In a recent decision the Australian Patent Office has rejected applications to extend the term of three patents related to the highly successful anti-inflammatory drug HUMIRA.

The patents are part of a family in which extensions of term had been granted in connection with earlier patents. These earlier extensions were based on the initial listing of HUMIRA on the Australian Register of Therapeutic Goods (ARTG) for the treatment of rheumatoid arthritis.

The present extension applications were based on subsequent ARTG listings for additional indications, specifically Crohn’s disease, ulcerative colitis and ankylosing spondylitis. All of the claims of each patent were either method of treatment claims or Swiss-style use claims, i.e. the claims were characterised by a therapeutic use. One of the eligibility requirements for an extension of term was that one or more pharmaceutical substances when produced by recombinant DNA technology must in substance fall within the scope of a claim or claims of the specification.

With reference to an earlier decision the Hearing Officer noted that “a substance when produced by a process involving recombinant technology means that product as such, not characterised by its therapeutic use, mode of delivery or features other than its process of production.”

Because the claims of the three patents were not directed to a product as such but rather characterised by a therapeutic use, the extension applications were rejected.

Again with reference to an earlier decision the Hearing Officer went on to state that “it seems clear that patents covering new therapeutic uses of old substances produced by old processes should not be extended even if they involve recombinant DNA technology.” This position is entirely consistent with previous decisions where patentees have unsuccessfully sought to extend the term of patents having only secondary use claims, i.e. method of treatment claims and Swiss-style claims.

Patent protection for HUMIRA will cease in Australia in December 2018 opening the way for biosimilar versions.