Court of Appeal, Eli Lilly v. HGS
In the January 2012 edition of this newsletter, we reported on the English Supreme Court's finding that the patent owned by HGS for neutrokine-a antibodies was capable of industrial application. This decision left over for determination by the Court of Appeal the question of the sufficiency of the claims to isolated antibodies. The court has now held that the claims are sufficient.
Claim 13 effectively claimed any antibody that binds specifically to neutrokine-a. Both Lilly and HGS have neutrokine-a antibody products and Biogen and Genentech have potential antibody products. Commercially therefore what is at stake is whether the developers of these products have to pay tribute to HGS because it has the "master" claim to all neutrokine-a antibodies.
It was accepted that antibodies that bind to neutrokine-a could be made and isolated; the issue was whether the claim should be read as being confined to valuable products. Lilly argued that it would take undue effort to find out which of the millions of antibodies that bind would actually be useful. Andrew Waugh QC (acting for Lilly) compared the problem to identifying which of a large pool of tadpoles was a tadpole which would develop into a frog which when kissed would turn into a prince.
The Court of Appeal rejected Lilly's submissions. Sir Robin Jacob (giving the main judgment) said that at the level of generality of the patent all the antibodies had a "use". All the claim called for was an antibody which specifically binds to neutrokine-a: that in itself was its potential utility. The court accepted that discerning any particular specific utility might involve a research project but that did not matter.
The court also objected to Lilly's argument on the grounds that it would involve reading into the claim a further limitation. They felt strongly that one did not read words into patent claims unless the context compelled this. The context here did not. Furthermore, the term "useful" did not have any precise meaning; another reason for rejecting such a limitation.
The sufficiency of claims 18 and 19 was also considered. Claims 18 and 19 were respectively for pharmaceutical and diagnostic compositions. At first instance the judge had held these to be insufficient. The Court of Appeal disagreed and found that because the claims were not tied to any particular application all that was required was compositions which could be formulated as suitable for administration as a pharmaceutical or suitable for a use as a diagnostic. As this could be done, the claims were sufficient.
All in all, the very general high level nature of this invention seemed to persuade the court that the only thing that was required in order for the claims to pass the sufficiency test was that the antibodies themselves could be made. It was irrelevant whether that antibody was pharmaceutically (or diagnostically) useful.
Given the Supreme Court's finding on industrial application, this decision is not surprising although it is disappointing. Both the Supreme Court and the Court of Appeal have acknowledged an "overlap" between the tests of industrial application and sufficiency. So, a conclusion on industrial application would now seem to entail a similar conclusion on sufficiency. This begs the question why there should be two separate requirements for patentability. The sufficiency bar (as well as that for industrial application) for antibody products seems to have been lowered