The decision of the House of Lords in the case of Biogen v. Medeva, holding a patent relating to hepatitis B antigen invalid, has attracted attention in view of its apparent conflict with a decision of the EPO Appeal Board upholding the patent. The English Court of Appeal decision, which was broadly affirmed by the House of Lords was noted in our April 1995 Newsletter (N.S. 185). The House's decision was essentially made on the ground that the patent was too broad. It was accepted that there may have been an invention at the core of what the inventors had done but what was claimed was in effect every way to solve an obvious problem. The claim defined the product claimed by its properties, namely, that it was recombinant DNA that carried the code for a protein having hepatitis B virus antigen specificity. In their Lordships' view it was not right to grant a patent that might stifle healthy competition by "allowing the first person who had found a way of achieving an obviously desirable goal to monopolize every other way of doing so". In their Lordships' opinion "it is inevitable in a young science, like electricity in the early nineteenth century or flying at the turn of the last century or recombinant DNA technology in the 1970's that dramatically new things will be done for the first time. The technical contribution made in such cases deserves to be recognized." However, the recognition should not be overly broad. In the present case, the real invention was apparently the particular means devised to reach a desired goal and the claim should be framed accordingly.

The claim defined a DNA molecule but in a functional way. The issue arose as to whether the broad claim was supported by the priority document which described the production of two polypeptides within the claim. The key to the decision seems to lie in the following dicta by Lord Hoffmann:

Once the earliest priority date was lost, it was conceded that the patent was obvious over the cited art. The House also held the patent invalid for insufficiency of disclosure for reasons analogous to those applied to the priority date question.

A significant basis for the decision seems to have been the conclusion reached by their Lordships that what the defendant did owed nothing to the invention made but rather was based on the subsequent publication of the sequence of the DNA in question.

The EPO had addressed the priority date issue in its decision and concluded that two examples were enough to support the broad claim and that what was missing could be inferred by those skilled in the art. The House noted this but held that the EPO had misapplied its own prior case law on this issue. Whatever the correctness of the decision, it seems likely that the scope of protection being afforded by claims in the biotechnology area is likely to be under much closer scrutiny in the future.