Answers - Legal

In the case of Les Laboratoires Servier and Another v KRKA Polska SP.ZO.O. and Another [2006], the claimants made an application for an interim injunction to prevent the marketing and distribution of a drug which they claimed infringed their patent. The claimant c

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

ompanies were in the business of manufacturing and researching pharmaceutical products. The first claimant was the second largest French pharmaceutical company worldwide, and the second claimant was a wholly owned subsidiary that marketed and researched such produc

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

s within the UK.

The defendants were members of a group of companies involved in the sale and distribution of a large number of generic pharmaceutical products worldwide.

The claimants' most successful product from a sales standpoint was an angiotensin converting

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

enzyme inhibitor drug by the name of Coversyl. That drug contained the active ingredient perindopril erbumine (“Perindopril”) in the alpha crystalline form. The claimants had registered patent EP (UK) 1 296 947, which related to the alpha crystalline form of Perin

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

opril and the method of its preparation. That patent had been unsuccessfully objected to by the defendants. The appeal by the defendants in relation to that decision was still pending.

The claimants discovered that the defendants had obtained marketing authorisati

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

n for a generic Perindopril in the United Kingdom. That authorisation had been granted via a neutral recognition procedure, the reference state being Hungary, where the claimants had previously successfully prevented the defendants from marketing a generic alpha cr

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

ystalline product.

Correspondence thus ensued between the parties, by which the claimants requested product descriptions and samples to be sent for independent analysis. Pending the outcome of the main action, the claimants issued proceedings and sought an interim

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

injunction preventing the defendants from importing, offering to dispose of or disposing of within the United Kingdom, a generic pharmaceutical product containing, as its active ingredient, Perindopril in the alpha crystalline form.

The claimants had previously ob

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

tained such an injunction against another generic pharmaceutical manufacturer, and a further manufacturer had undertaken not to market such products until the determination of the main action. However, the defendants resisted that application, and sought summary ju

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

gment against the claimants on the basis that they had shown no reasonable prospect of succeeding due to the patent being invalid.

The claimant submitted that there was indeed a serious issue to be tried. In relation to the balance of convenience, it was submitted

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

that if the defendants were allowed to market their generic product prior to the outcome at trial, the National Health Service (“NHS”) pricing policies relating to the prescriptions of generic pharmaceuticals would have caused irreparable continuing losses in respe

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

ct of revenues and market share.

In addition, the claimants maintained that the patent was valid, and therefore the defendants had failed to demonstrate that the claimants' action had shown no real prospect of success. The defendants submitted that the patent had

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

een invalid on the following two grounds:

Lack of novelty and obviousness on the basis that a previous patent, EP 0 308 341 (patent 341), described the manufacturing process for the alpha crystalline variant; and

The claimants had caused prior sales

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

of the alpha crystalline variant before the priority date, and, that prior sale would have enabled a skilled person to discover the manufacturing process of the alpha crystalline compound.

Three main issues fell to be decided before the court, namely:

Whe

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

her there was a serious issue to be tried;

If so, whether the defendants had demonstrated that the case advanced by the claimants held no real prospect of success; and

If not, whether the balance of convenience lay in favour of granting the injuncti

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

n.

The court held that in this case, the issue of the validity of the alpha crystalline patent was undoubtedly a serious issue, and was one that fell to be determined at the trial of the main action. The defendants had strong arguments with which to question

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

the validity of the patent on both grounds of challenge. However, the basis of the challenge on the ground of lack of novelty concerned the construction of a particular section of the methodology contained within patent 341.

Furthermore, whilst the defendants had

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

shown that there had been a prior sale of the alpha crystalline variant, the evidence supporting the proposition that that sale would enable a skilled person to discover the manufacturing process had been based upon a number of assumptions. Although these assumptio

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

ns were compelling, the evidence provided by the defendants had not demonstrated that the claimants' case had no real prospect of success.

The court therefore decided that in those circumstances, the irreparable, continuing, and unquantifiable losses that would ha

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

e been suffered by the claimants (had the defendants been allowed to market their generic product pending the outcome of the trial) resulted in the balance of convenience falling in favour of the claimants. Therefore, the injunction that was sought would be granted

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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