IP SPOTLIGHT 14 April 2021

IP SPOTLIGHT NEWS FROM AUSTRALIA

14 Apri l 2021

UPDATE ON THE TGA’S NEW TRANSPARENCY MEASURES FOR PRESCRIPTION MEDICINES

By way of background, on 9 October 2020, the Therapeutic Goods Administration (TGA) released a notice on the following changes. a. The TGA will release certain information about applications for the registration of new medicines shortly after preliminary assessment; and b. Only the first applicant for a generic or biosimilar will need to notify the patentee of a relevant patent when their application is accepted by the TGA. All other applications by subsequent generic / biosimilar applicants will be subject to the notification scheme, whereby the generic or biosimilar applicant certifies to the TGA that it believes on reasonable grounds it will not infringe a valid patent (or less usually that a patent has been granted and the applicant proposes to market the therapeutic good before the end of the term of the patent). Regarding (a), this is a reminder to our clients that since 1 January 2021, the TGA now publishes details of applications under evaluation for major innovator medicines. The new publication regime will apply to new medicines (Type A),

new combinations of medicines (Type B) and new indications for an existing medicine (Type C). Prior to 1 January 2021, this information was confidential. To search major innovator medicines applications under evaluation from January 2021, please click here. It is important to note that biosimilar and generic medicines and variations to existing medicines are excluded from publication of applications under evaluation.

At the writing of this report, change (b) was not yet implemented but it is expected to be implemented in 2021.

Please contact Wrays if you require any assistance monitoring TGA applications.

DR LOUISA KING IP Search Expert

CRAIG HUMPHRIS Principal

Inventions in the chemical, life sciences and pharmaceutical fields differ from mechanical inventions due to their need for the invention to be confirmed by experiments. Many of these experiments are carried out after filing, to confirm inventions predicted but not fully explored in at the time of filing. Previously when prosecuting patents in China, both the China National Intellectual Property Administration (“CNIPA”) and the courts took a relatively strict position against post-filing supplementary data and submitting experimental data generated after the filing date in support of the patentability of inventions was not permitted. However, recent changes to the Patent Law and Guidelines for Examination have established that post-filing data for demonstrating the patentability of the claimed inventions shall not be prohibited. The recent Economic and Trade Agreement between the Government of China and U.S. (published 16 January 2020) firmly confirms that “China shall permit pharmaceutical patent applicants to rely on supplemental data to satisfy relevant requirements for patentability, including sufficiency of disclosure and inventive step, during patent examination proceedings, patent review proceedings, and judicial proceedings”. The result of this is that the CNIPA recently announced the “Revised Patent Examination Guidelines”, which came into force from 15 January 2021. As a result of the Revised Guidelines, if the claimed invention was a technical effect predictable or expected on the basis of the original specification as filed, then the examiner should review any supplementary experimental data submitted in support. However, they do not have to accept the data if they do not think the disclosure was sufficiently predictable based on what was in the original specification at the filing date.

The first example describes a claim directed to a compound. The application describes the compound as having the effect of lowering blood pressure and provides methods of measuring the compound’s blood pressure lowering activity, but experimental data was not disclosed in the application at filing. The Revised Guide states that the examiner should consider the applicant’s post-filing data demonstrating the compound did lower blood pressure as predicted. The second example describes a claim directed to compounds having formula I. Data in the application at filing shows the IC 50 of the compound’s antitumor effect is in the range of 10-100 nM. The specification of the second example also describes the methods for determining the antitumor effect. The applicant submitted post-filing data to demonstrate the compound is inventive, and comparison data showing that the compound has an IC 50 of 15 nM in treating tumours, while the reference prior art compound has an IC 50 of 87 nM. The Revised Guide requires that in this scenario, the examiner should consider the post-filing data when determining the inventive step of the claim. We therefore suggest that, to provide a clear basis for the submission of post-filing data in China, it is good practice to describe the technical effect as well as the methods for determination thereof in the application at the time of filing.

DR PENNY FARBEY Special Counsel

SUBMITTING POST-FILING DATA DURING PATENT PROSECUTION IN CHINA

The Revised Guide provides two examples relating to pharmaceutical inventions.

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Fortunately, according to Australian design legislation, the fact that overall impression of the design is dictated by external factors (such as governmental regulations) permits that newness and distinctiveness of the design be determined exclusively in the light of the factors that can be controlled by the designer and all features that are essential to the product to undertake their function may be discarded 2 . Thus, it is appropriate to assess newness and distinctiveness on the basis of factors which are under the designer’s control. Also, more weight has to be given to differences or variations; this result in that more consideration must be given to the details that make up the difference between two similar designs than relying exclusively on the overall impression of the design under dispute. Therefore, at least for heavily regulated products, an interesting scenario may be formed in which a plurality of designs are protected even though they, at first glance for the general public, appear to be substantially similar in overall impression. This is particularly true provided the guidelines below are followed: – the differences and variations between the designs should be located at a significant location toward which the eye of the informed user is drawn to – the features that make up the differences need to be referred to in the statement of newness and distinctiveness – it is essential to talk to your preferred Australian patent firm such as WRAYS to ensure it is done right.

This continuous evolving - occurring at an amazing rapid pace never seen before - of the external appearance of existing products has brought about that protecting the external appearance of the improved products may become difficult or even impossible. In fact, in the light of current design legislations, the improved product when compared against the existing products (e.g. the product that has been improved) may be considered to be substantially similar in overall impression and therefore not protectable via design protection. This is particularly true when the improvements made to the existing products (resulting in the improved product) are such that, for the general public, not necessarily the overall impression of the existing products is changed. A particular circumstance where an apparently substantially similar design may be protected via design protection is when heavily regulated products are the ones that are being improved. A particular example of heavy regulated products are street posts of, for example, the type having an upper top signage for displaying information for advertisement or commercial purposes. With the advent of LED screens of a relatively large magnitude there has been the obvious choice of replacing the old-fashioned plexiglass screens including neon lights common to conventional street posts with these LED screens. The question that arises is whether an enforceable design right could be obtained for a street post which have been changed by only replacing the plexiglass screen with a LED screen. As will be explained below, there may be an option of gaining enforceable Australian design rights provided the top signage is at a location (such as mounted on the street post) that draws the attention of the informed user 1 . Also, preferably, some changes should be made to the frame that once supported the plexiglass screen and will receive now the LED screen. The fact that a particular product is heavily regulated results in that designer’s freedom to innovate is greatly limited. For example, in street posts their poles need to be inherently long bodies, their naming signs need to extend perpendicularly from poles, located at specific heights, and oriented at specific azimuth angles about the posts.

PROTECTING THE IMPOSSIBLE – THE SUBSTANTIALLY SIMILAR DESIGN IN AUSTRALIA In order to keep up with market demands, industries have teams of designers continuously improving products that are currently in the marketplace. This is common place in this day and age of rapidly evolving technologies and with consumers wanting nearly instant gratification. An example of such improvements can be varying the external appearance of products of competitors with the objective of eroding the competitor’s market share.

PETER HILLE Senior Associate

1 The informed user is the hypothetic individual created to ensure an objective test is applied during assessing whether an enforceable design right may be granted to a particular design – see Australian Manual of Design Examination @ D09.4.6.2 – Informed User. 2 Australian Manual of Design Examination @ D09.4.5. Freedom of the creator of the design to innovate.

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