Astrazeneca AB v Ranbaxy (Malaysia) Sdn Bhd

Tan Sze Yao AR:

[1] This is an application by the plaintiff to strike out certain references and paragraphs in, inter alia, the Defence and Counterclaim pursuant to Order 18 Rule 19(1) of the Rules of Court (Cap 322, R 5, 2006 Rev Ed) (“Rules of Court”). According to the plaintiff, these references and paragraphs put into issue certain claims and patents belonging to the plaintiff for which the plaintiff had not, in the first place, brought any infringement proceedings against the defendant.

[2] The plaintiff filed the present suit against the defendant for, inter alia, a declaration that claims 1, 2, 3, 11 and 12 of the plaintiff’s Singapore Patent No. 49283 (“SG 49283”) would be infringed by the defendant’s “intended acts to import and/or keep whether for disposal or otherwise and/or dispose of and/or offer to dispose of and/or make and/or use” certain pharmaceutical products in Singapore, which products the defendant had applied to the Singapore Health Sciences Authority for the grant of product licences pursuant to the Medicines Act (Cap 176, Rev Ed 1985) (“Medicines Act”). Subsequently, the defendant filed its Defence and Counterclaim and Particulars of Objection against Singapore Patent Nos. 49283, 32642 and 32641 (“Particulars of Objection”, with the latter two patents referred to henceforth as “SG 32642” and “SG 32641” respectively). In both its Defence and Counterclaim and Particulars of Objection, the defendant put in issue and challenged the validity of SG 32641, SG 32642 and claims 4, 5, 6, 7, 8, 9, 10, 17 and 18 of SG 49283.

[3] The plaintiff took exception to the defendant’s pleadings and brought this application for striking out the following (collectively referred to as “the disputed pleadings”):

(a) all references to claims 4 to 10 and claims 17 to 18 of SG 49283 in paragraph 12 of the Defence;

(b) paragraphs 17, 18 and 19 of the Defence, which make reference to SG 32642 and SG 32641 and claim invalidity of the same;

(c) paragraphs 22 and 23 of the Counterclaim, which repeat paragraph 18 of the Defence and claim that SG 32642 and SG 32641 are invalid;

(d) all references to SG 32642 and SG32641 in paragraphs 24 and 25 of the Counterclaim, which claim invalidity of the same;

(e) paragraphs 16 to 23 of the Particulars of Objection, which refer to and claim invalidity of claims 4 to 10 of SG 49283;

(f) all references to claims 13 to 16 of SG 49283 in paragraphs 25 and paragraphs 27 to 33 of the Particulars of Objection; and

(g) paragraphs 34 to 88 of the Particulars of Objection, which refer to and claim invalidity of SG 32642 and SG 32641.

[4] The basis for the plaintiff’s striking out application appears to be all four grounds enumerated under Order 18 Rule 19(1) of the Rules of Court, namely that the disputed pleadings: (a) disclose no reasonable defence and/or cause of action; (b) are frivolous or vexatious; (c) may prejudice, embarrass or delay the fair trial of the action; and/or (d) otherwise comprise an abuse of process of the Court.

[5] In its submissions, the defendant argues that “the court should allow the [d]efendant’s Defence and Counterclaim in respect of claims 4 – 10 of SG 49283 … there is a risk of the [d]efendant being estopped from raising the same grounds of invalidity if the [p]laintiff takes out another infringement action in respect of its other claims in SG 49283 which are not expressly pleaded”. Elsewhere in its affidavit evidence, the defendant also contends that:

[6] The plaintiff responds to this argument by reiterating the principle that an action which seeks to litigate points which should have been brought forward (but were not) in previous proceedings may be struck out as being an abuse of process of the court. According to the plaintiff, authority for this comes from the Court of Chancery case of Henderson v Henderson [1843] 3 Hare 100 (“Henderson”), endorsed by our courts in Lee Hiok Tng (in his personal capacity) v Lee Hiok Tng (executors and trustees of the estate of Lee Wee Nam, decd) [2001] 1 SLR(R) 771. In Henderson, Vigram VC had stated at 115:

[7] In the present case, the plaintiff asserts that the defendant is premature in seeking to take issue with claims 4, 5, 6, 7, 8, 9, 10, 17 and 18 of SG 49283, which claims the plaintiff never alleged would be infringed by the defendant. It is tempting to agree with the plaintiff’s submission that “it does not behoove the [d]efendant to waste the time and resources of the Court and to oblige the [p]laintiff to defend the validity of the said claims which have not been asserted against the [d]efendant”, bearing in mind the proper recourse countenanced by the words of Vigram VC above.

[8] However, when one reads the language of s 82(1)(a) of the Patents Act (Cap 221, 2005 Rev Ed) (“the Patents Act”) carefully, some uncertainty arises. From the provision, it appears that the defendant has every right to put into issue the validity of SG 49283 in its Defence vis-à-vis the infringement proceedings instituted against it by the plaintiff:

Unfortunately for the defendant, however, the intuitive reading of the statute here cannot be maintained. As is well known by those in the industry, there are two types of claims that might subsist in a single patent: independent claims and dependent claims. Independent claims stand alone and do not have to be read with other claims in order to be properly understood or interpreted. Dependent claims, on the other hand, take as their point of departure another claim (or claims) within the same patent, and include all of the limitations of the claim or claims from which they depend.

[9] A brief survey of the additional claims in SG 49283 that the defendant is seeking to invalidate reveals some of the claims to be independent and others to be dependent. Regardless, it is trite patent law that even where an independent claim is rendered invalid, a claim dependent therefrom may still be valid and enforceable. In other words, each claim of a patent requires a separate validity analysis. Accordingly, I am unable to accept to the defendant’s reasoning in seeking to put into issue claims 4, 5, 6, 7, 8, 9, 10, 17 and 18 of SG 49283. It is justified in putting into issue the validity of the claims as indicated by the plaintiff in the Statement of Claim, but claims beyond that are barred by the fact that even within a single patent, individual claims have to be assessed separately. By virtue of claim independence and as a matter of logic, the act of putting the validity of claim 4 into issue, by way of example, cannot in any way function as a defence to any alleged and/or proposed act of infringement with respect to claim 1.

[10] Separately, it should be noted that the plaintiff’s reservation of right to “assert any other claims of SG 49283 … in the event that more information is obtained regarding the [d]efendant’s products which are the subject of this suit” is by no means inconsistent with its own argument that a party should bring forward its whole case in a timely fashion, lest it run the risk of having erstwhile points raised at a later juncture struck out. At present the plaintiff has put into issue all the claims of SG 49283 which it sees the defendant’s conduct as potentially infringing; should anything more come to light hereafter, the question of whether the plaintiff may have its subsequent claims under SG 49283 added via court sanction or struck out shall properly be decided in another forum. For now, for this and reasons stated above, the defendant’s pre-emptive attempt to invalidate claims 4, 5, 6, 7, 8, 9, 10, 17 and 18 of SG 49283 appears to be out of order. I will deal with the general principle that counterclaims are claims in their own right shortly.

[11] Finally, the defendant submits that “Singapore is just one of the many jurisdictions that this case is being litigated in” and that the plaintiff was at all times sufficiently apprised of all the necessary information relating to the defendant’s product to enable it to frame its claim comprehensively, at least in respect of SG 49283. While I appreciate the logic behind this sentiment, which agitates for a disavowal of the plaintiff’s reservation of right evinced in [10] above, no evidence has been led on this point and I make no finding thereon.

[12] Order 15 Rule 2(1) of the Rules of Court makes clear that “a defendant in any action who alleges that he has any claim or is entitled to any relief or remedy against a plaintiff in the action in respect of any matter (whenever and however arising) may, instead of bringing a separate action, make a counterclaim in respect of that matter” (emphasis added). On the face of things, therefore, the defendant appears vindicated in including the disputed pleadings in its Defence and Counterclaim.

[13] The statutory regime governing patents, however, employs strict language to bar this. The relevant provisions from the Patents Act are reproduced here:

[14] The defendant argues that s 82(1) of the Patents Act “is not exhaustive in setting out all the instances where the invalidity of a patent may be put in issue … [it only] states that ‘the validity of a patent may be put in issue’ … [and] does not exclude the issue of invalidity from being put in issue in other instances”. But a straightforward parsing of s 82 as a whole indicates this argument to be untenable. Section 82(2) specifically states that “[t]he validity of a patent may not be put in issue in any other proceedings and, in particular, no proceedings may be instituted (whether under this Act or otherwise) seeking only a declaration as to the validity or invalidity of a patent” (emphasis added). The phrase “any other” in s 82(2) has meaning only relative to the list manifested in s 82(1). No other interpretation makes sense.

[15] The same approach was taken by Jacob J in Organon Teknika Limited v F. Hoffmann-La Roche AG [1996] FSR 383 (“Organon”), a case that counsel for both sides are citing to me (selectively, I may add) and which deals with the equivalent provision under English law. In the interests of clarity, I cite the entire relevant passage from pp385-386 of Organon here:

Counsel for the plaintiff submit that the holding in Organon makes clear that as long as the declaration sought by the defendant is premised on a basis that falls outside the list circumscribed by s 82(1), there should be no other avenue for the defendant to put the validity of the plaintiff’s patents into issue. To this, the defendant has two responses: one, it has properly sought a declaration of non-infringement under s 78 of the Patents Act, pursuant to the ground specified in s 82(1)(c); and two, it has sought a declaration for non-infringement under the court’s inherent jurisdiction, in much the same way that was countenanced in Organon.

[16] I pause for the moment to note that like Jacob J, I find it difficult to read the language used by s 82(2) as allowing questions of validity to arise in a claim for declaration of non-infringement pursuant to the inherent jurisdiction. The wording in the statute is specific, and there is only so much latitude that judicial innovation permits. Notwithstanding this, it appears to me that declarations of non-infringement pursuant to the inherent jurisdiction and declarations of non-infringement under s 78 of the Patents Act are somewhat different animals. As was held by Lewison J in Nokia Oyj v IPCom GmbH & Co KG [2010] EWHC 3249 (Pat) at paragraph 6,

Accordingly, since a declaration of non-infringement pursuant to the inherent jurisdiction would entail only a declaration vis-à-vis non-future and non-hypothetical events, that manner of declaration cannot be what the defendant is seeking in its pleadings here, since no explicit act of alleged infringement has actually taken place as yet. Indeed, that the defendant is making arguments based on the court’s inherent jurisdiction as only an afterthought is indicated nowhere better than the defendant’s doggedness in seeking to avail itself of the s 78 procedure, which procedure I will go into shortly from [21] below. I will only note for now that at paragraph 7 of its submissions, the defendant states unequivocally that they have prayed for “a declaration of non-infringement under s 78 of the Patents Act”.

[17] Separately, counsel for the defendant further attempt to elude the unequivocal language in s 82(2) by stating that it has included in its pleadings prayers asking for the revocation of the claims and patents contained within the disputed pleadings. By including prayers seeking the revocation of SG 32642, SG 32641 and claims 4, 5, 6, 7, 8, 9, 10, 17 and 18 of SG 49283, the defendant appears convinced that it has sidestepped the statutory restriction in s 82(2). The rationale here, at least according to the defendant, is that s 82(2) bars proceedings that only seek a declaration of validity or invalidity; proceedings that seek a declaration along with revocation fall outside the purview of the limits countenanced by s 82(2). Therefore, by the defendant’s reckoning, all that is left for s 82(2) to apply to is a very specific variety of mischief, given the ease with which most litigants may elide the fetters of the provision. According to the defendant, s 82(2) is to apply only in situations where the patent in question is not yet registered. In support of this contention, counsel for the defendant cite to me the case of Arrow Generics Ltd v Merck & Co Inc [2007] EWHC 1900 (Pat) (“Arrow”), which involved the plaintiff seeking a declaration as to its right to make and sell its own product despite the existence of s 74(2) of the United Kingdom Patents Act 1977 (“the UK Patents Act”), which is in pari materia with s 82(2) of the Patents Act.

[18] At paragraphs 53-55 of his judgment in Arrow, Kitchin J stated:

[19] Accordingly, Arrow stands only for the principle that our s 82(2), like s 74(2) of the UK Patents Act, does not apply where the patent in question has not yet been properly registered; such a patent application falls outside the scope of the provision, applying as it does only to properly registered patents. Arrow does not stand for the principle that s 82(2) applies only to the very specific niche category of yet-to-be-registered patent applications. The same result in both cases, but reached in importantly different ways. Without this alleged raison d’être justifying the existence of s 82(2), therefore, the defendant’s reasoning appears to be premised on an otiose statutory provision, which in my view cannot have been Parliament’s intention.

[20] In any case, by concentrating only on the latter half of s 82(2), the defendant appears to have been misguided from the start. As can be seen from the excerpt at [13] above, the provision may be divided into two halves: a general rule – “[t]he validity of a patent may not be put into issue in any other proceedings …” – and an elaboration, viz, “… in particular, no proceedings may be instituted (whether under this Act or otherwise) seeking only a declaration as to the validity or invalidity of a patent”. By simply focusing on the elaborative portion of s 82(2), the defendant fails to recognize that the first portion has already decisively disposed of the issue: having put the validity of the plaintiff’s unasserted patents in issue on a basis falling outside of those enumerated in s 82(1), the defendant has invariably run afoul of the general rule in s 82(2). Without more, this alone is fatal to the defendant’s attempt to include the disputed pleadings.

[21] I return now to the outstanding issue of the declaration of non-infringement that the defendant claims that it has properly sought under s 78 of the Patents Act, touched on earlier at [16]. In its Defence and Counterclaim, the defendant sets out prayers in the alternative for declarations that SG 49283, SG 32641 and SG 32642 will not be infringed by the defendant’s acts undertaken to procure the issuance of product licenses by the Singapore Health Sciences Authority. The issue of whether the validity of the plaintiff’s patents may be put into issue via a declaration pursuant to the court’s inherent jurisdiction having already been dealt with, I now set out s 78 of the Patents Act in full:

[22] From the above, it is easy to appreciate that the defendant must first apply to the plaintiff in writing for a written acknowledgement of the desired declaration of non-infringement, and also furnish the plaintiff with full particulars, in writing, of the defendant’s intended (and potentially infringing) acts.

[23] In this connection, the defendant submits that the notices it served on the plaintiff pursuant to compliance with s 12A(3)(a) of the Medicines Act are sufficient to satisfy the notice requirements of s 78(1)(a) of the Patents Act. The relevant portions of s 12A of the Medicines Act are reproduced as follows:

[24] Comparing the language of s 78(1)(a) of the Patents Act and s 12A(3)(a) of the Medicines Act, it becomes immediately apparent that the former provision demands substantially more than the latter. Section 78(1)(a) of the Patents Act requires the furnishment of “full particulars in writing of the [defendant’s proposed infringing] act in question”, whereas s 12A(3)(a) requires only delivery of a “notice in the prescribed form” of the defendant’s application. This “prescribed form”, detailed at s 12A(2) of the Medicines Act, countenances only information such as the name and particulars of the proprietor of the potentially infringed patent (in this case, the plaintiff) and the defendant’s own opinion as to whether or not the potentially infringed patent is invalid and/or likely to be infringed. It does not have as its threshold “full particulars” as set out in s 78(1)(a) of the Patents Act, and in theory cannot be said to fulfil the requirements of that provision.

[25] Examining the actual notices received by the plaintiff from the defendant on 13 June 2011, one can see how theory translates into practice. In each of the six notices sent by the defendant to the plaintiff, only the following skeletal details are set out:

(a) application number assigned by the Singapore Health Sciences Authority;

(b) name of defendant’s relevant product;

(c) active substance and strength (in mg);

(d) dosage form;

(e) date of the product licence application filing;

(f) patent number of the plaintiff’s relevant patent;

(g) expiry date of the plaintiff’s relevant patent; and

(h) the defendant’s opinion as to the invalidity of the plaintiff’s relevant patent and the non-infringing nature of its own product.

[26] The above are a far cry from the “full particulars” as required by the language of s 78(1)(a) of the Patents Act. In this connection it is interesting to note that the defendant cites the case of MMD Design & Consultancy Ltd’s Patent [1989] RPC 131(“MMD Design”) in support of the proposition that the rule in s 71(1)(a) of the UK Patents Act (in pari materia with s 78(1)(a) of the Patents Act) should not be interpreted in an “oppressively bureaucratic” way. But the present facts are easily distinguishable from those in MMD Design. In that case, the declaration sought was eventually granted because the applicants “had so clearly and unambiguously described their machine so that no machine falling within that description could reasonably be taken to infringe the claims of the patent” (see MMD Design at p 132). In the present case, however, requests for samples of the defendant’s product to be sent to the plaintiff for inspection appeared to have fallen on deaf ears and the only “full particulars” the plaintiff had to work with were notices issued pursuant to s 12A(3)(a) of the Medicines Act, which notices have already been discussed and found wanting.

[27] The explanation for the lack of response to the plaintiff’s request for samples appears to be that the defendant had not been given sufficient time, and that counsel for the defendant had been “in the midst of taking instructions”. I found this explanation to be somewhat of an afterthought and rather difficult to understand. In the first place, it was the defendant that had set in motion the 45-day time period prescribed under the Medicines (Licensing, Standard Provisions and Fees) Regulations (Cap 176, R 6, 2000 Rev Ed) by initiating service of the notices on the plaintiff. If any party should have been hard-pressed for time under this framework, surely it would have been the plaintiff, which had to take out an application for a court order restraining the defendant’s proposed acts within this stipulated 45-day period.

[28] The defendant contends consistently that the statutory provisions governing the present issues ought not to be construed in an officious manner, and that the reality is that due to worldwide litigation currently extant, the plaintiff is already intimately familiar with the defendant’s product. Consistent with this logic, the defendant contends that the plaintiff should not be permitted to “cherry-pick” its claims as asserted against the defendant – instead, it should be obliged to bring all of its claims at once. Accordingly, the defendant believes that it is justified in seeking to include the disputed pleadings.

[30] In any case, there is at present nothing to stop the defendant from taking out fresh revocation proceedings before the Registrar against the plaintiff, as provided for in s 82(1)(d) of the Patents Act (see above at [13]). Indeed this course of action should arguably have been the one taken by the defendant from the beginning; certainly it would have been preferable to its present attempt to hijack the plaintiff’s suit (which it was responsible for precipitating) for its own revocation agenda.