In recent years, advances in medical and human genetics have led to exciting and revolutionary advances in medicine. One such area, which is now benefitting from the fruits of genetic research, is personalised medicine. In May of this year, the actress Angelina Jolie made headlines worldwide after undergoing a double mastectomy, following the discovery of an abnormal variation in her BRCA1 gene. In her case, possessing this mutation apparently led to an estimated 87% risk of developing breast cancer.
The case of the BRCA1 gene is an obvious example where knowledge of a particular genetic trait can lead to a targeted medical intervention, for example, surgery. However, the field of personalised medicine stretches far wider than just oncology. Personalised medicine encompasses the tailoring of medical decisions, practices and products to individual patients, and encompasses fields such as customised pharmaceuticals, pharmacogenomics, proteomics and metabolomics. For example, the field of pharmacogenomics is concerned with studying the impact of genetic variation on drug response. This can lead to effective targeting and even specific dosing of particular pharmaceuticals, based on knowing certain genetic traits (biomarkers) present in the patient.
This emerging field of medicine and pharmaceuticals poses some interesting questions concerning patents. Last year, the US Supreme Court’s decision in Mayo v Prometheus cast significant uncertainty over the patentability of personalised medicines. More recently, in The Association for Molecular Pathology et al. v Myriad Genetics Inc et al., the Supreme Court again decided on a case, which made headlines worldwide and has implications for personalised medicine.
How Are The EPO & The UK Courts Dealing With Patentability For These Kinds Of Pharmaceuticals?
One of the key pillars of patentability is the requirement of novelty; a patentable invention must be new. The EPC defines a novel invention as one which does not form part of the state of the art (Art 54(1)). The state of the art is defined as comprising everything made available to the public by written of oral description, by use or in any other way, before the priority date of the application (Art 54(2)). The novelty of a new product or process is easy to conceive; additionally, over the last 40 years, novelty of use and particularly medical use has been developed and expanded by the EPO Boards of Appeal and national courts.
Section 2(6) UKPA and Article 54(5) allow a claim for a new medical use of a known substance to be novel by virtue of the new use. Since G 5/83 (confirmed in the UK in Wyeth’s Application), a claim for a new second or further medical use of a known substance can be novel by virtue of the new second or further use. Further, since G2/08 (confirmed in the UK in Actavis v Merck), a second medical use claim can be distinguished from the prior art by virtue of a new dosage regime or method of administration.
What if the only aspect of a medical use claim distinguishing it from the prior art is a new patient group? For example, an invention may lie in the use of a substance to treat a disease in patients having a specific biomarker, but the use of the substance to treat the disease is already known.
The earliest major EPO decision on this question appears to be T233/96, which interprets T19/86 and T 893/90, and proposes a two-part test for assessing novelty of this kind of use claim.
- The patient group mush be clearly distinguishable, with respect to its physiological or pathological status, and must not overlap with any patient groups previously treated in the prior art.
- The choice of the new group must not be arbitrary; there must be a functional relationship between the physiological or pathological status of the new group and the effect achieved.
Subsequent cases of the Technical Board of Appeal have not adopted this two-part test. In T1399/04, the impugned patent concerned a claim that included the selection of a specific patient subgroup, which overlapped with the patient group disclosed in the prior art. Thus, based on the two-part test set out in T233/96, the claim would appear not to be novel. However, in T1399/04 the Board found in favour of novelty, despite the patient sub group overlapping with the patient group disclosed in the prior art.
The Board in T1399/04 disagreed with how the Board in T233/96 had interpreted T19/86 and T893/90, and thus seem to question the basis for the two-part test. The Board in T1399/04 also appear to distinguish T233/96 and the case in T1399/04 on their facts. In T1399/04 the Board held that the impugned patent provided convincing evidence that the claimed patient group profited most from the claimed treatment, whereas in T233/96, there was no functional relationship between the claimed patient group and any physiological or pharmacological effect. It seems that as long as the new patient group is not explicitly disclosed in the prior art, and its choice is not arbitrary, but leads to some kind of new technical effect, then the new patient group can confer novelty over the prior art.
This approach is also consistent with two further cases: T836/01 and T1642/06. In both cases, the patent applications effectively claim patient groups, which overlap with patient groups disclosed in the prior art.
Thus, it would appear that from the jurisprudence of the Technical Board of Appeal, a medical use claim can be distinguished from the prior art by virtue of it claiming a new patient group, provided that there is some kind of functional relationship between the patient group and the effect achieved. This even appears to be the case when the patient group overlaps with a group disclosed in the prior art. This would mean that in the situation where the prior art discloses the use of a substance x to treat a disease y, a claim to the use of substance x to treat disease y in patients having biomarker z could be novel. Furthermore, it would appear that this may even be the case when some of the patients disclosed in the prior art would inevitably have possessed biomarker.
However, in practice EPO examiners appear to be following a stricter approach to novelty, than is required by T1399/04. This view was confirmed in a meeting between the EPO and the EPI Biotech Committee held in 2011. In this meeting, the EPO discussed new patient groups defined by a single-nucleotide polymorphism (SNP). They went on to state that “often claims lack novelty, as one patient will have inevitably been treated with the SNP, even if the art does not explicitly say so”. Some practitioners feel that the EPO may be looking for a test case to settle the law in this area, so definitive answers may yet be on the horizon.
The UKIPO and UK courts also seem to be applying a strict approach to novelty for this type of use claim. According to the new Examination Guidelines for Patent Applications relating to Medical Inventions, a second medical use claim is not novel if the substance has already been used to treat the same group of patients amongst others, with the same disease. This approach departs from the teaching in T1399/04, but is consistent with the UK decision: Bristol-Myers Squibb v Baker Norton. The UK courts consider the discovery that a treatment works particularly well for a group of patients does not render a claim novel if that same group of patients has already been treated for the same disease with the same substance. Nonetheless, a general disclosure that a substance may treat a disease does not necessarily anticipate a claim to the treatment of a subgroup of patients with that disease unless it can be demonstrated that treatment of this subgroup was inherently or explicitly disclosed in the prior art.
The field of personalised medicine and pharmacogenomics highlights some fundamental questions of patentability, not least methods of diagnostics and treatment, but also novelty and inventive step. If developing highly personalised and targeted pharmaceuticals is to succeed, the patent system will need to provide adequate protection as an incentive for research and development.
We hope that if the EPO choose to clarify the law on medical use claims limited by patient group, their approach to novelty will reflect the importance of this emerging area of pharmaceuticals and medicine.
In the mean time, it may be possible that on a case-by-case basis, claims to second medical use limited by patient group could be worded in such a way to achieve novelty. Furthermore, alternative approaches can also be explored, such as protecting the method of identifying a particular biomarker. For advice in this area, please feel free to contact the Biotechnology, Chemistry and Pharmaceuticals team at Reddie and Grose LLP.
This article is for general information only. Its contents are not complete statements of the law on any subject. Professional advice should be sought before any course of action is pursued.
This article is for general information only. Its content is not a statement of the law on any subject and does not constitute advice. Please contact Reddie & Grose LLP for advice before taking before any action in reliance on it.