The Authors' Take[s] - Obviousness: what’s the problem?

[This is an Authors' Take post, which provides readers with an insight into current IP scholarship, featuring preliminary comments and thoughts from authors of articles accepted for publication in forthcoming issues of the Journal of Intellectual Property Law & Practice (OUP). The full text of this contribution is available in Advance Access.

A few months ago, Roy Marsh, a British and European patent attorney currently practicing in Munich, approached JIPLP to express his disagreement with the criticism expressed by some authors and judges towards the EPO's Problem and Solution Approach. We encouraged him to discuss his point of view in an article, also to stimulate further debate among our readers and more widely. In the following Authors' Take posts, Roy provides not one but two short summaries of his work: the first is a more typical abstract, while the second illustrates Roy's ideas with his characteristic verve and enthusiasm We hope readers will appreciate both versions, as well as Roy's full article (available here)!]

Obviousness: what’s the problem?

by Roy Marsh

Take 1

When it comes to judging obviousness, the simplest mechanical contrivances can present the most ticklish problems. The author, upon entry to the profession in 1973, discovered that one of the landmark House of Lords cases on patent validity in England was the tractor-drawn hay rake case between van der Lely and Bamfords.  Being the son of a dairy farmer, he well knew the products of the respective parties, their attributes in the field, and the commercial success of the patentee’s “ACROBAT” device, not at all surprising to him, given its elegant and robust design and its delightful effectiveness, speed and agility in use.  

Since then, the author has gradually come to the view that the EPO’s “effects-based” problem-and-solution-approach (PSA) to obviousness has manifold public policy benefits which continue to go largely unrecognized even today, 40 years after its creation back when the EPO first opened its doors for business. PSA cut through the encrustations of national law on obviousness. But that is not all. PSA also:

1)    obliges patent drafters to render their specifications attractive reading for R&D people;

2)        short-circuits the “eligibility” argument in the software space; and

3)        subsumes much of the argument on enablement. 

Today, more than ever, in an era of dangerous climate change, we need technical progress. The raison d’être of a patent system is to promote such progress. We ought therefore to be urgently seeking ways to make patents more accessible to R&D people, and worth their while to read them. One way is to adjudicate obviousness using EPO-PSA. 

Courts and litigators are already influenced by the EPO case law on novelty.  It is vital that they also open their minds to the public policy benefits of doing obviousness like the EPO does it. 

Take 2 

Must it be?  Must the law get ever more complicated?  Look at tax law and one might suppose that the competition between gamekeepers and poachers – the State vs. the legal eagles – makes inevitable an ever-increasing complexity, and with it ever-diminishing levels of respect for the Rule of Law. 

Well, it is not inevitable.  At least not in patent law. 

Back in the 1970s, we made a fresh start, with the PCT and the EPC, sweeping away the accumulated encrustations of the former patent law of the UK.  With this re-boot a whole new style of drafting patent applications came into force. Imperative was to explain to their readers what technical features constitute the invention and what technical problem the invention is solving. Patents are addressed to technical readers, are supposed to promote the progress of the useful arts, and so ought to be accessible to engineers and scientists, and to stimulate them into devising different and better solutions to problems in technology. Today, more than ever, we need technical solutions to save our planet from climate change effects. More than ever, we need as many design-arounds as we can stimulate. 

The EPO’s problem-solution-approach (PSA) does this, and much more, but there are few people that grasp its importance. With this article, I want to change that. 

By taking its “effects-based” approach to patentability over the prior art, PSA not only forces better drafting.  It also cuts through over the accumulated layers of dissimulation that have become part of the enquiry whether the subject-matter claimed is “obvious”.  And its success, in streamlining the obviousness enquiry, has enabled it to solve problems in the enquiry as to patentable eligibility (Art. 52 EPC) and the one into sufficiency of disclosure (Art. 83 EPC). 

Can this article alert members of the litigation community to the public policy advantages of following the EPO-PSA method of exploring the ticklish obviousness problem? I do hope so. 

Malaria combination patent invalidated for obviousness

Author: Keo Shaw (McDermott Will & Emery UK LLP)

Glenmark Generics (Europe) Limited & others v The Wellcome Foundation Limited & Glaxo Group Ltd [2013] EWHC 148 (Pat), Patents Court, England and Wales, 7 February 2013

Journal of Intellectual Property Law & Practice (2013) doi: 10.1093/jiplp/jpt101, first published online: June 25, 2013

The Patents Court, England and Wales, has held that a patent for the 5:2 ratio combination of two anti-malarial drugs (atovaquone and proguanil) was obvious, based on prior art that disclosed the two drugs in combination, but not at the claimed ratio.

Legal context

The claimants, Glenmark and Mylan, sought revocation of European Patent (UK) No 0 670 719, protecting the invention of a combination anti-malarial drug, in order to clear the way for the launch of their own generic versions of the drug. The defendants were both part of the GlaxoSmithKline group of companies. The Wellcome Foundation Limited was the registered proprietor of the patent, and Glaxo Group Ltd was the patent's beneficial owner and exclusive licensee.

Facts

The patent related to an anti-malarial medication with a priority date of 26 November 1992, comprising a combination of atovaquone and proguanil in the ratio 5:2. The only ground on which the claimants contended that the patent was invalid was obviousness in relation to two pieces of prior art: a presentation by Dr David Hutchinson, one of inventors named in the patent, and an abstract from a plenary lecture by Dr A T Hudson, who also worked for the defendants.

The defendants sold a pharmaceutical composition consisting of a 5:2 combination of atovaquone and proguanil under the trade mark Malarone. The claimants wanted to launch a generic version of Malarone, resulting in the defendants counterclaiming against both for infringement. There was no dispute that the proposed products would infringe the patent if it was valid. Notably, the defendants made an unconditional application to amend the patent by deleting Claim 1 (a claim to a method of treatment using a combination of atovaquone and proguanil in any ratio), which was granted.

Analysis

There were certain areas of dispute as to what fell within the common general knowledge, the most interesting of which related to combinations. One of the claimants' experts, Professor Molyneux, gave evidence as to the benefit of additive combinations of drugs where there is some resistance to one or both drugs and an absence of any synergy, arguing that it was rational to use an additive combination in the appropriate circumstances. Arnold J agreed with this, commenting that he found a combination that was shown to be significantly synergistic in vitro (experimentation ‘within the glass’, ie in a test tube or petri dish) would encourage the skilled team to go forward to in vivo (experimentation using a whole, living organism) trials.

Arnold J continued by setting out the law on obviousness by reference to consideration of the ‘Windsurfing’ test in Pozzoli v BDMA SA [2007] EWCA Civ 588 and in MedImmune Ltd v Novartis Pharmaceuticals Ltd [2012] EWCA Civ 1234.

Arnold J then applied the test to the patent's claims. He found that there was no technical significance in the 5:2 ratio set out in the claims. The correct question therefore was whether or not it would be obvious to proceed with the development of a medication consisting of atovaquone and proguanil in combination. As the prior art disclosed the combination for the treatment of malaria and set out promising clinical trials results, the defendants needed to show that the skilled team would not proceed with the development of the combination of atovaquone and proguanil in order to be successful. Arnold J rejected the defendants' arguments that critical comments made about the findings would have deterred the team of skilled persons from investigating the combination further. He also rejected arguments claiming that the invention was not obvious because at the time few pharmaceutical companies supported such investigation on account of a perception of limited profit in anti-malarial drugs; he stated that commercial factors are irrelevant in determining obviousness. Arnold J concluded that, against the backdrop of a pressing need for new anti-malarial drugs, the skilled team would have reached the conclusion that the combination merited further investigation and that this would, in turn, have led to a formulation based on suitable proportions of the two drugs. As such, the invention was obvious.

Practical significance

This judgment is another adverse decision for combination patents at the hand of the courts of England and Wales and, once again, highlights the dangers of inventors publicly disclosing the findings of their research before a related patent application has been filed. While this is not a welcome decision for pharmaceutical combination patent owners, especially where their combination product has no other patent protection, the issue of a combination patent where the patent discloses a synergy that was not disclosed in any prior art remains to be tackled by the courts.