Servier best method & amendment

Servier has lost what may be its last round[1] in the arginine perindopril litigation against Apotex. Servier began the litigation back in 2007. Ultimately, it lost with its patent being found invalid on the ground that Servier had failed to disclose the best method of performing the invention. After that ruling, Servier applied to amend its patent to include the best method. Its application failed on discretionary grounds. Now, we have the Full Court’s decision dismissing Servier’s appeal from that refusal.

Best method

Servier’s first argument was that, following the High Court’s Kimberley-Clark decision, all s 40(2)(a) required was a disclosure sufficient to enable a skilled person to produce something within each claim without new invention or additions or prolonged study of matters presenting initial difficulty. Servier argued that there was no separate and independent requirement to disclose the “best method”.

After an extensive review of the case law, the Full Court rejected that argument, ruling that disclosure of the best method was indeed a separate requirement. In this case, Servier had failed to comply with that requirement.

Claim 1 of the patent was for the arginine salt of perindopril. There had been an earlier patent for perindopril and sodium and maleate salt forms had been identified. According to the Specification, the arginine salt form had particular stability advantages in conditions of heat and humidity which resulted in longer shelf life and permitted the use of less expensive forms of packaging. The achievement of these advantages, however, could be affected by the method of production. The Specification described the claimed arginine perindopril only as being produced by “a classical method of salification”.

The experts agreed this description of how to prepare the salt was “pregnant with ambiguity” and following from this evidence the trial judge had found this description was “wholly inadequate” and did not:

allow the skilled addressee to follow a routine process of deduction from that description because it leaves open too many variables.

Servier itself had used two different methods before the filing date – the 1986 method and the 1991 method – and another method – the 2002 study – after the priority date. The evidence showed that the method of salification used and variables such as the solvent used and whether and when to stir significantly affected the properties of the resulting salt, including its stability.

Accordingly, the Full Court upheld the trial judge’s conclusion that Servier had not disclosed the best method known to it of performing the invention.

Amendment

Servier had applied after the trial to amend the Specification to add the best method.

The Full Court affirmed the Pfizer Full Court’s ruling that the best method requirement required disclosure of the best method of performing the invention known to the applicant at the filing date. However, it was possible to remedy a failure to disclose the best method by amendment of the Specification made after the filing date.

The Full Court agreed with the trial judge that the amendment power under s 105 could be invoked even after trial and judgment finding all claims invalid. While there was a proprietal interest in being allowed to amend, it was still necessary for the patentee to satisfy the Court that discretionary grounds did not warrant exclusion.

In this case, however, discretionary grounds warranted refusal. Back in 2004, the examiner had issued a report as a result of which Servier’s patent attorney had advised Servier to include a description of the method of manufacture of arginine perindopril, even if it was well known. The inhouse instructor replied “we will see later”.

Although there was no suggestion of bad faith on the part of the inhouse instructor, the Full Court upheld the trial judge’s conclusion that the inhouse instructor’s decision to ignore the advice of her Australian patent attorney was not reasonable.

The Full Court considered that there was no error of principle in the trial judge’s rejection of the length of the delay as otherwise warranting rejection of the application. However, they would appear themselves have felt the trial judge had been overly generous.

Finally, the Full Court allowed Apotex’ appeal from the trial judge’s order that Apotex pay 66% of Servier’s costs. Rather, Servier should pay 40% of Aptex’ costs of the revocation proceeding and 75% of Aptex’ costs of the amendment proceedings.

Les Laboratoires Servier v Apotex Pty Ltd [2016] FCAFC 27 (Bennett, Besanko and Beach JJ)


  1. Barring (potentially) a special leave application.  ?

Online copyright infringement in australia

Playing catch up: last month saw some significant developments for online copyright infringement in Australia:

  1. First, Dallas Buyers Club’s lawyers announced it is no longer pursuing its court action to get prelimiary discovery of the contact details of the 4726 alleged infringers: it’s over;
  2. Secondly, Mr Burke from Village Roadshow announced that the proposed Graduated Response industry code has been shelved;
  3. Thirdly, Village Roadshow and Foxtel announced that they are both bringing court proceedings to obtain website blocking injunctions against ISPs.

Graduated response (or 3-strikes)

One of the factors in the iiNet case which influenced the High Court to find that iiNet did not authorise the infringing acts of its subscribers was that iiNet could not credibly threaten to discipline subscribers accused of infringing by peer to peer downloading because, in the absence of an Industry Code, the subscribers could simply switch to another provider.

In response to that, the draft Industry Code arose from [a Government warning][agltr] that, if the parties did not come up with a solution, the Government would impose one.

However, Mr Burke has now reported that it would cost between $16 and $20 to issue each Infringement Notice under the proposed scheme because it would be necessary to check each notice manually. As he pithily explained, it would be cheaper to give the (putative) infringer a copy of the film:

“And it’s just so labour intense, that it’s somewhere in the vicinity of $16 to $20 per notice, which is prohibitive. You might as well give people a DVD.”

According to Mr Burke, if it is possible to develop an automated scheme, the costs should fall to “cents”. Until then, the scheme has been shelved.[1]

Finally, Mr Burke did go on to say that it was incumbent on rights holders to fight piracy by improving access to their content.

I wonder if we shall see a resumption of efforts to “fix” the authorisation provisions in the Act?

Website blocking injunctions

In the meantime, you will remember that last year Parliament added s 115A to the Copyright Act 1968, giving rights holders power to go to court to get injunctions ordering ISPs to block access to offshore piracy websites.

Now Village Roadshow and a number of Hollywood studios have brought action in the Federal Court seeking orders to block access to Solamovie, which is alleged to facilitate unauthorised streaming. There are 50 named ISP respondents including Telstra, Optus, M2 and TPG. The first directions hearing appears to be scheduled before Nicholas J in Sydney at 9:30am on 16 March. The website s115a.com has links to the Court documents, including the Originating Application and the Statement of Claim uploaded by Rohan Pearce.

Meanwhile, in a separate action, Foxtel has also gone after The Pirate Bay, Torrenz, TorrentHunt and IsoHunt. Nicholas J is holding the first directions for this one at 9:30am on 15 March. As with the Village Roadshow case, s115a.com has links to the documents, courtesy of Mr Pearce.


  1. The announcement seems to have come as some surprise to the ISPs. The report did not indicate who would pay for the development of the prognoticated automated system.  ?