COMMONWEALTH OF AUSTRALIA
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`Patents Act 1990
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`698543
`
`IN THE MATTER OF Australian patent application 2009221630
`
`in the name of RESMED LIMITED
`
`AND
`
`IN THE MATTER OF Opposition thereto by FISHER & PAYKEL
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`HEALTHCARE LIMITED
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`STATUTORY DECLARATION
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`I, Alistair Edwin McAu|ey, consultant, of Rotorua, New Zealand do solemnly and sincerely
`
`declare that:
`
`1.
`
`1.1
`
`Background
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`I am a medical device consultant, including in relation to devices for the treatment of
`
`obstructive sleep apnea (USA).
`
`I am the sole director of the company Medlands
`
`Consulting Limited (Medlands).
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`1.2
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`I currently work as a consultant to the CEO of Airway Management, a company that
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`produces and sells products for the treatment of sleep apnea.
`
`In my current role I do
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`design work, marketing and intellectual property (IP) analysis. The main focus of my
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`role currently is product design and upgrades, and finding buyers for the company's
`
`products and ultimately the company's assets.
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`1.3
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`I am a part owner and director of a distribution business Airway Management Asia
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`Pacific, distributing Airway Management products, and other companies’ products, in
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`New Zealand and Australia. These products are all in the OSA field and include an oral
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`appliance, a CPAP interface, CPAP machines and other accessories.
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`I travel in the
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`market making sales and training calls and attended the Australasian Sleep Association
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`tradeshow in 2014, where we exhibited our products.
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`1.4
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`I also do some consulting with Auckland University of Technology, around the
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`commercialisation of its IP, in the OSA field.
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`1.5
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`Ialso consult to Human Design Medical (HDM), a United States based medical device
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`company. That work involves giving them advice on product design, testing,
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`manufacturing and regulatory requirements.
`
`1
`
`I‘
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`Opt
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`1
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`RMD 1041
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`1
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`RMD 1041
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`

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`1.6
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`1.7
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`1.8
`
`1.9
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`I graduated with a Bachelor of Technology degree, with honours, in engineering and
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`automation from Massey University in 1998 (my final year of study at Massey was
`
`1997).
`
`I started my career with Fisher 8: Paykel Healthcare Limited (FPH) in 1997 and started
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`working in the company‘s sleep apnea treatment business in 1998.
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`I worked for FPH for 14 years. From 1998 I was in the new mask development team.
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`FPH was producing CPAP (continuous positive air pressure) devices, but needed an
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`interface to be sold with them (an interface is the part of the device for treating sleep
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`apnea which connects the CPAP to the patient, for example, a mask).
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`In 2000, I was made the head of that team, where I stayed until 2010.
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`I then spent
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`two years as the Business Development Manager for sieep apnea. During my time at
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`FPH and with Airway Management I have been involved extensively in the intellectual
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`property management area. This includes conducting freedom to operate searches or
`
`reviewing them, filing new inventions and helping to respond to examiners‘ responses.
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`I have filed over 75 United States patent applications as an inventor, of which 45 have
`
`been granted. All the applications have been related to the OSA field, mostly interfaces
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`with some related to CPAP and CPAP humidification. These patients have been cited by
`
`478 other patent applications due to their relevance in the OSA device field.
`
`1.10
`
`In 2011, I left FPH to set up a company that operated as a joint venture with a United
`
`States company, Airway Management (Airway Technologies). My involvement with
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`Airway Management began when Airway Management had initial discussions about a
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`joint venture with Medlands. The idea behind the joint venture was that we would
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`design and tool a nasal pillow mask, and design an oral appliance. As part of this, it
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`was agreed that I would go over to the United States for six months to help Airway
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`Management get their new products into the market. The company's main product line
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`was oral appliances to treat OSA (devices that fit inside the patient's mouth, to adjust
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`how the jaw sits).
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`I was also assisting with Airway Management getting FDA and ISO
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`13485 approval for its devices. For one year I worked on research and deveiopment
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`working very closely with Airway Management. We developed a CPAP interface there.
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`1.11
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`After about a year of the joint venture, Airway Management wanted help integrating its
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`products into the market and into Europe, so I became president of the company for a
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`year and a half. The CEO decided to appoint me as president to allow me to manage
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`the company, integrating the new products and upgrading the quality systems to
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`achieve ISO 13485 compliance. The owner and CEO of Airway Management was part
`
`time so did not have daily involvement in the running of the company.
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`[was the most
`
`experienced person in the company, from a medicai device design and manufacturing
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`,.r
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`functions reporting to me.
`
`point of view. My president role was the equivalent of being a general manager, with all
`M
`2
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`I reported to the CEO.
`
`
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`2
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`1.12
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`A copy of my curriculum vitae as at February 2015 is attached as exhibit AM—1.
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`1.13
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`I have read the Federal Court of Australia Practice Notes CM7 titled ‘Expert witnesses
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`and proceedings in the Federal Court of Australia‘.
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`I understand what is expected of me
`
`as an expert witness and I confirm I give the following evidence in accordance with
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`Federal Court guidelines.
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`1.14
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`In particular the issues I address and the evidence I give in this declaration are within
`
`my areas of expertise.
`
`I realise that my overriding duty is to assist the Commissioner
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`impartially on relevant matters within my areas of expertise and I am not an advocate
`
`for FPH who has engaged me as a witness.
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`1.15
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`I am being paid within my standard range of remuneration for consulting work, for my
`
`time spent in preparing this evidence and attending at the hearing if necessary.
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`1.16 The evidence I give is my own assessment and opinion. My opinions are wholly or
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`substantially based on my specialised knowledge.
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`1.17 A} Park asked me to explain how interfaces are generally developed within the industry,
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`and the considerations and features that go into the development of an interface.
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`Unless stated otherwise, the points I make in this declaration reflect the position as at
`
`February 2008.
`
`I also discuss some examples of headgear. My discussion of headgear
`
`is to reflect the position as at January 2003, unless I state otherwise.
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`1.18 Where I refer to examples of masks or patents, I confirm that these are masks I was
`
`aware of (which the patents record details of), prior to February 2008, when I was
`
`working in this area.
`
`I have done some limited patent searching in order to refresh my
`
`recollection of the masks and patents I was aware of prior to that date.
`
`I restricted this
`
`searching to patents before 2008.
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`1.19 To assist, I have prepared a document that details common terms and definitions in this
`
`area.
`
`I attach this as exhibit Al‘/I-2.
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`2.
`
`The interface market
`
`2.1
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`The market for CPAP treatment (CPAP machines and interfaces) is a global market.
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`There is no real variation in the products available throughout the market, just the size
`
`of the distribution in different areas.
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`2.2
`
`The major players in the market are ResMed (who has around 50% of the market),
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`Philips (who acquired Respironics, a significant manufacturer of CPAP machines and
`
`interfaces, around seven years ago), and FPH, who are large, but distinctly smaller than
`
`V
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`the other two big players. There is then a second tier, of companies who have around a
`1-2% market share each, these include Breas and Deviibiss i-ieaithcare. And a third tier
`which would encompass less than 5% of the total market between them. Airway
`Management sits in this third tier.
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`M 3
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`3
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`

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`2.3
`
`In the 2014 calendar year, ResMed had revenue of US$1.616 billion.
`
`I estimate this
`
`represents around 50% of the total OSA market, from a manufacturer's point of view.
`
`I
`
`estimate Philips had revenue from CPAP machines and interfaces (Sleep Therapy
`
`business, excluding hospital and other non CPAP related respiratory business) of around
`
`US$1.2 billion and this represents around 38% of the market.
`
`I estimate (based on
`
`reported results and extrapolations) that FPH had revenue of around US$210 million
`
`from CPAP machines and interfaces and this represents around 6.5% of the market.
`
`The remainder of the market has a revenue of around US$160 million, which is around
`
`5% of the market, once again this is an estimate as not all of these companies report
`revenue.
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`2.4
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`2.5
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`2.6
`
`My assessment of the Philips market share is an estimate. When Philips bought
`
`Respironics it stopped publically reporting its OSA market results separately. At the
`
`time Philips bought Respironics it was around 50% of the market.
`
`I estimate it is now
`
`more like 38%, being stronger in CPAP and weaker in interfaces.
`
`ResMed primarily operates in the OSA business.
`
`It publically reports its results, and
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`reports on the CPAP machine side of its business and the interface side of its business
`
`separately. FPH also reports its OSA financial information.
`
`Philips is relatively strong in CPAP machine market, however its masks are regarded as
`
`not as good as ResMed or FPH masks.
`
`I estimate that they have a lesser share of the
`
`mask market than they have in the CPAP market. Philips, or Respironics as it was then,
`
`was very strong in the 19905 because they were an early player in the market. But
`
`ResMed and FPH have since taken a lot of market share from Philips, particulariy in the
`
`interface market. There is a feeling that Philips masks were overly complex and
`
`consumers did not rate them as highly in areas of comfort and leak performance.
`
`ResMed and FPH are stronger in their interface business than CPAP machine business.
`
`They would both have a greater market share in the interface business than the CPAP
`
`side, although ResMed's CPAP revenue is higher that its interface revenue as the CPAP
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`market is larger.
`
`It is common for consumers to have a CPAP machine supplied by one
`
`company and an interface supplied by another. For example, it would be quite common
`
`for a consumer to have a Philips CPAP machine used with a ResMed interface.
`
`Knowledge of the market
`
`From my experience, people involved in the development of interfaces need to have a
`
`knowledge of the market. At FPH, the design team would spend time in the market, at
`
`trade shows, and with sales reps visiting sleep labs, doctors‘ offices and CPAP dealers.
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`This enabled FPH to get feedback on the products and develop products that best meet
`
`the users‘ needs.
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`3.2
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`The New Zealand market, and to some extent the Australian market is very small and
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`as there is no need to develop interfaces specifically for New Zealand or Australian
`
`if
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`it
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`Vi
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`CM
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`4
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`4
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`

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`needs it is important to visit the larger markets of North America and Europe regularly
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`to gain feedback from the key markets. Furthermore, as the New Zealand market is so
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`small even if there were some specific needs identified it would most likely be
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`uneconornical for companies to develop specific products for it. Products are developed
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`for the market globally, but developers do focus to some degree on the North American
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`market, because it is around 50% of the market, and insurers‘ have particular
`
`requirements there. For example, insurance may provide for a replacement seal every
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`three months. Therefore, United States dealers are likely to prefer masks that have a
`
`seal that is able to be replaced. Because of this, developers would try to develop masks
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`with a replaceable seal.
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`3.3
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`While with FPH, I travelled several times a year to major trade shows, conferences, and
`
`sales meetings. FPH would also visit overseas component manufacturers, such as
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`tooling suppliers or headgear fabricators such as Acumed Technologies in the United
`
`States, a global ieader in the design and manufacture of headgear for CPAP masks.
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`when I was managing the FPH interface R&D team I would usually take a two week trip
`
`to the United States once or twice a year and a three week trip to Europe every couple
`
`of years. The marketing team would also travel regularly in the same manner.
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`I was
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`also in email and phone communication, almost every week, with the marketing
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`manager for FPH in the United States, he would give us feedback on the market,
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`specificaliy about any performance issues with our products and the key competitors.
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`3.4
`
`Of these United States trips one week would be spent at a trade show. The following
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`are examples of these trade shows:
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`3.4.1 APSS (Associated Professional Sleep Societies—a joint meeting between the
`
`American Academy of Sleep Medicine and the Sleep Research Society)
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`conference. This is a show where clinicians, sleep technicians and physicians
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`attend. At the APSS conference there would be presentation of clinical papers
`
`and research in the sleep field, as well as a trade show area where
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`manufacturers would display their products and highlight new products. At the
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`APSS I have seen sleep lab staff from New Zealand, as well as sleep physicians
`
`from New Zealand and Australia. They would attend the clinical sessions and
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`visit the manufacturers‘ booths to see the latest products on offer. This is
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`relevant to them as manufacturers release the same products in the United
`
`States as they do in Australia and New Zealand.
`
`I have also visited these people
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`in New Zealand and Australia, at their sleep labs or offices.
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`1 have also seen
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`independent medical distributors from Australia attending this show, as they
`
`source many of their products from United States manufacturers exhibiting at
`these types of shows.
`
`Oi‘
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`5
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`

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`3.4.2 MedTrade, which was a show primarily for CPAP dealers (home care medical
`
`equipment providers), with all major manufacturers displaying and marketing
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`their products.
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`I first went to a MedTrade show in 2000 and I recall going every
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`year up to and including 2013, apart from 2012. There would typically be
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`representatives from the large national home care medical equipment (HME)
`
`providers attending, as well as regional and local HMEs that may be located close
`to the show.
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`There are also trade shows in Europe (eg Medica), which I also visited while with FPH.
`
`The North American market is approximately 50% of the global market for CPAP
`
`interfaces, so it was the market FPH visited the most.
`
`It was common for CPAP dealers
`
`and clinicians from other countries to attend the United States based shows as they
`
`were generally the largest. For example people from Europe, Asia, Central and South
`America would also attend.
`
`ASA is the Australasian sleep association, which also has an annual conference.
`
`I did
`
`not attend that show until 2014, where I exhibited with my distribution company Airway
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`Management Asia Pacific. However, FPH does exhibit at ASA (or its equivalent) every
`
`year, and has done since around the early 2000's. The other big two manufacturers
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`would also exhibit at this.
`
`1 attended a Thoracic Society of Australia and New Zealand
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`meeting in the early 2000's with the OSA sales representative for New Zealand, where
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`FPH exhibited its OSA products.
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`I also spent some time travelling with sales reps in
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`Australia, conducting ‘road show‘ tours where FPH presented its new products at
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`evening functions.
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`I also spent many weeks on several occasions in the Brisbane area
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`conducting patient trials of new interfaces, involving 30-80 patients per trial.
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`I recall
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`these trials were conducted around 2000 and 2002.
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`The trade shows would be held in a building like an exhibition centre. The companies
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`producing interfaces would be present, with their products displayed. The companies
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`also sent product specialists, not just the marketers, so that they could answer technical
`
`questions and often at the same time provide training to local staff.
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`I also attended some of the FPH national (annual) sales meetings in the United States.
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`This would consist of all the FPH sales reps in North America, getting together for about
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`three days to conduct new product training, sales training, award sales performance
`
`from the past year and participate in team building activities. FPH has approximately
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`50 sales reps, sales managers and marketing personnel for OSA in North America.
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`It
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`3.5
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`3.6
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`3.7
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`3.8
`
`3.9
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`was common for someone from the R&D team to go to these meetings to deliver
`information and training on products.
`Sales reps get feedback every day, from doctors, sleep ciinics, and CPAP dealers. The
`
`3.10
`
`people trying to sell the products are getting that direct feedback from customers about
`
`what they do and don't like about the products. The sales reps wouid feed this
`
`Y
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`Ola?-
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`
`
`6
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`

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`feedback back to the development team, either informally in discussions between sales
`
`reps and members of the development team, or formally from the marketing team. For
`
`example, the FPH United States marketing manager would visit FPH at Auckland around
`
`once per yea r.
`
`3.11 At the trade shows we would get feedback from the customers. This would not be the
`
`end users, but people like the CPAP dealers. These dealers receive a lot of feedback
`
`directly from the users of the masks, who would then feed this back to FPH.
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`3.12 At the trade shows FPH would also sometimes run surveys by having a laptop present
`
`that people could answer the survey on. For around the last four years of my time at
`
`FPH, FPH would run these surveys at a trade show once or twice a year. Examples of
`
`the types of questions asked are:
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`3.12.1 What percentage of the time do you set up patients on full face, nasal or pillow
`
`masks respectively?
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`3.12.2 What are the top three full face masks you prefer to use?
`
`3.12.3 What are the top five features important to you when considering a mask?
`
`3.12.4 Rank the following mask attributes in order from highest to lowest-reliability,
`
`ease of use, price, comfort, noise level, having all sizes in one box, appearance,
`
`sealing performance, size, etc.
`
`3.13 There is relatively little clinical research on specific masks (compared with CPAP itself).
`
`Masks are updated every two to three years, so as this technology is moving quite
`
`quickly, studies may take too long to do.
`
`It's also hard to see that clinical studies would
`
`produce data that would help the market. However, Sleep Review Magazine
`
`(httg:ggwww.s|eegreviewmag.com), an industry magazine, runs surveys and reports on
`
`product trends. CPAP.com is also another good source of user feedback and general
`
`product sales trends.
`
`3.14 The website CPAP.com is a retailer of masks, which has been operating since around the
`
`beginning of 2003. On that site it is possible to see all new products, customer
`
`feedback from user reviews, and consumer trends by seeing which masks are forming
`
`what percentage of total sales. While this is a reasonable indication of sales trends it
`
`doesn't accurately represent the total market, as its saies are cash sales, whereas most
`
`product in the United States is sold through insurance coverage and large HME
`
`providers.
`
`3.15 To lower costs, the home care companies will try to limit the range of products they
`
`offer to increase their purchasing power, and to work with the companies that have the
`
`broadest range of product. This results in the top three companies (ResMed, Philips and
`
`'
`
`All“
`
`7
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`

`
`FPH) having most of the HME market, and the smaller companies having more share of
`
`the retail (CPAP.com) market than they have of the HME market.
`
`3.16
`
`FPH would also analyse competitors’ products. FPH would trial products internally, and
`
`get feedback on them from users.
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`If a competitor launched a new product in the
`
`market, FPI-l's sales reps would tell the OSA interface team. FPH also did patent
`
`searching, to make sure it was not going to run into problems.
`
`I, and the FPH
`
`development team more generally, regularly reviewed patents covering technology in
`
`this area. All major companies were going to the same conferences, where everyone
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`would see each other's products. The companies would also swap new products, to
`
`save each other having to buy them, as they were freely available anyway. FPH would
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`buy competitors‘ new products if necessary.
`
`3.17
`
`Magazines from within the industry were circulated in the FPH office.
`
`In particular,
`
`Sleep Journal carries the latest scientific papers, and Home Care Medical Equipment
`
`News (HME News) and Sleep Review carried a lot of dealer advertising. There are full
`
`page adverts of new products from major manufacturers and sometimes third tier
`
`manufacturers.
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`3.18
`
`The OSA interface team would also look at patents for scuba diving masks, and masks
`
`from other industries (eg aviation), when considering different options. At FPH the
`
`design team also looked at 3M industrial protection masks (for example, dust and
`
`painting masks} and similar brands.
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`I recall we purchased some of these around 2002,
`
`the time we were developing our first full face mask. These masks had similar contours
`
`as they covered the nose and mouth, had a flexible seal to accommodate facial variation
`
`and had straps to hold them in place. They were made out of silicone or rubber, were
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`of a full face style that sealed around the nose and mouth, and had filters and valves.
`
`3.19
`
`The team would also sometimes look to other areas entirely, for example, at one point it
`
`looked at how speaker covers were constructed and how they connected to the main
`
`speaker housing, for clipping mechanisms. The FPH team also looked at the type of
`
`straps, buckles and clips used to adjust bags or back packs that could be applied to
`
`headgear straps, adjustment and connection to the mask. We also looked at scuba
`
`mask headgear to see how they adjusted, connected to the mask and the materials that
`
`were used.
`
`I recall in the early 2000‘s (in around 2002), designing and prototyping a
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`silicone headgear strap similar to a scuba mask strap for the Oracle mask.
`
`3.20
`
`There were also several large folders containing interface prior art that were in the
`
`interface R&D team's office area. They contained a large number of disclosed or expired
`
`IP for interfaces. Some of the patents were for CPAP interfaces, but many were also for
`
`aviation masks or industrial protection masks. They contained most of the key features
`
`that were required, such as a face seal, connection to an air supply, headgear and
`
`connection mechanisms for the headgear to the body or frame of the interface. Many of
`
`8
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`8
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`

`
`3.21
`
`3.22
`
`the fighter pilot or aviation masks dated back to the early to mid 1900's and contained
`
`hand drawn images as they were filed before electronic means were available.
`
`I recall
`
`they stood out for this reason, they seemed very dated. As they covered the nose and
`
`the mouth they seemed to be most relevant to full face masks and in particular
`
`headgear for full face masks.
`
`FPH would identify the problems with existing products from feedback from these
`
`various sources, and take this back into deveiopment of new products.
`
`The feedback FPH constantly received was that the most important considerations for a
`
`mask were comfort, seal and ease of use. Comfort means how the mask feels to the
`
`patient when in use. Seal means the mask would seal well without leaks. Ease of use
`
`refers to that it can't be overly complex, have too many components, be overly
`
`engineered and you need to easily be able to get it to work well and take it apart for
`
`cleaning and put it back together, or simply easy for the patient and provider to setup
`
`and use. The commonness of this response meant that comfort, seal, and ease of use
`
`became an FPH tagline. After we started using this as an internal focus the marketing
`
`manager for interfaces picked up on this and started using it for external marketing
`
`material related to FPH interfaces, in brochures and magazine advertising. The term ‘C-
`
`S-E' was used to represent ‘comfort, seal and ease of use‘.
`
`3.23
`
`It was apparent that for masks price was less important than those three features. The
`
`masks have a large influence in helping the patient to become compliant with their CPAP
`
`treatment. Dealers are required to get patients compliant with their treatment, to
`
`receive ongoing payment from medical insurance companies for the CPAP machines.
`
`Therefore, from a dealer's point of view, using a cheap mask is not going to result in the
`
`best outcome for the patient or for the dealer from a financial point of view.
`
`3.24
`
`Also, as CPAP compliance is very poor, in large part due to mask comfort issues, the
`
`latest masks that work the best will not be subject to strong price erosion.
`
`If there is a
`
`strong—performing mask on the market, a less—cornfortab|e mask will not be able to
`
`compete effectively with this, even if it is cheaper. This means that the price of masks
`
`is only a strong competitive factor if there are two to three strong performers on the
`
`market between the top manufacturers. This is not the case with CPAP. CPAP is
`
`regarded as being closer to a commodity, where price is more important. This may
`
`explain why Philips is able to compete better in the CPAP market, and why CPAP profit
`
`margins are very low and interface profit margins are very high.
`
`3.25
`
`The approach that FPH took is for staff to be cross functional or multifunctional. FPH
`
`staff were therefore required to have a good knowledge of the market. As far as I
`
`know, at least ResMed was taking a similar approach.
`
`I recall reps that had worked for
`
`ResMed in the past or customers that we visited stating that they had met an interface
`
`engineer from ResMed (Philip Kwok), who had been traveliing and asking similar
`
`9
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`9
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`

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`questions to me in the market.
`
`I note that he is also a significant inventor for ResMed.
`
`I also saw some ResMed engineers at the United States tradeshows—they ca me to the
`
`FPH booth to see the latest products. At one United States tradeshow a Philips
`
`marketing or sales manager was talking to me, stating that they were not happy with
`
`some of their interfaces but had recently hired new engineers into the R&D team to
`
`create some new products. Having a high rate of staff turnover and not getting good
`
`customer feedback may be some of the reasons for Philips‘ loss of interface market
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`share.
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`3.26 In recent years FPH would have several interface RSLD managers that travel in the
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`market and would have around 10 years‘ experience in that field.
`
`3.27 I believe that it is relatively rare for engineers to remain focused on one product type
`
`for over a decade, so my level of involvement in the market over the length of time may
`
`be relatively rare. At FPH I estimate that the average term for an engineer would have
`
`been around 4-6 years before they moved overseas or to a different product group or
`
`company. Secondly, I believe only the three major companies would have maintained a
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`permanent interface R&D team. For example Devilbiss, which is a second tier company
`
`in the market, do not have any internal interface R&D engineers.
`
`It outsources the R&D
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`to a design contractor or design house when it wants a new interface, resulting in
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`people with little or no interface—specific experience designing a mask. Philips seems to
`
`have a higher turnover and their engineers seem to spend less time in the market,
`
`although they may do this outside of tradeshows without my knowledge.
`
`It seems
`
`ResMed have staff that have a similar level of experience to me, or at least Philip Kwok
`
`seems to, having filed around 167 United States patent applications as an inventor.
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`3.28 Sales staff seem to be longer serving in the industry, many working for decades in the
`
`same industry, in the United States. They are focussed more on selling what they have
`
`today, and overcoming objections, as opposed to conducting research and digging deep
`
`into the underlying customer needs, as that is not their role. So while the sales reps are
`
`a good source of customer feedback, they do not necessarily explore the fundamental
`reasons for that feedback.
`
`4.
`
`Development of interfaces
`
`4.1
`
`An interface is designed by a team. The ideal team to develop patient interfaces would
`
`be made up mostly of mechanical engineers, and someone with clinical knowledge
`
`(possibly with a degree in physiology, or through consultation with doctors or other
`
`clinicians).
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`4.2
`
`The engineers would spend time in sleep labs, talking to patients and sleep technicians,
`
`Kr
`
`testing products in sleep labs, travelling with sales reps, visiting customers and
`
`attending tradeshows to get feedback and learn about market needs.
`
`10
`
`M
`
`if}
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`10
`
`

`
`4.3
`
`In New Zealand there is no formal tertiary training for medical device engineering, or at
`
`least there wasn't 10-15 years ago. This means that most develop their interface
`
`design skills on the job, after initially gaining an engineering degree, typically some
`
`form of mechanical engineering or general product industrial design. Useful skills
`
`include materials science skilis, particularly in plastics, tooling and manufacturing skills,
`
`as it is important the designs are able to be manufactured in high volumes, general
`
`product development skills, industrial design, and practical skills so that they can make
`
`products and prototypes themselves. Other useful skills may include knowledge of fluid
`
`dynamics, CAD-CAM (computer assisted design and manufacture), and general problem
`
`solving.
`
`4.4
`
`4.5
`
`FPH would also provide training to its engineers, for example engineers would go on
`
`courses in physiology, plastics processing, and CAD—CAM etc.
`
`While I was at FPH there was also someone in the team with knowledge of fluid
`
`dynamics. That employee did his Masters in that area for a specific OSA project FPH
`
`was working on. At FPH we spent some time looking at fluid dynamics, particularly for
`
`the issue of condensation in masks. We wanted to understand the variability for why
`
`condensation would accumulate in some areas of masks and not others. Sorneone also
`
`looked at fluid dynamics in relation to the bias flow,
`
`in relation to the design of the holes
`
`and what influenced the sound of the airflow.
`
`4.6
`
`At FPH there were three or four teams working on patient interfaces. One on nasal
`
`masks (masks that just seal around the nose), one on nasal pillows {interfaces that sit
`
`under the nose and seal the nostrils), and one on full face masks (masks that seal
`
`around the nose and mouth). Later FPH also had a greenfields team, which would look
`
`at development in a less structured way, I believe one of these teams was established
`
`around 2008, this resulted in the development of the Pilairo mask. Also, when FPH
`
`started developing new mask types, at the beginning when it did not have that type of
`
`mask it may also be considered to be a greenfields approach, as there was no existing
`
`base to start from. That was the case around the years 1999, 2002 and 2004 when FPH
`
`started to develop their first nasal, full face and pillow masks, respectively. The teams
`
`would also see what each other were working on, and would talk to each other about
`
`problems and developments.
`
`These teams would work on developing one new mask at a time.
`
`New developments depended on feedback.
`
`If an existing product was getting good
`
`feedback and had a good market Share, the teams at FPH could spend time on
`
`developing something more radical, as there was the comfort of knowing that the
`company had a good performer in the market.
`In this case the team would spend many
`months looking into any and all options.
`If a product was not going well, but was
`
`obviously upgradeabie in a short time period that would resoive the issue, it would be
`
`Mk0
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`11
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`11
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`4.7
`
`4.8
`
`
`
`11
`
`

`
`worth the resources to upgrade that product. An example of an update was taking the
`
`407 nasal mask and upgrading the seal connection to include a rigid clip, to improve the
`
`ease of use. The 407 was released in 2003, and smaller size was released (the 406) in
`
`2005 and the Zest upgrade was released in 2008. The foam cushion was also upgraded
`
`to improve durability.
`
`4.9
`
`At FPH, development of an upgraded mask could occur within 12-18 months. This was
`
`the case if we had existing knowledge or had done previous work on the particular issue
`
`we were addressing. This would lead us to having a clear understanding of what we
`
`wanted to achieve and wouldn't require drastic changes from the existing model, many
`
`components of the mask may remain unchanged with work focusing on the components
`
`that were being upgraded, for example the clip upgrade from the 407 to the Zest.
`
`However, at FPH if we were aiming to deliver something and we weren't sure how it was
`
`going to look or how we would be able to achieve the aim, we were more likely to be
`
`producing a new iteration every one to two months,