Intellectual Property Laws Amendment Bill 2014 Passed
Following earlier approval by the House of Representatives the Senate has now approved the Intellectual Property Laws Amendment Bill 2014, which was passed by the Australian Parliament on 9th February 2015.
The Bill will amend the Patents Act 1990, Trade Marks Act 1995, Designs Act 2003, and the Plant Breeder's Rights Act 1994 in order to:
• implement the Protocol amending the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property (TRIPS Protocol), enabling Australian medicine producers to manufacture and export patented pharmaceuticals to countries experiencing health crises, under a compulsory licence from the Federal Court
• extend the jurisdiction of the former Federal Magistrates Court, the Federal Circuit Court, to include plant breeder's rights matters
• allow for a single trans-Tasman patent attorney regime and single patent application and examination processes for Australia and New Zealand, as part of the broader Single Economic Market (SEM) agenda
• make minor administrative changes to the Patents, Trade Marks and Designs Acts to repeal unnecessary document retention provisions that are already adequately governed by the Archives Act 1983
• make minor technical amendments to the Patents Act to correct oversights in the drafting of the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 which was passed by Parliament in March 2012.
The Bill is now awaiting royal assent. Most provisions will commence either when the Bill is given royal assent or 6-months after that date. However, the provisions relating to the single trans-Tasman patent attorney regime and single patent application and examination processes for Australia and New Zealand will commence on a date to be fixed by proclamation, with the proviso that they will be repealed if not commenced within 24-months of receiving royal assent.
Consultation Paper on Streamlining IP Processes Relaesed
IP Australia has released a consultation paper in which it seeks feedback on various proposals aimed at streamlining IP processes and supporting small businesses. It is considered that there are a number of administrative processes that unnecessarily differ between the rights. Others processes are more burdensome than they need to be or take too long to resolve. Submissions should be sent to firstname.lastname@example.org by 7th April 2015. Some of the notable changes are:
• Create a consistent renewal grace period and clarify that each IP right remains ‘live’ during that time.
• Limit payment of renewals to the 12-months before the due date.
• Only issue renewal reminders to unrepresented trade mark owners.
• Provide for re-examination of all registrable IP rights.
• Make ‘despite due care’ extensions of time available for all IP rights and limit the ‘error or omission by applicant/owner’ extension to 12 months.
• Remove the requirement to publish Journals, instead relying on publication in the relevant databases. Time periods would commence from relevant publication in database.
• Allow authorised applicants and / or agents to make administrative amendments, such as to address details, directly using the eServices portal.
• Allow IP Australia to correct obvious mistakes, although the applicant would be subsequently notified.
• Remove the requirement for signatures on a limited number of patents documents where there is considered to be a minimal risk of the action being done without proper authorisation.
• Removing the requirement to issue certificates of examination, registration or grant. Documents approved by the Commissioner or Registrar would constitute prima facie evidence.
• Align the ‘Address for Service’ requirements across all IP rights and remove the ‘Address for Correspondence’ requirements.
• Allowing third parties to directly request examination, rather than doing so via the Commissioner, with the cost split 50/50 between the third party and the applicant.
• Allowing colour drawings for both national and international patent applications.
• Reducing the timeframe for putting trade marks in order for acceptance from 15-months to 6-months from examination.
• Removing the option of requesting publication of a design and proceeding directly to registration.
• Removing the requirement to provide multiple copies of a design.
• Aligning the unjustified threats provisions across the IP rights and allowing additional damages for blatant and unjustified threats of infringement.
• Allow more than two breeders to lodge a joint application for a plant breeder right.
Launching of One Portal Dossier
In March 2015, as part of the IP5 cooperative project, the Korean Intellectual Property Office (KIPO) will launch a service called One Portal Dossier (OPD). The OPD service will provide the public with a single point of access to patent examination progress information from the five largest IP offices, namely: the EPO, JPO, KIPO, SIPO, and USPTO.
From the launch date the OPD service will provide examination progress information from Korea, Europe, and Japan. China’s information will be available during the second half of 2015, while American examination progress information will be available via the OPD by 2016.
Dosage Claims Not a Method of Medical Treatment
In AbbVie Biotechnology Ltd v Canada the Federal Court allowed AbbVie's appeal from a refusal to grant their patent application on the basis that the claims at issue covered a method of medical treatment. The claims at issue were for a dosage regime, claiming the use of a known drug at a specified fixed amount and a fixed interval.
The Commissioner refused to grant the claims on the basis that they contravened the prohibition on claiming methods of medical treatment. The Commissioner interpreted a prior Federal Court judgment as holding that there is a broad prohibition against patenting the how and when in the administration of a drug, on the basis that such claims would prevent physicians from exercising their skill and judgment.
However, the Court held that the Commissioner had misapplied the prior judgment. It was not a change in the law, but rather the application of the prevailing law to the particular claims and evidence of that case. The prior judgment involved a dosage range with several variables in which the physician is required to monitor the patient and make adjustments. That was held to cover a pure form of medical treatment.
In contrast, the current case concerned a fixed and precise dosage regime requiring no further skill and judgment to be exercised by the physician in order to be exercised. Nor did it restrict the physician’s skill and judgment in determining whether the claimed use is appropriate for the patient.
European Patents Capable of Validation in Morocco
European patent applications with a (deemed) filing date on or after 1st March 2015 can be validated in Morocco. To clarify this, a European application that is filed after 1st March 2015 but which is based on a PCT application that is filed before 1st March 2015 does not qualify for validation in Morocco, since the deemed filing date is before 1st March 2015. As with other states, validation needs to occur within the later of 6-months of the mention in the European Patent Bulletin of publication of the European search report or before European regional phase if Europe is entered via the PCT. A 2-month grace period is allowed upon payment of a late fee. European patent applications that are validated in Morocco will be subject to Moroccan patent law. Morocco will be the first independent country outside of Europe that allows European patents to be validated within its territory.
Novel Dosage Regime Found to be Obvious
In Hospira UK Ltd v Genentech Inc the Court of Appeal upheld a Patents Court Judge’s finding that a patent for a dosing regime was invalid for obviousness. Genentech’s patent was for a novel dosage regime of herceptin beginning with a dose of 8mg/kg and subsequent doses of 6mg/kg every 3 weeks. The Patents Court Judge found that the evidence available to a skilled team at the priority date would establish efficaciousness beginning with a dose of 8mg/kg and subsequent doses of 7.14mg/kg every 3 weeks.
The Court of Appeal noted that the criterion for deciding whether the claimed regimen was obvious was whether the skilled team would consider the prospects of it working to be sufficiently good to warrant a small clinical trial. The Court of Appeal also found that the dosage regime available to the skilled team at the priority date did not preclude a lower dosage regime being efficacious. Indeed, the evidence showed that the 7.14mg/kg dosage exceeded the targeted minimum concentration. The Court of Appeal noted that the Judge did not have to determine the lower limit of that range in order to make a determination on obviousness. The Judge only needed to be satisfied on the balance of probabilities that the lower dosage regime lay within it, which the Court of Appeal held the Judge was justified in so finding.
Consequently, in the absence of any evidence of the lower dosage regime having any unanticipated of surprising advantage, Genentech’s patent was revoked on account of obviousness.
United States of America
Supreme Court Limits Review of Claim Construction
In Teva Pharmaceuticals USA Inc v Sandoz Inc the Supreme Court held that the factual findings underlying the claim construction should not be reviewed de novo when the lower court’s judgement is appealed.
The Court of Appeals for the Federal Circuit (CAFC) has a long history of reviewing lower court’s claim construction as a pure question of law. However, the Supreme Court held that claim construction is a practice with evidentiary underpinnings which inform the meaning of claim terms in the context of the patented invention and to those skilled in the associated technology.
The Supreme Court held that claim construction is not an exception to the ordinary rule governing appellate review of factual matters. In particular, appellate courts should only review factual findings subsidiary to claim construction under the ‘clearly erroneous’ standard. For example, where background science is consulted, or the history of how the term is understood is reviewed, any such factual findings should only be reviewed for clear error when on appeal.
However, when the district court reviews only evidence intrinsic to the patent (the patent claims and specification, along with the patent's prosecution history), the Judge’s determination will amount solely to a determination of law, and the Court of Appeals will review that construction de novo.