Celltrion, Inc. v. Genentech, Inc.

HCA 1873/2013

IN THE HIGH COURT OF THE

HONG KONG SPECIAL ADMINISTRATIVE REGION

COURT OF FIRST INSTANCE

ACTION NO. 1873 OF 2013

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DECISION

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Introduction

1.Genentech Inc. (“Genentech”) makes two applications under sections 102 and 103 of the Patents Ordinance, Cap.514 (“the Ordinance”) in respect of its Hong Kong Standard Patent No.1048260 (“the Patent”) titled “Dosages for Treatment with Anti-ErbB2 Antibodies”, the validity of which is under attack in these proceedings.

2.First, by its summons dated 23 July 2014 (amended with leave on 29 June 2016) (“the 1^st Summons”), Genentech applies to amend the claims of the Patent in the manner shown in the draft annexed to the 1^st Summons.

3.Second, by another summons dated 29 August 2014 (“the 2^nd Summons”), Genentech applies to amend the specification of the Patent in the manner shown in the draft annexed to the 2^nd Summons.

4.By way of background, Celltrion, Inc. (“Celltrion”) instituted these proceedings in October 2013 for an order that the Patent be revoked on the grounds that it lacks novelty and an inventive step. The Patent was granted on 13 March 2008 on the basis of a PRC patent (Chinese Patent No.ZL00814590.3) granted on 17 December 2008 (“the PRC Patent”). The PRC Patent was declared invalid by the Patent Re-examination Board of the State Intellectual Property Office of the PRC.

5.Section 102 of the Ordinance is available to Genentech to apply for amendments to be made to the specifications of the Patent when its validity is put in issue. Section 103 confines the scope of such amendments. In gist, no amendments under section 102 is allowed if it extends the subject-matter disclosed in the application as filed or extends the protection conferred by the patent.

6.Celltrion and Genentech made a joint application for a consent order, among other matters, that Celltrion shall discontinue this action forthwith with no order as to costs including these applications upon its undertaking that it shall not oppose or otherwise contest these applications. Master Ho made such a consent order on 2 February 2016 accordingly.

7.Thus, these applications are uncontested and Celltrion did not appear at this hearing. Mr Lau representing the Registrar of Patents attended the hearing to render assistance for which this court is thankful.

The applications

8.These applications are supported by the affirmation of Diane L. Marschang filed on 23 July 2014 (the 1^st Summons) and the Affidavit of Chu Monique and the second Affidavit of Evans Anthony Clinton Dudley (the 2^nd Summons).   

9.Madam Chu is a Chartered Patent Attorney employed by Marks & Clerk, a firm of patent and trade mark attorneys. She explains the nature of the proposed amendments in the following terms.

10.In regard to the 1^st Summons, the proposed amendments seek to limit the claims to the use of the huMab4D5-8 anti-ErbB2 antibody to treat patients diagnosed with breast cancer characterized by the overexpression of ErbB2 receptor by intravenous injection on a three weekly dosage regimen comprising an initial dose of 8 mg/kg and subsequent doses of 6 mg/kg given every three weeks.

11.With respect to the 2^nd Summons, the proposed amendments merely seek to correct a number of translation errors and typographical mistakes in the specifications.

12.Madam Chu confirms that the proposed amendments in the 1^st and 2^nd Summonses do not fall foul of section 103. The Registrar holds the same view.

13.I have gone through the proposed amendments myself. Those relating to the 1^st Summons largely consist of deletions. I am satisfied that the conclusion of Madam Chu and the Registrar cannot be faulted and it is not necessary for me to go into the details of the proposed amendments for present purposes. 

14.Then I proceed to consider whether this court should exercise the discretion to allow such proposed amendments. Both Mr Lau and Mr Clark, for Genentech, have helpfully drawn to my attention the relevant principles governing the exercise of such discretion. Mr Lau refers to several English authorities decided before the UK Patents Act was amended in 2007. Mr Clark points out that by reason of the amendment, namely, the introduction of a new subsection to section 75 of the Patents Act 1997[1], the English courts have dismissed considerations formerly considered relevant to the discretion to allow amendments such as conduct of the patentee as no longer relevant: Markem v Zipher [2009] FSR 1 at §219 per Floyd J.

15.Mr Clark goes on to submit that the Australian cases would be more pertinent. The Australian courts also apply the English pre-amended patent law as with Hong Kong and they nevertheless take a more relaxed approach to applications for amendments of patents.

16.Mr Clark contends that in particular the Australian courts are more tolerant of delay and delay alone cannot be fatal to an application for amendments. There has to be found improper conduct or resultant detriment caused to a particular person or the public more generally: Apotex Pty Ltd v Les Laboratories Servier (No.2) and Ors. (2009) 83 IPR 42 per Bennett J. and Bristol-Myers Squibb Co and Anor. v Apotex Pty Ltd 87 IPR 516 per Yates J.

17.I find the following oft-cited dictum of Aldous J in Smith, Kline and French Laboratories Ltd v Evans Medical Ltd [1989] F.S.R. 561 at p.569 to be instructive:

“First, the onus to establish that amendments should be allowed is on the patentee and full disclosure must be made of all relevant matters. If there is a failure to disclose all the relevant matters, amendment will be refused. Secondly, amendment will be allowed provided the amendments are permitted under the Act and no circumstances arise which would lead the Court to refuse the amendment. Thirdly, it is in the public interest that amendment is sought promptly. Thus, in cases where a patentee delays for an unreasonable period before seeking amendments, it will not be allowed unless the patentee shows reasonable grounds for his delay. Such includes cases where a patentee believes that amendment was not necessary and had reasonable grounds for that belief. Fourthly, a patentee who seeks to obtain an unfair advantage from a patent which he knows or should have known should be amended, will not be allowed to amend. Such a case is where a patentee threatens an infringer with his unamended patent after he knows or should have known of the need to amend. Fifthly, the court is concerned with the conduct of the patentee and not with the merit of the invention.”

18.In my view, this remains good law in Hong Kong in the absence of the corresponding change in the Ordinance. I too agree with Mr Clark that this court has to take into account the whole circumstances of this matter and cannot just focus on the issue of delay and determine these applications on that basis.

19.It is clear that the lateness of this application should cause some concern. The Patent was granted in March 2009, this action was commenced in October 2013 and the 1^st Summons was taken only in July 2014.

20.In this connection, Madam L. Marschang, Principal Patent Counsel of Genentech, in her affirmation seeks to give an explanation of the delay. In summary, first, Genentech believed in the validity of the PRC Patent and erroneously thought its validity would be similarly upheld in Hong Kong. Thus, it saw no need to amend the Patent. Second, in the absence of any other marketing approval granted for trastuzumab or any other anti-ErbB2, Genentech has not found it necessary to consider enforcement action and hence did not reconsider carefully the validity of the Patent in the context of Hong Kong law. Lastly, she confirms that since the grant of the Patent, no threat of enforcement action has ever been made in Hong Kong or elsewhere.

21.I am not impressed with the explanation. Nevertheless, I bear in mind the lack of any unfair advantage obtained by Genentech by the use of the Patent and any complaint of detriment arising from the delay, coupled with the fact that neither Celltrion nor the Registrar of Patents opposes these applications, I am minded to accede to allow the proposed amendments despite the delay.

Conclusion and Dispositions

22.For the reasons given, I am of the view that the proposed amendments do satisfy the requirements of sections 102 and 103 of the Ordinance and, looking at this matter in the round, I am persuaded that this court should exercise the discretion to allow amendment. With the agreement of the Registrar of Patents, I make the following orders to dispose of the 1^st and 2^nd Summonses:

1) Genentech do have leave to amend the claims of the Patent in the manner as annexed to the 1^st Summons as amended;

2) Genentech do have leave to amend the specification of the Patent in the manner as annexed to the 2^nd Summons;      

3) Genentech do within 28 days file a sealed copy of this order with the Patents Registry;

4) There be no order as to costs between Celltrion and Genentech in respect of the 1^st and 2^nd Summonses;

5) Genentech do pay the Registrar of Patents a sum of HK$12,940.00 as its agreed costs of the 1^st and 2^nd Summonses; and

6) There be liberty to apply.

The plaintiff, represented by Bird & Bird, absent

Mr Douglas Clark, instructed by Anthony Evans & Co, for the defendant

Mr Derek Lau, Senior Solicitor (Patents Registry) for the Registrar of Patents