In a significant decision in Arrow v Merck the Court has held that a generic drug 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.
In 2003, the English Court of Appeal revoked Merck’s EP998292 Patent (‘292), which covers method to treat osteoporosis patients with 70mg alendronate sodium trihydrate over a week, rather than 10mg once a day, on grounds of obviousness and lack of novelty, and because it was, in substance, a method of treatment of the human body by therapy. In 2004 the Opposition Division of the EPO revoked the same patent, and in 2006 the Technical Board of Appeal dismissed an appeal, finding the patent invalid for added matter. The Board did not consider arguments of obviousness and lack of novelty.
Alendronate preparations were first sold in 1995, with a 10mg oral formulation being introduced in 1997. In 1998, (priority date 22 July 1997) Merck applied for a 70mg once a week formulation, that patent (’292) being revoked by Arrow Teva and Generics (UK) in 2003, for lack of novelty, lack of inventive step, and because it was a method of treatment of the human body by therapy. That decision was upheld by the Court of Appeal in November 2003.
Following revocation of the ‘292 Patent, Arrow and other generic companies sold the 70mg product throughout Europe, the markets have become generic, and the cost of a 4 x 70mg pack has fallen from around £15-£18 to around £1-£2, no doubt resulting in a very substantial loss of revenue to Merck. During the course of prosecution of the ’292 Patent, Merck filed four divisional applications. These applications were stayed during the ’292 Patent opposition proceedings, but revived on the conclusion of those proceedings.The Examining Division of the EPO has found one of these divisional applications to be inventive, and allowed it to proceed to grant, as EP1175904 (“’904”). Claim 1 of ’904 is a “Swiss claim” directed to the use of alendronate to make a medicament for the treatment of osteoporosis in the human, where the medicament is orally administered as a unit dosage comprising about 70mg of alendronate, according to a continuous schedule having a once weekly dosing interval. The key idea therefore appears to be essentially the same as that of the ’292 Patent, namely to give osteoporosis patients 70mg of alendronate once a week.The Examining Division has justified this change in position, on the basis of the declaration by a Dr. Goldberg of Merck, which apparently gives details of the statistically significant effect arising from administration of 70mg of alendronate once a week, rather than a once a day 10mg tablet.
As the judge noted, Arrow v Merck was an exceptional case. Arrow had cleared the path for its generic version of Merck’s Fosamax 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. 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 – 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. 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. (Source :Arrow v Merck [2007] EWHC 1900 (Pat), Anna McKay, Ralph Cox)
In 2003, the English Court of Appeal revoked Merck’s EP998292 Patent (‘292), which covers method to treat osteoporosis patients with 70mg alendronate sodium trihydrate over a week, rather than 10mg once a day, on grounds of obviousness and lack of novelty, and because it was, in substance, a method of treatment of the human body by therapy. In 2004 the Opposition Division of the EPO revoked the same patent, and in 2006 the Technical Board of Appeal dismissed an appeal, finding the patent invalid for added matter. The Board did not consider arguments of obviousness and lack of novelty.
Alendronate preparations were first sold in 1995, with a 10mg oral formulation being introduced in 1997. In 1998, (priority date 22 July 1997) Merck applied for a 70mg once a week formulation, that patent (’292) being revoked by Arrow Teva and Generics (UK) in 2003, for lack of novelty, lack of inventive step, and because it was a method of treatment of the human body by therapy. That decision was upheld by the Court of Appeal in November 2003.
Following revocation of the ‘292 Patent, Arrow and other generic companies sold the 70mg product throughout Europe, the markets have become generic, and the cost of a 4 x 70mg pack has fallen from around £15-£18 to around £1-£2, no doubt resulting in a very substantial loss of revenue to Merck. During the course of prosecution of the ’292 Patent, Merck filed four divisional applications. These applications were stayed during the ’292 Patent opposition proceedings, but revived on the conclusion of those proceedings.The Examining Division of the EPO has found one of these divisional applications to be inventive, and allowed it to proceed to grant, as EP1175904 (“’904”). Claim 1 of ’904 is a “Swiss claim” directed to the use of alendronate to make a medicament for the treatment of osteoporosis in the human, where the medicament is orally administered as a unit dosage comprising about 70mg of alendronate, according to a continuous schedule having a once weekly dosing interval. The key idea therefore appears to be essentially the same as that of the ’292 Patent, namely to give osteoporosis patients 70mg of alendronate once a week.The Examining Division has justified this change in position, on the basis of the declaration by a Dr. Goldberg of Merck, which apparently gives details of the statistically significant effect arising from administration of 70mg of alendronate once a week, rather than a once a day 10mg tablet.
As the judge noted, Arrow v Merck was an exceptional case. Arrow had cleared the path for its generic version of Merck’s Fosamax 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. 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 – 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. 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. (Source :Arrow v Merck [2007] EWHC 1900 (Pat), Anna McKay, Ralph Cox)
