Innovative, international Intellectual Property experts
Potter Clarkson LLP is one of Europe’s top rated firms of patent and trade mark attorneys. We advise clients around the globe on intellectual property rights in biotechnology & pharmaceuticals, chemistry, engineering, computing and a wide range of related areas.
Our highly qualified attorneys have been working with companies in Sweden, Denmark and throughout Scandinavia for over 20 years, helping our clients to develop a strong patent and trade mark portfolio, and to defend their commercial interests against competitors. Having worked with over 60 companies, ranging from multi-national corporations to newly-formed spin outs, we have the experience and the enthusiasm to deliver the best possible advice, on time and at highly competitive rates.
“I have worked with Potter Clarkson for many years and they always deliver top quality work. They are very reliable, always deliver on time and are excellent team players. I look forward to continuing to work closely with them in the future.”
CEO at ImCred Patent AB
“Having worked with Potter Clarkson for over a decade with a variety of companies, I have valued their deep understanding of life science, and their friendly, resourceful and flexible approach, which always manages to solve our problems. I can certainly attest to their consistent interest and presence in Sweden.”
Prof. Carl A.K. Borrebaeck, Pro Vice-Chancellor,
Department of Immunotechnology, Lund University
“The difference between Potter Clarkson and some other patent firms is that they give you the advice that your business needs to hear; they don’t just tell you what you want to hear.”
Dr Ann-Christin Malmborg Hager,
CEO of SenzaGen AB
Current Trends and Hot Topics in IP
Diagnostic methods: Obtaining effective protection for diagnostic markers, particularly diagnostic signatures (i.e. biomarker combinations), presents various challenges, both in Europe and worldwide. Although methods of diagnosis of the human or animal body are excluded from patentability in Europe, careful drafting of claim language can be used to circumvent this relatively easily.
A more challenging aspect is obtaining sufficiently broad and flexible patent protection to be an effective deterrent to third parties. In practice, diagnostic signatures can be quite flexible. Typically, removal or addition of one or more markers from a signature is not significantly detrimental to their function. However, patent examiners generally require signatures to be limited to a single biomarker. Third parties are therefore free to use the disclosed signature, provided that it does not comprise that single marker.
What is more, recent decisions in the US exclude from patentability the use of ‘laws of nature’ including correlations between biomarkers and disease states, effectively prohibiting diagnostic uses or methods from patentability altogether. These decisions also exclude from patentability claims to diagnostic markers themselves where they are natural products, potentially limiting severely the options for protecting diagnostic inventions in the US. At Potter Clarkson we have experience in devising strategies for structuring how the invention is claimed and distinguished from other signatures in its field so as to maximise the opportunity of obtaining effective patent protection.
New medical uses: It is a principle of many patent systems that protection may be sought not only for a novel therapeutic agent but also for a new medical use of a known agent. At the European Patent Office (EPO), recent case law indicates that the definition of what constitutes a ‘new use’ is much broader than some had thought. Although it has long been accepted that a new use of a known agent can be based on the treatment or diagnosis of a disease or disorder to which that agent had not previously been applied, it was not clear whether a use could be ‘new’ for other reasons. In a recent case, the EPO was asked to consider whether a new use could be found in the treatment of a previously-treated disease using a new dosage regime. In confirming that it could, the EPO indicated that a new use can in fact be any use that is in some way different to that previously known, provided that such a use would not have been obvious.
This highlights the possibility of obtaining European patent protection for many different applications of known therapeutic agents, such as new dosages, routes of administration and combination therapies, and uses based on the treatment of specific patient groups, such as those suffering from specific sub-groups of a disease or having particular responses to previous treatments.
Medical devices: A major challenge in obtaining a strong suite of patents to protect a medical device derives from laws intended to prevent medical professionals being liable for patent infringement. In Europe, methods of treatment and surgery are unpatentable by law. Unlike other exclusions, such as those relating to software or business methods, it cannot be worked around if the heart of the invention can be described as something “technical”. If any part of the invention relates to a method of surgery or therapy, the EPO would grant no patent. This can be particularly challenging when looking to protect a new use for a known product.
In some circumstances there is a chink of light. New medical uses of pharmaceutical products are permitted patent protection in Europe and we at Potter Clarkson have been successful in applying this to certain medical devices. For example, in EPO Board of Appeal case T2003/08 we successfully argued that the ligand attached to a column for removing autoantibodies from a patient’s blood was a chemical product and therefore entitled to this “second medical use” protection.
While physical products are still likely to encounter objections in Europe, applicants should remember that in other parts of the world, legislatures tackle the problem in different ways. The USA, the world’s biggest healthcare market, permits patents to surgical and therapeutic methods but does not permit their assertion against clinicians. They can however be used to pursue manufacturers of the devices.
SPCs: Supplementary Protection Certificates (SPCs) provide up to 5½ years of additional protection, beyond patent expiry, for medicinal and plant protection products that require a marketing authorisation. The European SPC legislation, combined with numerous decisions from the Court of Justice of the EU (CJEU), national patent offices and national courts, has resulted in a complex and evolving area of patent law affecting all life science companies.
Recent CJEU decisions have increased the importance for innovators to coordinate their regulatory strategies with their IP portfolio management. For example, obtaining accelerated approval for a product under an “emergency” authorisation may impact upon the duration of any SPCs that might be available, or may even render the product ineligible for SPC protection. In other decisions, the classification of substances within marketing authorisations has had a varying impact upon the SPC eligibility.
In a key decision issued in 2012, the CJEU also opened the door to SPCs covering new uses, and potentially new formulations, of existing drugs. Prior to this, it was previously considered that only new active substances were eligible for SPC protection. It is important to be aware of the new opportunities that continue to arise for strengthening the protection available for pharmaceuticals and other medical products that require regulatory approval.