This is based on a talk given by Philip Webber at the CIPA Life Sciences Conference on 15 November 2013.
1. As background to human embryo stem cells: the Biotech Directive lists inventions which are seen as immoral. This was brought into the Rules of the EPC in 1999. The Enlarged Board of the EPO decided in WARF G2/06 in 2008 that if an invention required a human embryo to be destroyed then it was not patentable, though it seemed from the decision that if appropriate embryo stem cell lines were publically available at the priority date then the invention was patentable, even if creation of those cell lines required destruction of an embryo.
However in 2011 the CJEU decided in C34/10 Brustle that if the invention made use of embryo stem cells that had required destruction of an embryo at any stage then it was not patentable, i.e. a stricter test than the EPO set in WARF G2/06. In 2012 the EPO informally indicated that it would follow the CJEU’s decision.
2. There are 3 dates which are important when looking at the patentability of embryo stem cells. Firstly, embryo stem cell lines were first made in December 1997. Secondly, the EPO accepts that human embryo stem cell lines were publically available from May 2003. Thirdly, in February 2008 a paper was published showing how embryo stem cell lines could be made without destroying an embryo, essentially by taking a cell from an 8 cell embryo and letting the remaining 7 cells continue to develop.
3. In 2013 there was a new referral to the CJEU from the UK on whether a parthenote is a human embryo (presently pending as C-364/14). The patent application concerned activating an unfertilised oocyte and causing it to develop into a parthenote. Embryo stem cells can be produced from the resultant parthenote, but the parthenote is incapable of developing into a human. The Advocate General’s opinion in the Brustle decision had been in favour of a test requiring the embryo to be capable of forming a viable human, but the subsequent CJEU decision did not include this.
4. The German Brustle patent has now been granted with a disclaimer to embryonic stem cell lines which are derived by destruction of a human embryo. There is a corresponding European patent which has the same disclaimer and which has been opposed by Geron on the grounds of morality and insufficiency. Geron argued that at the priority date it was not possible to make embryo stem cell lines without destroying an embryo. The opposition division revoked the patent in June 13 on the basis that the sufficiency issue led to the disclaimer adding matter. This will now go to appeal.
It is clear from European Patent No. 2283117 granted in October 2013 that the EPO is granting cases filed after 2008 without an appropriate disclaimer being required.
5. In the UK High Court , Lilly v Janssen concerned treating Alzheimer’s with an antibody to amyloid-β. The prior art, Konig, disclosed the concept of using such antibodies to treat Alzheimer’s but did not provide any data. The question was whether this disclosure was novelty-destroying. The UKIPO Guidelines on medical use claims say that there does not need to be disclosure of clinical trials in a prior art document for it to be novelty destroying, but there is no further clarification of what sort of disclosure would be novelty-destroying. The EPO decision T1437/07 says the sufficiency test must be identical for the prior art and for the patent, and thus there needs to be credible disclosure of the treatment. A previous UK House of Lords decision, Synthon v SmithKline Beecham had said that anticipation and enablement must be same test. Ultimately the UK Court decided in Lilly v Janssen that since Konig had not have experimental data it is speculative, and therefore not novelty destroying. Given there were reasons to expect the antibodies would not work the claims were also inventive over Konig.
6. The Court in Lilly v Janssen also considered sufficiency, both classical and Biogen insufficiency (the latter corresponds to the EPO’s Agrevo test). For Biogen insufficiency the court asked ‘do all antibodies against amyloid-β work?’ Given that only antibodies to the N terminus of the protein would work the specification did not make it plausible that any antibody against amyloid-β could be used and therefore the patent was insufficient. The Court also considered classical insufficiency asking whether it was undue burden to make therapeutic antibodies. The sequence of the antibodies or deposits of them were not available. The evidence showed they would require 30 months to make. However there were doubts about efficacy in mice and human trials. There had been success in a phase II trial, but failure in a phase III trial. Given all of this it was decided the patent was also insufficient for classical sufficiency.
7. The UK IPO case Aueon (BL O/248/13) concerned a method of diagnosing cancer that included a step of checking a database to identify potential treatment options. The applicant argued that one can have technical and nontechnical steps in a diagnostic claim given the EPO decision G1/04. However the hearing officer treated the invention as computer program and used the approach in Aerotel, leading to refusal.
8. The UK IPO case Lalvani (BL O/220/13) concerned inventive step of a formulation for lactating mothers. Essentially the hearing officer said that all of the ingredients recited in the claim would be obvious to use in the formulation, and in the absence of showing synergy the invention was obvious. The applicant’s arguments that there was bound to be synergy in such a biological system was rejected in the absence of data.
9. The UK High Court case Glenmark v Wellcome concerned the obviousness of an antimalarial with two components in in a particular ratio. The Court said that if there was an urgent need the skilled person would pursue a ‘hope to succeed’ which is different from the usual test of reasonable expectation. The claims were found to be obvious in view of a prior art oral presentation.
10. There is the perception that the EPO is getting stricter every year on added matter. However recent decisions T667/08 and T2619/11 may make it easier for applicants. Essentially these require the EPO to look at the application in its entirety, and not just at the literal wording. The EPO Guidelines have been changed as a result to make it clear that implicit features should be taken into account when judging added matter.