Working a patent for regulatory approvals

Patently-O considers a new Federal Circuit case in the USA dealing with the scope of s 271(e)(1) – a defence to infringement by working the patent to prepare regulatory data.

It would appear that the defence should now apply in proceedings against imports before the ITC.

Patents Act 1990 (Cth) s 119A (introduced with effect from 25 October 2006 following ACIP’s report) permits such activity where the working:

  • is for purposes of having a therapeutic pharmaceutical product included in the Australian Register of Therapeutic Goods;
  • or a similar foreign regulatory approval.

Although working for a foreign regulatory approval may take place only in the supplementary protection period (see e.g. ACIP on experimental use p. 44 (pdf)).

See now Alphapharm Pty Ltd v H Lundbeck A/S [2008] FCA 559 at [643]ff.

IP Australia is considering extending this: see paragraphs 9 and 17 of IP Australia’s Consultation Paper on experimental use (pdf) [NOTE: submissions should be in by 8 May 2009. Submissions on the Getting the Balance Right paper (pdf) are also due by then.]

WIPO’s Standing Committee on Patents has a study paper on exceptions and limitations as an area of increased focus.

Patents, pharmaceuticals and exports

I’m not quite sure why, but the blogosphere is increasingly chattering again about relaxing the rules against infringing a patent by making the protected product (esp. a pharmaceutical) for export:

IP’s What’s Up reviews the TRIPS status including the DOHA declaration and its rather tentative take up.


The USTR has released a 6 page (pdf) outline of issues being dealt with under the proposed ACTA.

Link via Intellectual Property Watch.

The IP Dragon has links to a 48 page document with rather more information.

More tea leaf sifting here.

(Sino) Free Trade Agreements

IPDragon reviews Professor Yu’s analysis of why free trade agreements (STAs) are different from the things the USA imposes on people or EU agreements here (with links to Professor Yu’s article Sino Trade Agreements and China’s Global Intellectual Property Rights).

Free trade Dream Time

Australia has entered into Free Trade Agreements (1) with NZ and ASEAN and (2) with Chile.

ASEAN as a bloc is apparently our largest trading partner.

Chapter 13 deals with Intellectual Property. Various fact sheets, e.g. Pharmaceuticals, deal with our exports or imports thereto.

Minister Crean’s press releases here and here.

AANZFTA here and chapter 13 here; Australian guide with links to all sorts of things. Trade overview. The words “may” and “shall endeavour to” feature quite a lot in Chapter 13.

Australia-Chile FTA index and chapter 17 (IP) here.

Hey, our 12 month grace period for filing patents will work in Chile, see art. 17.22! Can’t spot a corresponding provision in the AANZFTA? Also, to facilitate domain name dispute resolution, Chile has agreed to adopt an UDRP-style dispute resolution process for its cc.TLD (assuming it doesn’t already have one, of course).

Unfair contracts

The Australian Government has announced that it will be fastracking new consumer laws protecting against unfair contracts, with the aim of the law being introduced in June 2009 and in force by January 2010.

David Jacobson has a detailed report with links to consultation papers etc. here.

Stephen King gets exercised about the economics here.

Whatever happened to that old case involving Fleetwood Mac and Clifford Davis management or Amadio?

The USA, China and the WTO dispute

The dispute resolution panel’s decision in the USA’s complaint against China’s rules on enforcement, “Measures affecting the protection and enforcement of intellectual property rights” (DS362) (background here) has been published.

There’s a range of commentary around the web.  The  IPKat reproduces the conclusions and, applying sophistaKatted Euro reading between the lines, scores it at 3-all.

Intellectual Property Watch’s summary here.  According to the USTR, the US won.

Not sure what has happened to the “market access” dispute?

USA, China, Famous Brands and WTO

The USA has has commenced formal consultations – the first steps in another WTO complaint – in the WTO against the People’s Republic of China, alleging China is providing illegal protection for famous Chinese brands.

From the fact sheet:

China appears to be providing numerous WTO-illegal subsidies at multiple levels 

of government.  These include providing exporters: 

• Cash grant rewards for exporting 

• Preferential loans  

• Research and development funding  

• Cash grants to lower the cost of export credit insurance  

• The subsidies at issue offer significant benefits, particularly through cash grants that can reach over $400,000 to a single producer from a single level of government.

It would seem these are different “famous” brands to all those famous brands that are now “made in China”.

USTR press statement here.

USTR fact sheet here.

ACTA – December meeting

The Canadian and US governments carry short press releases on the latest (15 – 18 December) round of negotiations over the secretive ACTA.

Australian (DFAT) homepage (not updated) here.

Pharmaceutical patents

The European Commission has published its preliminary report into its inquiry into the state of competition in the pharmaceutical industry in the EU – comment and links via IPKat.

The IPKat also has links to what they describe as “the powerful speech” delivered by Sir Robin Jacob (aka Jacob LJ) in the Commission’s public meeting on the issue.

Meanwhile, the developing countries are developing a proposal which envisages greater involvement of WHO; see here, while there are also reports of the Director General of the WTO appearing to acknowledge some significance to the issue.