Amgen sues Mylan over NeulastaAmgen has sued Mylan over patents relating to its Neulasta (pegfilgrastim) chemotherapy support drug.

In its complaint, filed at the US District Court for the Western District of Pennsylvania, Amgen explained that approval of the biosimilar and Mylan’s potential importation and sale of its product would be “infringing”.

In February, the US Food and Drug Administration (FDA) accepted Mylan’s abbreviated Biologics License Application (aBLA) for the Neulasta biosimilar for review.

Both Amgen and Mylan started exchanging information in March this year under the so-called ‘patent dance’ procedure of the Biologics Price Competition and Innovation Act (BPCIA).

But Amgen suggested that Mylan failed to provide certain information and “materially prejudiced and impeded Amgen’s ability to review the Mylan aBLA”.

Amgen alleged that Mylan “failed to provide other information that describes the process or processes used to manufacture the

biological product that is the subject of the Mylan aBLA”.

In June, Amgen took to the US Supreme Court to challenge a US Court of Appeals for the Federal Circuit decision that said the patent dance procedures were completely optional and that a biosimilar applicant can decide to withhold a copy of its biosimilar application.

Amgen said the patent dance was part of the BPCIA’s trade-off and balanced the rights of reference products against those of biosimilar applicants.

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Adding to Mylan’s woes, the Saint Regis Mohawk tribe has filed to dismiss an inter partes review (IPR) challenge from Mylan.

Allergan transferred its patents for its Restasis dry eye treatment to the tribe in September, granting the patents immunity from IPR at the US Patent Trial and Appeal Board.

Native American tribes hold sovereign immunity against any IPR challenges.

In its motion to dismiss the IPR review, filed on 22 September, the tribe said that the US Supreme Court had previously been asked to limit the scope of tribal immunity in the commercial context, but declined to do so and later reaffirmed the holding when asked to scale back tribal immunity on policy grounds. The Supreme Court said that only Congress can “determine whether or how to limit tribal immunity”.

Allergan had previously said that its agreement with the tribe would have no impact on its patent litigation against the manufacturers of proposed generic versions of the drug.

Bob Bailey, chief legal officer at Allergan, explained that the tribe had come to it with a “sophisticated opportunity to strengthen the defense of our Restasis intellectual property in the upcoming IPR proceedings before the Patent Trial and Appeal Board”.

Bailey added: “Allergan evaluated this approach closely, with expert counsel in patent and sovereign immunity law.”

He said: “We are impressed with the Tribe’s thoughtful and enterprising approach, which will allow them to achieve their goals of self-reliance and help them address the most urgent needs in their community.”

The tribe said this is an important step towards diversifying its economic strategy and ensuring it remains self-reliant. It said that it agrees and supports Allergan’s social contract to make their drugs accessible and affordably priced for their consumers.

UK-China symposium: IP system adapts to technology trends

The intellectual property system is adapting to technology trends such as AI and big data, attendees of the 2017 UK-China symposium, held on 22 September, heard.

The ‘Future proofing the IP system’ event, attracted over 200 thought leaders and policy makers. The event was co-hosted by the UK’s Intellectual Property Office (IPO) and China’s State Intellectual Property Office (SIPO).

Delegates heard about the latest policy and practice innovations in the patent and trademark fields, as well as the challenges for online and offline IP enforcement.

Practical advice for innovative and creative business, including in design-intensive industries was shared at the event.

Keynote speaker Lord Prior, UK business minister, and vice commissioner of SIPO Gan Shaoning, highlighted the increased co-operation and work sharing between the UK and China on IP.

Lord Prior stated: “The fourth industrial revolution will be based above all on new ideas and new technology. This means that the need for a robust IP regime has never been stronger.”

He added: “This symposium presents a key opportunity for UK industry to engage with Chinese policy makers to discuss a wide range of IP issues, ensuring we deliver an IP system that protects innovation and creativity that can help boost economic growth and trade for both countries.”

IPO chief executive Tim Moss will visit China this Autumn as part of continued engagement with his Chinese coutnerparts.

Amgen sues Mylan over Neulastacontinued from page 1 IPPro Patents Issue 040

Awareness SummitThe Center for Intellectual Property Understanding will hold the first ever intellectual property awareness summit on 6 November

P3

IP AgreementGoogle and HTC have signed a $1.1 billion agreement that will net Google a portion of HTC’s smartphone research and development team

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Patent ProfileFord patents a retractable table, Hyundai looks at advanced carbon fibre plastics and more

P5

Patent EligibilityBarney Dixon speaks to James Muraff of Neal, Gerber & Eisenberg on how to tackle patent subject matter eligibility

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News Round-Up

Red Hat expands Patent Promise

Open-source software provider Red Hat has revised its Patent Promise, which was initially intended to discourage patent aggression against free and open-source software.

The expanded version of the defensive patent aggregation scheme extends the zone of non-enforcement to all of Red Hat’s patents and all software under “well-recognised” open-source licenses.

In its original Patent Promise in 2002, Red Hat said software patents are “inconsistent with open-source and free software”.

The company said: “Red Hat representatives have addressed this issue before the National Academies of Science, the US Federal Trade Commission, and the US Department of Justice. Red Hat is also a signatory to a petition to the European Union encouraging the EU not to adopt a policy of permitting software patents.”

Red Hat said that, despite this, the world does not operate in that way and currently permits software patents.

It said: “A relatively small number of very large companies have amassed large numbers of software patents. We believe such massive software patent portfolios are ripe for misuse because of the questionable nature of many software patents generally and because of the high cost of patent litigation.”

“One defence against such misuse is to develop a corresponding portfolio of software patents for defensive purposes.”

Red Hat says the updated Patent Promise “represents the broadest commitment to protecting the open-source software community to date”.

Michael Cunningham, executive vice president and general counsel at Red Hat, added: “Red Hat’s Patent Promise now covers the lion’s share of open-source code and continues to cover all of our patents.”

IP Awareness Summit to be held in November

The Centre for Intellectual Property Understanding (CIPU) and the Chicago-Kent College of Law will hold the first Intellectual Property Awareness Summit in Chicago on 6 November.

The event will be the first conference to dissect what CIPU calls “widespread confusion over the purpose and use of IP rights, like patents and copyrights”.

It will look to increase IP recognition, improve education and reduce theft.

Bruce Berman, CIPU chairman, said: “Disdain for IP rights is growing among both individuals and businesses.”

He added: “Contrary to the headlines, not all IP rights are impediments or all licensers ‘trolls’. Uncertainty about what patents and other IP rights achieve, and for whom, has led to confusion about their purpose and value. [The summit] will seek to identify ways to bridge the IP information gap.”

Sessions at the summit will try to identify what audiences need to know about IP rights and how best to convey this type of information.

Manny Schecter, chief patent counsel at IBM, said: “The Intellectual Property

Awareness Summit will bring together people from throughout the IP community to brainstorm about what can be done to improve IP awareness.”

He added: “The participants will help identify concrete action items that CIPU can implement, working with other organisations in the US and abroad.”

Brian Hinman, chief IP officer at Philips, said: “The Intellectual Property Awareness Summit is the perfect opportunity for attendees to gain an appreciation of the role of all forms of IP in cutting edge innovation, and how IP captures novel ideas and creative thinking.”

Marshall Phelps, vice president of IP business and strategy at Microsoft, added: “The IP Awareness Summit is the first time the IP community, including government, IP holders, inventors, recording artists, academics and associations, have been brought together to examine the ‘disconnect’ between why IP rights exist how and how they are seen.”

“Free-riding is a growing menace that comes in many shapes and sizes, and audiences need to understand that it is theft and impacts jobs and competition.”

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News Round-Up

Cunningham said: “We encourage others to make commitments like these. The innovation machine represented by the open-source community is an enormous positive force for society. Our patent promise—we believe the broadest in the industry—is intended to support and nurture that community and force.”

Google and HTC sign $1.1 billion deal

Google and HTC have signed a $1.1 billion agreement that will net Google a portion of HTC’s smartphone research and development team and a separate non-exclusive intellectual property licence.

HTC will receive the $1.1 billion in cash as part of the transaction for its staff, which have already been working with Google on its Pixel smartphone.

Google will have access to HTC’s smartphone IP, but the non-exclusivity of the deal means that HTC will continue to own its IP and license it freely.

Both companies said the agreement is a “testament to the decade-long history of teamwork” between them, which included the first ever Android smartphone.

Google senior vice president of hardware, Rick Osterloh, said it was still early days for Google’s hardware business, but the deal will fuel more product innovation in the coming years.

He added: “We’re focused on building our core capabilities, while creating a portfolio of products that offers people a unique yet delightful experience only made possible by bringing together the best of Google software—like the Google Assistant—with thoughtfully designed hardware.”

“HTC has been a longtime partner and has created some of the most beautiful, high-end devices on the market.”

“We can’t wait to welcome members of the HTC team to join us on this journey ... we’re

excited to see what we can do together as one team,” Osterloh said.

Cher Wang, chair and CEO of HTC, said the company is proud of its history of innovation and place as a pioneer in the smartphone industry.

She added: “Our unmatched smartphone value chain, including our IP portfolio, and world-class talent and system integration capabilities, have supported Google in bolstering the Android market.”

Wang continued: “This agreement is a brilliant next step in our longstanding partnership, enabling Google to supercharge their hardware business while ensuring continued innovation within our HTC smartphone and VIVE virtual reality businesses.”

“We believe HTC is well positioned to maintain our rich legacy of innovation and realise the potential of a new generation of connected products and services,” she said.

4 IPPro Patents www.ippropatents.com

News Round-Up

Dali and Fiplex settle down

Dali Wireless has settled with Fiplex Communications over patents for its Public Safety distributed antenna systems (DAS) products. Fiplex has agreed to license three of Dali’s patents as part of the settlement and the two companies have ended their pending litigation at the US District Court for the Southern District of Florida.

Fiplex will use the patents for its commercial and military telecoms devices, including digital DAS.

Matias de Goycoechea, CEO of Fiplex, said: “We are very glad to settle this lawsuit amicably with Dali Wireless.”

“The licence agreement will allow Fiplex to add some of Dali’s patented inventions to its Digital Fiber DAS line, and also builds a productive relationship with Dali.”

Albert Lee, CEO of Dali Wireless, added: “We have an extensive worldwide patent portfolio, and are committed to protecting our innovations and intellectual property rights. Fiplex has demonstrated its respect for the intellectual property rights of others by licensing Dali Wireless’s intellectual property.”

Motorola wins infringement challenge

Motorola has won its direct patent infringement appeal against Intellectual Ventures, but failed to secure an invalidity ruling.

The telecommunications company failed to convince the panel at the US Court of Appeals for the Federal Circuit, which upheld the validity of two Intellectual Ventures patents relating to a file transfer system and portable computing devices.

But, the court did not support the district court jury’s finding of direct infringement, because Intellectual Ventures failed to demonstrate that Motorola had obtained “benefit” from each and every element of the system.

Intellectual Ventures claimed that evidence of Motorola customers using Multimedia Messaging Services (MMS) on

their Motorola phones directly infringed its patents and that Motorola had also directly infringed the patents by testing the service’s functionality.

The court said: “The critical question here is whether there was substantial evidence that Motorola’s customers obtained a ‘benefit’ from the generation of delivery reports.”

It added: “Neither of Intellectual Ventures’s direct infringement theories purported to explain how Motorola’s customers satisfied this claim limitation by using the accused phones. Indeed, there is no evidence that the customers ever ‘generated a delivery report’.”

Instead, the court said that Intellectual Ventures had relied on testimony and evidence that delivery reports were generated by MMS Centres maintained and operated by the customers’ wireless service carriers, when the customers used the accused phones.

“Here, Intellectual Venture’s sole record citation contains just one sentence about the delivery report,” the court said.

“That sentence says nothing about the benefits flowing from the delivery reports to the customer sending the message.”

Nokia and LG complete arbitration

Nokia and LG Electronics have finally settled their patent licence dispute at the International Court of Arbitration.

The court, which sits under the umbrella of the International Chamber of Commerce, issued its award for the arbitration today (18 September). Nokia and LG had previously agreed that this award would settle the royalty payment obligations for Nokia’s royalty-bearing smartphone patent licence. The details of the award and licence are confidential, but LG will join Nokia’s licensing programme, gaining access to an undisclosed number of patents out of its library of 30,000.

Maria Varsellona, chief legal officer at Nokia, said: “The use of independent arbitration

to resolve differences in patent cases is a recognised best practice.”

He added: “We believe that this award confirms the quality of Nokia’s patent portfolio.”

“We continue to see potential for additional licensing opportunities in the mobile communications market and beyond.”

Nokia will disclose its patent licensing revenue in its quarterly announcements and expects the revenue from the agreement to show up in its Q3 2017 results.

In July, Nokia announced its Q2 2017 patent licensing revenues and revealed an approximate €1.7 billion upfront cash payment from Apple, as part of a settlement to end all outstanding litigation between the companies earlier this year.

iRobot agrees with Micro-Star International over patent litigation

iRobot Corporation has reached an agreement with Micro-Star International (MSI) over its robot vacuum patents.

iRobot asked the US International Trade Commission to investigate several companies, including Hoover Inc, for illegally importing robot vacuum cleaning devices that infringe iRobot’s patents for automated vacuum cleaners.

MSI produces various technologies, including smart cleaning robots.

As part of the agreement, MSI will exit the robotic cleaning industry worldwide, and iRobot has agreed to remove the Hoover Quest 600, 700, and 800 products sold and distributed by Hoover Inc from the pending US International Trade Commission.

Details of the rest of the agreement are confidential and have not been disclosed.

Glen Weinstein, executive vice president and chief legal officer at iRobot, said: “The agreement by MSI to exit the robotic cleaning industry signifies the value of iRobot’s intellectual property.”

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Ford has been granted a patent for a retractable vehicle table, complete with airbags, that can be used in autonomous cars and will allow occupants to face each other during the drive.

The US patent (0259772) describes a table that can be used for the occupants to relax and interact with each other, while the autonomous vehicle drives itself.

The round table can be retracted into the floor and may be telescopic to allow it to move between the retractable and extended position.

Any seats surrounding the table would also be adjustable, allowing passengers to switch between using the table and sitting in a more traditional vehicle position.

Ford says there remains other opportunities to design vehicle amenities for the occupants that takes into account “reduced operation monitoring provided by the autonomous vehicle”.

Hyundai has patented advanced carbon fibre reinforced plastics for use in the front structure of its cars.

The US patent (0259856) describes the carbon fibre as forming the cross member for the cowl.

The cowl is a part of the vehicle body between the passenger and engine bay, and usually made out of steel or aluminium.

Hyundai says that most vehicles bodies are made from carbon fibre for weight reduction, which reduces fuel consumption, but steel and aluminium are mostly used on cowls for structural integrity.

Hyundai’s invention uses a braiding method that connects the carbon fibre material together and reinforces the structural integrity of the cowl.

A recent patent from Tesla revealed the company’s work on a battery swapping system for its cars.

The US patent (9688252) describes an electrical energy system station that is configured to lift an electric vehicle from the ground and replace its battery.

Tesla says the invention could change the battery pack of the vehicle in less than 15 minutes.

According to the electric car company, as more sustainable energy sources for vehicles become available and combustion-engine vehicles become less prevalent, this method of securing energy for the car could become a viable alternative to slow charging, which can take up to an hour.

Tesla says: “Because the process of charging such cells usually takes some amount of time, some vehicles are designed so that the battery can be replaced with another battery, to replenish power in the vehicle or to address malfunction in the current battery.”

It adds that its new invention can “provide a more rapid way of replenishing the electric energy for the electric vehicle and can enable electric vehicles to travel essentially nonstop on long road trips”.

A patent from Jaguar Land Rover has recently surfaced, revealing technology for an automated weather forecast service based on conditions picked up on sensors on the vehicle.

The patent (WO026779) was filed in an international patent application at the World Intellectual Property Organisation (WIPO) and promises to offer automated solutions to different weather types.

For example, the patent application describes the vehicle automatically operating its windscreen wipers to combat rain, or triggering windscreen heating at low temperatures.

Jaguar Land Rover describes the invention as “computer implemented” and relating mostly to data and sensors.

The patent has already been published in the US and is working its way through the national phase of WIPO’s Patent Cooperation Treaty. IPPro

Fast cars and weather forecastsFord patents a retractable table, Hyundai looks at advanced carbon fibre plastics, Tesla reveals a new way of battery swapping for electric cars and Jaguar Land Rover has developed automated weather detection

7 IPPro Patents www.ippropatents.com

Have a patent we should shout about? Let us know via: barneydixon@blackknightmedialtd.com

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How does Neal Gerber & Eisenberg’s approach to Section 101 litigation differ from other law firms?

Arguing the first step equally to, if not more than, the second is important because it gives a patent examiner a better sense of what the invention really is and the meaning of the specific required claim limitations, all up front. This often causes the examiner to realise the invention is really not just some broad (abstract) idea, at the outset of the arguments. I think the firms with better success argue both steps strongly, especially the first step.

The two steps are not mutually exclusive, although you only need to win one to win.

If one can characterise an invention in a much more detailed set of required functions and solutions, and characterise such solutions being carried out in a technical and non-conventional manner, then a patent claim will more likely not be ‘merely directed’ to a patent ineligible concept. The more non-conventional detail can be attributed to the concept of the invention, the more likely step one will be satisfied. Since step two considers whether there is something

Barney Dixon speaks to James Muraff of Neal Gerber Eisenbeg on how to tackle patent subject matter eligibility in the ever-growing wake of Alice

Old dog, new tricks

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Patent Eligibility

more than the idea itself, similar arguments of the detail and around how such functions are being carried out are also not necessarily a part of step two.

For step two, you should try to argue that functions of the implementations of the invention are different to the functions of other similar technology (which may just happen to solve the same higher-level concept). These functions and implementations provide distinct advantages over conventional manifestations of performing that same higher-level functionality. This should be done for each significant element of the claim, and for the combined claim language as a whole. But, I think arguing part one of the two-step test is very important to characterising the claim and invention in the best light.

A lot of the time you can get on the phone with the Examiner and you can work through some of the specifics and come up with ways to clarify these matters. The Examiners are not always trying to dig their heels in; they’re doing their job to the best of their ability. Getting on the phone with them can be a good initial step, to see if there is some clarifications that can be made that will make getting over the hump easier.

We want to be efficient with clients’ resources, and an initial interview with the Examiner can go a long way with a lot of the applications and avoid a long drawn-out battle.

What are Neal Gerber & Eisenberg’s key strategies when handling Section 101 cases?

I think the whole strategy begins with inventor interviews of what has been created.

Instead of only getting a higher-level understanding of functionality and how it is implemented, you should drill down on aspects of an invention that could be argued improves how computer technology and its interoperations function.

Trying to find nuggets here, especially when the overall invention is necessarily a product of such nuggets, can be very helpful. Quite often this allows for a characterisation of an invention that will keep the patent application out of certain examination groups at the

USPTO, which have very low allowance rates and much higher rates of patent eligibility rejections.

Also, the extent to which computer technology is used within a system, when other technology is also used within a system—such as a mobile phone, kiosk, point-of-sale system, or even an automobile—focusing in on the functionality of the non-computer aspects of the system and how such other functionality is improved, can go a long way to avoiding or overcoming patent eligibility issues. This can often work even when the computer technology is heavily involved in a system (as it most often is).

Do you think certain case law, such as the Alice Corp v CLS Bank International case, should be looked at by Congress to better strengthen the patent system?

From my perspective, yes, and I’m not alone here. The American Intellectual Property Law Association and the Intellectual Property Owners association both have proposals to amend section 101 of US Code Title 35. Why? Because the case law is inconsistent.

Part of the strategy to try to overcome rejections is to find some case law that is similar to or in the same area of technology as, your invention and use that to argue the invention. Because the case law is inconsistent, it can be hard to do that without opposing views from the bench. These associations recognise that inconsistency, and have come up with proposals to amend the statute. In my view, their main purpose is to remove the concepts of novelty from patent eligibility. There are other statutory sections that deal with novelty and nonobviousness. The patent eligibility section had, for a long time, been interpreted as not including the novelty and nonobviousness requirements. The Supreme Court has confused that, conflating sections 101, 102 and 103. The associations are putting forward proposals to make it clear that they are separate requirements.

I think right now it is absolutely stifling invention. For app developers, for example, unless there is some underlying improvement to the computer itself, it can be very difficult to get patent protection, even if they have made some novel and functional improvement. In the pure software category, there is no question in my mind that the problems with section 101 are stifling innovation. IPPro

The patent eligibility section had, for a long time, been interpreted as not including the novelty and nonobviousness requirements, the Supreme Court has confused that

James Muraff, Partner, Neal, Gerber & Eisenberg

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Patent Eligibility

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WHAT’S THE PROGRAMME?

New hires at Buchalter, Adams and Reese, Goldberg Segalla and moreBuchalter has hired Willmore Holbrow as shareholder and member of its intellectual property and litigation practice groups in Los Angeles.

Holbrow’s practice focuses on IP litigation specialising on patent, trademark, copyright and trade secret matters.

He works with clients in various industries, such as medical devices, apparel, chemical compounds, software, furniture, internet-based applications, LED technology, locks, wheel designs and electronics.Previously, Holbrow has also served as an engineer in the Air Force and first-chair trial attorney in the Air Force Judge Advocate General’s Corps.

Adam Bass, president and CEO of Buchalter, said: “Strengthening our intellectual property litigation capabilities has been a focus of ours for quite some time.”

Bass added: “I am so pleased to welcome Willmore Holbrow as we continue to strategically expand, and we are excited that his practice further enhances the legal services we offer our national and international business community clients.”

Adams and Reese LLP has expanded its intellectual property team with the hire of Michael Bednarek as partner and member of its IP practice.

Bednarek, who will be based in the company’s Washington DC office, has experience in cross-border patent, industrial design, cyber security and trade secret issues. Previously, he has worked with companies in the US, Asia and Europe covering a range of industries such as information technology, application-specific integrated circuits, circuits, optoelectronics, consumer goods and electronics, medical devices, toys and gaming, manufacturing, automotive and financial services.

Bednarek’s appointment will enhance the firm’s capabilities with federal agencies. Prior to joining, Bednarek served as partner at various other firms, including Shearman & Sterling, Axinn and Locke Lord LLP.

Mitch Boult, intellectual property attorney, who leads Adams and Reese’s strategic growth initiative, commented: “Bringing Bednarek into our DC office continues the upward trajectory of our global IP team. His formidable skills and contacts are a powerful value-add for our multinational clients.”

14 IPPro Patents www.ippropatents.com

Industry Appointments

Ex-Oblon attorneys Kirsten Grüneberg and Eric Myers have launched their own patent boutique law firm in Virginia.

The new firm, Grüneberg and Myers, will provide strategic patent counseling to clients ranging from startups to multinational corporates.

Joining them is another former Oblon attorney, Richard Chinn, who focuses on chemical patents.

Overall, the firm will cover the chemical, materials science, life science and pharmaceutical fields.

Grüneberg focuses on chemical, biotech and pharmaceutical companies, while Myers works on patentability, invalidity and non-infringement issues.

Grüneberg said the firm plans to take a “diversity-minded approach to attract the best talent in patent law”.

She added: “Our differences and diverse perspectives make us stronger.”

Myers added that the firm would weather industry changes, such as the introduction of the America Invents Act and various uncertain Supreme Court decisions, “by providing high-quality service through a low-overhead framework”.

He said: “We have strategically designed our firm with a keen eye on every dollar to ensure that we remain agile and lean.”

“Minimised overhead will free us up to treat every case with individualised care. We won’t need to churn through volume quickly just to stay profitable.”

Goldberg Segalla has appointed patent litigator Michael Siem to its intellectual property practice.

Siem, who joins the firm’s New York office as partner, will represents both patentees and alleged infringers in the pharmaceutical, consumer electronics, chemical processes, computer networks and biotechnology industries.

Previously, he worked at Devlin Law Firm, where he served as partner leading its life sciences practice.

He has particular experience with the framework of the Drug Price Competition and Patent Term Restoration Act, as well as the Hatch-Waxman Act.

Siem also has experience with trademarks under the Anticybersquatting Consumer Protection Act and has drafted and filed patent and trademark applications across various industries.great value to our IP practice as we work hard to protect our clients’ world-class brands.” IPPro

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