IP SPOTLIGHT 17 August 2020

IP SPOTLIGHT NEWS FROM AUSTRALIA

17 August 2020

WRAYS PROMOTES TWO LIFE SCIENCES ATTORNEYS

Wrays is delighted to announce the promotion of two attorneys from our Life Sciences team. Dr Penelope Farbey has been promoted to Special Counsel and Dr Daniel Beck has been promoted to Associate. Dr Penelope Farbey joined Wrays in 2001 and is a molecular microbiology specialist, working closely with small to medium biotechnology, pharmaceutical and agri-biotech firms as well as universities. Penelope says “I feel very fortunate that I am able to have a career working directly with scientists at the forefront of their fields. I have never lost my fascination with science and I enjoy collaborating with clients to protect their innovations. Wrays continues to provide opportunities to expand my scientific and intellectual property knowledge. The fact that I have been at Wrays nearly 20 years speaks volumes about the firm and my colleagues.” Dr Daniel Beck specialises in chemistry, pharmaceuticals and biotechnology. Based in Melbourne, Daniel joined Wrays after 11 years working at the Australian Patent Office (IP Australia), providing him with an insider’s perspective on patent prosecution and oppositions to grant. Daniel’s career

also includes working as a research scientist at Novartis Institute for Biomedical Research in Switzerland. Of his recent promotion, Daniel said “I love working at Wrays because the culture here is one of consultation and collaboration. We work together and help each other to produce the best result for the client. Intellectual Property is a fascinating career and it is immensely rewarding to work with clients to draft and prosecute patent applications”. Head of Wrays’ Life Science Group Todd Shand, made the announcements saying “On behalf of Wrays, I congratulate Penelope and Daniel on their recent promotions. During her time at Wrays Penelope has contributed enormously to the success of the firm and in particular the Life Sciences Group. She is highly regarded by her clients for both her technical expertise and commercial focus. Daniel has a wealth of chemistry and biotechnology knowledge. His focus on providing the most efficient and effective service to clients makes him ideal for our Melbourne Life Sciences team. Well done to Penelope and Daniel.”

GARY COX Chairman & Principal

IP AUSTRALIA TO CHANGE THEIR OFFICIAL FEES

DES IGN FEES The most significant change to the fees for designs is the introduction of a $200 fee for having more than one design in the same category. PLANT BREEDER ’S R IGHTS FEES New Plant Breeder’s Rights application have increased to $400. Additionally, the Qualified Person’s (QP) fee has increased with a designation of a QP being raised to $240 per 3 years. Renewal of a QP is likewise raised to $240 per 3 years.

Type of excess claim fee Claims 21 to 30 Caim 31 and over Each claim in excess of 20 claims added post-acceptance

Old Fee (AUD) per claim

New Fee (AUD) per claim

110 110 110

125 250 250

To avoid incurring excess claim fees, we strongly recommend advancing prosecution of all pending patent applications (where more than 20 claims are necessary) with the aim being to gain acceptance of the application prior to 1 October 2020. Finally, renewal fees are set to increase significantly, and particularly in the last five years of a standard patent. Renewal fees for pharmaceutical patents which benefit from a patent term extension will see an even greater fee increase. Therefore, we recommend reviewing the years remaining on your patent, the costs associated with future renewal fees and considering paying the fees in advance and prior to 1 October 2020. On a positive note, patent applicants will benefit from the change in the fees associated with voluntarily requesting a Preliminary Search and Opinion which will decrease from $2,200 to $950. TRADE MARK FEES The most significant change to trade mark fees results from applications that do not make use of the “Picklist”. Under the new fee structure, filing fees for non-Picklist applications will increase to $400 per class. Adding an additional class of goods/services to an application during the examination phase will rise to $400. The good news is that the increased filing fees do not apply to applications lodged using the Headstart Request service or using the Picklist. Renewal fees for trade marks remain unchanged. Trade mark hearing fees have also been changed. However, changes to trade mark opposition fees have been placed on hold for now. Further information on the changes in the trade mark fee structure may be found on our website.

LINDA KENNAUGH Principal

DONNA MEREDITH Associate

The Australian Patent Office (IP Australia) will soon implement changes to their fee structure. To assist with an understanding of these changes, we provide a brief summary of the changes, and include some proactive recommendations to avoid some significant cost increases.

As of 1 October 2020 , IP Australia will significantly increase some of their Patent, Trade Mark, Design and Plant Breeders Rights (PBR) fees. The fee changes have the greatest impact on patent fees (with renewals being the hardest hit); with the major impact in trade mark fees occurring during the application process. Designs and PBR will see only modest changes, but in general, an increase in fees. The following changes have been reproduced from information provided by IP Australia on their website (see https://www.ipaustralia.gov.au/about-us/public-consultations/ archived-public-consultations/fee-review-2019-2020). PATENT SERV I CE FEES Filing fees for standard and innovation patent applications will remain unchanged except where patent applicants are unable to electronically file the application, in which case a filing fee increase of $100 will apply. The current excess claim fee ($110 per claim in excess of 20 claims) has been abolished and replaced with a tiered structure.

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TIMELY REMINDER TO UPDATE TRADE MARK REGISTRATION WHEN MAKING A BRAND REFRESH

Periodic brand refreshes offer several benefits for a business such as staying relevant, distinguishing your business from your competitors, realignment with new or changing values, products or services and reconnecting with customers. Every successful business will need to refresh their brand from time to time. Usually, the essential ‘look’ of the brand is retained, with minor alterations, so that the brand still remains recognisable. For example, the following logos show the changes The Body Shop brands have undergone from the early 80s to the present day.

In Australia, a trade mark registration may be cancelled if the owner has not used the trade mark in relation to the goods and/or services for a continuous period of three years. Periodic brand refreshes are taken into account - the Registrar may decide that the owner (or an authorised user) has used a trade mark if it can be established that the owner (or the authorised user) has used the trade mark with additions or alterations that do not substantially affect the identity of the trade mark. In this case G. & K. Fine Foods Pty Ltd was unable to convince the Australian Trade Mark Office that their use of DELUCA’S since 2015 was effectively a continuation of use of their previous trade mark BY DELUCAS. Simple changes as part of the brand refresh, which removed BY and added an apostrophe to DELUCAS to change it to DELUCA’S, were considered sufficient for the Hearing Officer to conclude that the trade marks were not substantially identical and that use of DELUCA’S was not use of BY DELUCAS. The trade mark registration for BY DELUCAS has now been cancelled. If a business has decided that there are good reasons to undergo a brand refresh, then we recommend that they also consult a trade mark attorney at Wrays to ensure that their existing trade mark registrations remain protected against cancellation for non-use and that the new branding is appropriately protected with additional trade mark registrations, particularly if the rebrand is associated with the release of new goods and/or service offerings.

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A recent decision by the Australian Trade Marks Office, G. & K. Fine Foods Pty Ltd v J DeLuca Fish Company, Inc. [2020] ATMO 97 (2 June 2020) is a timely reminder to businesses that a careless brand refresh may leave them vulnerable to cancellation of their trade mark rights unless they take steps to update their trade mark registrations along with their brand. G. & K. Fine Foods Pty Ltd was a gourmet food wholesale and distribution company established in the late 1980s. In 2009 it started using the trade mark BY DELUCAS in relation to packaged food products such as pasta-based meals and it registered this trade mark in respect to a wide range of food products. In 2015, the business underwent a brand refresh – it phased out the use of the word ‘BY’ and the updated trade mark became DELUCA’S. The essential element DELUCA was retained but these minor changes accompanying the brand refresh had significant consequences for retention of the registered trade mark.

MARY TURONEK Principal

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“ ... the line between a sufficient expectation of success and “worth a try” remains elusive. ”

SWI SS-STYLE CLA IMS Swiss-style claims require the use of a therapeutic substance to manufacture a pharmaceutical product (often referred to as a “medicament”) for the treatment of a condition. The Treatment Patent claimed the use of fenofibrate for the manufacture of a pharmaceutical product for treating diabetic retinopathy. Pharmaceutical products that can be used to treat multiple conditions, with some but not all conditions claimed by the patent, raise difficult questions as to the circumstances in which the exploitation of that product infringes a Swiss-style claim. The Full Court explained that the question of infringement of a Swiss-style claim depends on whether the product is “for” the claimed therapeutic purpose, and that that question must be answered by reference to the characteristics of the product (as opposed to the manufacturer’s intention). The most important characteristics are the products formulation, dosage, packaging and labelling. That said, the manufacturer’s actual intention in making the product and the reasonably foreseeable uses to which that product will be put might still be relevant (albeit not determinative). Where a product will be used “extensively” for purposes that fall outside the Swiss-style claim, the fact that it is reasonably foreseeable, or even likely, that a substantial portion of the product would also be used for the claimed therapeutic purpose is not determinative of infringement. The Full Court thus confirmed that it is easier to establish infringement of a method of treatment claim than a Swiss- style claim. The generic product in suit was found not to infringe the Swiss-style claims of the Treatment Patent primarily because they were not indicated for diabetic retinopathy. It was not enough that the innovator product did include that indication, that the generic product was bioequivalent to the innovator product and that the labelling of the generic product contained no explicit disclaimer against its use for treating diabetic retinopathy. Although not considered by the Full Court, it is worth noting that the primary judge held that the Treatment Patent’s method of treatment claims would have been infringed (had they been found valid).

The Full Court’s decision thus demonstrates that Swiss-style claims provide a patentee a narrower scope of protection than method of treatment claims.

NOVELTY The Treatment Patent lacked novelty in light of a prior art protocol that included a hypothesis that administering a fibrate with a statin would reduce the rate of development or progression of diabetic retinopathy compared to administering only a statin. The Full Court considered that the publication of this hypothesis was sufficient to anticipate the Treatment Patent, even though it was expressed as a hypothesis that required testing, and the prior art disclosed no data to verify that the hypothesis might be correct. The Full Court pointed out that a patent need not include scientific proof or substantiation, and no greater requirement is imposed on a prior documentary disclosure in order for it to be anticipatory. Accordingly, a speculative statement in the prior art can anticipate a patent. As the Full Court stated, “what is required is that the prior art document discloses that which is subsequently claimed as an invention”. I NVENT I VE STEP With respect to inventive step, the Full Court offered more clarification than transformation as to the state of the law, although it continues a recent trend of the court holding patents to a higher standard on obviousness and more readily finding a lack of inventive step. The Full Court confirmed that an invention cannot be obvious merely because it was “worth a try” at the priority date. The person skilled in the art ( PSA ) must be directly led to the invention with the expectation that it might well be useful in light of the common general knowledge and any relevant prior art. However, it is not necessary that the PSA believe that there is a better than 50% chance of success. The Full Court declined the opportunity to identify the level of expectation required to satisfy the inventive step case, saying that the requisite level of expectation depends on the circumstances.

AUSTRALIA’S FULL FEDERAL COURT CONSIDERS INFRINGEMENT OF SWISS-STYLE CLAIMS: MYLAN HEALTH PTY LTD V SUN PHARMA ANZ PTY LTD [2020] FCAFC 116

Mylan v Sun Pharma is the latest word from the Full Federal Court on the infringement of Swiss-style claims, novelty, inventive step and fair basis. Before the Full Court was three patents relating to fenofibrate, a drug used to treat cholesterol and diabetic retinopathy in patients with type 2 diabetes. The three patents related to (1) the use of fenofibrate to treat diabetic retinopathy ( Treatment Patent ), (2) fenofibrate compositions comprising fenofibrate in nanoparticulate form and with a surface stabiliser ( Nanoparticle Patent ) and (3) an immediate-release fenofibrate composition with micronized fenofibrate and a hydrophilic polymer that produced a desired dissolution profile ( Dissolution Patent ). All three patents were found invalid, and the Swiss-style claims not infringed, at first instance. The Full Court upheld that decision.

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The Full Court’s decision suggests that it will be more difficult to establish inventiveness based on a lack of expectation of success. Instead, a patentee defending an obviousness case may be better served by providing reasons for why the PSA would not be directly led to try the invention, or that the path from the prior art to the invention would require inventive work as opposed to routine trial and error. FA I R BAS I S The Dissolution Patent included a claim to a fenofibrate composition with a specified dissolution profile. The Full Court, applying well-established principles, found this claim lacked fair basis because, although the specification included references to compositions with the specified dissolution profile, those compositions also contained micronized fenofibrate. There was thus no “real and reasonably clear” description of compositions with the specified dissolution profile per se . The Full Court’s decision is a further reminder of the importance, when claiming an invention by reference only to the results that it achieves (as opposed to the means of achieving those results), of drafting the specification carefully to ensure that it is clear that the invention disclosed in the patent includes achieving that result by any means.

“In the context of s 7(2) of the Act, the legal standard, expressed by the word ‘obvious’, is a flexible and indeterminate standard which poses a question of fact to which there is often, perhaps usually, no single, right answer.” Thus in answering the question whether an invention is obvious, an evaluative judgment is called for and, in order to answer the question affirmatively, the Court must be persuaded that the invention, as it is claimed, is indeed obvious. As a general proposition, reasoning to such a conclusion is not assisted by a percentage-based analysis.” The Treatment Patent was held obvious in light of second prior art publication that disclosed the results of a clinical trial suggesting that a reduction of elevated serum lipid levels may help prevent vision loss associated with diabetic retinopathy. The publication did not specifically test whether the use of a lipid-lowering agent (like fenofibrate) would be useful for treating diabetic retinopathy. Further, the scientific method employed by the publication was imperfect, leading to some minor doubts as to the significance of its observations. However, the Full Court adopted a practical approach when interpreting the publication and considered that these imperfections did not raise enough doubt as to the likelihood of success to render the Treatment Patent inventive. Similarly, in relation to the Nanoparticulate Patent, doubts expressed by witnesses as to the likelihood of the claimed formulations being useful (one witness described trying the invention as a “gamble”, and that he could not be sure that it would work) were not enough to support a finding that its claims were inventive. The Full Court was also unperturbed by the need to conduct some experimentation in order to implement the invention, characterising that work as routine optimisation and trial and error. As a result, the line between a sufficient expectation of success and “worth a try” remains elusive.

ANDREW MULLANE Special Counsel

About Wrays

Wrays is one of the largest independent IP specialist firms in Australia – bringing together the right combination of experts to protect, grow and defend our client’s intellectual property assets locally and globally for 100 years.

And when you combine our passion for achieving the best result with our broad capability across the IP spectrum, it’s our clients who enjoy the benefits. In day-to-day reality, this means bringing the right people in the room every time and working together across disciplines to deliver what’s needed.

It doesn’t stop there. Through our extensive local and global networks, we can connect clients with like-minded experts who deliver supporting services, such as private equity, tax advisors, corporate and employment law, as well as IP specialists around the world servicing other jurisdictions. wrays.com.au

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