PTE alert: Patent Office cancellation of PTE paves the way for potential launch of generic YASMIN products

We have previously reported on a number of Federal Court decisions in 2021 invalidating patent term extensions (PTEs) in Australia: Biogen International GmbH v Pharmacor Pty Ltd [2021] FCA 1591 (Biogen), Ono Pharmaceutical Co, Ltd v Commissioner of Patents [2021] FCA 643 (Ono) and Merck Sharp & Dohme Corp. v Sandoz Pty Ltd [2021] FCA 947 (Sandoz).  In a very interesting new development we now see the impact of those decisions filtering through to the Patent Office, resulting in the removal of a PTE from the Patents Register in respect of a significant commercial contraceptive product, and leaving a patent which has now expired on its ordinary term.

The decision in Bayer Pharma Aktiengesellschaft [2022] APO 7

On 7 February 2022 the Delegate of the Commissioner of Patents issued his decision to rectify the Register to cancel a PTE because it was not based on the first Australian Register of Therapeutic Goods (ARTG) listing of a product containing a pharmaceutical substance per se covered by the patent.  The decision followed an application for rectification filed under s191A of the Patents Act 1990 (Cth) on the basis that the PTE had been wrongly entered into the Register.   The granted PTE extended the term of Bayer’s patent from 31 August 2020 until 8 February 2023.  Subject to appeal, the patent is now therefore expired, and so the decision has the potential to immediately open the way for generic competition.

Bayer’s patent claimed pharmaceutical compositions of drospirenone and ethinylestradiol in tablet form with specified dissolution features.   It was not disputed that Bayer has obtained approval for, and marketed, two contraceptive pill products falling with the scope of the patent claims, YASMIN and YAZ, each containing different amounts of the claimed active ingredients.  It is also worth noting that the patent has already been the subject of lengthy litigation proceedings between Bayer and Generic Health, which ultimately upheld the validity of the patent and resulted in a substantial damages claim for infringement.  However the validity of the PTE was not challenged in those proceedings.

A PTE must be based on the ‘earliest first regulatory approval date’ of a pharmaceutical substance per se covered by the patent.   The PTE will extend the patent for a period of time (up to five years) equivalent to the length of time between the patent filing date and the relevant ARTG listing date, minus five years.  In other words it is intended to compensate the patentee for delay of more than five years in obtaining ARTG listing after filing its patent.  The PTE in this case was originally granted on the basis of the ARTG listing of the YAZ product, on 8 February 2008.  However YASMIN had been ARTG-listed on 6 July 2001.  As the YASMIN listing date was less than five years after the patent date (31 August 2000) a PTE calculated by reference to YASMIN would be zero.

Bayer submitted to the Delegate that the relevant product for ascertaining the applicable first regulatory approval date was that containing the pharmaceutical substance per se identified in Bayer’s PTE application, i.e. YAZ, rather than any substance falling within the scope of the claims.  In other words, where more than one product falling within the patent scope has been ARTG-listed, the patentee can select between such products, at least where an earlier ARTG-listed product is not entitled to a PTE.

On 12 August 2021, after the hearing but before the Delegate’s decision, Jagot J’s judgment in Merck issued, addressing this specific scenario of multiple approved products claimed by a single patent.   As for Bayer, the products in Merck were both sponsored by the patentee.  In Merck her Honour found that the nomination or selection by the applicant of a pharmaceutical substance per se does not affect ‘what is, in fact, the earliest inclusion on the ARTG’ of any substance falling within the claims.  Moreover, Jagot J distinguished the decision of Beach J in Ono in which, pointing to the purpose of the PTE system to reward a patentee, he accepted that the relevant product must be that of the patentee and not a third party product falling within the patent claims with an earlier ARTG listing date.

The impact of the Merck decision therefore was that, for the purposes of a PTE application, a patentee must rely on its first ARTG-listed product falling within the scope of the relevant patent claims, and is not entitled to a PTE if any relevant product is approved within five years of the patent date.  Bayer did not dispute that Jagot J’s decision was relevant, but noted that it was (and is) on appeal.   The Delegate found that the decision in Merck could not be relevantly distinguished from the facts in the case before him and so found the PTE invalid on this basis.

Implications

S191A permits the Commissioner to rectify the Register if it is satisfied on the balance of probabilities, subject to giving the patentee a reasonable opportunity to be heard, that there is either an omission of an entry on the Register, an entry without sufficient cause, an entry wrongly existing on the Register, or an error or defect in any entry.

Although the Delegate had the benefit of certain findings by the Federal Court in the infringement litigation (that the YASMIN product fell within the scope of the claims), the rectification procedure was still heard in a remarkably short time, the hearing being held approximately three months after the rectification application was filed.  The time to issue a decision, 14 months, was much longer, however this may well have been attributable to the impending hearing and judgment in Merck.

Additionally, and importantly, unlike a request for rectification by the Court under s192 of the Act, s191A does not require that the applicant be a person aggrieved by the error.  This means that an application for rectification can be filed anonymously, as was presumably the case here where the application was filed in the name of a solicitors’ firm.

Appeals in both Merck and Ono have been heard by the Full Federal Court and are awaiting judgment.  If Jagot J’s decision in Merck is upheld, the rectification procedure will be a potentially powerful tool for generics to remove problematic PTEs.  There are likely numerous patents on the Register subject to PTEs which may be invalid on the same basis, or because they are based on EPC 2000 claims, as was the case in Biogen.  The market opportunities which may arise as a result will remain to be seen.