IP SPOTLIGHT AUG 4

4 August 2020 IP SPOTLIGHT NEWS FROM AUSTRALIA THE WRAYS’ LIFE SCIENCES TEAM MAKING AN IMPACT ON THE WORLD PHARMACEUTICAL MARKET

Approved drugs are included in the FDA’s so-called ‘Orange Book’. Used by Medical Professionals and researchers world- wide, the Orange Book is the gold standard reference for identifying generic equivalents to brand name drugs, drug patents, and drug exclusivity. It also helps in making important intellectual property decisions and strategies for pharmaceutical companies. Driven by local innovation and investment, Australia’s thriving biotechnology research industry has numerous other drugs in late-stage development and we look forward to seeing more Australian-developed products achieve their own FDA approval.

Australia is producing impressive results on the world pharmaceutical stage. To date, Australia has developed 12 drugs that have received approval from the United States Food and Drug Administration (FDA). Of these 12, 5 were patented by the services provided by Wrays, including FDA approved drugs from iCeutica and Sarepta. Wrays’ Chairman Gary Cox said “We congratulate our clients iCeutica and Sarepta for the major achievement of receiving FDA approval for their products. They are great examples of world class intellectual property being developed in Australia and making a real impact on the world pharmaceuticals market. Receiving FDA approval requires all parties to integrate seamlessly, achieving a balance of scientific and technical understanding, and strategic IP proficiency.” Achieving FDA approval requires rigorous assessment against strict safety, effectiveness and patent criteria. In 2019, only 48 new drugs were approved by the FDA, putting into perspective the significance of this remarkable achievement.

More information about the Wrays’ Life Sciences Team can be found at wrays.com.au.

TODD SHAND Principal

JULIA HOGAN Business Development Consultant

CLAR I TY Norbrook argued that the claims lacked clarity because a third party could not ascertain, without difficulty, whether or not the antiseptic was killing or preventing spread of mastitits producing organisms in vivo , particularly because the barrier itself had a prophylactic effect by preventing pathogens from entering the teat. However, the examples demonstrated in vitro tests that could be used to assess this factor, which were shown to translate into in vivo activity. The claims were therefore clear. SUPPORT All of the examples in the specification used chlorhexidine as the antiseptic (not PVP-I). Norbrook argued that the claims did not encompass the examples, that PVP-I was only merely mentioned in the specification, and that the real technical contribution was the use of chlorhexidine as the antiseptic. The Hearing Officer rejected these arguments, deciding that the technical contribution was the use of a class of antiseptics (including PVP-I) that have specific properties. It was not necessary to have a worked example on every member of that class. SUFF I CI ENCY Norbrook argued that there would be an undue burden to develop a working formulation with PVP-I instead of chlorohexdine because of the variables and costs in formulation development. This argument failed because the specification provided examples of in vitro and in vivo assays to assess the formulations, and there was not enough evidence that the formulation of PVP-I into the teat-seal was difficult or required significant experimentation. UT I L I TY The claims were limited by function, so this ground could only succeed if there were no working embodiments in the claims. There was evidence that one PVP-I containing formulation prepared by Norbrook’s expert was ineffective, but this was insufficient to demonstrate that no useful formulations exist.

I NVENT I VE STEP Norbrook raised 18 prior art documents that disclosed either teat-seals with oil-based bismuth barriers with other active ingredients, or teat-seals/teat dips comprising PVP-I but without a barium or bismuth containing oil based carrier. The Hearing Officer was not satisfied on the evidence that it was obvious to substitute in PVP-I or barium or bismuth containing oil based carrier in the formulations disclosed in these prior art documents, when the teaching of the documents, and what was known about PVP-I at the priority date was taken into account. Norbrook was criticised for not providing any specific reasoning for why the differences between the prior art and the claimed invention were obvious. worked examples in a specification in order to be adequately supported. However, explanations in the specification of a principle of general application that covers the scope of the claim (beyond a mere mention) will be required. – – Examples in the specification of how the skilled person can design and test additional embodiments can be useful for refuting that there would be an “undue burden” for the sufficiency ground. – – When relying on the lack of inventive step ground, evidence and submissions demonstrating why the gap between the prior art and the claimed invention would be obvious to the skilled addressee to overcome should be provided. KEY TAKEAWAYS – – The claims do not need to encompass or reflect the

BAYER PREVAILS AGAINST NORBROOK IN AUSTRALIAN PATENT OPPOSITION TO ITS TEAT SEAL FORMULATION PATENT APPLICATION

In the latest chapter of the dispute between Bayer New Zealand Limited (Bayer) and Norbrook Laboratories Limited (Norbrook), Bayer has successfully defended an opposition to its Australian patent application for a teat-seal formulation used to prevent mastitis in cows. 1

Norbrook opposed Bayer’s patent application on the grounds of lack of clarity, lack of sufficiency, lack of support, lack of utility and lack of inventive step. The opposition was determined under the provisions of the Raising the Bar Act. 2 I NVENT ION AND CLA IMS The patent application related to formulations addressing the problem of mastitis during the period when cows are not producing milk, and where pathogens can access the teat. The claims were for a formulation for the prevention of mastitis in animals, comprising an oil-based barrier material including barium or bismuth, mixed with povidone-iodine ( PVP-I ), an antiseptic which kills or prevents the spread of mastitis causing organisms in the animal’s teat.

BINDHU HOLAVANAHALLI Associate

1 Norbrook Laboratories Limited v Bayer New Zealand Limited [2020] APO 31

2 The IP Laws Amendment (Raising the Bar) Act 2012, which amended the Patents Act 1990, is Australia’s biggest IP system change in twenty years.

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OPPOSITION HEARINGS IN

Wrays is pleased to advise of its recent success in defending one of its client’s patent applications in opposition proceedings before the Australian Patent Office (Desaln8 Pty ltd v Crisalis International Pty Ltd [2020] APO 30 (24 June 2020)). The opposition hearing was notable because it was held just as COVID-19 lockdown measures were being implemented. The hearing was initially set to be heard in person in Canberra but to comply with social isolation obligations this was changed to a video conference and later, because of technical difficulties on the day, the parties had to resort to a hearing by telephone. All parties were to be congratulated on remaining flexible in rapidly changing circumstances and maintaining professionalism under trying conditions. Well, the show must go on! The invention of the opposed application resided in a groundwater desalination system having a production borehole in an aquifer for withdrawal of groundwater and one or more reinjection boreholes spaced apart from the production borehole at a distance and a direction relative to the production borehole to minimise dipole flow of concentrate back to the production borehole. The boreholes were also provided with seals to inhibit mixing of water above and below the seals so as to prevent oxygen or oxygenated water from mixing with the groundwater. In this way, the system was configured to continuously produce a stream of desalinated water from groundwater over an extended period of time without subsequently recapturing concentrate produced by the desalination process, and to ensure continuous operation by minimising fouling due to oxygen ingress. The Opponent pressed all available grounds of opposition but none were made out.

In its case against novelty, the Opponent relied on prior art documents and its prior use of a groundwater desalination system at Flemington Racecourse (home of the Melbourne Cup) and the dual borehole system it developed to solve the problems of concentrate reinjection disturbing the silt near desalination systems operating via a single borehole. The evidence showed that the reinjection boreholes used by the Opponent were pre-existing and upstream of the production boreholes and consequently did not teach minimisation of dipole flow. Additionally, the Opponent’s boreholes were not provided with seals to prevent oxygen or oxygenated water from mixing with the groundwater. None of the claims were held to have been anticipated by the prior art. The claims were also found to be inventive in light of the common general knowledge alone and in light of the prior art. The Opponent also pressed a lack of entitlement to the application on the basis that the inventor was a director of the Opponent up until 7 June 2010 and was aware of the installations at Flemington Racecourse, Victoria, including the dual borehole systems, and was later in possession of confidential information about the dual borehole systems. Beyond the information provided regarding the systems installed at Flemington Racecourse, however, the Opponent was unable to provide any further evidence that the Opponent or one of its employees were responsible for the ideas that constituted the inventive concept. Consequently, this ground of opposition also failed. Grounds under Sections 40(2) and 40(3) were also not made out (Disclosure/Support/Best Method).

SOCIAL ISOLATION THE SHOW MUST GO ON

MARY TURONEK Principal

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MYANMAR WITNESSING THE BIRTH OF TRADE MARK LAW

A good Hong Kong colleague said to me recently, “How often do you get to witness the birth of trade mark law in a country? Not just new but original?”

Myanmar, previously called Burma, is such a country.

Myanmar is the largest country in mainland South East Asia. It is bordered by Bangladesh, India, China, Laos, Thailand, and coastally, by the Andaman Sea and the Bay of Bengal. Myanmar was governed by the British from 1824 to 1948. Queen Victoria was not only Queen of Wales, Scotland and England, she was also once Empress of British India, which at the time included Burma. Myanmar is reported to have a young dynamic population of close to 54 million, living in a country where rich relatively untapped natural resources abound. It is quite possibly a country on the cusp of Western type consumerism in the next 10 years or so.

There is currently no official trade mark law in Myanmar. But there is new trade mark legislation which was enacted on 30 January 2019. A further period for the preparation and issuance of rules and regulations is still required. Therefore, it is still uncertain what are the procedures, details and related costs involved in the registration of trade marks. At this stage, the new legislation is to be submitted with the Myanmar Parliament on a date to be confirmed but quite possibly sometime in August this year. Currently, Myanmar operates under an archaic system of Cautionary Notices. Firstly, a mere declaration of ownership of a trade mark is required to be filed at the Registry of Deeds and Assurance in the country. Secondly, after official endorsement is received from the Registry with no official checks on any claims made in the declaration, a Cautionary Notice claim must be published by the endorsed owner of the relevant trade mark in a local newspaper. Once the new trade mark legislation is effected, all existing trade mark claimants who have recorded their rights under Myanmar’s current system must file new applications to protect their marks or risk losing any protection. A Myanmar colleague has advised me that Australian trade mark owners should consider proceeding now under the current system of Cautionary Notices if they would ultimately like to register their trade mark in Myanmar because if a mark for which registration is sought is already on record at the Registry of Deeds and Assurance, the

submission of a certificate confirming the same is will stand as evidence of trade mark ownership by the claimant. We have also been informed that there is likely to be a six-month “soft opening” period for the Myanmar Department of Intellectual Property (MDIP)’s new e-filing system, during which time the MDIP will only accept applications to re- register old registrations recorded with the Registry of Deeds and Assurance. Therefore, for key trade mark owners this period is intended to provide a period of priority against an influx of “new” applications once the new law is promulgated. Trade mark owners need to be watchful of applications by unscrupulous parties or trade mark squatters who seek to profit by the registering the trade marks of others. For us trade mark attorneys, the birth of trade mark law in Myanmar is indeed a rare occurrence and something to remember from an “I was there…” perspective. But for key trade mark owners, this is something that may need to be acted upon sooner rather than later, with no time to waste, to ensure valid trade marks rights are not lost, especially if Myanmar represents a possible important market in the not too distant future.

JENNIFER MCEWAN Principal & National Practice Leader - Trade Marks

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CHANGES TO PCT FEES FOR AUSTRALIAN FILERS

Australian filers of PCT applications are set to receive some welcome financial relief as the Australian patent office (IP Australia) will be adjusting their fees for PCT-associated patent filings, effective from 1 August 2020.

I NTERNAT IONAL PCT FEES

FEE TYPE

CURRENT FEE AUD

NEW FEE AUD

1

Transmittal Fee

$200

$200

2

International Search Fee

$2200

$2200

3

International Filing Fee*

$2,356

$2150*

If the application contains 30 pages or less including the request form E-FILINGS

Electronic filings filed in PDF format via ePCT*

$354

$323*

Electronic filings filed in XML format via ePCT*

$531

$485*

PLUS

For each page in the application in excess of 30 sheets (per page)* Cost of preparing certified copy of basic document (per document Copies of specifications cited in the International Search Report (per copy)

$27

$24*

4

$50

$50

5

$50

$50

I NTERNAT IONAL PREL IMI NARY EXAMI NAT ION FEES

FEE TYPE

CURRENT FEE AUD

NEW FEE AUD

1

International Preliminary Examination Fee

If the search was performed by IP Australia

$590

$590

If the search was not performed by IP Australia

$820

$820

2

International preliminary handling Fee*

$354

$323*

Total (if search performed by IP Australia) = $913

DONNA MEREDITH Associate

Total (if search not performed by IP Australia) = $1143

Some of these fees are set to see a further reduction in September. We will keep you updated on further developments.

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IP in FOCUS Series Two

We invite you to join us for IP in Focus - Series Two, where our experts will take a deeper dive into key considerations to help you manage your intellectual property more effectively.

Short, sharp learning with direct connection to the speakers to ask your questions, done virtually. Or, for those of you located in Perth, you may wish to join us in person - a chance to network with peers and chat with our specialists.

Pick as many or few sessions as you’d like.

To register click on a session below.

EFFECTIVELY MANAGE YOUR IP COSTS

THE POWER OF SEARCH

MAXIMISING YOUR TIME WITH AN IP EXPERT We’ll provide some tips on what to think about and how to get organised before your meeting.

ESSENTIALS FOR YOUR TOOLKIT

Create a competative advantage through a well- executed IP search.

Understand the items you need, and how to build a better IP culture within a business. Thursday 6 August 2020 9am (AWST)

How you can reduce your IP spend across filing, prosecution & maintenance. Wednesday 5 August 2020 9am (AWST)

Wednesday 5 August 2020 10am (AWST)

Thursday 6 August 2020 10am (AWST)

WHO TO CONTACT

HELEN EVANS Marketing & Communications Coordinator +61 2 8415 6525 helen.evans@wrays.com.au

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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