Commonwealth

Commonwealth can sue on the undertaking as to damages

1 Comment / Enforcement, Patents / / / , , , , , , , , , , , ,

The Full Court (Dowsett, Kenny and Nicholas JJ) has upheld the Commonwealth’s power to sue for damages on the undertaking as to damages given by Sanofi and Wyeth when obtaining interlocutory injunctions against generic suppliers.

Sanofi sued Apotex (then called GenRX) for patent infringement when the latter sought to registration in the Therapeutic Goods Register of drug containing clopidogrel. Sanofi obtained an interlocutory injunction preventing the listing and sale of Apotex’ product, on terms of the “usual undertaking as to damages”. Thus, as a condition of obtaining the interlocutory relief, Sanofi undertook to the court:

(a) to submit to such order (if any) as the Court may consider to be just for the payment of compensation, to be assessed by the Court or as it may direct, to any person, whether or not a party, adversely affected by the operation of the interlocutory order or undertaking or any continuation (with or without variation) thereof; and

(b) to pay the compensation referred to in (a) to the person there referred to. (emphasis supplied)

After the trial judge found Sanofi’s patent valid and infringed, the Full Court on appeal held that the patent was invalid. Ultimately, the High Court refused special leave.[1]

The Commonwealth, which was not a party to either the Sanofi or Wyeth proceedings is now claiming compensation from Sanofi and Wyeth under the “undertaking as to damages”. In broad terms, it says it suffered losses because the price it paid under the Pharmaceutical Benefits Scheme was higher than it would have been if the generic parties had not been prevented from listing and selling their products by the interlocutory injunctions.

Sanofi and Wyeth argued that sections 26B, 26C, 26D of the Therapeutic Goods Act[2] precluded the Commonwealth from claiming under the usual undertaking as to damages. The Full Court held, however, that these provisions were ancillary or additional to the Court’s powers under the undertaking. They did not provide an exhaustive code which excluded the operation of the undertaking.

Dowsett J delivered a concurring judgment, suggesting at [20] that some restriction on the scope of the usual undertaking should have been sought and then questioning, if such a restriction had been sought, whether it would have been appropriate to grant the interlocutory injunction:

…. As the Commonwealth was not a party to the proceedings in which the undertakings were given, they were presumably not extracted at its request. I infer that the Court extracted the undertakings. It is not suggested that it lacked the power to do so in order to protect the interests of identified or unidentified third parties. In submitting that the Commonwealth may not recover other than pursuant to s 26C, the Sanofi and Wyeth parties effectively seek to resile from their undertakings. It may be simply too late for them to do so. Any limitations upon the undertakings ought to have been sought at the time at which they were given. The Court would then have had to consider whether such limited undertakings were sufficient to justify the grant of the interlocutory injunctions. The Commonwealth has not put its case in that way. However, in any event, I see no basis for limiting the Commonwealth’s right to seek to enforce the undertakings to the extent that it benefits under them.

If only the regime under sections 26B, 26C, 26D had been available, it looks like Sanofi’s and Wyeth’s exposure would have been limited to situations where they had given false or misleading certificates or did not have “reasonable prospects of success”.[3]

Commonwealth of Australia v Sanofi (formerly Sanofi-Aventis) [2015] FCAFC 172

  1. Similarly, in the Wyeth proceedings an interlocutory injunction was granted on the usual undertaking as to damages, but the patent was ultimately found to be invalid.  ?
  2. These provisions were introduced as part of the package implementing the Australia – United States Free Trade Agreement relating particularly to the 5 year data exclusivity for pharmaceutical test data.  ?
  3. Defined in s 26C(4) as “(4) For the purpose of paragraph (3)(b), proceedings have reasonable prospects of success if: (a) the second person had reasonable grounds in all the circumstances known to the second person, or which ought reasonably to have been known to the second person (in addition to the fact of grant of the patent), for believing that he or she would be entitled to be granted final relief by the court against the person referred to in paragraph (1)(a) for infringement by that person of the patent; and (b) the second person had reasonable grounds in all the circumstances known to the second person, or which ought reasonably to have been known to the second person (in addition to the fact of grant of the patent), for believing that each of the claims, in respect of which infringement is alleged, is valid; and
    (c) the proceedings are not otherwise vexatious or unreasonably pursued.”  ?

Commonwealth can sue on the undertaking as to damages Read More »

Abilify interlocutory injunction continues pending appeal

Leave a Comment / Enforcement, Patents / / / , , , , , , , , , , , ,

Last month, Yates J found that Otsuka’s patent for aripiprazole was invalid.[1] As a consequence, his Honour ordered that the interlocutory injunction preventing Generic Health from listing its product on the PBS and selling it be dissolved. Otsuka has appealed and now Nicholas J has granted a stay to preserve the interlocutory injunction pending the appeal.

While not being prepared to characterise Otsuka’s prospects on the appeal as higher than arguable, Nicholas J considered the balance of convenience favoured continuation of the interlocutory injunction.

Otsuka relied principally on the fact that there would be an automatic reduction of 16% the price payable under the PBS for Abilify[2] once Generic Health’s product was listed. It contended that it would not be possible to recover that price drop if its appeal were successful.

Generic Health countered that it risked losing the benefits of first mover advantage if it were enjoined and other generic producers were not. Generic Health’s evidence was that pharmacists would usually only carry one generic brand of each drug and that was likely to be the first brand “in”. This would exacerbate the difficulties in calculating its losses. Nicholas J did not dismiss that argument, but Otsuka said it would be seeking interlocutory injunctions against any other generics who tried to enter the market pending the appeal. Nicholas J noted further that, if Otsuka failed in an injunction applications against a second or further generic, that would be a strong basis to terminate the stay.

The Commonwealth also sought a specific undertaking to pay damages from Otsuka as the price of the injunction. It argues it will suffer loss, in the form of the higher prices payable under the PBS, if Generic Health continues to be enjoined but the appeal ultimately fails.

Nicholas J noted that a case has been stated to the Full Court on whether the Commonwealth can indeed claim under the “usual undertaking as to damages”. Subject to the outcome of that case, his Honour considered the Commonwealth was sufficiently within the scope of the usual undertaking and so did not need a separate, specific undertaking.

Nicholas J increased the security for costs that Otsuka had to provide to Generic Health in the amount of an additional $8.7 million[3] and, in addition, required a security of $6 million separately to the Commonwealth. His Honour also noted that the Commonwealth could apply to extend that security if the appeal was not decied in the first half of 2016.[4]

Otsuka Pharmaceutical Co., Ltd v Generic Health Pty Ltd [2015] FCA 848

  1. Otsuka Pharmaceutical Co., Ltd v Generic Health Pty Ltd (No 4) [2015] FCA 634. Patentology looked at the ‘swiss claims’ aspects of his Honour’s decision.  ?
  2. The commercial name under which aripiprazole is marketed by Otsuka and its licensee.  ?
  3. Otsuka has already provided $6.5 million pursuant to the orders made by Yates J at first instance.  ?
  4. At [35], Nicholas J recored that the Commonwealth estimated its losses from the continuation of the interlocutory injunction would be $6 million over the next 12 months and $15 million over the next 18 months.  ?

Abilify interlocutory injunction continues pending appeal Read More »

PPCA v Commonwealth

Leave a Comment / Copyright / / / , , , , , , , , , , ,

The High Court has rejected the constitutional challenge to the validity of the “1%” cap on licence fees payable by broadcasters to the record companies on very narrow and specific grounds.

Section 109 of the Copyright Act 1968 provides a compulsory licence for the broadcasting to the public of sound recordings. Section 152, however, caps the royalty payable to record companies by broadcasters at 1% of the gross earnings of the broadcaster.

No such limitation had applied to the “corresponding” copyright in sound recordings under the 1911 Act.

The 1911 Act was repealed when the 1968 Act came into force on 1 July 1969. Section 220 of the 1968 Act provided that sound recordings in which copyright subsisted immediately before 1 July 1969 qualified for copyright under the 1969 Act effectively as provided for under the 1968 Act.

The record companies argued that the imposition of the 1% cap was an acquisition of their property in sound recordings made before July 1969 otherwise than on just terms in contravention of s 51(xxxi) of the Constitution.

The High Court has unanimously rejected that claim.

French CJ, Gummow, Hayne and Bell J said the record companies’ argument was predicated on a wrong assumption. They no longer owned copyright under the 1911 Act which had been qualified. Rather that copyright had been terminated and replaced with a new and different copyright under the 1968 Act. So at [10] and [11]:

[10] The assumption by the plaintiffs is that the copyright presently enjoyed in respect of the pre?1969 recordings, and which will expire in accordance with the extended term fixed by the operation of the Free Trade Act upon the 1968 Act, is that which arose under the 1911 Act and was carried forward by the 1968 Act, but with the impermissible imposition upon those copyrights of the “cap” in the compulsory licensing system introduced by the 1968 Act. The Commonwealth denies that assumption. The Commonwealth submission, which should be accepted, is that upon the proper construction of the 1968 Act: (a) copyrights subsisting in Australia on 1 May 1969 under the Imperial system were terminated; (b) thereafter, no copyright subsisted otherwise than by virtue of the 1968 Act; and (c) to that copyright in respect of sound recordings there attached immediately the compulsory licensing system including the “cap” upon the royalties payable thereunder.

[11] It should be emphasised that the plaintiffs do not assert that the 1968 Act is invalid by reason of its bringing to an end the operation in Australia of the Imperial system without the provision of just terms. To do so successfully would be to leave them with such rights in respect of the pre?1969 recordings as they had under the 1911 Act and the 1912 Act, and without any copyrights subsisting under the 1968 Act. Rather, the plaintiffs seek to attack the validity of the attachment to their rights under the 1968 Act of one aspect of the compulsory licensing system for sound recordings. For the reasons which follow, that attack must fail.

Heydon J to similar effect at [63]:

In short, the 1968 Act did not preserve the second to sixth plaintiffs’ rights under the 1911 Act and the 1912 Act. It abolished those rights. It substituted for them distinct and fresh rights – some more advantageous to those plaintiffs, some less. Thus ss 109 and 152 did not cause any property to be acquired. Property may have been extinguished by other provisions, but the plaintiffs’ case was not concerned with them.

After considering the application of s 51(xxxi) of the Constitution to statutory intellectual property rights generally, Crennan and Kiefel JJ reached the same conclusion at [129], pointing out at [130] that the record companies could not accept s 220 of the Copyright Act as valid and at the same time contend that ss 109 and 152 were invalid.

[129] When ss 8, 31, 85, 89(1), 207 and 220(1) of the 1968 Act are read together, it is clear that the copyright of the relevant plaintiffs under the 1911 Act, which included the exclusive right to perform the record in public, is not continued under the 1968 Act; rather it is replaced. Whilst it is true that, as the plaintiffs submit, certain records in which copyright subsisted under the 1911 Act are brought within the scheme of the 1968 Act, that is achieved by the re enactment, in substance, of qualifying provisions in the 1911 Act in, and for the purposes of, the 1968 Act. The effect is that the plaintiffs’ entitlement to sue for infringements under s 101 of the 1968 Act in respect of sound recordings in which copyright subsists pursuant to s 89(1) is an entitlement to sue in respect of infringements of the copyright in sound recordings contained in s 85, which replaces the copyright in records under s 19(1) of the 1911 Act. Inasmuch as ss 109 and 152 operate to qualify a record manufacturer’s exclusive rights by providing an exception to infringement, it is the exclusive rights under s 85 which are affected, not the exclusive rights under the 1911 Act (which have been replaced).

[130] Whilst the plaintiffs mount no attack on the validity of provisions of the 1968 Act which effect the replacement of the relevant plaintiffs’ copyright under the 1911 Act with a copyright under the 1968 Act, their attack on the validity of ss 109 and 152, which depends on the continuing subsistence of copyright under s 19(1) of the 1911 Act, is untenable. If the plaintiffs were to attack the validity of the provisions of the 1968 Act which effect the replacement of copyright under s 19(1) of the 1911 Act with a differently constituted copyright under s 85 of the 1968 Act, they would risk being left not only with the awkwardly expressed copyright under s 19(1) of the 1911 Act in respect of records, but also with a copyright, the term of which was limited to 50, rather than 70, years.

Now the High Court have reminded themselves of all these matters, they will be primed for the tobacco companies challenge to the validity of the Tobacco Plain Packaging Act 2011, the hearings for which start in April.

Phonographic Performance Company of Australia Limited v Commonwealth of Australia [2012] HCA 8

PPCA v Commonwealth Read More »

Copyright Agenda

Leave a Comment / Copyright / / / , , , ,

The Attorney General opened the Copyright Futures conference in Canberra yesterday.

As part of his speech he mentioned that last week he held a roundtable forum with ‘about 30 of the key representative groups’.

Wonder what that was about? According to the Attorney-General, some of the emerging themes were:

  • whether the Government would benefit from an independent source of advice in addition to my Department, especially for technology and competition issues 
  • access to justice considerations for individual creators and also the effectiveness of the Copyright Tribunal
  • addressing piracy in the online environment
  • the roles and responsibilities of declared collecting societies
  • whether there should be new rights for visual artists, indigenous creators  and audio-visual performers
  • the relationship between copyright and contract law, and
  • whether there should be new exceptions to allow greater access to copyright materials.

Then, he identified the Government’s agenda:

These include the issues of resale royalty legislation for visual artists and the review of restrictions on the parallel importation of books. 

I am also evaluating proposals on the use of internet material by educational institutions, the role of Internet Service Providers in relation to online infringements, and appropriate enforcement of intellectual property crimes.

There is also the push for Governments to consider how to enhance access to and re-use Government information.

(Of course, in the best traditions, the printed speech is followed by a copyright warning notice.)

The speech is online here.

Copyright Agenda Read More »

Scroll to Top