|
Arrow points towards clarity: Arrow v Merck - Alendronate again…
England is a tremendously important forum for patent litigation relating to generic pharmaceuticals. Our courts are often willing to hear arguments relating to validity and infringement before a patent has come to the end of the EPO opposition period, and evidence and judgments are comprehensive. Sometimes, arguments are made here before being made in other countries, or to the exclusion of other countries. Parties may be influenced by an English decision and persuaded from litigating elsewhere, settling matters in other jurisdictions. Or, they may rehearse arguments here, refining them for other jurisdictions.
I have written about the strategic value to generic companies of the English courts, and how to maximise the effectiveness of proceedings. However, it is not always plain sailing, as is highlighted by the recent case concerning Arrow –v- Merck, and once a week alendronate (70mg) (TM “Fosamax”)[1].
Generic companies know that in England, they must clear obstacles out of the way. They cannot be assured of launching a product without risk of injunction if they have not sought clearance from the Patentee and/or the courts.
This recent case shows how difficult it can be to achieve clarity. If you are thinking this is not the first time that you have heard of litigation concerning Arrow, Merck and alendronate, you are right.
In 2003, the English Court of Appeal revoked Merck’s EP0998292 Patent (‘292), the key idea of which was to treat osteoporosis patients with 70mg alendronate 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.
There has also been a case concerning the right of the MHRA to grant marketing authorisations for alendronate 70mg, which I wrote about in an earlier issue of GenericsWeb’s INNsight.[2]
Having revoked Merck’s ’292 Patent, received a marketing authorisation, and penetrated the market for 70mg alendronate, Arrow now finds itself at risk of a future action for patent infringement, with potential damages going back to its launch of the product.
How?
Background.
Let me remind you of the background.
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[3].
As reported above, the EPO held the same patent invalid, for added matter, without considering other arguments. 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.
In fact, Merck has withdrawn the “GB” designation for the ‘904 Patent but the other divisional applications remain in place so, despite having been successful in earlier proceedings, Arrow (and other generic companies) now finds its alendronate business threatened. If any of the divisional applications survive in the UK, Arrow (and others) would face damages (based on Merck’s loss of profit) for its sales of 70mg Alendronate tablets going back to its launch of the product.
Its risk would be similar in any other country to which the divisional applications relate. Merck has apparently brought proceedings against Arrow in Italy and Sweden, and against other companies in Holland, Sweden, Italy and France.
Arrow’s application
Merck’s withdrawal of the “GB” designation for the ’904 Patent was made before Arrow’s claim to revoke the patent had been issued, but that was not apparent until some time later, and Arrow applied for:-
• A declaration that ’904 was invalid.
• An order that ’904 be revoked.
• A declaration that any other European patent for an alleged invention relating to osteoporosis medicaments for administration of 70mg Alendronate once a week would be invalid.
• A declaration that Merck was not entitled to rely on the ’ 904 patent or any other European patent granted pursuant to the divisional applications to prevent Arrow from selling 70mg once weekly Alendronate.
Judgment
In a judgment given on July 31st, Kitchin J, decided that he couldn’t revoke ’904, since it had already been withdrawn at the relevant date. He could consider the third and fourth applications, which amounted to a claim that it was obvious as of July 1997 to use Sodium Alendronate Trihydate to make a 70mg once a week tablet. In effect this was an application for a declaration by Arrow that its own product was obvious at the priority date of the divisional applications. If Arrow was able to obtain a declaration that its own alendronate product was obvious, that would give it security in relation to any claim by Merck for infringement of patents granted pursuant to the divisional application.
It should be noted that it was not open to Arrow to claim that Merck’s divisional applications were invalid, since the High Court does not have jurisdiction until patents have been granted. In the meantime, potential damages would continue to rise.
The Judge decided that it was a matter of discretion as to whether he could grant a declaration of this kind. He followed a direction of Pumfrey J, in which it was said that;
“The use of negative declarations should be scrutinised and their use rejected where it would serve no useful purpose, but where such a declaration would help ensure that the aims of justice were achieved, the court should not be reluctant to grant a negative declaration.”[4]
He held that whilst revocation proceedings could not be commenced until a patent has been granted, following S74 of the Patent Act, 1977, that Section did not exclude the right of a person to seek a declaration in relation to its own product. So, the Judge decided that he was not excluded from applying discretion and granting a declaration. Should he do so? Would declarations serve a useful purpose? He decided that they would.
Arrow had taken proceedings to clear the path, and succeeded and the EPO had reversed its position. Whilst the ‘904 Patent had been dropped in the UK, other divisional applications followed, and presented potential difficulties. There was a public interest in commercial certainty, and no reason against Arrow seeking a declaration because its own product was obvious at the priority date.
The application was allowed to continue.
And so, it is established that, where a Patentee holds over another a threat of patent infringement proceedings, based on divisional applications, the threatened party can to seek the determination of its rights. Certainty can be achieved, and generic marketing pursued, albeit at a cost of time and money.
In the UK, and elsewhere, a successful generic pharmaceutical market depends on generic companies such as Arrow being prepared to fight patentees. Of course, proactive companies open up the market for others, which must be galling, but without this, given the obligation to ‘clear obstacles’, the market could not exist.
If you would like to discuss this issue, or any other issue relating to pharma matters, call me.
Footnotes:
[1] Arrow v Merck [2007] EWHC 1900 (Pat)
[2] http://www.annamckay.com/article5.html
[3] Merck v Teva, Generics(UK) and Arrow [2003] EWCA Civ 1545
[4] Nokia Corporation v InterDigital Technology Corporation [20067] EWHC 802 (Pat)
Anna McKay
August 2007
anna@annamckay.com
+44 (0)20 8347 8734
To register for GenericsWeb's free monthly newsletter 'INNsight', click here |
Home
INNform