FEDERAL COURT OF AUSTRALIA

Watson Pharma Pty Ltd v AstraZeneca AB [2012] FCA 200

THE COURT ORDERS THAT:

1.    The proceeding be listed for hearing in respect of the form of the interlocutory orders to be made and such other directions as are necessary at 9.30 a.m. on a date to be determined in consultation with the parties.

Note:    Entry of orders is dealt with in Rule 39.32 of the Federal Court Rules 2011.

THE COURT ORDERS THAT:

1.    The proceeding be listed for hearing in respect of the form of the interlocutory orders to be made and such other directions as are necessary at 9.30 a.m. on a date to be determined in consultation with the parties.

Note:    Entry of orders is dealt with in Rule 39.32 of the Federal Court Rules 2011.

REASONS FOR JUDGMENT

THE APPLICATIONS

1        These reasons for judgment concern interlocutory applications by AstraZeneca AB and AstraZeneca Pty Ltd (together Astra) against Watson Pharma Pty Ltd (Watson Pharma) and Ascent Pharma Pty Ltd (Ascent). In both applications Astra seeks orders, pending the final hearing and determination of the proceedings or other order, restraining Watson Pharma and Ascent from infringing three patents and associated orders to give effect to the restraints on infringement.

BACKGROUND

2        The interlocutory applications against Watson Pharma and Ascent are brought against the background of other proceedings in which Astra sought and obtained interlocutory orders restraining another pharmaceutical company, Apotex Pty Ltd (Apotex), from infringing the same three patents. The two decisions relating to the proceedings between Astra and Apotex are Apotex Pty Ltd v AstraZeneca AB [2011] FCA 1520 per Rares J and Apotex Pty Ltd v AstraZeneca AB (No 2) [2012] FCA 142 per Emmett J.

3        Rares J at [1] explained that Astra has three patents in Australia for what it claims are innovations in relation to rosuvastatin, a compound that is an active ingredient in a drug for treating high blood cholesterol levels and related conditions, marketed by Astra under the name “Crestor” (apparently, the third highest selling product on the Pharmaceuticals Benefits Scheme). At [3] Rares J identified the three patents in a shorthand form as the 051 patent, the 842 patent and the 165 patent. For his part Emmett J identified these patents as the low dose patent, the cation salt patent and the HeFH (for heterozygous familial hypercholesterolemia) patent. Emmett J’s nomenclature relates to the subject of the claims in each of the patents.

4        Claim 1 of the 051 or low dose patent is as follows:

A method of treating a patient suffering from hypercholesterolemia which comprises administration as a starting dose of a single, once daily, oral dose of 5 to 10 mg of [rosuvastatin] or a pharmaceutically acceptable salt thereof, in the form of a pharmaceutical composition.

5        Claim 1 in the 842 or cation salt patent is as follows:

A pharmaceutical composition comprising [rosuvastatin] or a pharmaceutically acceptable salt thereof as the active ingredient and an inorganic salt in which the cation is multivalent, provided that:

(i)    the inorganic salt is not synthetic hydrotalcite; and

(ii)    the counter anion to the inorganic salt is not a phosphate.

6        Claim 1 in the 165 or HeFH patent is as follows:

A method for treating heterozygous familial hypercholesterolemia in a patient suffering heterozygous familial hypercholesterolemia, comprising administering to the patient [rosuvastatin] or a pharmaceutically acceptable salt thereof.

7        Rares J considered Astra’s evidence on infringement and the balance of convenience (which is also in evidence before me in relation to the present applications), and that of Apotex, which included material relevant to Apotex’s claims that the 051 or low dose patent is invalid. At [48] Rares J concluded that the “evidence of Dr Nestel and Dr Williams satisfies me that there is a sufficient prima facie case that, if things remain the same at the trial, AstraZeneca will be able to establish a claim for infringement”. At [50] Rares J dealt with the balance of convenience in these terms:

Each of the parties will suffer some damage to its present position, whether or not an injunction is granted. Nonetheless, it seems to me that the balance of convenience, at the moment, is strongly in favour of maintaining the status quo ante. This is a proceeding in which AstraZeneca, as an innovator, would be irreparably damaged in its ability to exploit its invention for another eight years if it is forced to drop its prices to meet demand over the next seven weeks pending the hearing of the application for further interlocutory relief by the docket judge.

8        At [63] Rares J also made the following comment:

Here, Apotex substantively opposed AstraZeneca’s application. That opposition was based on a deal of evidence and submissions. Apotex was aware that it ran the risk that by doing so I would make an order until further order. The time of the Court is public time. It would be contrary to the ordinary practice I have referred to and to the overarching purpose in Pt VB of the Federal Court of Australia Act to permit Apotex to have the benefit of requiring AstraZeneca to prove its case for interlocutory relief once more on 31 January 2012. I am satisfied that I should grant interlocutory relief as sought until further order.

9        On 31 January and 6 February 2012 the Apotex proceedings came before Emmett J. After explaining the procedural background, Emmett J noted at [13] as follows:

When the matter came before me again on 6 February 2012, I indicated that I would entertain the application by Apotex but would require Apotex to satisfy me why, by reason of the additional evidence now available, I should reach a conclusion different from that reached by Rares J.

10        At [14] Emmett J said:

The injunction granted by Rares J was not specific in relation to the patents that supported it. It was common ground before me that, if I were satisfied that there is a prima facie case of infringement of the Cation Salt Patent, there would be no need to consider whether there is also a prima facie case of infringement of the Low Dose Patent and the HeFH Patent. Nevertheless, it would be necessary to consider any additional evidence as to the balance of convenience, assuming that a prima facie case had been established.

11        Emmett J dealt with the competing submissions about the construction of claim 1 of the 842 or cation salt patent concluding, at [20], that:

…claim 1 requires nothing more than a pharmaceutical composition comprising rosuvastatin, or a pharmaceutically acceptable salt thereof, as the active ingredient, and an inorganic salt in which the cation is multivalent. There is no reference in claim 1 to the inorganic salt being in close proximity or intimate contact or uniformly or thoroughly mixed with the rosuvastatin. Nor is there any wording in claim 1 to which that meaning can be attributed by any process of construction.

12        At [24] Emmett J observed:

The evidence indicates that the term salt is capable of being used in more than one sense, being a narrow or traditional sense in which it refers to the product of reaction of an acid and a base, on the one hand, and a broader compositional sense, in which it refers to a class of compounds made up of cations and anions, such as ferric oxide and titanium dioxide, on the other hand. It is certainly arguable that the Specification indicates that the term salt is used in the latter broader sense. Both the description and various claims expressly state that the counter anion of the inorganic salt may be oxide, amongst other possibilities. That is incompatible with the narrow traditional meaning of the term salt, which excludes the possibility of oxide as an anion. Further, the descriptions and claims also state that the cation may be iron, thereby including in the preferred embodiments iron oxide. There is also no reference in the Specification to an acid-base reaction as a requirement for the formation of a salt.

13        At [28] Emmett J concluded:

…I am not persuaded that the additional evidence, which was not before Rares J, is sufficient to lead to the conclusion that there is not a prima facie case of infringement, assuming that the Cation Salt Patent is valid.

14        Overall, at [46], Emmett J concluded in these terms:

I was not persuaded that any additional evidence adduced by Apotex is of such a character as to lead to the conclusion that the findings of Rares J should be varied. In the circumstances, I concluded that I should not, at this stage, accede to the application by Apotex to vary the terms of the injunction granted on 14 December 2011. However, Astra has commenced proceedings against other generic suppliers of rosuvastatin. Those proceedings are listed for directions for the purpose of considering applications for interlocutory relief on 1 March 2012. Issues similar to those raised in this application will be raised in those proceedings. Accordingly, I considered that the appropriate course was to adjourn the hearing of this application by Apotex to 1 March 2012. If it were not for the fact that those other proceedings were listed for the purpose of considering interlocutory relief, I would have dismissed the present motion with costs. The present motion will be listed for hearing on 1 March 2012 on the basis that it will be treated as a fresh application to vary the orders made by Rares J on 14 December 2011 by reason of any change in circumstances that might arise as a consequence of orders made in the other proceedings.

15        The Apotex proceedings came before me on 1 March 2012. However, by that time, Apotex’s position had changed. Apotex contended that it had changed the coating of its generic rosuvastatin product so as to remove the factual basis for any argument that its coating contained a “salt” in the broader compositional sense described by Emmett J. As Apotex’s new application to vary the injunction by reason of this asserted change in circumstances had not been listed for hearing on 1 March 2011 and Astra was not ready to deal with it, I listed the interlocutory applications in the Apotex proceedings for hearing on 13 March 2012.

16        On 1 March 2012 I heard Astra’s applications for interlocutory relief against Watson Pharma and Ascent, on effectively the same basis as which Astra had sought and obtained interlocutory injunctions against Apotex. Watson Pharma and Ascent opposed any interlocutory orders against them on the basis of their evidence and submissions which were different from and further to those on which Apotex relied. Watson Pharma and Ascent also noted that: - (i) despite their request to be heard at the same time as the Apotex proceedings, the Court had declined to do so, and (ii) due to the different procedural history it would be wrong to approach Astra’s applications against them on the basis that they should satisfy the court why the result should be any different from that reached in the Apotex proceedings; to the contrary, Astra bears the onus of persuading the court that interlocutory relief should be granted. The latter proposition is plainly correct and I proceed on that basis.

17        It is also relevant to note that Astra has commenced proceedings alleging infringement of the three patents against another pharmaceutical company, Actavis Australia Pty Ltd (Actavis). Astra and Actavis resolved the terms of interlocutory orders between themselves, which were made on 1 March 2012. By those orders Actavis has undertaken not to launch any generic rosuvastatin products in Australia in exchange for certain cross-undertakings from Astra including as to damages. An arrangement to the same effect has also been entered into between Astra and yet another pharmaceutical company, Sandoz Pty Ltd (Sandoz).

18        Finally, I note that all of the existing proceedings have been listed for final hearing from 15 October to 2 November 2012.

COMPETING CASES

Overview

19        The parties relied on extensive evidence and written submissions. It is not necessary to refer in detail to all of that material in order to resolve their competing cases for the purpose of the present interlocutory applications.

The 842 or cation salt patent

20        Despite the different evidence and submissions of Watson Pharma and Ascent, it is apparent that the two issues of construction between the parties in respect of the 842 or cation salt patent are the same as those considered by Emmett J and resolved, at least for interlocutory purposes, in Astra’s favour.

21        Astra’s case on infringement of the 842 or cation salt patent depends on the presence of titanium dioxide in the coating of the proposed Watson Pharma and Ascent products (as it did for the Apotex product). Astra contends titanium dioxide is “an inorganic salt in which the cation is multivalent” so that there is threatened infringement of the patent. Watson Pharma and Ascent contend that there is no infringement because: - (i) titanium dioxide is not “an inorganic salt”; to a person skilled in the art (such as Dr Pitman who has given evidence to this effect) a “salt” is the product of the reaction between a base and an acid, and (ii) even if titanium dioxide is “an inorganic salt” it is present only in the coating of the product whereas the invention claimed is a composition complete without any coating (the coating being “an optional addition”); in other words, the salt must be admixed with or in close connection to the agent (rosuvastatin).

22        In addition to Dr Pitman’s evidence, Watson Pharma and Ascent submitted that it should be doubted that the statements in the claims and specification that the counter anion of the inorganic salt may be oxide support the broader construction of “salt”, as the specification is replete with erroneous references and inconsistencies (particularly repeated references to the counter anion being able to be a phosphate when phosphate is expressly excluded from the permissible counter anions on p2.11 of the patent, as well as a meaningless range for the percentage of the agent at p2.20-23). Otherwise, in respect of the asserted admixture or close connection requirement, Watson Pharma and Ascent submitted that its construction was supported by numerous aspects of the specification including that: - (i) p3.14-18 refers to the composition having a good flow rate to assist processing into tablets, (ii) p3.24 refers to the pharmaceutical composition of the invention preferably being formulated into a tablet, (iii) p5.18 refers to the ways in which the pharmaceutical composition of the invention may be prepared, (iv) p6.6 refers to the fact that a tablet coating “may then be applied”, and (v) p6.15 refers to the composition “having a...coating” (not, as Watson Pharma and Ascent put it, “including” a coating). According to Watson Pharma and Ascent these references (as well as Dr Pitman’s evidence) all support a construction in which the “pharmaceutical composition” in claim 1 of the 842 or cation salt patent is the composition irrespective of the subsequent processing into a particular tablet form or application of a coating. Watson Pharma and Ascent also submitted that if Astra’s construction is correct, the effect of it would be to deny the patent any quality of invention. As the specification discloses, before the priority date of the patent, rosuvastatin was a known agent, with a known effect, and the coatings in question were also known and commercially available. Accordingly, the patent as construed by Astra would be obvious and involve nothing inventive at all.

23        For its part Astra relied on the reasons set out in Emmett J’s judgment to support its construction and particularly noted the reference on p6.10 of the specification identifying a coating to tablet weight ratio which treats the coating as part of the composition. As Emmet J put it at [22]-[23] and [25] on this point:

22    The term pharmaceutical composition encompasses all typical dosage forms. Thus, claim 7 of the Cation Salt Patent refers to a pharmaceutical composition that is a tablet or powder. It draws no distinction between the different parts of the tablet, being, for example, a tablet core and a tablet coating. The Specification does not indicate that the coating is something separate from, and not forming part of, the pharmaceutical composition. The language of the Specification suggests that the coating is a feature of the composition. Thus, the Specification states that a feature of the invention is a pharmaceutical composition comprising rosuvastatin, the composition having a ferric oxide light protective coating. That suggests that the coating is part of the composition.

23    On the other hand, the Specification then goes on to state that a further aspect of the invention comprises a method of preparing a stabilised pharmaceutical composition which comprises admixing rosuvastatin with a an inorganic salt in which the cation is multivalent. It states that a yet further aspect of the invention comprises a method of producing a stabilised pharmaceutical composition which comprises incorporating an inorganic salt in which the cation is multivalent in a pharmaceutical composition containing rosuvastatin. The Apotex products do not satisfy that description. Nevertheless, there is nothing in claim 1, or in the consistory clause of the Specification, to say that that is an integer of the invention.

…

25    There is some evidence that both ferric oxide and titanium dioxide may provide a stabilising effect on rosuvastatin, even if they are incorporated as part of the coating of a tablet rather than in its core. Even if the objective of a stabilising effect is to be taken into account in construing the claims, it is arguably present on the construction proposed by Astra. The invention is concerned with the provision of an effect, not the mechanism by which it is produced.

24        Astra also said the submission that its construction leads to the invention being obvious was misconceived. The specification identifies the issue as one of stability. The patent solves the stability problem by selection of an inorganic salt to be added to the composition. Solving that problem by even a mere coating was not obvious.

25        As to the salt argument, and in common with Emmett J, it is certainly arguable that the 842 or cation salt patent uses “salt” in the broader or compositional sense. The arguments mounted by Watson Pharma and Ascent to the contrary are not without some force but it is apparent from the evidence that “salt” can take two meanings. There are also strong indicators in the specification in favour of the broader meaning; indeed, to conclude otherwise would involve finding that the references to the counter anion of the salt possibly being an oxide in the specification are an error. The only basis upon which it might be supposed that these references are an error, apart from the narrower meaning itself which is incompatible with the references, are the inconsistencies and references to phosphate which Watson Pharma and Ascent identified. Neither, in my view, provides a sufficiently persuasive basis to conclude that the construction of salt proposed by Watson Pharma and Ascent should be preferred.

26        As to the admixture argument, it may be that I perceive greater ambiguity than Rares or Emmett JJ in the references to “pharmaceutical composition” in the claims. Nevertheless, it is true that nothing in the claim suggests that the inorganic salt must be mixed or in intimate contact with the agent rosuvastatin. Moreover, construing claim 1 in context, it is apparent (for example) that claim 7 treats the pharmaceutical composition as one that “is a tablet or powder”. In other words, and as Emmet J said, the phrase pharmaceutical composition encompasses all dosage forms. On balance, I am not persuaded to reach a view on this issue different from that reached by Rares and Emmett JJ.

27        It follows that, on the evidence, Astra has established a prima facie case of infringement of the 842 or cation salt patent.

28        Watson Pharma and Ascent argued that the 842 or cation salt patent is invalid on the basis of alleged lack of inventive step and manner of manufacture (see above) and lack of fair basis (an inconsistency in the exclusion of phosphate from the specification and its inclusion in the claims). As to the first two grounds, I accept Astra’s submission that while the issues put forward by Watson Pharma and Ascent are not hopeless, they are by no means of sufficient persuasive force to weigh against the grant of interlocutory relief. As to the lack of fair basis ground, and again as Astra submitted, phosphate is clearly excluded by the consistory style clause commencing at p2.6 of the patent in terms consistent with claim 1. Other references to phosphate in the body of the specification have to be read as subject to the exclusion. The claim does not travel beyond the matter disclosed in the specification. This argument also has force.

29        Watson Pharma and Ascent otherwise argued that damages would be an adequate remedy for infringement and the balance of convenience weighed against Astra. Watson Pharma and Ascent relied on the evidence of Mr Waters, the Managing Director of Spirit Pharmaceuticals Pty Ltd (another company in the Watson Pharma group of which Watson Pharma and Ascent also form part). Mr Waters provided extensive evidence discussing: - (i) that the Watson Pharma and Ascent products (in common with Apotex’s approach) will not be indicated for heterozygous familial hypercholesterolemia, relevant particularly to the 165 or HeFH patent, (ii) the effect of generics first entering the market including first mover or shared first mover advantages, (iii) the capacity for Astra to introduce generics into the market (in respect of which cross-undertakings were suggested), and (iv) the impossibility of assessing losses to Watson Pharma and Ascent. Mr Waters concluded in these terms:

140    Based on the matters discussed above, I expect that an injunction which prevents Watson from entering the market with the Watson rosuvastatin product will have the following effect:

(a)    any first mover advantage or joint first mover advantage would likely be diluted substantially (or even lost altogether) if the time before an injunction is lifted allows other generic manufacturers to “catch up” to Watson, Ascent, Actavis and Apotex;

(b)    separately Watson may lose the advantage of being the first or joint first generic to enter the market because during the pendency of the interlocutory injunction, AstraZeneca may enter the market with its own generic version of rosuvastatin, or license a generic brand. This is consistent with market factors including the size and value of the market, the fact that AstraZeneca has already registered on the ARTG five alternative brands of rosuvastatin, and the past behaviour of originator pharmaceutical companies of which I am aware;

(c)    Watson will not be able to make sales of the product to customers. It is impossible to estimate the amount of damage suffered from losing those sales because of uncertainty in respect of:

(i)    the volume of market (ie market share) that Watson would have obtained;

(ii)    the price at which Watson would have been able to sell the product. This is dependent on a number of unpredictable factors, including Watson’s internal costs, the price at which other generics and the originator are prepared to sell their product, and the relative bargaining power of Watson and the particular customer;

(iii)    the effect of Ascent, Actavis and any other generic manufacturers which may enter the market;

(d)    Watson will be left storing large volumes of stock which it cannot supply to Australian customers. Depending upon the time period until the injunction is lifter, Watson will be forced to either incur storage costs or face the prospect of the entire stock becoming worthless; and

(e)    notwithstanding the effects on Watson as an intending supplier of rosuvastatin, financial benefits which would otherwise accrue to pharmacists due to the reduction in market price (while the amount of reimbursement remains unchanged) will not arise.

141    Alternatively, if Watson is not prevented from entering the market with a generic rosuvastatin product, it will be able to sell its product to customers. If the Court later imposes an injunction requiring Watson to withdraw the product, it will be possible to accurately calculate:

(a)    the volume of product that Watson sold (and thus its share of the total market), from Watson’s internal financial records;

(b)    the volume of product that any other generic has sold, from the generic’s internal financial records;

(c)    the price at which Watson sold each product, from Watson’s internal financial records;

(d)    the price at which any other generic has sold each product, from the generic’s internal financial records; and

(e)    the price at which AstraZeneca’s internal financial records.

142    Once Watson and any other manufacturers have withdrawn their products, there will be no ongoing impact on the volume of AstraZeneca’s sales, as its product/s will be the only available brand/s of rosuvastatin available, thus returning AstraZeneca’s sales, as it product/s will be the only available brand/s of rosuvastatin available, thus returning AstraZeneca to capturing 100% of the rosuvastatin market.

143    Accordingly, based on my experience in the pharmaceutical industry particularly in relation to the introduction of new generic products into the market, for the reasons I have described above I consider that:

(a)    Watson will suffer irreparable harm should it be prevented from entering the market; and

(b)    it will be much more difficult to quantify Watson’s damages on the basis of a hypothetical situation with a high number of unknown variables if it is prevented from entering the market when it should not have been, than it will be to later measure the effect of AstraZeneca’s product entering the market if it should not have been allowed to do so.

30        Although each case must be determined on its own merits and having regard to the particular evidence which is available, it is relevant that this type of evidence was also considered by Rares J in the Apotex proceedings but was not accepted as leading to a conclusion that the balance of convenience weighed against the grant of relief to Astra (which itself relied on the same evidence as to balance of convenience as in the Apotex proceedings). Apotex, of course, is one of the competitors to Watson Pharma and Ascent, and wishes to enter the same market with its own generic rosuvastatin product and obtain for itself the “first mover” advantages which Watson Pharma and Ascent also seek.

31        Without wishing to be seen as discounting the extent or cogency of the evidence on which Watson Pharma and Ascent relied in respect of the balance of convenience, the fact is that I share the view Rares J reached that the balance of convenience, fairly overwhelmingly, favours preservation of the status quo pending the final outcome of the proceedings between Astra and the multiple other parties. As Astra submitted: - (i) the proposed trade of Watson Pharma and Ascent is new and, indeed, does not presently exist, (ii) in contrast, Astra has marketed and sold Crestor for five or more years, it being a highly successful product, (iii) the patents are long-standing (sealed in 2004, 2005 and 2007 respectively) and have not been challenged as invalid during their existence until now, (iv) Watson Pharma and Ascent have acted with their “eyes open” and must have known that Astra would seek to enforce its patents (revocation proceedings were not commenced until 23 December 2011), and (v) the relative harm to Astra if no injunction is granted for the threatened infringement would far outweigh the harm Watson Pharma and Ascent will suffer if an injunction is granted. On the evidence I am not persuaded either that damages would be an adequate remedy for Astra (especially given the pressure to which Astra will be subject to reduce prices in the face of the entry of generics into the market and the irreversible impact which Astra will suffer in terms of its market share) or that damages in the case of Watson Pharma and Ascent will be impossible to quantify. It seems to me that the real position is that damages cannot adequately compensate Astra in the circumstances but can adequately compensate Watson Pharma and Ascent, irrespective of any difficulties in quantification.

32        For these reasons I am satisfied that Astra has made good its case for interlocutory relief against Watson Pharma and Ascent based on threatened infringement of the 842 or cation salt patent. At this time I see no reason why the injunctions should not be in the same general form as that which Rares J made. I accept that Astra should give adequate notice to Watson Pharma and Ascent if it proposes to exploit or authorise the exploitation of its patents in respect of rosuvastatin other than by its Crestor product. At this time I see no reason why notice does not sufficiently protect the interests of Watson Pharma and Ascent in this regard. However, and contrary to the agreed position in the hearing that the form of the interlocutory orders could be resolved without hearing further from the parties, both parties indicated by subsequent email that they did wish to be heard if I did not accept their form of the orders. As I do not presently accept the form of orders proposed by Watson Pharma and Ascent the matters will have to be listed for a further hearing about the form of the orders.

33        Given these conclusions about the 842 or cation salt patent I propose to deal with the 051 or low dose patent and the 165 or HeFH patent in summary terms only.

THE 051 AND 165 PATENTS

34        On the evidence I am persuaded Astra has made out a prima facie case of threatened infringement of these patents. As to the 051 or low dose patent, the threatened infringement is the proposed supply of the generic rosuvastatin products in 5, 10, 20 and 40mg dosages in circumstances where, as per s 117(2)(b) of the Patents Act 1990 (Cth), Watson Pharma and Ascent as suppliers would have reason to believe that its generic products would be put to an infringing use. This is clear as to the 5 and 10mg doses. In relation to the 20mg dose there is sufficient evidence about tablet splitting to support the existence of reason to believe that the generic products would be put to an infringing use. The asserted small proportion of tablet splitting activities is also not a material discretionary factor in the overall balance. As to the 40mg dose I am unable to accept Astra’s point about the lack of an express or implied licence. As Watson Pharma and Ascent said, there is no primary infringement of the 051 or low dose patent in respect of the 40mg dosage form. Otherwise I note that the lack of any proposed product information for the Watson Pharma and Ascent generic rosuvastatin products is immaterial. The regulatory context makes it reasonable to infer, at least for present purposes, that Watson Pharma and Ascent will have approved product information for their generic rosuvastatin products which will include a starting dose of 5-10mg consistent with Astra’s approved product information.

35        As to the 165 or HeFH patent, the threatened infringement is the proposed supply of the generic rosuvastatin products in circumstances where Watson Pharma and Ascent as supplier would have reason to believe that its generic products would be put to the infringing use. In summary, the proposed lack of indication for HeFH is not to the point. On the evidence, treating physicians do not identify the disease for which the prescription is required but the compound or brand name. Watson Pharma and Ascent must have reason to believe that their generic products will be used for the treatment of HeFH irrespective of the proposed lack of indication for HeFH. The relatively small number of people with the HeFH version of hypercholesterolemia (1 in 250), as Astra said, involves a very large number of people overall and an equally large amount of product. This consideration does not suggest that injunctive relief should be withheld or modified as Watson Pharma and Ascent proposed.

36        Watson Pharma and Ascent made the following principal points about invalidity of these patents: - (i) claim 1 of the 051 or low dose patent was already disclosed in the 471 patent (published before the priority date of the 051 patent), the only difference between the two being the words “starting dose” in the 051 patent, (ii) the disclosure in the 471 patent is admittedly broader because it refers to a dose range of rosuvastatin of 1 to 100mg but it is plain that the range in the 051 patent of 5-10mg is within that range and thus also disclosed, (iii)  the claimed novelty of the 051 patent is thus “hopeless” given the 471 patent, (iv) the 165 patent also identifies the 471 patent as part of the prior art, (v) the 471 patent discloses the use of rosuvastatin to treat hypercholesterolemia, (vi) the only difference in the 165 patent is the reference to the words “heterozygous familial” but this is beside the point as the 471 patent discloses rosuvastatin as a treatment for all forms of hypercholesterolemia whether genetic or not, and (vii) the HeFH trial and open label study as described in Dr Colquhoun’s evidence also disclosed rosuvastatin as a treatment for heterozygous familial hypercholesterolemia. The written submissions for Watson Pharma and Ascent referred to other alleged novelty depriving publications but their oral submissions focused on these examples, presumably as the best available for interlocutory purposes.

37        For present purposes it is enough that there is sufficient persuasive force in the contrary arguments which Astra put to conclude that these arguments as to invalidity are insufficient to deny Astra relief to which it has otherwise established an entitlement. In summary, those arguments were that: - (i) the 471 patent discloses a wide dosage range for three diseases, only one of which is hypercholesterolemia, and thus does not teach a dose of 5-10mg of rosuvastatin as a treatment for hypercholesterolemia, (ii) the same argument was put and rejected in the re-examination of this patent, and (iii) as explained in the affidavit of Dr Miller, the HeFH trial was a double blind trial (so neither physicians nor patients knew who got what treatment) subject to a strict confidentiality regime and the open label study was for the purpose of ascertaining the safety and efficacy of rosuvastatin as a treatment for HeFH whereas the 165 patent is for a method of treatment which, inherently, must mean a method of treatment which is safe and effective. Thus, no method of treatment was disclosed by the open label study.

38        Otherwise the factors relevant to the balance of convenience remain the same. Astra thus would also be entitled to the interlocutory injunctions it seeks on the basis of threatened infringements of the 051 or low dose patent (other than for the 40mg dose form) and the 165 or HeFH patent.

CONCLUSIONS

39        I am satisfied that Astra has established that interlocutory orders should be made in its favour generally as sought. As the form of the orders remains in dispute and the parties have indicated their wish to be heard in this regard I will provide the parties with these reasons for judgment and list the matters for further hearing at 9.30 a.m. on the first available date in consultation with the parties.

Associate:

Dated:    9 March 2012