BIO fears return of the Innovation Acthave severe unintended consequences on legitimate patent holders who employ thousands of Americans”.

Multiple House judiciary committee members issued statements outlining their support for the reintroduction of the Innovation Act, with Goodlatte saying: “The bipartisan Innovation Act contains commonsense reforms and makes the patent litigation process more transparent.”

“This same legislation passed the House by an overwhelming margin last Congress. I look forward to working with the Senate Judiciary Committee to see this legislation sent to the president to be signed into law.”

Jim Greenwood, CEO and president of BIO, said in a statement that while the biotechnology trade association supports the act’s aim, it is worried about unintended consequences.

The Innovation Act has been re-introduced by the House of Representatives, in a move that has worried BIO, the biotechnology trade association.

House judiciary committee chairman Bob Goodlatte and other members reintroduced the unchanged act, which was rejected by the Senate last year, into Congress on 5 February.

The committee claims the act builds on reforms made in the America Invests Act in 2011 and will introduce rules to reduce the costs of discovery and give courts the opportunity to access patent validity more quickly.

The House voted to pass the Innovation Act late last year, but Senate judiciary committee chairman Patrick Leahy put a hold on the bill after weeks of unproductive negotiations amid fears it “would

Federal Circuit rules in first AIA IPR appeal

The Federal Circuit has ruled on the first inter-partes review (IPR) appeal, affirming that the US Patent and Trademark Office’s (USPTO) authority cannot be challenged after the Patent Trial and Appeal Board (PTAB) issues a final decision.

US Court of Appeals for the Federal Circuit judges ruled two to one in favour of upholding the PTAB’s decision to find three claims in a speed limit display patent to be obvious.

The 4 February ruling was the first time that an America Invents Act IPR proceeding has been appealed since the act’s passage in 2011.

Eli Lilly blames patent expiries for Q4 2014 decreases

Eli Lilly has reported decreased revenue for Q4 2014 due to the expiry of key patents.

In Q4 2014, total revenue hit $5.121 billion, a decrease of 12 percent on the precious quarter.

The decrease was attributed to the loss of US patent protection for the Cymbalta drug in December 2013 and Evista in March 2014.

Net income also decreased by 41 percent to $428.5 million.

“While Eli Lilly’s Q4 2014 results continue to reflect the impact of patent expirations, we are moving to a period of growth led by diabetes, oncology and animal health,” said John Lechleiter, chairman, president and CEO of the company.

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BIO fears the Innovation Act’s returnContinued from page 1

He said: “BIO supports targeted reforms to reign in abusive patent enforcement practices but any efforts to accomplish this must be done in a way that preserves the patent-based incentives necessary to sustain our nation’s global leadership in biotechnology innovation and the creation of high-wage high-value jobs throughout our country.”

“BIO is concerned that the Innovation Act as re-introduced today fails to meet that test by undermining the ability of legitimate patent owners to commercialise their inventions and enforce their patent rights against infringers.”

Bio’s Greenwood urged Congress “to proceed cautiously with proposals for additional changes that would continue to shift the legal balance against patent owners”.

“Strong patents … are critical in ensuring a steady stream of capital to biotechnology companies developing innovative medicines, alternative energy sources, and insect and drought resistant crops.”

“And they are essential to the technology transfer process that leads from inventions in the lab to products on the shelves.”

Federal Circuit rules in first AIA IPR appealContinued from page 1

Garmin International challenged the Cuozzo Speed Technologies-owned patent through the IPR proceeding, arguing against the validity of claims 10, 14 and 17. The post-grant review procedure came into force a year after the passage of the America Invents Act.

The PTAB, which is overseen by the USPTO, ultimately ruled the claims as obvious, but Cuozzo appealed, arguing that the agency improperly instituted the petition and the

incorrect standard was applied when evaluating the scope of the claims.

Ruling in Garmin’s favour, Federal Circuit Judge Timothy Dyk, who was joined by Judge Raymond Clevenger, said that the USPTO has ultimate authority over IPRs and so they cannot be appealed after a final decision, even if proceedings are improperly instituted.

“Contrary to Cuozzo’s contention, we hold that we lack jurisdiction to review the USPTO’s decision to institute IPR,” he wrote.

Section 314(d) of the US Patents Act “prohibits review of the decision to institute IPR even after a final decision”, explained Judge Dyk.

“On its face, the provision is not directed to precluding review only before a final decision. It is written to exclude all review of the decision whether to institute review.”

Cuozzo also challenged the USPTO’s use of the ‘broadest reasonable interpretation’ standard when reviewing patent applications, arguing that the narrower standard used by district courts is more appropriate.

Dismissing the argument, Judge Dyk wrote: “There is no indication that the America Invents Act was designed to change the claim construction standard that the USPTO has applied for more than 100 years.”

In her dissent, Judge Pauline Newman claimed that if the IPR system is to function as US Congress intended, a low-cost and speedy alternative to district court litigation, then it must apply the same standard to patent review.

The USPTO cannot “serve as a surrogate for district court litigation if the PTAB does not apply the same law to the same evidence,” she argued.

The Federal Circuit has ruled on the first inter-partes review (IPR) appeal, affirming that the US Patent and Trademark Office’s (USPTO) authority cannot be challenged after the Patent Trial and Appeal Board (PTAB) issues a final decision.

Latest newsWarner-Lambert is denied interim relief in the UK over generic competition from Actavis Group for its Lyrica drug

p4Conference reportThe Biotechnology and Money Conference in London offered advice on how to turn an idea into a lifesaver p7GIPC insightA preliminary look at the results of the latest edition of the International IP Index from the US Chamber of Commerce’s Global Intellectual Property Center p8Case studyBeing part of a team can take an idea from the drawing board to the operating table, according to Innovate Calgary

p9People movesKilpatrick Townsend & Stockton makes a string on changes, and more p11

IPProINBRIEF

Meissner Bolte is one of the leading intellectual property law firms in Germany, and offers the full range of services in the field of intellectual property protection. From filing through to enforcement and thesusuccessful exploitation of your IP rights, Meissner Bolte provides complete support from a single source.

Our teams of competent, highly quaOur teams of competent, highly qualified patent attorneys and lawyers are on hand to represent you and offer strategic advice over the whole spectrum of legal protection possibilities covering patents, trademarks and designs.

Meissner Bolte – a powerful combination of legalexcellence and technical expertise.

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NewsInBrief

Eli Lilly blames patent expiries for Q4 2014 decreasesContinued from page 1

“Despite the loss of significant revenue for Cymbalta and Evista following the expiration of our US patents, we saw strong performance from other products.”

Worldwide Humulin sales increased 7 percent in Q4 2014, to $395.6 million, while Forteo sales achieved a 6 percent increase over Q4 2013.

Pfizer acquires Hospira for $17 billion

Pfizer has combined forces with injectable drug infusion technology company Hospira for a cool $17 billion.

The global marketplace value for generic sterile injectables is expected to be worth $20 billion by 2020.

Ian Read, chairman and CEO of Pfizer, said: “Hospira’s business aligns well with our new commercial structure and is an excellent fit for our global established pharmaceutical business, which will benefit from a significantly enhanced product portfolio.”

Hospira’s portfolio includes several biosimilars. Pfizer will develop and commercialise Hospira’s products, which are currently distributed in the US, Europe and emerging markets.

“The Pfizer-Hospira combination is an excellent strategic fit, presenting a unique opportunity to leverage the complementary strengths of our robust portfolios and rich pipelines,” said Michael Ball, CEO of Hospira.

FTC approves Ranbaxy acquisition

Sun Pharmaceuticals has received backing for its $4 billion acquisition of Ranbaxy Laboratories from the US Federal Trade Commission (FTC).

Ranbaxy has been ordered to sell its interests in generic minocycline tablets to Indian manufacturer Torrent Pharmaceuticals because the FTC believed the merged company would be anti-competitive.

At the end of January, the FTC complained that the merger would harm future competition by reducing the number of generic drug suppliers in the US market.

The FTC said that Sun’s entry into the generic minocycline tablets market would have resulted in significantly lower prices for three dosage strengths.

According to the court, Pfizer offered to take a number of steps to ensure that generic pregabalin is neither prescribed or dispensed for pain treatment.

Ailsa Carter, senior associate in Wragge Lawrence and Co’s IP team, said judges will be “reluctant to issue interim injunctions restraining [the] launch of generic medicines authorised with a ‘skinny-label’, based on patent claims in Swiss form directed to a ‘carved-out’ therapeutic indication”.

“Swiss form claims are process claims, and on the basis of Arnold’s decision it is only the manufacturer who would infringe them,” she added.

Pfizer reports $440 million revenue loss in USPatent expiries and generic competition in the US is to blame for revenue loss, claims Pfizer in its Q4 2014 results report.

Pfizer found there was a three percent ($440 million), drop in its sales over Q4 of 2014 due to generic versions of its drugs Celebrex (celecoxib) and Enbrel (etanercept), losing its patent protection in the US.

Its drug Spivira (tiotropium) was also terminated in other countries.

Ian Read, Pfizer chairman and CEO said that during 2014 there were “significant continued revenue headwinds from product losses of exclusivity and co-promote expiries.”

Pfizer also reported that a collaboration with Merck, a higher tax rate and legal matters reflecting unfavourable financial impact on the company.

But Frank D’Amelio, CFO, shared that “we achieved or exceeded all elements of our 2014 financial guidance despite an operating environment that remains challenging”.

AstraZeneca collaborates over genome projectAstraZeneca has promised to collaborate with four research institutions to use genome-editing technology CRISPR to develop medicines to treat genetic causes of diseases.

CRISPR is a genome-editing tool that allows scientists to change specific genes in a quick and precise manner.

Dr Mene Pangalos, executive vice president of innovative medicines at AstraZeneca, said: “By combining with industry partners, we will be able to integrate this technology.”

The Wellcome Trust Sanger Institute in Cambridge will ‘delete’ specific genes related

TechPats acquires Global Intellectual StrategiesUS patent consultancy TechPats has acquired an intellectual property firm based in Canada.

Following the deal, TechPats will have offices in Philadelphia, San Francisco, Tokyo and Ottawa. GIS CEO Marek Wenik will become president of the combined companies.

Chris Wichser, CEO of TechPats, commented: “We are excited about this combination and the joining of these two great companies.”

“The addition of GIS and their highly skilled team of IP professionals expands our service offerings for current and future clients, and also expands our global reach.”

Wernik added: “TechPats’ team of experts and engineers is impressive and their leadership team’s vision for the future growth of the company and for meeting the needs of our clients is exciting.”

“GIS has a proud history of service and commitment to our clients and we look forward to continuing our work as TechPats.”

Warner-Lambert denied relief in UK courtsPfizer subsidiary Warner-Lambert has been denied interim relief in the UK over generic competition from Actavis Group for its Lyrica (pregabalin) drug based on a Swiss form claim.

High Court of Justice of England and Wales Judge Richard Arnold his decision on 21 January, stating that granting the relief sought by Warner-Lambert would create “a greater risk of injustice” than refusing it.

He ruled that “wrongly granting the relief is more likely to cause Actavis substantial unquantifiable harm than wrongly refusing it is likely to cause Warner-Lambert substantial unquantifiable harm”.

Lyrica treats neuropathic pain, epilepsy and generalised anxiety disorder (GAD). The basic composition patent for pregabalin and the associated supplementary protection certificate (SPC) have expired.

But a second patent protecting pregabalin’s use in the treatment of neuropathic pain is under a Swiss patent claim.

This type of protection is known as ‘skinny label’ where a patent covering treatment has expired, but it may cover other disorders and remain under protection.

Actavis’s patent for its generic drug Lacaent, which it plans to launch in the UK, covers GAD and epilepsy, not pain relief. It believed it would not infringe Warner’s patent.

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to cancer, cardiovascular and metabolic diseases to understand the role they play in the conditions.

Dr Kosuke Yusa, member of the faculty at the Sanger Institute, explained about the technology: “CRISPR has transformed the way we study the behaviour of cells and now the application of this powerful technology to the search for effective drugs has the potential to benefit patients.”

Under the agreement, the Innovative Genomics Initiative will also inhibit or activate CRISPR genes.

“I’m confident that by working with AstraZeneca, our collaboration will positively impact drug discovery,” said Jacob Corn, scientific director of the Innovative Genomics Initiative.

Thermo Fisher Scientific and Broad Institiue/Whitehead Institute, both in Massachusetts, will also complete research work to understand the genes with AstraZeneca.

“Application of the CRISPR technology should enable us to identify novel targets, build better test systems for drug discovery and enhance the translatability of our safety models,” said Dr Lorenz Mayr, vice president, reagents and assay development at AstraZeneca.

collections are expected to continue to show increases over the same period even with a fee reduction that was recently implemented.”

In coming to its $3.5 billion budget projection for 2016, the USPTO decided to continue with increased investment in IT by withdrawing funds from the patent and trademark operating reserves, “and then rebuilding the operating reserve balances over the course of the next several years”.

As a result, it requires a $500 million increase in its patent budget over a six-year period that began in 2014, with a view to seeing a $1.2 billion reduction in patent fee collections.

This will lead to a cumulative $1.7 billion reduction to its patent operating reserve balance in 2019.

The 2016 budget also reflects an increase of $85 million in trademark budgetary requirements, an increase in fee collections of $28 million and a cumulative reduction in the trademark operating reserve balance of $173 million over the 2014 to 2019 period, according to the USPTO.

The $3.5 billion budget for 2016 would allow the USPTO “to fund operations and to further implement administrative actions proposed by the president’s patent task force”, added the Department of Commerce.

USPTO anticipates reduced funding for 2015The US Patent and Trademark Office (USPTO) could receive $3.5 billion in funding next year, although patent filing fees that it receives during 2015 might miss estimates that ultimately determines its budget.

The Department of Commerce, which oversees the USPTO, has requested $3.5 billion to fund the agency through 2016, but fees received during this year could be lower than previously anticipated.

The USPTO receives a budget from the president, but its funding depends entirely on the fees that it receives from patent and trademark filings, and other work.

It was assigned almost $3.5 billion in funding for 2015, but the agency believes that signs of lower-than-planned growth in patent application filings, due to the global economy and international filings, recent judicial rulings, and process changes, could result in a $1.2 billion reduction in projected patent fee collections for the period of 2014 to 2019.

“This reduced growth rate also caused us to lower our patent examiner hiring estimates,” commented the USPTO in its 2016 budget projection. “Trademark workloads and fee

http://www.ssrana.in

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ConferenceReport

The Biotechnology and Money Conference in London featured an in-depth look at technology transfer and how it helps to produce ground-breaking technology.

In the technology transfer and commercialisation discussion, led by Michael Capaldi, commercialisation director of Edinburgh Quarter, all parties agreed that technology transfer is about people.

Tony Hickson, managing director of tech transfer at Imperial Innovations of Imperial College London, Mene Pagalos, vice president of innovative medicines and early research at AstraZeneca, David Philips, partner at SR One, Iain Thomas, head of life sciences at Cambridge Enterprise and Patrick Verheyen of the Johnson & Johnson Innovation Centre London took part in the discussion.

Verheyen commented: “Sometimes it might be a licence, or a spin out or partnership with various companies. It is driven by the expertise of the people; do we have the right people and are they correctly incentivised?”

Verheyen added that collaborations no longer focus “on just IP; it’s people presenting their IP”.

“If people are passionate and show that if you advance the technology you can have an impact and can display the impact this will have, that’s how you get people going; it’s about trust.”

Pangalos added: “You invest in science and people. You can have the same IP and you’re going to invest in one or the other. It’s down to people and the quality of their thinking

that’s ultimately what you invest in. The IP comes as a consequence.”

This approach could dominate collaboration. Academics who present pre-clinical programmes to industry are still trying to work out how to make their work attractive, explained Thomas. “[They have to ask themselves] does it have x, y, z, and if not, then pharma needs to educate the academics to understand what they’re missing and encourage them to go and find the additional data.”

AstraZeneca offers trade-offs to encourage academics and build relationships that could turn profitable in the future.

“We have had academics who work for us and we don’t receive anything in return. It’s about building relationships. Ultimately, it becomes easier when someone makes a call and says I’d like to work with you,” shared Pangalos.

Philips added that SR One prefers access to high quality compounds over immediate returns. “We can invest and share preclinical value. It’s an important shift from where pharma was seven years ago.”

“The symbiotic relationship building is growing. More companies are doing it.”

The discussion then moved on to current trends in gene editing, which emerged as the hot topic of the conference.

In January, AstraZeneca announced that it will collaborate with four research institutions to use genome editing technology CRISPR

to develop medicines to treat genetic causes of diseases.

AstraZeneca’s CRISPR is a genome-editing tool that allows scientists to change specific genes in a quick and precise manner.

The triumphs and collaborations that AstraZeneca has made with its CRISPR technology would not exist without “good science” and “basic research”, said Pangalos.

“CRISPR technology would not have come about if we did invest in basic research and understanding how bacteria detect themselves is one of the most exciting research modes out there. So funding basic research is important. We need to make sure our universities understand the agenda.”

A criticism often levelled at academia is the speed at which technology moves into industry. One of the problems slowing the process down is finding the resources and deploying them rapidly to pass through to the next phase.

But, the panel agreed, this must not be solved if the solution leads to hurried studies and poor research.

Pangalos added that although criticism is often levelled in a constructive manner, industry in the UK sees failure as a negative, much to its detriment.

“In the US, people won’t invest if you haven’t failed a few times, but in the UK failure is viewed as something where you can’t try again. We need to build a culture where people can be entrepreneurial, to fail, and to get up and try again.” IPPro

Turning water into wineThe Biotechnology and Money Conference in London offered advice on how to turn a jotted down idea into a lifesaverTAMMY FACEY REPORTS

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GIPCInsight

Intellectual property is the key to promoting the innovation that creates breakthrough new products and technologies, but unfortunately IP standards vary greatly around the world.

The US Chamber of Commerce’s Global Intellectual Property Center (GIPC) recently released a tool to help assess the strength of IP standards in global economies. The GIPC’s International IP Index, UP: Unlimited Potential, ranks the IP environments in 30 economies, comprising nearly 80 percent of the global gross domestic product.

The full index can be viewed at www.theglobalipcenter.com/gipcindex

This year marks the third edition of the index, which serves as a statistical, data-driven tool for governments to understand what businesses consider necessary for an innovative economy. The index ranks the economies based on 30 criteria across six categories critical to innovation, such as patent, copyright, trademark, trade secrets protections, enforcement, and engagement in international treaties. Further, for the first time in the index’s history it included data on the correlation between robust IP protections and certain socio-economic development factors.

The GIPC index is a uniquely private-sector developed resource. The indicators evaluated in the index were chosen by industry as those indicative of a strong IP environment. Further, the economies selected were not only chosen to reflect economic and geographic diversity, but also destinations were industry is seeking to expand their market access.

Ultimately, the GIPC index provides a tool for businesses and policymakers to evaluate the strength of an economies’ innovative environment. The 2015 GIPC index found that IP—and in turn innovation—was ascendant in 2014. Twenty out of the 25 economies examined in both the second and third editions improved their scores, a strong reflection of the fact that IP protections are heading in the right direction. As societies chart the path towards becoming a knowledge-based economy, the

continued support for policies, which foster innovation will be critical to their success.

But why does that all matter? As the index clearly shows, strong IP protection is critical to the creation of dynamic, innovative economies.

One of the most telling correlations was the strong relationship between advanced IP protection and private sector spending on research and development (R&D). In fact, companies in economies with advanced IP systems are 40 percent more likely to invest in R&D.

That’s significant because it enables firms to invest in economies to create new products, technologies, and processes, with greater assurances that their innovation will be protected. One of the areas that this makes the most impact is the healthcare space.

According to the Pharmaceutical Research and Manufacturers of America (PhRMA), biopharmaceutical companies have invested more than $500 billion in R&D since 2000, and there are more than 5,000 new drugs in the pipeline. Those numbers are significant. That represents longer, healthier lives, and, for many, a life continued.

For example, childhood cancer survival rates have dramatically increased from 58 percent in 1970 to 83 percent today, according to PhRMA, and there’s been significant declines in death rates for patients battling diseases such as HIV/AIDS (85 percent decline since 1995), heart disease (30 percent decline between 2001 and 2011) and cancer (20 percent decline between 1999 and 2006).

That progress would not be possible without robust protections to safeguard innovation and investments. With the proper legal mechanisms in place, economies will continue to attract increased investment in those innovations.

Indeed, the index found a strong relationship between the strength of an economies’ IP system and increased biomedical foreign direct investment (FDI).

Many in life sciences can attest to the significant resources needed for clinical research, which often entails extensive investment from international sources, which brings in added value to an economy. In fact, economies in the upper half of the index host, on average, nine to 10 times more clinical trials than those in the lower half. It goes without saying, then, that the economies on the lower half of the index miss out on the significant investment and other economic benefits that go along with the trials.

However, investment in R&D is just one measure of an economy’s innovativation capacity. The GIPC index also found a strong relationship between economies with strong IP environments and greater innovative output, with economies with robust IP systems producing on average 50 percent more innovative output—from new pharmaceutical drugs to cell phones to other inventions and ideas—compared with those with weak innovation economies.

The economic benefits of strong IP protections—particularly in the life sciences—are endless. As the GIPC index shows, IP underpins innovation, which is the foundation for economic success.

We look forward to working with stakeholders around the world to ensure that 2015 truly is a year for unlimited potential to increase global innovation. IPPro

Encouraging innovation through IP standardsMark Elliot of the US Chamber of Commerce’s Global Intellectual Property Center takes a preliminary look at the latest edition of the International IP IndexTAMMY FACEY REPORTS

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CaseStudy

A testament to its innovative thinking and entrepreneurial spirit, Calgary is home to the largest number of technology startups per capita in Canada, and home to the University of Calgary, one of the top 10 research universities in the country. A region driven by ingenuity, Innovate Calgary is helping to drive the success of Calgary and southern Alberta’s innovation ecosystem—working with start-ups, entrepreneurs, researchers, investors, industry and partners in numerous areas of the advanced technology sector, ranging from software and energy to the health and life sciences.

As the technology transfer and business incubator for the University of Calgary, Innovate Calgary works closely with researchers to help commercialise and bridge the gap between discovery and innovation.

Raja Singh, senior intellectual property manager at Innovate Calgary, manages a portfolio of technologies in the medical device and clean energy space from both the University of Calgary and independent inventors from the community.

“Innovate Calgary is a hub of innovation, helping to make connections and catering to researchers and entrepreneurs to help take new ideas to market in a faster, more effective manner,” says Singh. “We are taking a tailored approach to technology commercialisation.”

The technology

Singh is currently working closely with a life sciences technology that is taking a unique path to commercialisation, where the academic has come together to collaborate

with a Canadian company to develop a solution for a specific challenge.

OPTIHIP, a surgical instrument originally conceived by a surgeon and an engineering researcher at the University of Calgary, is a device for improving accuracy in hip replacement surgery. The final design resulted from an expanded collaboration with a biomedical engineering PhD student and a local design firm.

The technology initially came to Innovate Calgary in 2011 for review. Following a full assessment, which identified novelty, non-obvious features of the technology and determined the market potential, Innovate Calgary developed a strategy that includes worldwide IP protection, prototype development with support from the industry

A guide system for total hip replacement surgery: helping to bring technology to lifeBeing part of a team can take an idea from the drawing board to the operating table, as Andrea Mendizabal of Innovate Calgary explains

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CaseStudy

partner leading into clinical validation and regulatory approval.

“The idea for the OPTIHIP started when a surgeon here in Calgary and I were speaking about what would make his surgical life easier,” says Dr Carolyn Anglin, lead researcher of the OPTIHIP, and a professor in biomedical engineering at the University of Calgary. Both the surgeon, Dr Jim Mackenzie, and Anglin are members of the McCaig Institute for Bone and Joint Health. “He wanted a way to take his pre-operative X-ray plan and transfer it into the patient, improving the accuracy and placement of the acetabular cup in hip replacement surgery.”

Having served the orthopaedic field in various capacities, and a specialist in bone and joint health, Anglin took on the challenge.

The challenge

Total hip replacement is a common and effective surgery for hips damaged by injury or disease. This surgery frequently involves securing an acetabular cup in the pelvis. The challenge is that the ideal placement for the cup is unique to each patient because of individual variations in pelvis geometry.

The intended orientation is generally determined by the surgeon using pre-operative imaging including a CT scan or X-rays. Accurately achieving this orientation during surgery is challenging due to the hemispherical shape of the cup, and it can be further complicated by extensive soft tissue limiting the surgical access.

Any inaccuracies in the placement can lead to pain, damage to the implant and risk of dislocation, oftentimes requiring the patient to have revision surgery.

OPTIHIP is a guide system that is configured pre-operatively to the patient’s specific optimal orientation. It is inserted during surgery to establish the reference orientation against the bone of the pelvis. Markers are then temporarily attached to bone. These orientation markers form an accurate guide that can be followed to ensure accurate orientation and position for the acetabular cup. The device is then removed, and disposed.

Anglin says: “We started with a more complicated design and overtime it became simpler and simpler. We’re still evolving the design but the end result is a very simple, intuitive instrument.”

Collaboration with an industry partner

It takes an ecosystem to drive the commercialisation success of an innovation and teaming up with Calgary-based Tangent Design Engineering for design and prototyping was a natural choice.

“Carolyn wanted to have a viable product, to make it as simple as possible and still deliver

the best results, and that’s where we became involved with this project,” says John Person, vice president of engineering at Tangent Design Engineering.

“Having that industrial design input early on had a good influence on the design in terms of how a surgeon will use it,” says Anglin. “I really felt that the more heads we had at the table, the better the design that we would generate, ultimately benefiting the patient.”

Collaborating with Anglin’s research team, Tangent worked closely with an industrial designer and key surgeons, working through the early stage concept refinement and boiling the initial design down to the important features. The team was even brought into surgeries to observe exactly where the challenges were being encountered.

“Having the engineers involved at that level was really a great collaborative experience and I don’t know if that’s unique but it’s certainly the way you want things to go,” explains Person.

“Because everyone was committed to making it a team effort, it went very smoothly and I think we have come up with a really great solution because of it.”

In order to help move the product forward, Tangent was encouraged to obtain its medical device certification ISO 13485:2003, which is a quality management system that facilitates regulatory requirements for new medical devices and is required by Health Canada and the US Food and Drug Administration to license medical device products. Tangent is one of few firms in western Canada with this certification.

An adjustable patient-specific mechanical guide (Optihip) for guiding acetabular cup orientation in hip replacement surgery showing: (a) V-bottomed landing base, slider with selection of offset holes and sheath for the bone pin; (b) mounted on the pelvis to insert a bone pin for inclination guidance, posterior approach. Image courtesy of: Dr Carolyn Anglin, University of Calgary.

“Raja knows the medical world intimately and he has been able to provide key advice and information on how these kinds of tools work in that kind of patient situation,” says Person. “We’re now working with a few larger orthopaedic companies to talk about licensing or manufacturing and Raja is helping us navigate through that technology setting at that higher scale.”

Current stage of development

“This technology has taken a truly collaborative approach to commercialisation, where academic has come together with local organisations to leverage the excellent resources we have in Calgary,” says Singh. “The team is committed to moving the product forward for regulatory approval and successful entry into the market.”

A prototype of the OPTIHIP has been built and tested by an orthopaedic surgeon. Initial testing using cadavers and simulation techniques demonstrated accurate placement of the acetabular cup within three degrees, compared to a range of seven to 10 degrees with current methods.

“We have shown that this is in fact an accurate instrument under the controlled conditions but we need to prove that it’s also an accurate instrument on a patient, so that’s the next step,” says Anglin.

The team is now working to secure a commercial partner in order to move forward with human trials, pending regulatory approval.

“I would love to see this used in a patient and I think we are very much in line to have it happen in 2015,” says Anglin. IPPro

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Industry appointments

PeopleMoves

Editor: Mark Dugdalemarkdugdale@ipprolifesciences.com Tel: +44 (0)208 663 9620

Reporter: Tammy Faceytammyfacey@blackknightmedialtd.com Tel: +44 (0) 208 663 9649

Editorial assistant: Becky Butcherbeckybutcher@blackknightmedialtd.com Tel: +44 (0)208 663 9621

Associate publisher: Carlos Northoncarlosnorthon@ipprotheinternet.com Tel: +44 (0)208 663 9623

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Kilpatrick Townsend & Stockton has expanded with the addition of a chemistry and life sciences team to its Washington DC office.

The team includes partners Justin Krieger, Keith Fredlake and Jeffery Gendzwill, along with counsel Rodney Rothwell and associates Nicoletta Kennedy and Troy Petersen.

Krieger specialises in client counselling, district court litigation, and prosecution. He has technical expertise in chemistry, chemical engineering, medical devices, nanotechnology, mechanical engineering, and consumer products.

Fredlake focuses on IP matters, including drafting and prosecuting patent applications, primarily in the chemical and life sciences industry, including chemistry, chemical engineering, medical devices and pharmaceuticals.

Gendzwill concentrates on patent-related matters with a focus on client counselling, domestic and foreign patent preparation and prosecution, and enforcement, primarily in the chemical and life sciences industry.

Rothwell practices preparing and prosecuting patent applications for a variety of technologies, including the chemical, electromechanical, mechanical, and biotechnology fields.

Kennedy focuses her practice on patent preparation, and prosecution in the chemical field.

Petersen focuses on patent procurement and counselling, and patent and trade secret litigation.

Jamie Graham, co-chair of the Kilpatrick Townsend’s health and life sciences team, commented: “The life sciences and chemical industries have seen considerable transformation over the years and bolstering the firm’s patent practice in DC has been a strategic goal of the firm.”

The firm has also named has named Bill Shaffer as managing partner of its San Diego office.

Shaffer, who is a member of the Kilpatrick Townsend executive committee and has been with the firm for more than 22 years, will take over from Ken Jenkins.

He has previously served as managing partner of the firm’s Silicon Valley office and also served as co-managing partner of predecessor firm Townsend and Townsend and Crew for six years.

He focuses his practice on patent prosecution and counselling, portfolio building and management, and analysis and post-grant procedures, including re-examination and reissue proceedings.

Shaffer commented: “I look forward to leading our talented collection of experienced intellectual property and corporate strategists located in one of the most exciting technology, medical and scientific communities in the world.”

Kilpatrick Townsend patent attorney Andrew Serafini has been appointed to the Washington Biotechnology & Biomedical Association’s board of directors.

He assists clients with obtaining, protecting and enforcing IP rights in areas including immunology, molecular biology, antibody engineering and therapeutics, vaccines, stem cell technologies, molecular genetics and pharmaceuticals.

Axinn has promoted Thomas Hedemann to counsel as part of a three-group promotion.

Hedemann will be based in Hartford and focuses his practice on IP and commercial litigation.

His experience includes the litigation of moer than a dozen of patent cases throughout the UK, including Hatch-Waxman cases, as well as commercial cases involving contract disputes, insurance issues and unfair trade practices.

He also has appellate experience before the Federal and Second Circuit Courts of Appeals.

James Veltrop, Axinn’s managing partner, commented: “We congratulate Hedman on his contributions to the firm.”

Lewis Brisbois has recruited George Matava and Donald Lake to the Denver office as partners and members of the IP and anti-trust practice groups.

Matava focuses his practice on matters in federal courts across the country in the areas of patent, trademark, biomedical devices, copyright, ecommerce, real estate franchising, telecommunications and consumer products.

Prior to joining, Matava was practicing in the Denver office of Lathrop & Gage.

Lake is a trial and appellate attorney who focuses his practice on IP and anti-trust litigation.

He has represented clients in appeals in both federal and state courts, including amicus curiae clients before the US Supreme Court.

He has served as lead counsel for clients in patent infringement suits involving subject matter as diverse as electrical engineering, fluidics and biomechanics of small particles, all chiefly in the biotechnology field.

Prior to joining Lewis Brisbois, he was a partner in the Denver office of Lathrop & Gage.

Jones Day has appointed Maureen Bennett to its Boston office as partner in the healthcare and life sciences practice.

Previously a co-chair of Squire Patton Boggs’s healthcare and life sciences group, Bennett represents entities in corporate and commercial transactions, with a particular emphasis on multi-jurisdictional clinical trials. IPPro

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