[Ip-health] Changes in Australia Compulsory licensing laws

Ruth Lopert ruth.lopert at gmail.com
Thu Aug 15 05:50:50 PDT 2019

I would love to know how a court is going to determine whether there is any
impact on innovation.

On Thu, Aug 15, 2019 at 2:47 PM James Love <james.love at keionline.org> wrote:

> https://www.lexology.com/library/detail.aspx?g=e9151698-cb34-4b33-bf45-8d5759329c65
> Australian Patent Update: three key changes underway
> Herbert Smith Freehills LLP
> Australia August 15 2019
> ..............
> Crown use of patents and designs
> Crown use sets out the circumstances in which the Australian Federal, State
> and Territory governments can access and use patented technology and
> registered designs without the prior authorisation of the patent applicant,
> the patentee, or in the case of registered designs, the registered owner.
> Responding to observations of the Productivity Commission that the current
> Crown use provisions were unclear and failed to sufficiently provide for
> transparency and accountability, the Bill expands Crown use so it can be
> invoked for the provision of services for which any Commonwealth, State or
> Territory government has the primary responsibility for providing or
> funding.
> When determining ‘primary responsibility’ all providers of similar services
> to those provided or funded by a government, including non-government
> providers, are to be included in the assessment.
> The explanatory memorandum gives the example of diagnostic genetic testing,
> which is invariably undertaken by private providers, but the government’s
> responsibility for and funding of the vast majority of genetic testing
> means it fulfils the ‘primary responsibility’ test.1
> The Bill’s amendments:
> clarify that for the Crown’s exploitation to be valid, the government must
> have attempted to negotiate with the patent owner “for a reasonable period”
> for an authorisation to exploit the invention (for example under a
> licence), and have the relevant Minister’s approval;2
> require prior notice to be given to the patent applicant or patentee at
> least 14 days before the exploitation commences (except in emergency
> circumstances);3
> provide that only in an emergency is a negotiation not required. An
> emergency could include a public health crisis such as a plague or
> epidemic, or pandemic. It could also include war, national security
> situations, perceived threats to law and order, natural disasters and other
> situations of urgency;4 and
> change the remuneration provision so that the Court is now required to
> determine remuneration that is “just and reasonable, having regard to the
> economic value of the exploitation of the invention and any other matter
> the court considers relevant”, rather than merely taking into account any
> compensation received.5
> Compulsory licenses
> A compulsory licence is an order made by the Court for a patentee to grant
> a licence to another party to exploit an invention. In its inquiry, the
> Productivity Commission found that the current compulsory licence
> provisions were unclear and suggested reform to improve the certainty and
> clarity of the legislation.
> The Bill’s amendments implement a stricter and more certain framework for
> compulsory licences and require the Court to only make an order for a
> compulsory licence where:
> there is an unmet demand in Australia for an original patented invention;
> the patent holder has failed to exploit the patent and provide reasons for
> this; and
> the applicant has attempted for a reasonable period to obtain a licence on
> reasonable terms and conditions, but without success.
> In addition to these factors, the Court must be satisfied that the grant of
> the licence is within the ‘public interest’. This replaces the existing
> ‘reasonable requirements of the public’ test and should please patent
> owners as it is likely to be comparable to the public interest requirements
> in other areas of law.
> The amendments require the Court to consider three factors in its
> assessment of whether a compulsory licence is in the ‘public interest’:
> the benefits to the public from meeting the relevant unmet demand for the
> original patented invention;
> the commercial costs and benefits to the patentee and the applicant; and
> any other matters that the Court considers relevant, including those
> relating to greater competition and any impact on innovation.
> Similarly to the amendments to determining remuneration for Crown use, the
> Bill has amended the method by which remuneration for compulsory licences
> is to be determined (by agreement or Court determination) and expanded the
> factors that the Court must take into account to include:
> “the right of the patentee to obtain a return on investment commensurate
> with the regulatory and commercial risks involved in developing the
> invention”; and
> “the public interest in the efficient exploitation of the invention.”
> ...
> --
> James Love.  Knowledge Ecology International
> U.S. Mobile +1.202.361.3040
> U.S. office phone +1.202.332.2670
> http://www.keionline.org <http://www.keionline.org/donate.html>
> twitter.com/jamie_love
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