Patents and the Trans-Pacific Partnership Agreement, Part 2

In addition to provisions relating to the scope of available patent rights and general procedures, which I wrote about in the first part of this series, the Trans-Pacific Partnership (TPP) Agreement prescribes certain minimum standards for terms of protection – including extensions or adjustments to patent term in certain circumstances.  These provisions apply particularly to regulated products, including  pharmaceuticals and biologics (a.k.a biopharmaceuticals).

In this article I will look at three specific aspects of the TPP:

1. the obligation to provide for adjustment of the patent term to compensate for ‘unreasonable delays’ in the grant of a patent, about which I expect Australia to do nothing;
2. the obligation to provide for extensions of the term of patents relating to pharmaceutical products as compensation for time lost in obtaining regulatory approval, about which I do not believe Australia needs to do anything; and
3. the obligation to provide an effective period of at least eight years of data exclusivity, and/or other protection for biologics, in respect of which I think Australia has a real problem following the High Court’s decision in D'Arcy v Myriad Genetics Inc [2015] HCA 35.

To make matters more interesting, on 3 December 2015, the US Industry Trade Advisory Committee on Intellectual Property Rights (ITAC-15) released its report on the IP provisions in the TPP [PDF, 198kB].  The report has been prepared pursuant to a statutory requirement that ‘advisory committees provide the President, the U.S. Trade Representative, and Congress with reports not later than 30 days after the President notifies Congress of his intent to enter into an agreement.’  The Committee is generally positive about the patent-related provisions, however it is not without its criticisms and concerns about those relating to pharmaceutical term extensions and biologics.

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Tags: Conventions, Extension of patent term, Genetic technology, International treaties, Trans-Pacific Partnership

Patents and the Trans-Pacific Partnership Agreement, Part 1

Negotiations in relation to the controversial multi-national free trade agreement known as the Trans-Pacific Partnership (TPP) were concluded on 6 October 2015.  The full text of the Agreement has since been published by the participating countries, including on the web site of the Australian Department of Foreign Affairs and Trade (DFAT).

The parties to the TPP are Australia, Brunei, Canada, Chile, Japan, Malaysia, Mexico, Peru, New Zealand, Singapore, the United States and Vietnam.  DFAT describes the TPP as ‘a regional free trade agreement of unprecedented scope and ambition’ (which, I suspect, nobody would dispute) which has ‘great potential to drive job-creating growth across the Australian economy’ (which would seem to be a more politically-motivated and contentious claim, though time will tell).

The full text of the TPP comprises some 6000 pages (or so I have read – not that I have made any attempt to count them all myself).  Its 30 chapters cover a huge range of trade-related matters, including market access and tariffs, customs administration, sanitary measures, competition policy, labour and the environment, as well as a number of specific areas of technology and commerce, such as telecommunications, electronic commerce and financial services.

It seems fair to say, however, that the provisions of the TPP that have received the most attention – little of it positive – are those relating to so-called investor-state dispute settlement (in Chapter 9 on ‘Investment’), and on Intellectual Property in Chapter 18.  Indeed, draft texts of IP chapter were repeatedly leaked and published by Wikileaks during the years of negotiation of the TPP, with the copyright provisions generally receiving the most attention and criticism.

In this two-part article, however, I am going to focus on what the TPP says about patents, and what this may mean for participating countries, including Australia.  In Part 1, I will cover most of the provisions relating to the scope of available patent rights, and general procedures, while Part 2 will look at provisions relating specifically to pharmaceuticals and biologics, and at extensions and adjustments of patent term.

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Tags: Conventions, International treaties, Trans-Pacific Partnership

How International Treaties Help Inventors With Patent Strategy

There is no such thing as a ‘world patent’.  As matters currently stand – and as I expect them to remain beyond the term of my natural life – there is no country on Earth that is willing to completely forego the right to determine what qualifies for a patent monopoly within its borders, or the right to collect ongoing fees to maintain this privilege.

So, anybody wishing to obtain patent protection in multiple markets will necessarily need to pursue some form of application in each corresponding jurisdiction.  With every country having its own patent laws (and this is true even in places, such as Europe, where some form of regional process is available), obtaining all of these patents can certainly become a complex, time-consuming, and expensive procedure.

Fortunately, however, over the years a majority of countries have got together to establish some basic standards, agreements and conventions that provide at least some certainty and simplification for inventors and companies seeking protection for their inventions in multiple jurisdictions.  In this article I want to talk briefly about the three I regard as being the most significant:

1. the Paris Convention for the Protection of Industrial Property, which ensures that all members will recognise the priority of an application filed in another member country for at least 12 months;
2. the Patent Cooperation Treaty (PCT), which creates a central mechanism for filing an ‘international application’ that can delay the costs and complexity of individual national/regional filings for at least 18 months longer than would otherwise be possible; and
3. the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), which sets minimum standards for patentability, guarantees non-discriminatory treatment of applicants and applications, and sets limits on the scope of national laws to exclude specific subject matter from patent-eligibility.

Knowing a little about these three international agreements is a good start on developing an international patenting strategy, although I would always recommend that you ultimately seek the assistance of somebody who works within these systems all the time, and is familiar with their many detailed benefits, and pitfalls.

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Tags: Conventions, Paris Convention, Patent Cooperation Treaty, PCT, Treaties, TRIPS