Patents

How you infringe a Swiss claim in Australia

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The Full Court has upheld Nicholas J’s ruling that Apotex infringed the Swiss claims in Warner-Lambert’s (Pfizer’s) pregabalin patent by making the product outside Australia and then threatening to import it into Australia for sale.

Claims 16 to 30 of the pregabalin patent were Swiss claims. For example, claim 16 was for “use of a compound of Formula 1 or a pharmaceutically acceptable salt diastereomer or an enantiomer thereof … in the manufacture of a medicament for the treatment of pain.”

Apotex’ plan was to have its product made overseas by a third party, then import the product and offer it for sale.

As you know, infringement requires the infringer to “exploit” the claim said to be infringed in the patent area.[1] For this purpose, the Dictionary defines exploit to mean:

“exploit ”, in relation to an invention, includes:

(a) where the invention is a product—make, hire, sell or otherwise dispose of the product, offer to make, sell, hire or otherwise dispose of it, use or import it, or keep it for the purpose of doing any of those things; or

(b) where the invention is a method or process—use the method or process or do any act mentioned in paragraph (a) in respect of a product resulting from such use.

Apotex argued that it was not going to infringe because Swiss claims are method claims[2] and so, according to Apotex, could be infringed only by practising the method in Australia. Therefore, according to Apotex, paragraph (b) of the definition of “exploit” should be limited to products made by practising the method in Australia only.

In Lundbeck at [693] – [694], Lindgren J had found infringement in similar circumstances, but through some rather convoluted reasoning. At [167], while rejecting Apotex’ criticisms of Lundbeck, the Full Court upheld the trial Judge’s finding of infringement on the basis of his Honour’s reasoning in preference to Lindgren J’s reasoning. Nicholas J found at [296]- [298]:

296 The definition of “exploit” makes no reference to the patent area. As I have said, the express territorial limitation upon the patentee’s exclusive rights is found in s 12 and s 13. In my respectful view, there is therefore no reason to read down the words of either para (a) or para (b) of the definition of “exploit” to found any territorial limitation. This is because the Act expressly provides that a patent only has effect in the patent area: see also s 70 of the Patents Act 1952 (Cth).

297 Paragraph (b) of the definition of “exploit” refers to the doing of an act referred to in para (a) which includes to make or import a product. The patentee’s exclusive rights are infringed (subject to available defences) if another person does any such act within the patent area. The fact that the patented method is performed outside the patent area does not avoid infringement of a method claim (including a Swiss claim) if the product imported and sold in Australia was made using the patented method because the acts of importation and sale occur within the patent area. The relevant act of infringement is not the use of the method outside the patent area but the exploitation (by importation and sale) in Australia of a product made using the patented method.

298 In my respectful opinion, contrary to the approach taken by Lindgren J, the relevant territorial limitation is reflected in the language of s 12 and s 13(3) and there is therefore no justification for importing words of territorial limitation into the definition of “exploit”. It follows that I take a somewhat different approach to the construction of the definition of “exploit” to that taken by Lindgren J in Alphapharm, though I do not think the difference has any impact on whether or not Apotex threatens to infringe the Swiss claims in this case.

So the question now appears to be “Is the respondent exploiting in Australia a product which was made by a method as claimed in the patent?” It does not matter whether the method was performed in or outside Australia.

If Apotex imported its product as planned, therefore, Apotex would infringe because it would be importing into Australia and then offering for sale a product which had been made by one of the claimed methods. Any other result, of course, would have seriously compromised the utility of method patents.

The Full Court also dismissed Apotex’ appeal against the findings that the Patent was fairly based and not invalidated by a false suggestion. That may be a topic for another day.

 

Warner-Lambert Company LLC v Apotex Pty Ltd (No 2) [2018] FCAFC 26 (Jagot, Yates and Burley JJ)

  1. Or authorise someone else to exploit the invention: s 13.  ?
  2. Otsuka at [120].  ?
  3. Article 83 of the European Patent Convention provides “The European patent application shall disclose the invention in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art.”  ?

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Productivity Commission intellectual property arrangements

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Part 1 of my article on the Productivity Commission’s Final Report on Intellectual Property Arrangements has been belatedly published in the Australian Intellectual Property Law Bulletin: (2018) Vol. 30 No. 10 p. 210.

Subscription only, I’m afraid.

This part looks at the Productivity Commission’s approach and treatment of patents. Part 2 will deal with copyright, designs and other issues.

This issue of AIPLB also includes a paper by Richard Hamer and Lev Gutkin on patents law in 2016 and Marina Olsen’s review of the Productivity Commission’s recommendations on designs.

Between writing the paper and its publication, the Government has published its response to the Productivity Commission’s report. Despite the Raising the Bar reforms to inventive step, that response included acceptance of the recommendation to change the inventive step requirement yet again. The Government has since published several discussion papers on ways to “reform” inventive step and the requirement for disclosure of the technical advance, a statement of objects and Crown use.

Productivity Commission intellectual property arrangements Read More »

Confidentiality orders in court proceedings

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Motorola is suing Hytera for infringement of its patents relating to mobile phone technology.1 As part of the proceeding, Hytera is seeking to invoke a Digital Mobile Radio Essential Properties Cross Licence Agreement. Hytera has obtained an order that information about various terms in the agreement be kept confidential (I.e., suppressed) for 10 years after the proceeding is decided.

Section 37AF of the Federal Court of Australia Act provides the Court with power to suppress or restrict the publication of evidence. In the case of confidential information, such as trade secrets, the party seeking to restrict access to the information must show under s 37AGthat the restriction “is necessary to prevent prejudice to the proper administration of justice”.

Perram J noted that some scepticism might be felt towards the idea that protection of confidential information met the strict standard of necessity. His Honour accepted, however, case law recognised that commercial sensitivity, especially if it were likely that competitors could benefit from information which made public through the Court system, is a circumstance in which the necessity standard could be met.The integrity of the litigious process might be undermined if parties were precluded from advancing relevant information as a result of the harm potentially flowing from publication. In this case, the agreement in question was still on foot. And the information would place Hytera at a competitive disadvantage in future negotiations with third parties. At [15], his Honour explained:

disclosure of the information would be prejudicial to the proper administration of justice because it would tend to ‘destroy or diminish’ (Origin Energy at 148) the value of confidential information with the possible consequence that commercial parties will be more reticent to approach the Court to settle their disputes. I am therefore satisfied that an order under s 37AF in this case is appropriate.

Perram J was not prepared, however, to grant Hytera’s request that the information be kept sealed for 10 years. There was no evidence about the nature and lifespan of the digital mobile radio technology in issue or the life cycle of the telecommunications standards. Having reviewed the agreement and the substance of the information that had been disclosed, Perram J was prepared to order suppression for three years only. His Honour was prepared to reconsider if further evidence were put on.

If you are going to seek suppression orders – i.e, that information be kept confidential, therefore, you will need to lead evidence which establishes (1) that the information is in fact confidential and (2) there is a real risk of prejudice if the confidentiality is not preserved. Another factor which the Court seems to be mentioning more often was that the affidavit evidence was through the solicitor “on information and belief”, rather than from someone knowledgeable within Hytera itself.

Motorola Solutions, Inc. v Hytera Communications Corporation Ltd (No 2) [2018 FCA 17

  1. Apparently, the trial is scheduled to run for 5 weeks. There are also parallel actions in the USA, China and Germany. ?

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IP Amendment (Productivity Commission Part 1 …) Bill – exposure draft

1 Comment / Enforcement, Patents, PBR, Trade marks / / / , , , , , , , ,

IP Australia has released an exposure draft bill and regulations to implement some of the Productivity Commission’s recommendations from its Intellectual Property Arrangements report. Intended to be the Intellectual Property Laws Amendment (Productivity Commission Response Part 1 and Other Measures) Bill 2017.[1]

According to the news release, the amendments will:

  • commence the abolition of the innovation patent system (PC recommendation 8.1)
  • expand the scope of essentially derived variety declarations in the Plant Breeder’s Rights (PBR) Act (PC recommendation 13.1)
  • reduce the grace period for filing non-use applications under the Trade Marks Act (PC recommendation 12.1(a))
  • clarify the circumstances in which the parallel importation of trade marked goods does not infringe a registered trade mark (PC recommendation 12.1(c))
  • repeal section 76A of the Patents Act, which requires patentees to provide certain data relating to pharmaceutical patents with an extended term (PC recommendation 10.1)
  • allow PBR exclusive licensees to take infringement actions
  • allow for the award of additional damages, under the PBR Act
  • include measures intended to streamline a number of processes for the IP rights that IP Australia administers,

and everyone’s favourite “a number of technical amendments”.

On the parallel imports front, the bill would introduce a new s 122A to replace s 123(1) with the object of overruling the Federal Court’s case law severely restricting the legality of “parallel imports” since the 1995 Act came into force. It’s a “doozy”.

For example, it attempts to reverse the onus of proof that the courts have imposed on parallel importers by providing that

at the time of use, it was reasonable for the [parallel importer] to assume the trade mark had been applied to, or in relation to, the goods by, or with the consent of, a person who was, at the time of the application or consent (as the case may be):

(i) the registered owner of the trade mark; or

(ii) an authorised user of the trade mark; or

(iii) a person authorised to use the trade mark by a person mentioned in subparagraph (i) or (ii), or with significant influence over the use of the trade mark by such a person; or

(iv) an associated entity (within the meaning of the Corporations Act 2001) of a person mentioned in subparagraph (i), (ii) or (iii).

 

I suppose “reasonable to assume” does at least require some objective support for the “assumption”.

The second part – (iii) and (iv) above – is trying to deal with the situation where the registered owner assigns the trade mark to someone in Australia, but with the capability of calling for a re-assignment.[2]

This will require considerable flexibility by the Courts in interpreting “significant influence”.

If you have made such and assignment, or your client has, you had better start re-assessing your commercial strategy, however. The transitional arrangements say the amendment will apply to any infringement actions brought after the section commences. Moreover, this will be the case even if the “infringing act” took place before the commencement date.

Comments should be submitted by 4 December 2017.

Exposure draft bill

Exposure draft EM

Exposure draft regulations

Exposure draft explanatory statement

  1. Seems like the “short title” of bills are reverting to the old form “long” titles!  ?
  2. For example, Transport Tyre Sales Pty Ltd v Montana Tyres Rims & Tubes Pty Ltd [1999] FCA 329.  ?

IP Amendment (Productivity Commission Part 1 …) Bill – exposure draft Read More »

AIPPI Sydney 2017 – Day 3: patents, copyright and …

Leave a Comment / Copyright, IP generally, Patents / / / , , , , , , ,

Some more reports from the AIPPI Congress 2017 in Sydney – Day 3:

  1. My post on the panel discussing the issues patenting medical devices (apparatus or apparatus + drug) including significant changes in the EU next year;
  2. Clare Cunliffe reporting on the panel discussing issues arising when an innovator is seeking a final injunction against another innovator (rather than a generic); and
  3. James Elmore’s report on the Business of IP – IP venturing.
  4. Clare also reports on intermediary liability for copyright infringement.
  5. Finally, James reports on the panel on whether not identification of the technical problem solved by the patent is required in the USA, the EPO, China and Japan.

AIPPI Sydney 2017 – Day 3: patents, copyright and … Read More »

AIPPI Sydney 3 – sufficiency

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My attempt to summarise Parma Session 1 ‘Sufficiently plausible’ has been posted on IPKat here.

Clare Cunliffe’s report on the session about IP and competition is here.

AIPPI Sydney 3 – sufficiency Read More »

AIPPI Sydney

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Over the weekend, I shall be attending the annual Congress of AIPPI in Sydney.

Lots of interesting sessions and practitioners from all round the world

If you are attending or in the vicinity, say “hello”.

AIPPI Sydney Read More »

Government consultation papers on patent and trade marks

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Government consultation papers on patent and trade marks

Government consultation papers on patent and trade marks

The Australian government has issued 5 consultation papers on how to implement some of the recommendations it has accepted from the Productivity Commission’s Final Report into Intellectual Property Arrangements:

Submissions are required by 17 November 2017 (with a view to introducing a bill as soon as possible).

I can’t say that introducing yet another inventive step test (there are 4 if you count common general knowledge alone – depending on which regime applies to the patent in question) makes much sense.

Most of the Productivity Commission’s reasoning was based on the common general knowledge alone test used in Alphapharm.1 It did find, however, that there had not been much change in the Commissioner’s rate of granting patents relative to the EPO since the Raising the Bar act was passed. However, so far as I could see, it doesn’t tell us how many applications the Commissioner had examined under the Raising the Bar regime and you would have to guess a large number were still under the 2001 regime.2

Essentially, the Raising the Bar regime allows any piece of prior art to be combined with common general knowledge to test obviousness. It also allows prior art information to be combined in the same way as one might expect an English court or an EPO board would.3 The Raising the Bar regime should in fact operate just like the UK/EPC regime and one would have thought we should give it a good chance to work!

  1. See e.g. the reliance on Angiotech Pharmaceuticals v Conor Medsystems Inc. [2007 EWCA 5 at [43]. ??
  2. The Merial case is the only judicial consideration I am aware of applying the regime introduced in 2001 but, if you know of others, let me know. ??
  3. See e.g. KCI Licensing v Smith & Nephew [2010 EWCA Civ 1260 at 6. ??

 

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Government response to Productivity Commission IP report

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The Government has published its response to the Productivity Commission’s Intellectual Property Arrangements – Final Report.

Further comment will have to await. In the meantime, the media release notes:

A key priority will be to align Australian inventive step law with international best practice to ensure that the necessary protections are available to deserving inventions. The Government has also accepted the Productivity Commission’s recommendation to phase out the Innovation Patent System.

and, in not accepting the proposal to adopt a general “fair use” defence to copyright:

It is important copyright reform is considered in a holistic context rather than focused on individual issues. We will continue to work closely with stakeholders over the next 12 months to develop effective options for copyright reform.

The Australia Copyright Council is very pleased.

There will also be a new IP Policy Group (within government) to, er, monitor IP policy!

According to the Government’s Media Release, the Government is still considering the merits of a number of other proposals and “will work on these further”.

Australian Government Response to the Productivity Commission Inquiry into Intellectual Property Arrangements (pdf)

Media release 25 August 2017

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No damages for unjustified threats

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Following on from the Full Court’s warnings in Australian Mud Company v Coretell, Dowsett J has now dismissed Morellini’s claim for damages for unjustified threats. This is a short point, but it bears notice as people often come to me thinking it is enough to show there has been an unjustified threat – it isn’t, if you want monetary compensation.

Mizzi and Morellini are both in North Queensland and came up with machines for planting sugar cane. Mizzi patented his. Dowsett J found that Morellini’s machine did not infringe Mizzi’s patent and Mizzi had made unjustified threats of patent infringement. On appeal, the Full Court also ruled that Mizzi’s patent was invalid for false suggestion.

There was no dispute that Mizzi had made unjustified threats. On 5 April 2010, it had caused to be published in the Canegrower trade magazine a notice about its pending patent and an article by “Invention Pathways” about the consequences “[i]f the patent owner decides to pursue his rights ….” Then in June 2011, Mr Mizzi made oral threats to a Mr Girgenti about the use of a Morellini machine.

The problems for Morellini were essentially two fold. First, much of the evidence about people’s reluctance to deal with Morellini related to things which happened before the threats were made or in circumstances where Dowsett J could not attribute them to the actual threats as opposed to just rumours circulating in the industry:

There is no direct evidence that anybody declined to deal with Mr Morellini as a result of the threats. It seems that even before the newspaper article on 5 April 2010, there was a degree of reluctance concerning any such dealings. That reluctance cannot have been attributable to the threats. Mr Morellini has not demonstrated that any adverse effect resulted from either of the threats.

Secondly, Dowsett J accepted that damages could be available for lost sales opportunities and delayed sales, if they could be linked to the threats. However, Morellini did not provide detailed evidence about how he would have exploited his machine commercially and why he had not been exploiting it “in more recent times”. That is, Dowsett J wanted to know what was Morellini’s plan (if he had one) for exploiting his machine commercially and why he had not been doing so.

Mizzi Family Holdings Pty Ltd v Morellini (No 3) [2017] FCA 870

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