Afghanistan Joining Paris Convention
On 14th May 2017 Afghanistan will become bound by the Paris Convention. Afghanistan is already a member of the World Trade Organisation, and so, according to PCT Rule 4.10(a), it is already possible to claim priority from an Afghanistan patent application for a PCT International patent application.
ARIPO and OAPI Work Towards Harmonisation
In February 2017 the African Regional Intellectual Property Organization (ARIPO) and the African Intellectual Property Organization (OAPI) signed a four year Cooperation Agreement, an aim of which is to work towards greater harmonisation of the two systems.
The Cooperation Agreement establishes a cooperation framework in intellectual property matters for the two parties, involving the exchange of documentation and technical information and mutual cooperation in the development of training and joint capacity building programs. However, the ultimate objective is the development of a single system for the protection of intellectual property in Africa.
Inadequate Disclosure Frustrates Premilinary Discovery Application
In Pfizer Ireland Pharmaceuticals v Samsung Bioepis AU Pty Ltd the Judge dismissed Pfizer’s preliminary discovery application for documents that would help it to determine whether the manufacture of Samsung’s registered biosimilar product infringes any of three process patents.
Prior to Samsung obtaining registration on the Australian Register of Therapeutic Goods (ARTG) for products containing the active ingredient etanercept in July 2016, Pfizer had the only ARTG registration for such products. Pfizer was concerned that Samsung’s product may have been obtained by a process that infringed one or more of three process patents, two of which belong to Pfizer.
In order to obtain ARTG registration for a biosimilar product Samsung had to lodge its application with the Therapeutic Goods Administration (TGA). The TGA Biosimilar Guidelines require a biosimilar product to be shown to have similar physicochemical, biological, immunological, efficacy and safety characteristics, as demonstrated by comprehensive comparability studies with the (Pfizer’s) reference medicine. However, the Guidelines also acknowledge that the manufacturer developing a biosimilar product would normally not have access to all information that could allow an exhaustive comparison with the reference medicinal product, particularly with regards to the manufacturing process. The Guidelines also assume that changes may be made to the manufacturing processes for biological medicines (whether originator or biosimilar) after regulatory approval has been given, so long as “comparability” requirements are met.
Pfizer sought preliminary discovery pursuant to r 7.23 of the Federal Court Rules 2011 of confidential documents that Samsung lodged with the TGA in order to obtain its ARTG listing, on the basis that they will enable it to decide whether or not to commence patent infringement proceedings.
While the various claims were published prior to Samsung commencing its development work, in the absence of other indicative evidence that the claims were used, the Judge gave only a little weight to the contention that Samsung had an incentive to utilize the advantages of the claimed processes.
The Judge did not accept the inference that the use of a very similar process for manufacturing etanercept can be inferred from the biosimilarity of the products. Rather, the evidence was found to show that the biosimilarity of a product does not inform the process by which it is made. The Judge found that the available evidence did not establish that Samsung’s product results from following any of the asserted claims.
The Judge was also critical of Pfizer seeking to have Samsung reveal its confidential process documents even though Pfizer itself failed to provide evidence that its own process fell within any of the claims. In the absence of such evidence (given on a confidential basis through external solicitors) Samsung (or even the Court) could not contest or properly consider the correctness of the assertion that Samsung’s process is similar to Pfizer’s. The Judge considered that the Court should only exercise coercive powers of discovery in cases of preliminary discovery if the applicant has placed before the Court all relevant evidence available to it.
The Judge also noted that while Samsung had not provided evidence from a witness to the effect that one or more claim integers are not present in its process, it is not appropriate in a preliminary discovery case to draw a negative inference on this basis since the respondent is entitled to remain passive.
EPO Expands Provisional Opinion on Patentability Service
From the 1st April 2017, where there is a finding of lack of unity at the search stage, the EPO begins issuing provisional opinions on patentability of the invention (or unitary group of inventions) first mentioned in the claims with the partial search results and invitation to pay additional search fees.
This service will apply in respect of European patent applications filed directly with the EPO, PCT applications where the EPO is the ISA, and Euro-PCT applications where a supplementary European search is performed. The notification will also inform the reasons for the non-unity finding. Such notifications will be for information only and replies addressing the points raised must only be submitted and will only be taken into account after the final European or international search report has issued. Such provisional opinions will, in due course, be available to the public via online file inspection.
Prior to this change, where there is a finding of lack of unity at the search stage by the EPO, applicants would only receive the opinion on patentability together with the final European or international search report.
United States of America
Claims Involving Mathematical Equations Not Necessarily Patent Ineligible
In Thales Visionix v United States the Court of Appeals for the Federal Circuit (CAFC) confirmed the continuing relevance of pre-Alice Supreme Court precedent on the patent eligibility of claims requiring the use of mathematical equations.
Thales sued the US government and a government subcontractor for infringing numerous claims of its patent for an inertial tracking system for tracking the motion of an object relative to a moving reference frame, on account of their use in a helmet mounted display system. However, the Claims Court held all claims directed to patent-ineligible subject matter on account of being directed to the abstract idea of using laws of nature governing motion to track two objects, and providing no inventive concept beyond that abstract idea.
The allegedly infringed claims included the two independent system and method claims as follows:
1. A system for tracking the motion of an object relative to a moving reference frame, comprising:
a first inertial sensor mounted on the tracked object;
a second inertial sensor mounted on the moving reference frame; and
an element adapted to receive signals from said first and second inertial sensors and configured to determine an orientation of the object relative to the moving reference frame based on the signals received from the first and second inertial sensors.
22. A method comprising determining an orientation of an object relative to a moving reference frame based on signals from two inertial sensors mounted respectively on the object and on the moving reference frame.
On appeal the CAFC found parallels with the 1981 Supreme Court decision of Diamond v Diehr, which concerned the use of a mathematical formula in rubber curing. The Supreme Court held that while the claims contained a mathematical formula that formula was just a part of an overall process involving subject matter that the patent laws are designed to protect. Namely, the claims were patent eligible, since they were directed to an improvement in the rubber curing process, not the mathematical formula.
For the case at hand the CAFC similarly held that, while the claims utilize mathematical equations to determine the orientation of the object relative to the moving reference frame, the equations serve only to tabulate the position and orientation information in this configuration. However, the claims are directed to a system or method that incorporates that information to reduce errors in the tracking of a moving object from a frame of reference which is also moving (relative to the earth).
The CAFC observed that in applying step 1 of the Supreme Court’s Alice test for patentability it is not enough to merely identify a patent-ineligible concept underlying the claim. Rather, the step involves determining whether that patent-ineligible concept is what the claim is ‘directed to’.
3. Trade Marks
Descriptiveness of Foreign Words Clarified
Recent Assistant Commissioner’s decision A Menarini Industrie Farmeutiche Riunite SRL clarified the assessment of descriptiveness in relation to foreign words.
Menarini applied to register KETUM in relation to an anti-inflammatory drug used to ease joint and muscle pain. The examiner objected to registration on the grounds of descriptiveness and non-distinctiveness after finding evidence that “ketum” is a recognised name for the Mitragyna speciosa species of plant, being a plant commonly used for medicinal properties including pain relief. In further correspondence the applicant stated that Ketum is a Malay term; that their product has no connection with the Mitragyna speciosa species of plant and that KETUM is an invented word when used in relation to anti-inflammatory drugs. They also offered to amend the specification to specifically state that it does not contain compounds or derivatives of the Mitragyna Speciosa plant. IPONZ refused the amendment on the basis that it would not remove the possibility of consumer confusion given its descriptive capacity in relation to similar pain relieving properties.
The Assistant Commissioner noted that IPONZ’s Practice Guidelines state the registrability of a mark comprising a foreign word is influenced by whether the foreign language is generally known to the relevant class of persons in New Zealand. The Assistant Commissioner held that the evidence did not establish that Ketum is a name used for the Mitragyna speciosa species of plant in New Zealand and that the meaning of the word would not be readily apparent to the average person in New Zealand.
While acknowledging that overseas internet use can be relevant to distinctiveness in New Zealand, the Assistant Commissioner gave little weight to such evidence as it was generally in a language that is foreign to many New Zealanders and involved use in countries where English is not an official language. It was also not clear on the evidence whether New Zealanders could purchase Ketum on the foreign websites and if so whether delivery could be made to New Zealand. The Assistant Commissioner also considered that pharmacists and medical professionals would be more likely to refer to the substance with the scientific name Mitragyna speciosa, which is how it is referred to in the Medical Regulations 1984. The Assistant Commissioner further held that other traders would be unlikely to want to use Ketum in good faith for products that compete with those of the applicant.
Consequently the Assistant Commissioner allowed the mark to proceed to registration and did not require any disclaimer to compounds or derivatives of the Mitragyna Speciosa plant to be entered on the specification.