PRACTICE NOTES
Biotechnology patentability in the UK and EU: Directive 98/44/EC, EPC Article 53(b), PA 1977 Sch A2, key CJEU/EPO case law, exclusions, and compulsory cross-licences
This Practice Note outlines which biotechnological inventions may and may not be patented. It cites Directive 98/44/EC (commonly called the Biotechnology Directive) and Schedule A2 to the Patents Act 1977 (PA 1977), which allow patents for biotechnological inventions while setting key exceptions. Those exceptions have been interpreted by the Court of Justice in cases including Oliver Brüstle v Greenpeace and Monsanto v Cefetra. The Note also reviews exclusions from patentability under Article 52(b) of the European Patent Convention (EPC) and pertinent European Patent Office (EPO) decisions, Tomatoes I, Tomatoes II and Broccoli II. It also takes account of the 2017 European Commission Notice on biotechnological inventions.
Patenting biotechnological inventions
As a general rule, biotechnological inventions are patentable. Although neither PA 1977 nor the EPC imposes a blanket prohibition, specific provisions control when such inventions can be protected (see: The regulatory framework for biotechnology patents below). Additionally, in practice, some biotechnological subject-matter, even if not expressly barred, may fail the standard thresholds of novelty, inventive step and industrial applicability. For further detail on these criteria, see Practice Note: Patentability and exclusions from patentability...
Life Sciences