INNsight articles by Ralph Cox

In a potentially significant decision in Arrow v Merck[1] the High Court has held that a generic drugs company could request a declaration that its product was obvious at the priority date of a patent application.  If so, were the patent granted from that application to cover the product it would be invalid.  The decision therefore opens up the possibility of generic companies (and any other would-be infringer) being able to clear a product’s path to market without having to wait for a patent to grant in order to bring invalidity or non-infringement proceedings.

As the judge noted, Arrow v Merck was an exceptional case.  Arrow had cleared the path for its generic version of Merck’s Fosamax[2] by successfully applying to the court for revocation of Merck’s relevant European patent (UK) in 2003.  The European Patent Office (EPO) also revoked the patent in opposition proceedings.  Arrow then proceeded to build up substantial sales in the EU for its drug only for Merck to be granted a second European patent earlier this year, based on the same application as the revoked one, with several more patents that might follow and all of which Arrow potentially infringed as they contained similar claims to the revoked patent[3].  Further Merck clearly intended to enforce its rights and refused to give undertakings not to sue Arrow and to withdraw the UK designations of the applications.

The court evidently sympathised with Arrow’s position.  While it could not give the declarations that Arrow actually sought – as they involved the validity of non-UK designations of Merck’s patent and applications over which the High Court had no jurisdiction[4]  – the judge decided that the court could rule on whether Arrow’s alendronate (formulated as a sodium salt in a weekly dosage form) was obvious as at the priority date of the patent and applications.  If obvious, then any patent that covered the product would be obvious too and so invalid.  This approach neatly avoided the limited circumstances in which declarations of invalidity of patents can by brought under the Patents Act 1977 and which Merck argued formed a complete bar to the relief sought by Arrow.  But more significant is the court’s view that businesses need commercial certainty in patent matters, as in any other, and that the court should assist in providing it where it properly could.  In particular Merck’s applications could take a further year or more to be granted as patents during which time Arrow would be accumulating substantial potential liability if it infringed them[5]. Merck could have avoided this effect on Arrow by giving the undertakings but it did not so there was a valid and valuable commercial purpose to the declaration for Arrow.

This decision gives a potentially attractive additional tool to declarations of invalidity and non-infringement of patents for those wanting to establish whether or not they infringe a patent and, if there is a risk they do, to clear the path for bringing their product to market.  Particularly useful is that, as the declaration on a product can be sought as soon as a patent application is published rather than having to wait for grant, a favourable declaration allows considerably earlier entry on to the market.  The decision will therefore be of obvious interest to generics drugs companies though, as it is not being appealed, it needs to be seen whether judges in other cases will follow it, or decide it is restricted to its facts or to exceptional circumstances only, before its full potential can be assessed.   

Ralph Cox is a partner in the Intellectual Property group of London law firm Fasken Martineau Stringer Saul LLP specialising in patent and other IPR litigation.

Note from GenericsWeb: Click here to read an article by Anna McKay on the same case, click here to search our archives.

[1]  Arrow Generics Ltd v Merck & Co, Inc (unreported; [2007] EWHC 1900)
[2]  Alendronate - used in the treatment of bone wasting diseases including osteoporosis
[3]  The new patent and applications were divisionals of the original patent and all concerned a weekly as opposed to daily dosage formulation
[4]  Merck had also withdrawn the UK designation of its second patent just before its grant
[5] Patent applications as published by a patent office can be infringed but no action can be brought until the patent itself is granted (and the patent has to be infringed as well)