Some recent life sciences IP case law...

Published on
5 min read

We have summarised some recent key case law that has happened in the past few months that directly affect the life sciences sector.

Patents

Shanks v Unilever – October 2019, UK Supreme Court. An outstanding contribution by an employed inventor.

Where an employee creates an invention, patent protection normally ends up in the hands of the person’s employer. The person is paid a salary for the work they do and the employer expects to own any resulting intellectual property. UK law offers employed inventors the opportunity to benefit financially if the invention proves to be of “outstanding benefit”.

Reversing a decision in the lower courts, the Supreme Court has set a new test for “outstanding benefit”. The size of the employer’s group as a whole was not relevant, and the benefit flowing from the employee’s inventive work far outstripped any investment put into the project by the employer.

Takeda v Roche - July 2019, UK High Court. Unclear claim boundaries.

It can be difficult to define the boundaries of your patent claims in a way that captures the invention but is able to withstand challenge.

Takeda disputed the validity of a Roche patent for glycosylated antibodies, in order to clear the way for launch of a competing monoclonal antibody product. The claims required glycosylation at a particular amino acid residue, with a sugar chain composed of at least 99% fucose. The level of fucose in sugar chains affects the usefulness of therapeutic antibodies in treating different conditions.

The patent was invalid both because of disclosures made before the priority date and because it was impossible to work out whether a product fell within the claims. There were several different ways to calculate the percentage of fucose in the chain, and each of them could give different results. Depending on which method was used, you might find that a product was inside or outside the claims. That meant the claims were ambiguous and could not be valid.

Illumina v TDL - June 2019, UK High Court. Broad claims justified by a correspondingly broad technical contribution.

Although broad claims put a patent at greater risk of invalidation, the courts are more willing to allow them when a widely applicable technical principle is provided in support.

Illumina’s patent included product-by-process claims involving isolation of foetal DNA using size separation. The technology permitted non-invasive prenatal diagnostic testing through use of size separation of DNA fragments found in the blood of the pregnant mother.

Earlier publications did not disclose the patented invention. The general principle of enriching foetal DNA by size separation was an important technical contribution and justified broad patent claims.

Actavis v ICOS - March 2019, UK Supreme Court. Dosage regimes flowing from normal clinical research.

Dosage regime patents can offer valuable additional protection for a successful product. However, this case casts a shadow over their validity. The patent claimed a lower dose of an erectile dysfunction drug that avoided side effects while remaining effective. The UK Supreme Court concluded that the patent was invalid for lack of inventive step. The normal course of clinical research, with standard dose ranging studies, would have led to the new, lower dosage regime. This means that greater attention should be given to identifying unexpected and striking features to minimise the risk of invalidity for patented dosage regimes.

Trade marks and branding

Glaxo Sandoz - October 2019, UK High Court. The dangers of a signature look for a product line.

This case relates to purple-themed packaging for combination salmeterol and fluticasone inhalers, and raises interesting issues as to the benefits and dangers of developing a signature look for a medicinal product. You can see more detail in our separate article “Signature coloured packaging for medicinal products – valuable or dangerous?”.

Viridis Pharmaceutical v EUIPO July 2019, EU General Court. At what stage in the clinical development process should you apply for trade mark protection?

Trade mark registrations cannot be maintained indefinitely in a dormant state. This is unfair to others who might want to make use of similar branding. A period of five years may be permitted, but after that, a trade mark owner is normally expected to put the brand to active use in the market.

In this case, a long period of relative inactivity led to the trade mark’s demise. Although the trade mark owner had carried out some clinical trials, this was not use on the market. Indeed, a marketing authorisation had yet to be granted. Delays in obtaining regulatory approval did not amount to an adequate reason either. The trade mark owner had simply applied too early in the process for protection.

Litigation and damages

Bayer v Gedeon Richter September 2019, EU Court of Justice. What does “appropriate compensation” mean in the context of provisional injunctions?

Enforcement of intellectual property rights is harmonised to some degree at EU level. A CJEU decision on the interpretation of the Enforcement Directive helps to show how the European courts will approach national procedures in order to promote a harmonised approach. The case related to a Hungarian dispute over a Bayer patent. The patent was found to be invalid, but only after provisional measures preventing Gedeon Richter from selling its product had been granted. Gedeon Richter sought compensation for losses they had been caused by the provisional measures, relying on the Enforcement Directive. The CJEU was not willing to interfere with Hungarian rules that required the injuncted party to mitigate its losses – EU level harmonisation did not go that far.

Pfizer v Roche June 2019, UK High Court. Arrow declarations to remove uncertain patent risk.

The development of a biosimilar product normally carries substantial patent infringement risks, and innovator companies sometimes engage in tactical patent prosecution to maintain a monopoly position for as long as possible. The UK courts have shown themselves willing to control this by use of Arrow declarations. These offer the biosimilar producer a clear route to market through a declaration that their product cannot infringe any patent that results from as yet ungranted applications.

In a recent case, however, the court did not grant an Arrow declaration because no UK applications remained on file.

Advertising

R v ASA (Actegy) September 2019, UK High Court. Claims about product efficacy in advertising need to be supported by adequate evidence.

The advertising of medicines and medical devices is strictly controlled in order to protect the public. A medical device producer advertised its product in newspapers, making claims about the benefits that could be achieved. Following complaints, the Advertising Standards Authority concluded that the newspaper adverts were misleading. The ASA’s requirements went beyond what was required to achieve CE-marking under medical devices regulation. However, the court supported the ASA’s decision. The ASA had not been disproportionate in requiring substantiating evidence to support the claims made for the device in the advert.

The above are summaries only of some key recent decisions. Please contact us for more details or specific advice.

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