Bayer Pharma Aktiengesellschaft  APO
In recent times, the Australian Patent Office and the Federal Court of Australia (FCA) have had a series of cases dealing with patent term extension (PTE) in which consideration of the term “earliest first regulatory approval date” was key. We have commented on these cases previously (Ono Pharmaceutical Co., Ltd. et al  APO 43 (Ono 1); Ono Pharmaceutical Co, Ltd v Commissioner of Patents  FCA 643 (Ono 2); Merck Sharp & Dohme Corp. v Sandoz Pty Ltd  FCA 947 (MSD)).
On 7 February 2022, the Australian Patent Office published its decision Bayer Pharma Aktiengesellschaft  APO 7 (Bayer), again considering “earliest first regulatory approval date”. This term is central to the calculation of PTE in Australia, which also requires that at least 5 years have elapsed between grant of the patent for which PTE is requested and first regulatory approval for the pharmaceutical substance upon which the PTE request is based. Issues have arisen where a patent covers more than one pharmaceutical substance with regulatory approval, i.e. listed in the Australian Register of Therapeutic Goods (ARTG). In these circumstances, the pharmaceutical substances may be listed in the ARTG by a third party as well as by the patentee.
Bayer fell in the latter group, because the patent in question covered two of the patentee’s products, each listed on the ARTG, each having a first regulatory approval date. The question then was which of the first regulatory approval dates was the earliest first regulatory approval date, the answer to which would dictate whether PTE would be granted. If the earliest first regulatory approval date was that of the pharmaceutical substance first listed in the ARTG, 5 years would not have elapsed between grant of the patent and first regulatory approval. If the earliest first regulatory approval date was that of the pharmaceutical substance second listed in the ARTG, more than 5 years would have elapsed between grant of the patent and first regulatory approval.
At the time of requesting PTE, the Commissioner of Patents was satisfied that the earliest first regulatory approval date was that of the pharmaceutical substance second listed in the ARTG, i.e. the pharmaceutical substance upon which the PTE was requested. Subsequently, a third party challenged the PTE by asserting that the patent register had an incorrect expiration date, beyond the true date of expiration. Bayer deals with the request for rectification of the register to void the PTE.
The patentee’s arguments in Bayer were akin to the FCA’s reasoning in Ono 2, which aligned with the Commissioner’s grant of PTE in the first instance based on the earliest first regulatory approval date was that of the pharmaceutical substance second listed in the ARTG.
As we noted at the time, our view was Ono 2 simplified PTE requests for patentees and provided a degree of certainty by allowing a patentee to ignore third party pharmaceutical substances listed in the ARTG. However, issues regarding a patent covering two or more pharmaceutical substances listed in the ARTG by the patentee remained.
As noted by the Delegate of the Commissioner of Patents at , Bayer was heard before MSD was decided and published. The FCA distinguished the facts in MSD from the facts in Ono 2, and the Delegate in Bayer has followed MSD. In short, in Bayer the Delegate held that where two pharmaceutical substances are covered by the same patent and both are listed in the ARTG by the patentee (or with the patentee’s approval), the earliest first regulatory approval date will be that of the pharmaceutical substance first listed in the ARTG. In many cases, including Bayer, this means that the patent in question will not be granted PTE (or according to the legislation, will be PTE-eligible, but will be granted PTE of zero days).
This continues to be a developing area with judgment reserved by the Full Court of the Federal Court of Australia in appeals of both Ono 2 and MSD. It is also possible that the decision in Bayer will be appealed.
In any event, as we have recommended, during patent prosecution, careful consideration should be given to the likelihood of listing in the ARTG more than one pharmaceutical substance that will fall within the scope of the claims of a patent granted on the application. If the likelihood is high, each pharmaceutical substance to be listed in the ARTG should be covered in a separate divisional application to maximise the chance of obtaining PTE for at least some of the patents. Alternatively, it should also be possible to have granted claims covering more than one pharmaceutical substance, and keep a divisional application pending. Because non-broadening amendments may be made after grant, when there is some certainty about what pharmaceutical substances will be listed in the ARTG, the granted patent could be narrowed to one pharmaceutical substance, and the divisional claims redrafted to cover the second pharmaceutical substance.
For more information on PTEs, please contact Dr Malcolm Lyons.