on 15 January 2012, had been granted over the basic patent EP 236684, validated in Spain as ES 2000428. Said patent (and accordingly its SPC) protects the use of the compound galantamine, or a pharmaceutically acceptable acid addition salt thereof -which is the active compound of Janssen's Reminyl® product- to prepare a medicinal product for the treatment of Alzheimer and related diseases.