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EUROPEAN PHARMACEUTICALS


Te European Patent Office’s (EPO) approach to granting patents and how it goes about doing this have a large influence on the health of the pharmaceutical sector. Te competitiveness and worth of innovative pharmaceuticals are linked to the strength of


its patents. Bringing new


and potentially life-saving drugs to the public requires huge investment and there is constant pressure on companies to innovate and produce results in both a timely and a profitable manner. Patents are essential to the process and so the industry is always looking to patent offices to examine and grant patents in a consistent way while being supportive of its needs.


Special case


As is common with other inventions, pharmaceuticals have to be examined for their novelty, their inventiveness, their industrial applicability and they must be described in a way that is reproducible for a person who is skilled in the art. Otherwise, a patent cannot be granted. However, there are some provisions in the European Patent Convention (EPC) and its regulations that are specific to pharmaceutical inventions.


For example, Article 54 (4) and (5) of


the EPC provides for “purpose-limited product protection” and is only available for pharmaceutical


inventions. Te EPC article


provides that, if a known product has been found to be useful for treating a human or animal for a disease or condition, and that was not known at the time of filing, then the product can be claimed as such and defined by its use, making it novel. Tis principle has been in the EPC since its inception and acknowledges pharmaceuticals as a special case.


Pharmaceutical inventions have sometimes also received special recognition in EPO case law. In terms of the law on novelty for example, the boards of appeal have held that a medical use of a substance can still be regarded as novel, even if it was publically known that a drug was in a clinical trial for that same medical indication, provided that the results were not published and its actual usefulness is not confirmed. Such a generous approach to the assessment of novelty is not likely to be applied in other fields.


At the same time however, EPO case law on inventive step and sufficiency of disclosure has put an increasing burden on pharmaceutical patent applicants to provide data in their patent applications that makes it at least plausible that the drug would work in the stated diseases.


While the EPO has made it very clear that it does not expect to see clinical trial data for this, it does expect the patent application to provide “some


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information in the form of experimental tests, to the avail that the claimed compound has a direct effect on the metabolic mechanism specifically involved in the disease”. Tis mechanism has to be evident in either the patent application itself or in the prior art. Te requirement might be met by an in vitro test on cells, for example, as long as it shows a link between the way in which the drug works and the cause of the disease.


Furthermore, applicants must meet this ‘plausibility test’ from the outset. In the past, the EPO would have allowed submission of data supporting a concept to an examiner aſter the filing date. Now, case law dictates that if the proposed medical treatment is not considered plausible from the application when filed, that deficiency cannot be made good by data showing the original suggestion was correct aſterwards. Tis means that patent applicants must undertake enough work to overcome the plausibility hurdle before filing and pharmaceutical companies have to decide how much of their R&D budget can be allocated to work that purely supports the IP position.


Positives and negatives


Te Enlarged Board of Appeal is the highest authority at the EPO. Its decisions are followed by the lower boards of Appeal, the opposition divisions and the examiners. In early 2010, there were two significant Enlarged Board decisions produced some positives and negatives for the pharmaceutical industry.


Te first of these concerned methods of surgery that are carried out on humans or animals. Under the EPC, these are excluded from patentability but it has been leſt to case law to determine the actual scope of the exclusion. Last year, the Enlarged Board sought to clarify this by confirming that all methods of surgery are excluded, regardless of the purpose of the surgery (therapeutic or not). It also opined that the term ‘surgery’ had been applied too broadly in the past. Procedures that the public might not generally consider as surgery such as injection, endoscopy or catheterisation had fallen within the exclusion. While the Enlarged Board acknowledged that a new approach was needed, they leſt it to the lower boards of appeal to decide what that new approach should be on a case-by- case basis. We may well find in due course that more procedures than before will be patentable but legal certainty will take several years to develop, which is regrettable.


In the second of the Enlarged Board decisions, it considered patent claims


for new medical


indications of a known drug and whether an invention which consisted only of a new


dosage regime, as opposed to a genuinely new therapeutic indication, could be patented. Te lower boards of appeal had previously handed down divergent decisions on this point. In a decision which was mostly favourable to the innovative pharmaceutical industry, the Enlarged Board approved dosage regime claims, removing the previous uncertainty. However, further legal questions were raised when the Enlarged Board decided that the previous style of claim approved for new medical uses of a known drug,


the


so-called Swiss claim, was no longer appropriate. Instead, a different style of claim was approved that may have a different scope to the Swiss claim. It will now be for the national courts to decide just what that scope is, as and when such claims are litigated. Tis is again an uncertainty that the industry would rather have avoided.


Te EPO’s approach and practice concerning pharmaceutical inventions has been shaped over many years


some doors and open others. Te EPO cannot please everybody. Recent case law has its upsides and downsides for the industry and no doubt applicants will continue to challenge the office by exploring the boundaries of pharmaceutical patenting. Companies and their advisers must keep abreast of developments and develop their IP strategies accordingly.


Claire Baldock is a chartered patent attorney and European patent attorney, and partner at UK firm Boult Wade Tennant. She can be contacted at: cbaldock@boult.com


and is continuing to close


Claire Baldock is the head of the biotechnology and life sciences group at Boult Wade Tennant. She has expertise in patent work in the chemical, pharmacological and


biotechnological fields, particularly


in relation to oppositions and appeals at


the EPO. She is a specialist in patent


due diligence exercises and she possesses technical expertise in the areas of drug delivery systems, herbal medicines, vaccines, diagnostics, fermentation technology, DNA sequencing techniques, therapeutic antibodies, biologics and pharmaceuticals.


Life Sciences Intellectual Property Review 2011


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