Enough is enough: sufficiency and technical contribution

The English High Court judgment in Lilly v Janssen, [2013] EWHC 1737(Pat) is a timely reminder of the difficulties of defending broad claims in the pharmaceutical and life science area.

Failure to enable the invention to be performed without undue burden is often referred to as “classical insufficiency” and failure to enable the invention to be performed over the whole scope of the claim is often referred to as “excessive claim breadth” (or Biogen) insufficiency.

Janssen was the proprietor of a patent claiming the use of antibodies to the peptide Aß for the treatment of diseases characterised by amyloid deposit, such as Alzheimer’s disease. Lilly sought a declaration that use of the Aß antibody, solanezumab, which Lilly currently has in Phase 3 development for the treatment of Alzheimer’s disease, would not infringe Janssen’s patent.

In extensive clinical trials carried out in collaboration with Pfizer, Janssen failed to show that bapineuzumab, another Aß antibody, had any effect in the treatment of Alzheimer’s disease. The judge accepted Lilly’s argument that the patentee had not succeeded in making an antibody to Aß which was for use in treating a disease which was characterised by amyloid deposit, despite an intensive research and development programme carried out over many years. This failure demonstrated that the patent was classically insufficient.

The claim was also of excessive breadth. The specification did not enable the skilled person to make suitable antibodies to Aß over the whole scope of the claim without undue burden. Further, some antibodies to Aß were not efficacious in mice, and indeed even in tests reported in the patent. Of course, such antibodies fall outside the claim, because they do not satisfy the functional requirement of being for use in treating a disease characterised by amyloid deposit.

However, finding active antibodies to Aß was a hit and miss affair. The result was that the patent did no more than invite the skilled team to perform a very significant research project with a high prospect of failure and, if they succeed, to claim the fruits of their research. It was therefore insufficient.

This line of reasoning follows the approach taken by the European Patent Office (EPO) to sufficiency, in cases such as Detergents/Unilever, T 435/91. It also is entirely consistent with the approach taken by the Court of Appeal in AHP v Novartis [2000] EWCA Civ231.

"The patent system should not be used to enable a person to monopolise more than that which he has described in sufficient detail to amount to an enabling disclosure."

That case concerned a patent which claimed the use of rapamycin for inhibiting organ or tissue transplant rejection and whether the patent was infringed by Novartis’s proposed transplant use of SDZ RAD, a chemical derivative of rapamycin.

At first instance, the judge accepted AHP’s position that the claim could be construed to cover derivatives with the same activity as rapamycin, such that SDZ RAD infringed.

He said: “To have done otherwise would have rendered the patent virtually valueless.

It would have left out of its scope, for example, those closely similar molecules which could be derived by standard chemistry from rapamycin and which probably would have included many which those in the art would have expected to have equivalent or even better immunosuppressant properties.

It would have disclosed to the art the novel seam of interrelated molecules but claimed only one of them. In practice it was inevitable that the discovery of the activity of rapamycin would lead workers in the art to look for similar molecules derived from rapamycin which would have a better profile of properties.”

The judge also accepted AHP’s argument that the broad claims were enabled in that the search for derivatives of rapamycin was routine medicinal chemistry. In consequence, the patent was sufficient. Both these findings were overturned on appeal, the judge finding that the patent system should not be used to enable a person to monopolise more than that which he has described in sufficient detail to amount to an enabling disclosure.

It seems that following Ariad v Lilly, 598 F.3d 1336 (Fed. Cir 2010), the US courts now take a similar approach to the EPO and the English courts. A neat illustration, with similarities to the AHP case, comes from Boston Scientific v Johnson & Johnson, 647F.3d 1353 (Fed. Cir. 2011), which concerned a patent claiming drug-eluting stents using either “rapamycin or a macrocyclic lactone analog of rapamycin” as therapeutic agent.

The patent did not disclose, use or provide a single example of a macrocyclic lactone analogue. The Court of Appeal for the Federal Circuit found that the specification did not fulfil the written description requirements of §112, first para.

The importance of the technical contribution to the art made by a patent was summed up in July by Lord Justice Floyd in Mylan v Yeda [2013] EWCA Civ 935. He said: “… the fundamental principle of patent law, which underpins many of the grounds of objection to validity, is that the extent of the monopoly conferred by a patent must be justified by the technical contribution to the art.

If some of the products covered by a claim demonstrate a particular property, but others do not, then the technical problem cannot be formulated by reference to that property. Either the products which do not exhibit the property must be excised from the claim by amendment, or the problem must be formulated by reference to some other, perhaps more mundane, technical contribution common tothe whole claim.”

Or, as Mr Justice Fortas said in the celebrated Brenner v Manson, 383 US 519 (Supreme Court 1966): “A patent is not a hunting license. It is not a reward for the search, but compensation for its successful conclusion.”

When drafting the specification for a patent application, the author must try and understand the real scope of the technical contribution to the art made by the invention and draft the claims accordingly.

Gordon Wright is a partner of Elkington and Fife LLP. He can be contacted at: gordon.wright@elkfife.com