The team is joined by Guest Kats Rosie Burbidge, Stephen Jones, Mathilde Pavis, and Eibhlin Vardy, and by InternKats Verónica Rodríguez Arguijo, Hayleigh Bosher, Tian Lu and Cecilia Sbrolli.

Monday, 21 November 2016

Rocket in the Patents Court: Napp Pharmaceutical v Dr Reddy's and Sandoz

The case of Napp Pharmaceutical Holdings Limited v (1) Dr Reddy's Laboratories (UK) Limited (2) Sandoz Limited [2016] EWCA Civ 1053 is a welcome reminder that the English Patents Court and Court of Appeal can, when required, deliver swift justice in a way that would be the envy of many IP Courts the world over.  Although practice guidance states that the Patents Court endeavours to bring patent cases on for trial where possible within 12 months of the claim being issued, the appeal stage alone can take 18 months + given the current backlog of cases.  Not so here, where the parties obtained an appellate decision in under six months from the issue of proceedings. [Are the lawyers still alive, wonders Merpel?]

The case was previously reported on the IPKat here (first instance) and here (interim application). The Court of Appeal's judgment has now been handed down and forms the basis of this post.

Expedited timetable

The claim in the present case was commenced on 19 Feb 2016, alongside an interim injunction application. On 16 March 2016, Arnold J ordered an expedited trial which was fixed to commence on 7 June 2016 - less than three months away.  Both defendants undertook not to launch their product pending determination of the claim.  Following the three day trial and judgment, where Dr Reddy's and Sandoz were held not to threaten to infringe, Arnold J continued interim relief against both respondents until 16 August 2016.  The appeal was heard during the vacation period on 2 August 2016. 

A snoozy IPKitten recovering from an expedited trial and appeal
Brief recap and issues on appeal

The case concerns EP 2 305 194 in respect of buprenorphine, formulated as a transdermal patch for use in the treatment of chronic pain.  Napp contended that both Dr Reddy's and Sandoz threatened to infringe the patent by marketing their own transdermal patches.
The appeal concerned the construction of claim 1 which reads as follows:

"A buprenorphine transdermal delivery device comprising a polymer matrix layer containing buprenorphine or a pharmaceutically acceptable salt thereof, for use in treating pain in humans for a dosing interval of at least 7 days, wherein the transdermal delivery device comprises 10%-wt buprenorphine base, 10 to 15%-wt levulinic acid, about 10 %-wt oleyloleate, 55 to 70%-wt polyacrylate, and 0 to 10%-wt polyvinylpyrrolidone."

The details of Dr Reddy's and Sandoz's formulations are confidential, but the judge's findings at first instance were sufficient to dispose of the issue of threatened infringement. 

1. Inputs vs outputs

The first issue was whether the quantities specified for the transdermal delivery device in claim 1 refer to 'input' amounts in the formulation (i.e. they are ingredients in a recipe), or to 'output' amounts in the finished device.  At first instance, Arnold J concluded that the claim was referring to the finished product. 

Napp advanced seven reasons on appeal as to why the claim referred to input amounts, but none impressed the Court of Appeal.  Floyd LJ noted that the starting point had to be the language of the claim, which requires a transdermal delivery device comprising a defined active pharmaceutical ingredient in a specific percentage and excipients also in a defined percentage.  It is a product claim, not a method claim. "The normal approach to such a claim would be to determine what the device contained, not to determine the percentages used in some earlier stage of the manufacturing process"...."It is therefore the proportions of the product in the finished product which are important".  

2. Numerical features of claim

The second issue was the correct interpretation of the numerical features of the claim, and in particular, what is meant by "10%-wt buprenorphine base", "10-15%-wt levulinic acid" and "about 10%-wt oleyloleate".  At first instance, Arnold J considered that buprenorphine and levulinic acid were expressed to the nearest whole number (and therefore covered 9.5-10.5%-wt for buprenorphine, and 9.5-15.5%-wt for levulinic acid).  As to "about 10%-wt oleyloleate", Arnold J held that this allowed a margin of error of 1% around the figure of 10%-wt, because the word "about" would be understood to give a small degree of imprecision over and above that permitted by normal rounding. 

The Court of Appeal reiterated the approach to construction of numerical features and ranges in patent claims as set out in paragraph 38 of Smith & Nephew plc v ConvaTec Technologies Inc [2015] EWCA Civ 607. Napp submitted that the patentee had chosen to express himself to the nearest 5% for at least buprenorphine and levulinic acid in claim 1, and noted that the patent worked in increments of 5%.  The Court of Appeal recognised that the figures in the patent were indeed in multiples of 5%, but that did not tell one anything about the degree of precision to which these numbers are expressed.  If the patentee had wished to claim, for example, 7.5-12.5%-wt buprenorphine he could have done so by making express provision in the claim.  The figures were expressed to the nearest whole number. 

In relation to oleyloleate, the Court of Appeal noted that there were obvious difficulties with trying to prescribe the outer limits to an integer which uses the word "about", but declined to disagree with the judge's conclusion that the claim extends no further than 9-11%. 

7 comments:

Anonymous said...

" If the patentee had wished to claim, for example, 7.5-12.5%-wt buprenorphine he could have done so by making express provision in the claim."

Prior art?

Anonymous said...

Certainty that high-relevant art cited during examination to produce over-narrow claims so? Reddy and Sandoz legal team asleep to opportunity for squeeze argument and risk taken not challenging validity, so lucky Judge decided in their favor.

Anonymous said...

Nappamatics.

1 + 1 = 2
2 + 2 = 5
3 + 3 = about 10
4 + 4 = the number napp are thinking of minus the number they first thought of.

Eibhlin Vardy said...

Thank you for these comments. There was no challenge to the validity of the Patent in these proceedings, save for an allegation of insufficiency advanced by Dr Reddy's by way of a squeeze on construction. On appeal, Dr Reddy's contended in its respondent's notice that if the patent was construed in the manner contended for by Napp then claim 1 would be insufficient because it does not enable the reader to determine where the boundaries of the claim lie. The Court did not consider this respondent's notice because of the Court's findings on infringement.

Anonymous said...

Eibhlin, Thank You. A rapid decision no doubt for readily-determined outcome? Odd I think we know the make-up of the napp product and not Reddys?

Eibhlin Vardy said...

I think we know a bit about the generic products i.e. (a) the broader ranges that they would have fallen within; and (b) the narrower ranges which fell outside.

Anonymous said...

Jeez, what a dog of a patent, dog of a case. These drug companies certainly take the biscuit for stringing along the judges more and more. Seriously, how can counsel file a claim with such an embarrassing patent!!! I don't know what the other anonymous commentators are on to miss the elephants in the room in this trial, but it sure ain't tylenol. The minnow must have been feeding everyone some of those happy patches. But hell, whatever they are fed sure ain't what they become, not if those arguments merited anything other than a swift kick out of the courthouse. Percentages amount to what goes in? Product claim? Client should have told counsel to take those suggestions and stick them wherever Hilary Clinton's e-mails have taken their vacation.

Only in Britain! I'm sticking with Alice.

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