[Ip-health] Ip-health Digest, Vol 66, Issue 7

Jing Luo jingluo1 at gmail.com
Thu Oct 8 12:07:02 PDT 2015

Any idea what additional market exclusivity taking into account local market circumstances means?

Seems unusually vague.


> On Oct 8, 2015, at 3:00 PM, ip-health-request at lists.keionline.org wrote:
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> Today's Topics:
>   1. NZ official TPP Factsheet on Intellectual-Property (Jamie Love)
> ----------------------------------------------------------------------
> Message: 1
> Date: Thu, 8 Oct 2015 09:01:09 -0400
> From: Jamie Love <james.love at keionline.org>
> To: Ip-health <ip-health at lists.keionline.org>,
>    "a2k at lists.keionline.org" <a2k at lists.keionline.org>
> Subject: [Ip-health] NZ official TPP Factsheet on
>    Intellectual-Property
> Message-ID:
>    <CA+aiKTSG4d0n5PWsTRqkOzfoyxSxnG+swaFai2kKoOyFqyV_kw at mail.gmail.com>
> Content-Type: text/plain; charset=UTF-8
> This is what NZ's analysis of the IP provisions are:
> ?https://www.scribd.com/doc/284024406/TPP-Factsheet-Intellectual-Property
> Disclaimer: This document is for information purposes only, and does not
> constitute legal advice.
> trans-pacific partnership intellectual property FACT SHEET
> Overview
> TPP contains an Intellectual property chapter that will establish a common
> regional framework for intellectual property.
> The chapter will harmonise intellectual property standards across the TPP
> region. Consistent enforcement standards will help New Zealand businesses
> protect their intellectual property in TPP markets. Rules on ?geographical
> indications? will also establish processes that should help preserve access
> for New Zealand exports that use generic names.
> Most provisions of the chapter are consistent with New Zealand?s existing
> intellectual property regime. But some provisions require New Zealand to
> make legislative changes before we can ratify the agreement. To limit the
> potential impact of many of these changes, New Zealand has negotiated
> flexible approaches to implementation. Exceptions and limitations have also
> been included. However, the changes required by the chapter will still
> entail some costs for New Zealand. These need to be considered against the
> benefits of the agreement as a whole.
> Objectives and principles
> New Zealand is a Party to the World Trade Organization Agreement on
> Trade-Related Aspects of Intellectual Property Rights (TRIPS). TPP?s
> Intellectual Property chapter incorporates important objectives and
> principles from TRIPS. For example, TPP Parties may take measures to
> protect public health and nutrition, promote the public interest in sectors
> of vital importance to their socio-economic and technological development,
> and prevent the abuse of intellectual property rights by right holders.
> Copyright
> New Zealand law currently protects copyright for 50 years1. Under TPP, New
> Zealand would be required to extend the copyright term to 70 years. The
> extension applies to works that are still within their current 50 year term
> of protection, but not those that have already fallen into the public
> domain. New Zealand copyright owners (including authors, musicians, artists
> and filmmakers) will in some cases benefit from a 70 year copyright term in
> TPP countries, but the benefits are likely to be modest. Extending the
> copyright term also means New Zealand consumers and businesses will forego
> savings they otherwise would have made from books, music and films coming
> off copyright earlier.
> The net cost of extending New Zealand?s copyright term from 50 to 70 years
> will be small to begin with and increase gradually over 20 years, reaching
> a relatively constant level after that. Over the very long term, including
> the initial 20-year period, the average annual cost is estimated to be
> around $55 million.
> TPP will require New Zealand to provide stronger protection to
> technological protection measures (TPMs) ? digital ?locks? that protect
> copyright works. The main new requirement is to provide civil and criminal
> remedies against people breaking TPMs. While TPP also includes obligations
> to prevent selling of devices and services that enable the breaking of
> TPMs, New Zealand already has rules in this area.
> The TPM provisions will not require New Zealand to criminalise uses of
> copyright works that are currently legitimate under New Zealand law. This
> is because New Zealand has negotiated an exceptions provision to ensure
> people can continue to break TPMs for legitimate purposes. These exceptions
> are not set out in TPP ? the Government will determine what they are during
> implementation.
> The Government intends to provide exceptions for situations where use of a
> copyright work either does not infringe copyright in the first place, or is
> otherwise permitted because there is a copyright exception under New
> Zealand law. Examples might include breaking a region-code on a DVD
> legitimately purchased overseas in order to enable it to be viewed on a New
> Zealand DVD player, breaking a TPM to allow reverse engineering of software
> or interoperability of devices, breaking a TPM to reformat a work to enable
> access by the print disabled, or breaking a TPM to protect privacy.
> A broad and flexible exceptions provision also applies to all the copyright
> provisions in TPP. This means TPP Parties will retain their current ability
> to adopt and maintain copyright exceptions under international law. New
> Zealand?s current copyright exception for temporary electronic copies (such
> as cached or buffered copies of websites and internet data) would not need
> to be changed.
> TPP Parties will also endeavour to achieve balance in their copyright and
> related rights systems, including through the adoption of new exceptions
> and limitations. This obligation will help ensure copyright laws remain
> relevant in light of changing technology.
> New Zealand will need to provide new exclusive rights to performers of
> copyright works such as musicians and actors. This will give performers
> rights similar to those of other copyright owners. Currently performers
> have more limited rights than copyright owners.
> TPP will not require New Zealand to introduce any major changes to internet
> service provider (ISP) liability provisions relating to internet copyright
> infringement. For example, the provisions will not require ISPs to
> terminate internet accounts or adopt a ?three strikes? - style graduated
> response regime.
> Parallel importing
> TPP will not require any changes to New Zealand?s laws on parallel
> importing. TPP allows Parties to freely determine international exhaustion
> of intellectual property rights.
> Data protection: Biologics, new uses of pharmaceutical drugs, and
> agricultural chemicals
> The TPP outcome on data protection for pharmaceuticals (including
> biological pharmaceuticals) can be met within New Zealand?s current policy
> settings and practice.
> New pharmaceuticals require safety and efficacy approval before entering
> the New Zealand market. Data protection sets a period of time that generic
> manufacturers have to wait before they can rely on the data provided by the
> supplier of a new pharmaceutical product to progress the approval of their
> own generic version. The length of data protection needs to balance
> producer and consumer interests by providing an incentive to bring new
> pharmaceuticals to New Zealand without unreasonably delaying the entry of
> generics to the market.
> New Zealand law provides five years of data protection for small molecule
> and biological pharmaceuticals (also known as biologics). TPP requires New
> Zealand to continue to provide five years of data protection for small
> molecule pharmaceuticals. For biologics, New Zealand will be required to
> provide the five years of data protection together with further effective
> market protection through other measures, taking into account local market
> circumstances. Although these are new obligations for New Zealand, they can
> be met within existing policy settings and practice.
> TPP Parties have also agreed to review the period of market exclusivity
> provided for biologics after 10 years.
> TPP would also require New Zealand to provide five years data protection to
> new pharmaceutical products that contain a new and a previously approved
> active ingredient. This is consistent with New Zealand?s current law.
> New Zealand will also need to provide 10 years of data protection for new
> agricultural chemicals. Protection of five years is already provided in New
> Zealand.
> Patent term extension to compensate for unreasonable delays
> New Zealand will be required to extend the term of a patent to compensate
> for any unreasonable delays in the patent examination process.
> Similarly, New Zealand would need to extend the term of a patented
> pharmaceutical product if there were unreasonable delays in the safety and
> efficacy approval process run by Medsafe.
> Very few unreasonable delays are expected to occur in New Zealand, and only
> in exceptional circumstances, given the efficiency of patent grant and
> regulatory approval by the Intellectual Property Office of New Zealand
> (IPONZ) and Medsafe respectively. This is because the agreement requires an
> extension of the patent only for certain types of delay:
> ? Patent office delays will only be counted if the patent has not been
> granted within five years of its filing date, or three years from the time
> the patent applicant requests its examination.
> ? Delays attributable to actions of applicants and third parties do not
> require an extension, for both patent office delays and delays in Medsafe?s
> regulatory approval process.
> Patent linkage
> New Zealand will need to provide for ?patent linkage? but will not need to
> adopt the patent linkage models found in some other TPP countries. Patent
> linkage under TPP will require the Government to put in place a system that
> enables a pharmaceutical patent holder to be notified that a generic
> version of their product has been submitted to Medsafe for regulatory
> approval. New Zealand will also need to ensure there is sufficient time and
> opportunity for a patent owner to seek preliminary injunctions to resolve
> patent disputes prior to a generic version of its patented medicine
> entering the market. New Zealand?s current law and practice is sufficient
> in this area. Medsafe will not be required directly to prevent a competitor
> placing a generic on the market until the patent expires, or resolve patent
> disputes. That will remain a matter for New Zealand Courts.
> Regulatory review exception
> TPP will require each Party to provide an exception to patent rights that
> allows the use of a patented pharmaceutical to produce information required
> to seek regulatory approval of a generic version of the pharmaceutical
> product.
> This exception is important as it will help enable pharmaceutical
> manufacturers to seek regulatory approval for a generic pharmaceutical
> product without infringing any patents. This exception is already provided
> for under New Zealand law.
> TPP does not prevent Parties from allowing pharmaceutical manufacturers to
> export generic pharmaceuticals in order to seek regulatory approval in
> other countries. Exporting for this purpose is currently permitted under
> New Zealand law.
> Grace period
> New Zealand will need to adopt a 12 month ?grace period? for patent
> applicants. This means that if inventors make their inventions public, they
> will not lose their ability to be granted a patent in New Zealand if a
> patent application is filed within 12 months of the disclosure.
> Geographical indications
> A geographical indication is a sign or name used in relation to goods that
> have a specific geographical origin and qualities attributable to that
> origin, like champagne. The provisions on geographical indications (GIs) in
> TPP will ensure that Parties to the agreement follow due process when
> protecting the majority of GIs under domestic laws and regulation. These
> include considering whether a term is a generic name in that market, and
> providing procedures to oppose and cancel GIs.
> Separate due process standards will also apply where TPP Parties agree to
> protect GIs through trade agreements. While these provisions are more
> flexible, they will ensure exporters in the TPP region have a sufficient
> opportunity to make comments on the terms that Parties are considering
> protecting through trade agreements. The provisions also safeguard against
> terms remaining protected where they are no longer legitimate GIs. It will
> benefit New Zealand exporters who use common names to market their goods
> overseas.
> Additional damages for trade marks
> New Zealand will need to give New Zealand courts discretion to award
> additional damages for trade mark infringement, on top of the compensatory
> damages already provided for under New Zealand law. This would align
> damages for infringement of trade marks with those for copyright
> infringement in New Zealand.
> Enforcement of copyright and trade marks at the border
> New Zealand would also need to provide the New Zealand Customs Service with
> further ex officio powers, to allow Customs to act on its own initiative to
> temporarily detain suspected infringing goods. Rights owners could then
> provide a notice requesting that Customs undertake the usual customs
> process in relation to such goods.
> Additional treaties: New Zealand accession
> The chapter contains a list of multilateral intellectual property treaties
> that the Parties have committed to join if they are not already members.
> Within three years of TPP entering into force, New Zealand will need to
> join the following:
> ? World Intellectual Property Organisation (WIPO) Copyright Treaty (WCT).
> ? WIPO Performances and Phonograms Treaty (WPPT).
> ? Budapest Treaty on the International Recognition of the Deposit of
> Microorganisms for the Purposes of Patent Procedure.
> New Zealand law is generally consistent with the WCT. While New Zealand law
> would be generally consistent with the WPPT some minor technical changes
> might be necessary, particularly in respect to the rights of performers.
> UPOV 91 and traditional knowledge
> TPP also includes a requirement for New Zealand to, within three years of
> entry into force of TPP, either accede to the most recent 1991 version of
> the International Convention for the Protection of New Varieties of Plants
> (UPOV 91), or alternatively, under a New Zealand specific approach,
> implement a plant variety rights system that gives effect to UPOV 91.
> When implementing this obligation, New Zealand is able to adopt any measure
> that it deems necessary to protect indigenous plant species in fulfilment
> of its obligations under the Treaty of Waitangi (and this is not subject to
> the dispute settlement provisions in TPP).
> This gives the Government flexibility to decide, in consultation with
> relevant stakeholders, how to best meet the obligations in respect of UPOV
> 91, while taking into account the recommendations in Waitangi Tribunal
> report Ko Aotearoa Tenei (WAI 262).
> TPP also includes a number of provisions aimed at improving the treatment
> of traditional knowledge in intellectual property systems. These encourage
> information sharing between intellectual property offices on their
> practices for dealing with traditional knowledge, and require Parties to
> endeavour to ensure that quality patent examination practices are applied
> when applications for patents relate to traditional knowledge.
> TPP also permits a Party to take measures to preserve, promote and respect
> traditional knowledge and traditional cultural expressions in a manner
> consistent with that Party?s international obligations.
> 1. This means that copyright in music recordings and films continues for 50
> years after they were made. Copyright in books, screenplays, music, lyrics
> and artistic works continues for 50 years after the death of the author.
> -- 
> James Love.  Knowledge Ecology International
> http://www.keionline.org/donate.html
> KEI DC tel: +1.202.332.2670, US Mobile: +1.202.361.3040, Geneva Mobile:
> +41.76.413.6584, twitter.com/jamie_love
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