UK Supreme Court Lowers The Threshold For Biologics Patents

Keywords: UK Supreme Court, threshold, biologics patents, EPC

Summary and implications

The UK Supreme Court has handed down an important judgment that establishes when patents for biological materials will satisfy the test of industrial applicability1.

This judgment will potentially have a strategically significant effect on the position across Europe and in member states of the European Patent Convention ("the EPC").

This decision is of considerable importance to the research-based biotechnology industry. If a new potentially biologically active protein is discovered a patent can legitimately be applied for it at an early stage of the R&D program. It need not be delayed until the industrial applicability of the protein can be fully demonstrated. One of the key new principles is that where the protein is said to be a family or superfamily member, if the disclosure is important to the pharmaceutical industry, the disclosure of the sequences of the protein and its gene may be sufficient, even though its role has not yet been clearly defined. As a matter of public policy there is a fine balance between the competing interests of allowing a patentee to have a monopoly over a particular biological molecule too early – which may shut out any competition - and setting the standard for patentability too high (which may negate the incentives of the patent protection system and have a chilling effect on investment in bioscience and innovation). The Supreme Court has reiterated that, as far as " possible, national patent law in the UK (and across EPC member states) should be interpreted in light of the relevant jurisprudence of the European Patent Office. The key issue in this case

Article 52(1) EPC provides that an invention must be "susceptible of industrial application" if a European patent is to be obtained for it. Article 57 states that an invention is susceptible of industrial application if it can be made or used in any kind of industry. The primary issue in this case is the way in which this requirement of industrial applicability extends to a patent for biological material.

The Supreme Court and the correct test for industrial applicability for biological material

There is very little UK authority on industrial applicability in the context of biological material. The applicable principles are all to be derived from the EPO jurisprudence. In HGS v. Eli Lilly the Supreme Court therefore extensively reviewed and summarised the corpus of relevant EPO case law on industrial applicability in relation to biological material. Given the importance of consistency of interpretative approach between national courts and the EPO - the so-called "dialogue" between a national court and the EPO and between national courts themselves – this careful and detailed analysis will be of central importance across Europe for the foreseeable future.

The Supreme Court held that the "essence" of the EPO jurisprudence on industrial applicability in relation to biological material is as follows.

The general principles are:

(i) The patent must disclose "a practical application" and "some profitable use" for the claimed substance, so that the ensuing monopoly "can be expected [to lead to] some ... commercial benefit"2

(ii) A "concrete benefit", namely the invention's "use ... in industrial practice" must be "derivable directly from the description", coupled with common general knowledge.3

(iii) A merely "speculative" use will not suffice, so "a vague and speculative indication of possible objectives that might or might not be achievable" will not do.4

(iv) The patent and common general knowledge must enable the skilled person "to reproduce" or "exploit" the claimed invention without "undue burden", or having to carry out "a research...