Bayer Pharma Aktiengesellschaft - [2022] APO 7

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Bayer Pharma Aktiengesellschaft [2022] APO 7
Patent:780330

Title:Pharmaceutical combination of ethinylestradiol and drospirenone for use as a contraceptive

Patentee:Bayer Pharma Aktiengesellschaft

Delegate:Keith Wagg

Decision Date: 07 February 2022

Hearing Date: 16 December 2020 via video conference

Catchwords: PATENTS – Amendment to the Register- s 191A - extension of term s 70 and s 77 considered – earlier inclusion of goods owned by the patentee on the Australian Register of Therapeutic Goods

Representation: Counsel for the applicant: Bruce Cain SC
Patent Attorneys for the Patentee: Davies Collison Cave Pty Ltd.

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE

Patent:780330

Title:Pharmaceutical combinations of ethinylestradiol and drospirenone for use as a contraceptive.

Patentee:Bayer Pharma Aktiengesellschaft
Date of Decision: 07 February 2022
DECISION

The Extension of Term is considered a wrong entry in the Register. After the appeal period of 28 days, I direct that the Register be amended to indicate the term expired on 31 August 2020.
REASONS FOR DECISION
Background
This matter concerns a request for an amendment to the Register of patent number 780330 (the patent)[1] in the name of Bayer Pharma Aktiengesellschaft (the patentee). The date of the patent is 31 August 2000 and, accordingly, the normal term of the patent expires on 31 August 2020. An application for extension of the term of the patent under section 70 of the Patents Act 1990 (the Act) was filed on 6 August 2008. The Commissioner granted the extension on 25 June 2009 and the patent was extended to 8 February 2023.
[1] The Patent also has the application number 200065895.
The request for an extension of term was based on the marketing approval of the pharmaceutical composition YAZ which was approved on 8 February 2008. YAZ is the patentee’s goods and there is no dispute that it is disclosed in the patent and falls within the scope of a claim.
On 17 August 2020 the Commissioner received a request to rectify the Register under s 191A(1)(c) in relation to the extension of term on the patent from the law firm Bird & Bird (the request). The request sought the Commissioner correct the extension of term because that extension was wrongly granted for the product YAZ when an earlier product, YASMIN, was Registered on the Australian Register of Therapeutic Goods (the ARTG) on 6 July 2001. YASMIN is also the patentee’s own goods[2] and YASMIN falls within the scope of the claims of the patent. The request stated that because of the existence of YASMIN on the ARTG, any extension should be based on the earliest first regulatory approval date under section 77, which was 6 July 2001.
[2] The ARTG sponsor is the same for both YAZ and YAZMIN, Bayer Australia LTD, and the patentee is Bayer Pharma Aktiengesellshaft; they benefit from both the patent and supply of both YAZ and YASMIN in Australia as per Jagot J in Bayer Pharma Aktiengesellschaft v Generic Health Pty Ltd (No 2) [2013] FCA 279 at [2].
On 18 August 2020, in response to the request, a delegate of the Commissioner notified the patentee that the Commissioner intended to rectify the Register. This was because the patentee’s goods,[3] YASMIN, was included in the ARTG earlier. The delegate also noted that the extension of term request of 6 August 2008 was filed both more than 6 months after the date of grant and more than 6 months after the date of commencement of YASMIN on the ARTG; and assuming it was timely filed, would not result in any extension being applied, since the period of time between the date of the patent and the date of inclusion of YASMIN on the ARTG is less the 5 years.
[3] Ibid.
The Patent
The patent relates to contraceptive pharmaceutical compositions of ethinylestradiol and drospirenone. Claim 3 of the patent is of relevance to the extension of term. Claim 3 reads as follows:
A pharmaceutical composition in oral dosage form comprising 3 mg of drospirenone and 0.01 mg to 0.05 mg of ethinylestradiol, together with one or more pharmaceutically acceptable carriers or excipients, wherein the oral dosage form is a table and wherein at least 70% of said drospirenone is dissolved from said composition within 30 minutes, as determined by USP XXIII paddle method II using 900 mL of water at 37 ̊C as the dissolution media and 50 rpm as the stirring rate.
This claim was found to be valid in long-running litigation between Bayer and Generic Health Pty Ltd.[4] The Commissioner also conducted a re-examination of the patent on 29 May 2019 following a request from Jones Tulloch, in that report a delegate of the Commissioner found that an adverse re-examination report was not justified.
[4] See Bayer Pharma Aktiengesellschaft v Generic Health Pty Ltd (No 2) [2013] FCA 279; Generic Health Pty Ltd v Bayer Pharma Aktiengesellschaft [2014] FCAFC 73 with special leave refused in Generic Health Pty Ltd v Bayer Pharma Aktiengesellschaft [2014] HCATrans 261.
Bayer’s Extension of Term
On 6 August 2008, Bayer filed an application under s 70 of the Act to extend the term of the Bayer Patent (the extension of term request). This extension of term request was made using the ARTG inclusion of the product named YAZ.
Part 3 of Chapter 6 of the Act provides a statutory framework for the extension of the term of standard patents relating to pharmaceutical substances. Section 70 relevantly provides:
“(1)The patentee of a standard patent may apply to the Commissioner for an extension of the term of the patent if the requirements set out in subsections (2), (3) and (4) are satisfied.
(2)Either or both of the following conditions must be satisfied:
(a)   one or more pharmaceutical substances per se must in substance be disclosed in the complete specification of the patent and in substance fall within the scope of the claim or claims of that specification;
…
(3)Both of the following conditions must be satisfied in relation to at least one of those pharmaceutical substances:
(a)   goods containing, or consisting of, the substance must be included in the Australian Register of Therapeutic Goods;
(b)   the period beginning on the date of the patent and ending on the first regulatory approval date for the substance must be at least 5 years.
(4)The term of the patent must not have been previously extended under this Part.
Meaning of first regulatory approval date
(5)For the purposes of this section, the first regulatory approval date, in relation to a pharmaceutical substance, is:
(a)   if no pre-TGA marketing approval was given in relation to the substance—the date of commencement of the first inclusion in the Australian Register of Therapeutic Goods of goods that contain, or consist of, the substance; or
(b)   if pre-TGA marketing approval was given in relation to the substance—the date of the first approval.”
YAZ is a blister pack which has 4 placebo tablets and 24 active tablets.[5] The active tablets each contain 3 mg of drospirenone and 20 µg of ethinylestradiol (as a betadex clathrate).[6] YAZ is indicated for use as an oral contraceptive; for the treatment of moderate acne vulgaris in women who seek oral contraception and in the treatment of symptoms of premenstrual dysphoric disorder (PMDD) in women who have chosen oral contraceptives as their method of birth control.[7] YAZ was first included in the ARTG on 8 February 2008.[8]
[5] See PRESENTATION and STORAGE CONDITIONS page 22 of the product information for YAZ.
[6] Ibid and DESCRIPTION page 1of the product information for YAZ.
[7] See INDICATIONS page 8 of the product information for YAZ.
[8] See DATE OF FIRST INCLUSION IN THE AUSTRALIAN REGISTER OF THERAPEUTIC GOODS (ARTG) page 23 of the product information for YAZ.
When Bayer’s extension of term was granted, the Commissioner was satisfied that the pharmaceutical substance (3 mg of drospirenone and 20 µg of ethinylestradiol betadex clathrate) was a pharmaceutical substance per se within the meaning of s 70 (2)(a), was disclosed in the patent and it fell within the scope of the claims. The YAZ product is a goods containing or consisting of the pharmaceutical substance included in the Australian Register of Therapeutic Goods (ARTG), s 70(3)(a). The time between the first regulatory approval date for YAZ (8 February 2008) and the beginning of the patent was at least 5 years (s 70(3)(b)). The patent had not previously been extended and the request for the extension was in the approved form (s 70(4) and s 71(1)).
The length of term extension was then calculated based using s 77 which states:
“(1)If the Commissioner grants an extension of the term of a standard patent, the term of the extension is equal to:
(a) the period beginning on the date of the patent and ending on the earliest first regulatory approval date (as defined by section 70) in relation to any of the pharmaceutical substances referred to in subsection 70(2);
reduced (but not below zero) by:
(b) 5 years.
Note: Section 65 sets out the date of a patent.
(2)However, the term of the extension cannot be longer than 5 years.”
The date of the patent is 31 August 2000. The “earliest first regulatory approval date” was taken to be 8 February 2008 based on the YAZ product. When this was reduced by 5 years (s 77(2)) the extension was calculated as 2 years 5 months and 9 days.
I note that there was no opposition to the Extension of Term Request and that extension was granted on 11 June 2009.
The Rectification Request
The Commissioner has the power to amend the Register through the operation of s 191A which reads as follows:
Section 191A.Commissioner’s power to rectify Register

(1) The Commissioner may rectify the Register if the Commissioner is satisfied, on the balance of probabilities, whether on application or otherwise, of any of the following:
(a)       the omission of an entry from the Register;
(b)       an entry made in the Register without sufficient cause;
(c)       an entry wrongly existing in the Register;
(d)      an error or defect in an entry in the Register.
….
(6) An appeal lies to the Federal Court against a decision of the Commissioner:
(a)       to make, or refuse to make, a declaration; or
(b)       to rectify, or not rectify, the Register;
under this section.
The Register includes extensions of term granted under s 70. The process of rectification is governed by regulation 10.7 which is as follows:
“10.7 Rectification of Register
(1) A person applying for rectification of the Register under section 191A of the Act must do so in the approved form.
(2) The Commissioner:
(a) may seek further information from any person for the purpose of considering the application; and
(b) is not required to consider the application while seeking the further information.
(3) The Commissioner must publish a notice of the rectification request in the Official Journal unless the rectification:
           (a) relates to an address included in the Register; or
(b) relates to a name included in the Register and does not relate to a change of identity; or
(c) relates to the title of an invention included in the Register; or
           (d) is to correct an obvious mistake made in the Register; or
           (e) does not materially alter the meaning or scope of an entry in the Register.
(4) However, the Commissioner is not required to publish a notice under subregulation (3) if the Commissioner is satisfied that the rectification should not be made.
(5) If the Commissioner publishes a notice under subregulation (3), the Commissioner must not rectify the Register until the later of:
           (a) 2 months after publishing the notice; and
           (b) if a person requests to be heard in relation to the rectification request—after the person has been heard.”
On 17 August 2020, Bird & Bird made a request to the Commissioner to rectify the Register to correct the extension of term. In that request the Commissioner was made aware of the existence of the patentee’s product YASMIN on the ARTG. YASMIN is a blister pack which has 7 placebo tablets and 21 active tablets.[9] The active tablets each contain 3 mg of drospirenone and 30 µg of ethinylestradiol.[10] YASMIN is indicated for use as an oral contraceptive.[11] YASMIN was first included in the ARTG on 6 July 2001.[12]
[9] See PRESENTATION and STORAGE CONDITIONS page 18 of the product information for YASMIN.
[10] Ibid and DESCRIPTION page 1 of the product information for YASMIN.
[11] See INDICATIONS page 5 of the product information for YASMIN.
[12] See DATE OF FIRST INCLUSION IN THE AUSTRALIAN REGISTER OF THERAPEUTIC GOODS (ARTG) page 23 of the product information for YAZ.
A delegate considered the rectification and was satisfied the extension wrongly relied upon the existence of YAZ on the ARTG because an earlier pharmaceutical substance existed on the ARTG. The delegate notified Bayer that a rectification of the Register would be advertised, and the patentee requested to be heard under Reg 10.7(5)(b). I note that, in correspondence, the delegate’s position was based upon the conclusion reached in Searle and Ono,[13] which were decisions of the Commissioner for the situation where two substances within the scope of the patent had been included in the ARTG at different times. The delegate in Searle concluded that such an extension had to be based upon the earliest included good on the ARTG, as did the delegate in Ono. I note that, since the hearing, Beach J issued a decision on Ono overturning the delegate’s decision,[14] where he found the relevant first inclusion on the ARTG does not extend to inclusions for goods made by third parties, such as competitors of the patentee.[15] However, since the hearing for the present matter, the decision in Merck Sharp & Dohme Corp. v Sandoz Pty Ltd[16] has also issued, providing guidance for circumstances like the current case where both goods are the patentee’s.
[13] Re: G.D.Searle LLC [2008] APO 31; Ono Pharmaceutical Co., Ltd. et al [2020] APO 43.
[14] Ono Pharmaceutical Co., Ltd. et al [2020] APO 43.
[15] Ono Pharmaceutical Co., Ltd v Commission of Patents [2021] FCA 643.
[16] [2021] FCA 947.
Consideration
Firstly, there is no dispute that the patentee’s earlier goods, YASMIN, falls within the scope of the claims. This is because a generic form of YASMIN called ISABELLE was the subject of an infringement case in Bayer Pharma Aktiengesellschaft v Generic Health Pty Ltd where Jagot J found:[17]
“Isabelle is a generic form of Yasmin. Isabelle was Registered on the ARTG based on bioequivalence with Yasmin (that is, the relevant molecule is the same, 3 mg [drospirenone] and 30 µg [ethinylestradiol]).
[17] [2017] FCA 250 at [215].
Her Honour also found that ISABELLE infringed claim 3 and claim 11.[18] This finding was not overturned on appeal.[19] It follows that the pharmaceutical substance of YASMIN is disclosed in the patent and falls within the scope of the claims of the patent.
[18] [2017] FCA 250 at [106].
[19] See Bayer Pharma Aktiengesellschaft v Generic Health Pty Ltd (No 2) [2013] FCA 279; Generic Health Pty Ltd v Bayer Pharma Aktiengesellschaft [2014] FCAFC 73 with special leave refused in Generic Health Pty Ltd v Bayer Pharma Aktiengesellschaft [2014] HCATrans 261.
The patentee noted that YAZ uses 20 µg of ethinylestradiol as a betadex clathrate, while YASMIN used 30 µg of ethinylestradiol, and that YAZ had a pack of 24 active tablets whereas YASMIN has a pack of 21 active tablet. Furthermore, the patentee submitted that YASMIN is not indicated for the treatment of moderate acne vulgaris in women who seek oral contraception, or in the treatment of symptoms of PMDD in women who have chosen contraceptives as their method of birth control. The patentee did not contend that YASMIN was not disclosed in the patent or fall within the scope of the claims, but instead argued that it was a different pharmaceutical substance per se and that it should not be considered the substance referred to in s 70(3) or s 70(5)(a). They contended that the substance meant, by construction of the Act, the pharmaceutical substance specified in the application for the extension of term.
The patentee submitted that the purposive approach to statutory construction required determining the underlying purpose, or object, that the legislation intended to achieve. The patentee referred to Project Blue Sky v Australian Broadcasting Authority [1998] FCA 28; 194 CLR 355, at [69] (citations omitted):
“The primary object of statutory construction is to construe the relevant provision so that it is consistent with the language and purpose of all the provisions of the statute. The meaning of the provision must be determined ‘by reference to the language of the instrument viewed as a whole’. In Commissioner for Railways (NSW) v Agalianos, Dixon CJ pointed out that ‘the context, the general purpose and policy of a provision and its consistency and fairness are surer guides to its meaning than the logic with which it is constructed’. Thus, the process of construction must always begin by examining the context of the provision that is being construed.”
The patentee also referred me to the Explanatory Memorandum and the Second Reading Speech of the Intellectual Property Laws Amendment Act 1998 (Cth), which introduced the current extension of term scheme in the Act. The patentee submitted that the purpose of the extension of term provisions was to restore the time lost to patentees prior to gaining marketing approval, and compensate the patentee for the additional time, expense and difficulty in developing and commercialising a “new drug”.
Section 70(2) makes it clear that a patent can disclose and claim one or more pharmaceutical substances (emphasis added). However, the patentee submitted that section 70(3) requires that “at least one of those pharmaceutical substances” (emphasis added) must be “the substance” (emphasis added) in goods on the ARTG and then the date restriction of s 70(3)(b) refers to the first regulatory approval date for the substance. The patentee argued that the substance is that specified in the application for the extension of term. This was argued because s 71 makes reference to s 70(3). Section 71 discusses the extension of term application itself:
Form and timing of an application
Form of application
(1) An application for an extension of the term of a standard patent must:
(a) be in the approved form; and
(b) be accompanied by such documents (if any) as are ascertained in accordance with the regulations; and
(c) be accompanied by such information (if any) as is ascertained in accordance with the regulations.
For this purpose, document includes a copy of a document.
Timing of application
(2) An application for an extension of the term of a standard patent must be made during the term of the patent and within 6 months after the latest of the following dates:
(a) the date the patent was granted;
(b) the date of commencement of the first inclusion in the Australian Register of Therapeutic Goods of goods that contain, or consist of, any of the pharmaceutical substances referred to in subsection 70(3), as worked out under subsection 70(5A) (if applicable);
Notwithstanding that reference, I note the calculation of term of extension is specified in s 77 and that section refers to s 70(2). On this point, the patentee submitted that the reference to s 70(2) in s 77(1)(a) is to any of the pharmaceutical substances referred to in subsection 70(2). However, I note that this section clearly states the earliest first regulatory approval date. This, in my view, does indeed allow there to be multiple pharmaceutical substances and multiple approval dates in the ARTG for goods that contain that substance; however, the extension is calculated based on the first of all relevant ARTG approval dates.
Since the hearing on the current case, Jagot J issued her decision on Merck Sharp & Dohme Corp. v Sandoz Pty Ltd (MSD).[20]In that decision, her Honour was faced with very similar circumstances to the current case. Two pharmaceutical substances within the meaning of s 70(2), one being sitagliptin on its own and the other being sitagliptin/metformin, were claimed and disclosed in Merck Sharp & Dohme Corp’s patent. Both the goods, sitagliptin and sitagliptin/metformin were the owned by the patentee in that case. Sitagliptin was included in the ARTG first on 16 November 2006, and the sitagliptin/metformin substance was included later, on 27 November 2008. The extension of term had been based on goods containing sitagliptin/metformin, which satisfied s 70(3), having been included on the ARTG more than five years from the date of the patent. However, goods containing sitagliptin alone were listed on the ARTG less than five years from the date of the patent.[21] On Her Honour’s construction the Act does not operate by reference to a nomination or selection of a pharmaceutical substance by the patentee, and that the extension is based on what is, in fact, the “earliest” inclusion on the ARTG. With Her Honour saying:
“As recognised in Ono, for practical purposes, however, it is for the patentee to identify a pharmaceutical substance which satisfies s 70(2) and (3) and which is the subject of a first inclusion in the ARTG which enables satisfaction of s 71(2)(b). In this sense only, there is a nomination or selection of a pharmaceutical substance by a patentee. But the statutory scheme does not operate by reference to a nomination or selection of a pharmaceutical substance by a patentee. It operates by reference to the facts. There either is or is not a pharmaceutical substance per se disclosed and claimed in the patent for the purposes of s 70(2). There either is or is not goods containing or consisting of that substance included in the ARTG where the period beginning on the date of the patent and ending on the first regulatory approval date for the substance is at least five years for the purposes of s 70(3). The patent either has or has not been previously extended as referred to in s 70(4). The application for the extension of term either is or is not made within six months of the dates specified in s 71(2). The nomination or selection of a pharmaceutical substance by the patentee cannot affect these objective facts.” [22]
[20] [2021] FCA 947.
[21] Ibid at [19].
[22] Ibid at [65].

Jagot J went on to discuss that, when one pharmaceutical substance disclosed and claimed in a patent is included on the ARTG within 5 years of the date of the patent and another pharmaceutical substance disclosed and claimed in a patent is included on the ARTG more than 5 years after the date of patent, that would result in the term of the extension being zero.[23] Based on those reasons, Jagot J, concluded that MSD’s extension would be zero and she made orders to amend the Register under 192(2)(b).[24]
[23] Ibid at [92]-[93].
[24] Ibid at [96].
The patentee was asked for further submissions following the handing down of MSD.[25] The patentee did not dispute that the decision was relevant to the issues arising in this matter but noted that the decision was on appeal[26] and requested that I either to wait until the appeal had been determined to issue my decision, or, if an adverse decision was to be issued, that I allow 28 days before rectification of the Register occurred.
[25] Merck Sharp & Dohme Corp v Sandoz Pty Ltd [2021] FCA 947.
[26] See VID517/2021.
While Ono was overturned on appeal since, inter alia, the earlier good was not the patentee’s good,[27] in the current case there is no third party and so Jagot J’s approach in MSD applies. Jagot J also made this distinction between MSD and Ono.[28] The issue here is whether the patentee can choose a later inclusion of a goods in the ARTG to rely on for the purpose of their request for an extension of term, or whether the Act only allows for an extension to be based on the earliest inclusion of any pharmaceutical substance disclosed and claimed by the patent.
[27] Ono Pharmaceutical Co., Ltd v Commission of Patents [2021] FCA 643.
[28] [2021] FCA 947 [55].
The patentee’s argument that the substance is to be construed as the substance referred to in the application for the extension of time is akin to making a nomination or selection of a pharmaceutical substance and, given Jagot J’s comments, cannot succeed.
In my view, given the facts of the current case, Jagot J’s findings in MSD cannot be ignored, or relevantly distinguished. The inclusion in the ARTG for YASMIN was made by the patentee, and it was included earlier than YAZ. The date of inclusion of YASMIN on the ARTG was 6 July 2001, this is less than 5 years after the date of the patent under s 70(3) and would lead to an extension of zero under s 77.
Conclusion
The Extension of Term is an incorrect entry in the Register. Following the appeal period of 28 days, I direct that the Register be rectified to indicate the patent term expired on 31 August 2020.
Keith Wagg
Delegate of the Commissioner of Patents