CASE COMMENT – MEDIMMUNE v NOVARTIS

In a mammoth judgment (71,000 words over 161 pages), Arnold J has dismissed Medimmune’s claim that Novartis’ Lucentis product (generic name ranibizumab), for treatment of wet age-related macular degeneration, infringed two of Medimmune’s patents.  The patents were also held to be invalid.  The judgment is of such length and complexity that we shall not attempt to summarise it, nor to consider all the issues raised (many of which are highly fact-specific).  Instead, we shall discuss only those issues raised which are of general importance and significance in patent law. read more…

Published in Bio-Science Law Review Vol. 12, Issue 1 (December 2011).

SINGLE ENANTIOMER CLAIMS ARE ONLY INFRINGED BY A SINGLE ENANTIOMER

The Patents Court has ruled that a claim to the use of a single enantiomer of an active substance to manufacture a medicament (i.e. a claim in the Swiss form) is not infringed by the importation into the UK of a medicament containing a mixture of the two enantiomers. This was held to be so even though the manufacturing process was admitted to use the single enantiomer as a raw material. The judgment provides an excellent illustration of the purposive approach to patent construction adopted by the English courts.  read more…

Published in Journal of Intellectual Property Law & Practice, Vol. 6: 843-845 (October 2011).

“MANUFACTURE OR REPAIR?” REVISITED

The Court of Appeal for England and Wales has overturned Floyd J’s judgment in Schütz v Werit. While it is still the case that there is no free-standing right to repair in patent law, it is no longer correct to ask in patent infringement whether, when the part in question is removed, what is left embodies the whole of the inventive concept of the claim. Instead, the correct approach is simply to ask whether the defendant has made a product falling within the scope of the patent claims. read more

Published in Journal of Intellectual Property Law & Practice, Vol. 6: 515-516 (May 2011).

HARGREAVES REPORT: IT’S A JUNGLE OUT THERE

A government-commissioned report on the UK’s intellectual property framework has just been published. The report makes sensible and sometimes radical recommendations, but whether the government will agree to support them is not yet known. read more

Published in Solicitors Journal, May 2011.

PATENT INFRINGEMENT BY PROVISION OF A KIT OF PARTS

The Patents Court has suggested that dealing in the UK in a complete kit of parts intended to be assembled abroad is not an infringement of a UK product patent. read more

Published in Journal of Intellectual Property Law & Practice, Vol. 6: 285-286 (April 2011).

CAN YOU RECOVER MONEY WHEN THERE ARE NO LOST SALES AND NO PROFITS?

The Patents County Court has confirmed that damages calculated on the ‘user’ basis are available in trade mark infringement cases, and that damages are therefore available even where the defendant’s activities have not led to lost sales for the trade mark owner or profits for the defendant. read more

Published in Journal of Intellectual Property Law & Practice, Vol. 6: 216-217 (January 2011).

MANUFACTURE OR REPAIR?

The Patents Court of England and Wales has confirmed that there is no free-standing right to repair in patent law, and has provided useful guidance for assessing whether repairing or reconditioning a patented product amounts to patent infringement. read more

Published in Journal of Intellectual Property Law & Practice, Vol. 6: 9-10 (November 2010).

TRENDS IN ENGLISH PATENT LITIGATION: ARE PATENTS MORE LIKELY TO BE UPHELD AS VALID NOW THAN 5 YEARS AGO?

In 2008, the validity of more than 25 patents was considered by the Patents County Court, Patents Court, Court of Appeal and House of Lords. Unsurprisingly, given such activity, the law is constantly evolving and being refined; in the past 5 years, an unprecedented six patent cases have been considered by the House of Lords, four of which were concerned with validity. This article considers whether recent case law developments have led to the courts becoming more ‘patentee friendly’, both by considering the case law itself and by an analysis of the outcome of patent cases over the past 5 years. read more

Published in Journal of Intellectual Property Law & Practice, Vol. 5: 158-162 (2010).

PATENTING ENANTIOMERS – THE HOUSE OF LORDS’ DECISION IN LUNDBECK v GENERICS

In an earlier article, the authors discussed the Court of Appeal’s decision in H Lundbeck a/s v Generics UK Ltd & others. Notwithstanding the presence of Lord Hoffmann in that Court, who gave the leading judgment, the House of Lords has now reconsidered the case and handed down its judgment at the end of February. read more

Published in Bio-Science Law Review, Vol. 10, Issue 3 (Nov 2009).

USING AFTER-THE-EVENT INSURANCE

Most British medium and large-sized businesses are sometimes faced with a claimant bringing a weak legal claim. With the increasing cost of litigation, this poses a dilemma. The business may be confident of successfully defending the claim, but recovery of legal costs following a successful outcome is usually limited to between 65 and 75 per cent. read more…

Published in Journal of Intellectual Property Law & Practice, Vol. 4: 19-22 (2009).

ON THE OTHER HAND: IS THIS THE LAST WORD ON PATENTING ENANTIOMERS?

The judgment of the Court of Appeal in H Lundbeck a/s v Generics UK Ltd and others may turn out to be the last word on the important issue of the patentability of individual enantiomers. This is perhaps more likely to be the case than it would usually be for a decision of the Court of Appeal… read more

Published in Bio-Science Law Review, Vol. 9, Issue 4 (2008).

GENERIC COMPETITION AND PHARMA PATENT STRATEGIES

In the earlier article, the authors explained that, following the Patents Court’s decision in Generics v Lundbeck, a patent claiming a single enantiomer of a known racemate will be of limited utility, as it will be invalid either on the grounds of obviousness (if the method of resolution of the enantiomer is obvious), or insufficiency, although the method of preparation of the single enantiomer may itself be patentable if it is non-obvious and sufficiently described. read more…

Published in Journal of Intellectual Property Law & Practice, Vol. 3: 799-800 (2008).

MANAGING GENERIC COMPETITION AND PATENT STRATEGIES

Research-based pharmaceutical companies are currently under considerable commercial and regulatory pressure. The increasing cost of developing new drugs and the growing number of drug candidates which fail during clinical trials mean that the new product pipelines of many pharmaceutical companies are shrinking. read more…

Published in Journal of Intellectual Property Law & Practice, Vol. 3: 226-235 (April 2008).

PATENTS AND ENANTIOMERS – GENERICS v LUNDBECK

Chemical patents are hard for many non-scientific IP professionals to understand. The recent decision of the High Court in Generics (UK) Limited & others v H. Lundbeck A/S confirms previous judgments that a single enantiomer of a known pharmaceutical compound is not patentable. Worry not, though, if the previous sentence is unintelligible. read more…

Published in Journal of Intellectual Property Law and Practice, Vol. 2: 808-811 (December 2007).

REACHING AGREEMENT: PART 2

In the first part of this article we considered the mechanisms that pharmaceutical companies use for entering into collaborative agreements with biotechnology/drug discovery companies to remedy the lack of candidates in their pipelines. Underlying any such arrangement must obviously be a means by which the large company (“LargeCo” in our examples) pays a fair price to the drug discovery company (“SmallCo” in our examples) for the rights that are assigned or licensed. read more…

Published in the July/August 2007 issue of Pharmaceutical Executive Europe.

REACHING AGREEMENT: PART 1

With the cost of developing new pharmaceutical compounds continuing to spiral, the number of new chemical entities (NCES) receiving approval failing to increase proportionately to R&D costs, and a growing number of biotechnology firms with promising new leads but without the resources to carry out clinical trials and bring products to market, pharma is increasingly entering into collaborative agreements with biotech and drug discovery companies. read more…

Published in the May/June 2007 issue of Pharmaceutical Executive Europe.

HOW TO SAVE MONEY IN ENGLISH IP LITIGATION

The English legal system is noted globally for excellence in IP litigation. In particular, the availability of specialist judges and the thoroughness of the procedure means that English judgments on IP matters are respected throughout the world. Unfortunately, despite these advantages, the cost of IP litigation in England has spiralled over the past few years, and controlling costs is arguably now the main issue confronting IP owners in England and Wales. In recent years, there has been a great deal of publicity. read more…

Published in the May 2007 issue of Managing Intellectual Property.

CLOSE BUT NO CIGAR… HAS SIR HUGH LADDIE’S MEDAL BEEN WON?

Current European trade mark law permits trade mark owners to divide the world into two blocks: European Economic Area (“EEA”) and non EEA. Article 7 of the Trade Marks Directive 89/104 provides that a registered trade mark “shall not entitle the proprietor to prohibit its use in relation to goods which have been put on the market in the Community under that trade mark by the proprietor or with his consent.” read more

Published in Trade Mark World (May 2007).

HARMONY OR FALLACY: AN INTERNATIONAL LITIGATION COMPARISON

Intellectual property laws and procedure around the world are becoming ever more harmonized. Nowhere is this more apparent than in the European Union where many could be forgiven for thinking that, particularly in the trade mark field, law and procedures are uniform across the continent. read more…

Published in the April 2007 issue of Trademark World.

OXALIPLATIN- A ‘BASIC’ PATENT PROBLEM

In an application for a declaration of non-infringement in respect of a patent claiming a method of preparation for a drug, a claim specifying that the pH is adjusted to be between 3.0 and 6.0 by adding an alkali solution required a distinct addition of alkali and was not infringed by use of a reagent that yielded a pH within the specified range without the need for separate addition of alkali. read more…

Published in Journal of Intellectual Property Law and Practice, Vol. 1: 692-693 (October 2006).

COURT OF APPEAL REFLECTS ON RANBAXY v WARNER-LAMBERT

In an earlier article the authors considered the decision of the Patents Court in Ranbaxy UK Ltd & Arrow Generics Ltd v Warner-Lambert Company (2006) FSR 14. The Court of Appeal has now upheld that decision ((2006) EWCA Civ 876), and in this article the authors seek to analyse its implications for research-based companies and generics manufacturers in the pharmaceuticals sector. read more…

Published in the September 2006 issue of Pharmaceutical Law Insight.

STEPPING UP – IVAX v CHUGAI ANALYSED

The decision of Kitchin J. in Ivax Pharmaceuticals v Chugai provides a useful indication of the English courts’ current approach to the issue of inventive step, giving an insight into the level of “hurdle” which must be overcome in order to justify a valid patent. read more

Published in Patent World (September 2006)

A PRACTICAL GUIDE TO INTERIM INJUNCTIONS

Fierce battles between branded and generic pharmaceutical companies have been played out in the English courts. Many generic pharmaceutical manufacturers have adopted a strategy of manufacturing and selling pharmaceutical products that are protected by a third party’s patent. read more…

Published in the July/August 2006 issue of Managing Intellectual Property.

CAN A REVOKED PATENT BE RESTORED BY CONSENT OF THE PARTIES?

Whilst the Court of Appeal will not “rubber stamp” a consent order which sets aside a decision at first instance such an order may, in certain circumstances, be obtained without the need for a full hearing before the Court of Appeal. read more…

Published in the June 2006 issue of Patent World.

PATENT CONSTRUCTION AFTER AMGEN

In the 18 months since the House of Lords gave its ruling on the parameters of patent infringement in Kirin-Amgen, the British courts have taken the opportunity to apply the approach laid down in that case with regard to patent infringements. read more…

Published in Journal of Intellectual Property Law & Practice, Vol. 1: 332-337 (April 2006).

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