US reviews India’s patent ‘progress’including the United States’ and India’s promising recent agreement to establish an annual high-level Intellectual Property Working Group as part of the bilateral Trade Policy Forum. The out-cycle-review will not re-visit India’s designation on the 2014 Priority Watch List.”

The public has until 31 October to submit comments, while foreign governments have until 7 November.

In its Special 301 report, the US urged India to clarify its consideration of whether it should grant compul-sory licences to more than a dozen patented drugs with rights holders’ input, and to curb the country’s burgeoning counterfeit medicine market.

The USTR did say that it was willing to wait for a new government to be installed in India, which is now a reality, before considering what it would do next.

The US has begun its out-cycle-review of India’s intellectual property regime to assess whether the country has listened to the criticisms levelled at it earlier this year.

The US Trade Representative (USTR) promised to review India’s progress when it kept the country on the Priority Watch List of its Special 301 report in April.

The USTR has now published “a request for the public [in the Federal Register] to provide all nec-essary information for identifying and assessing the quality of engagement with the Government of India on IP-related issues of concern”.

“The out-cycle-review will take stock of progress in our bilateral engagement on these important issues,

MHRA fights tooth and nail against dentistry fakersBuying counterfeit and unapproved den-tal equipment is dangerous, the Medi-cines and Healthcare products Regula-tory Agency (MHRA) has warned.

The MHRA has seized more than 12,000 poor-quality dental equipment imported from China and Pakistan that has been sold on eBay, Amazon and Alibaba in the past six months.

Alastair Jeffrey, head of enforcement at the MRHA, said: “Purchasing from auction websites and being unable to verify the integrity of the seller has the potential to increase risks to patients and cause reputational damage to the dental profession.”

Sequenom spends $14.55 million on University of OxfordGenetic analysis company Sequenom has bought the intellectual property rights to non-invasive prenatal testing from Isis Innovation, the technology transfer company of the University of Oxford, for $14.55 million.

Under the agreement, Sequenom made a $3.2 million final royalty pay-ment to Isis Innovation and a waiver of $2.1 million in paid legal fees.

Sequenom now owns the IP for non-invasive prenatal genetic diagnostic testing on paternally inherited fetal nucleic acids derived from maternal plasma or serum.

The company previously had exclu-sive rights to the IP under a licensing agreement agreed in 2005. Isis Inno-vation will maintain rights in certain fields of use under the new deal.

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US reviews India’s patent ‘progress’Continued from page 1

“In the coming months, the US will redouble its efforts to seek opportunities for mean-ingful, sustained, and effective engage-ment on IP-related matters with the new government, including at senior levels and through technical exchanges, that will both improve IP protection and enforcement in India, and support India’s efforts to achieve a ‘Decade of Innovation’ and advance its legitimate public policy goals,” according to the Special 301 report.

There were fears that the US would enforce trade sanctions against India, after US phar-ma companies expressed their dissatisfaction with India’s IP regime.

US pharma companies have been lobbying the US government to impose trade sanctions on India due to the allegedly unfair patent rulings and the issuance of a compulsory licence.

The Indian Supreme Court in April 2013 reject-ed a patent application from Swiss company Novartis AG for its cancer drug Glivec, citing section 3(d) of the Patent (Amendment) Act, which does not allow evergreening of drug pat-ents with a minor tweaking of the formula.

In March 2012, Hyderabad-based Natco Pharma was granted a compulsory licence to manufacture and sell a generic version of Bayer’s cancer-treatment drug Nexavar.

In September, the Doctors Without Borders Access Campaign director of policy and anal-ysis Rohit Malpani lobbied India to not cave into to pressure from the US.

“India’s production of affordable medicines is a vital lifeline for [our] medical humanitarian operations and millions of people in develop-ing countries. India’s patent laws and policies have fostered robust generic competition over the past decade, which has brought the price of medicines down substantially—in the case of HIV, by more than 90 percent.”

“The world can’t afford to see India’s phar-macy shut down by US commercial interests.”

MHRA fights tooth and nail against dentistry fakersContinued from page 1

Twenty four dental x-ray machines that emit high levels of radiation, 384 hand-piece drills that could malfunction inside a patient’s mouth and 3242 poor-quality canal root files were among the items seized.

The MHRA issued a safety alert to all dentistry professionals in January following an incident in November 2013 in which a counterfeit prod-uct for drilling and cleaning teeth shattered while being used on a patient.

Tony Reed, British Dental Industry Asso-ciation’s executive director, said: “We are delighted to be working closely with the MHRA to raise awareness of counterfeit and non-compliant products through our counterfeit and substandard instruments and devices initiative (CSIDI).”

Dr Barry Cockcroft, NHS chief dental officer, added: “It is imperative for patient safety that dentists do not purchase equipment, from any source where they cannot be confident of the origin or quality.”

Sequenom spends $14.55 million on University of OxfordContinued from page 1

The portfolio includes globally issue patents in the US, Japan and Europe.

“The patents purchased from Isis Innovation will enable us to strengthen our intellectual property position worldwide, while reducing future expenditures,” said William Welch, CEO at Sequenom.

Tom Hockaday, managing director at Isis In-novation, said: “This patent assignment ena-bles us to return considerable value to the University of Oxford, the inventors of the tech-nology and the others which supported the original research.”

Covidien wins Harmonic the ACE+7 banHealthcare company Covidien has won an in-junction against Johnson & Johnson.

The US District Court for the District of Con-necticut has granted Covidien a preliminary injunction against Ethicon End-Surgery, a Johnson & Johnson company.

The injunction results from a lawsuit filed by Covidien in June, in which it accused Ethicon of infringing three of its patents with the ultra-sonic surgical product Harmonic ACE+7.

Ethicon will not be able to market or sell the product in the US.

Ethicon’s Harmonic devices were found to infringe the same patents in a previous suit that resulted in Covidien receiving $175 mil-lion in damages.

This is currently under appeal.

Amgen takes a im a t Alirocumab imitatorsAmgen has filed a patent infringement lawsuit against biotechnology company Regeneron Pharmaceuticals and French pharmaceutical company Sanofi over its cholesterol drug Alirocumab.

Latest newsHealthcare company Covidien wins an injunction against Johnson & Johnson subsidiary over an ultrasonic surgical product

p2Latest newsEbola.com is up for sale, with pharma companies being targeted

p4Latest newsThe US Supreme Court hears oral argu-ments in Teva v Sandoz, with justices considering the standard under which patent should be interpreted p4Conference reportThe London IP Summit focuses on IP as an asset p6

Pharma futureTimes have changed dramatically and the organisations that grew out of vast chemical companies need to change in response, says Dr Chris Donegan of EverEdge IP

p8People movesMichelle Lee receives White House backing to become the next perma-nent leader of the USPTO, and more industry appointments p11

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Filed at the US District Court for the District of Delaware, Amgen sought an injunction against Regeneron and Sanofi to prevent the manufacture, use and sale of the companies’ generic version of the drug.

Amgen holds patents that describe and claim monoclonal antibodies to proprotein con-vertase subtilisin/kexin type 9 (PCSK9). Re-generon and Sanofi have created their version of the drug, an antibody that targets PCSK.

Regeneron and Sanofi have completed phase 3 clinical trials of alirocumab. They plan to market the drug in the US, following regula-tory approval.

Alirocumab lowers cholesterol by inhibiting the gene PCSK9. The gene produces a pro-tein that helps to regulate the amount of cho-lesterol in the bloodstream.

Buy ebola.com for $150,000The ebola.com domain name is up for sale.

Jon Schultz, president of Blue String Ventures, purchased the domain in 2008. He is hoping a pharmaceutical company will buy the domain ebola.com and use it as a website for updates on the disease, news and information.

The website currently lists news articles about the outbreak and a link to a Doctors without Borders donation page.

Schultz and his business partner Chris Hood also own domains focused on health including birdflu.com.

According to reports, the price of the domain “is subject to change as the situation evolves”.

USPTO and SIPO digitise patent applications The US Patent and Trademark Office (USP-TO) and the State Intellectual Property Of-fice of China (SIPO) have combined forces to create a new service allowing the respective offices to directly exchange priority patent ap-plications electronically.

The USPTO considers this service as a way of streamlining the patent system and reducing costs for businesses.

The service will come at no cost to consumers, whose applications will mean they will no longer have keep paper copies of important documents.

Patents are currently subject to a time limit un-der the Paris Convention for the Protection of In-dustrial Property, which dictates that applicants who file their patent in one country must wait 12 months before filing in other member country.

Michelle Lee, deputy director, and soon-to-be-head, of the USPTO, said: “By expediting the

The case is an appeal against the Federal Circuit’s decision to invalidate a patent that claims a process for manufacturing the active ingredient of Teva’s relapsing-remitting multi-ple sclerosis (RRMS) product, Copaxone.

Teva previously prevailed in the lower court over nine Copaxone patents, but the Court of Appeals for the Federal Circuit last year upheld some due to expire in May, while invalidating the patent that is the subject of its now-granted certiorari petition. It expires in September 2015.

The question-at-issue is whether federal ap-pellate courts should review a lower district court’s findings on how patents are interpret-ed under the de novo standard or the clearly erroneous standard.

The currently employed de novo standard sees an appellate court consider questions of law anew, without considering the district court’s findings. The other standard would see an appellate court review the lower court’s findings, and only overturn them if they were clearly erroneous.

Justices seemed reluctant during oral hearings to change the standard, with one questioning whether it is “worthwhile as a practical matter”.

The US government has suggested a combi-nation of the de novo and clearly erroneous standards, rather than dropping de novo, which has been used since Markman v West-view Instruments in 1996.

Teva has fought to protect the patents cover-ing Copaxone in multiple countries.

In October 2013, the Supreme Court turned down a request from Teva to stay a lower court order that denied patent protection to Copaxone from this year instead of 2015.

processing of patent applications we can pro-vide greater cost savings to applicants.

Lee added that the service will also “advance our goals toward stronger global intellectual property promotion and protection”.

Capricor acquires patent rights for heart failure treatmentBiotechnology company Capricor Thera-peutics has entered into an agreement with medical technology maker Medtronic to acquire its patent rights for a future heart failure treatment.

The acquired patents cover the formulation and pump delivery of natriuretic peptides.

With the patent, Capricor stated it will develop a programme using cenderitide, a natriuretic peptide, to treat heart failure.

Capricor signed an IP transfer agreement with Medtronic on 8 October, for all of its rights, title and interest in all natriuretic peptide patent and patent applications owned by Medtronic.

Dr Linda Marbán, CEO of Capricor, said: “We are now in a position to initiate a clinical pro-gramme for cenderitide with an enhanced IP position.”

Supreme Court considers appellate patent review standards

The US Supreme Court has heard oral argu-ments in Teva Pharmaceuticals v Sandoz, with justices considering the standard under which a federal appellate court should review a lower district court’s ruling on how patents should be interpreted.

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ConferenceReport

Jesper Landahl of Questel IP Business Intel-ligence led a panel discussion at the London IP Summit. His panel delivered a presenta-tion on monetising IP and offered winning strategies for growth.

The presentation was delivered by Landahl’s colleague Gilles Cruanes, sales director of Questel IP, who explained that Questel uses data from prior art searches to make an analysis of the market.

Zarif Imam of Iceberg Capital Partners, along with other panel speakers, delivered a pre-sentation on how to understand financial trends in relation to IP and to think of IP as an asset.

During his presentation, he asked the audi-ence whether they should care about IP as an asset class.

Stocks, derivatives and fixed income are all financial assets, but what about IP? Imam said that IP should be considered as an al-ternative asset.

Imam said that anything that has cash flow could be securitised. IP is an asset class but an “alternative”, he explained, as it does not fit the criteria of a mainstream investable asset.

Imam stressed that the move towards IP as a mainstream asset class depends on what and why the industry would want to do it. “There are positive and negatives of being recog-nised as a mainstream asset. If the aim of the industry is to create a transparent trading and

funding environment and bring the IP trans-action market into the mainstream investable asset class, there is a lot of work to do.”

Exchange much?

Basic pricing, standard documentation, and market making are not in place, said Imam. The most exciting transactions will not done on an exchange, but bilaterally, he ex-plained. “This is true of any asset class that seeks to get the best price. It needs prac-tioners who understand the market, the main players, and has access to credible buyers at the right time.”

In Imam’s view, the debate about whether a public exchange is the best place to sell IP is an “artificial” discussion in that many other assets trade on exchanges but also trade ‘over the counter’.

An exchange will bring transparency and show there is a market. Iceberg worked with Chinese technology exchange CTEX, to which Imam’s firm attempted give an IP valu-ation. But in Imam’s experience, most ex-changes are not really exchanges but more like auctions for low value IP.

“I don’t think that any company would risk putting their high value IP on an exchange.”

A member of the audience asked how a com-pany handles the value of a patent when its expiry date approaches.

“The value of a patent or IP is one of the main issues facing the industry. We often use the

words price and value interchangeably, how-ever, there is an important distinction.

“The value of IP to companies will vary de-pend on investment criteria, timing, use and many other factors. As a result, the price paid for IP will also vary, as the value ex-tracted will also differ.”

Options in Asia

Imam later revealed in an interview that there are significant opportunities to trade patents in Asia. He said: “At Iceberg, we have seen a lot more activity in Asia in the IP market. Whereas three years ago, it was predominantly US-led, now we find in terms of transactions it’s about 50/50 split between the US and Asia, just because there are more technology companies in those areas/countries that are producing high class IP or companies that would not previously sell are now changing policy.”

He added: “In Taiwan, Japan, South Korea, India and China, we have seen significant op-portunities. However, it’s still the US patent that has value, if you try to sell with China, Ko-rean and European patents there’s no value where there isn’t a US counterpart to it.”

The IP Summit also highlighted how brands can use licensing to achieve a return and sustain competitive market advantage.

Key speakers also delivered speeches on understanding IP as a route to cor-porate finance and how competition law affects IP. IPPro

Money, money, moneyMoney was the topic of the day at the London IP Summit, aptly housed in the London Stock Exchange, which also came under the spotlight, with panelists asking whether they are suitable venues through which to wheel and dealTAMMY FACEY REPORTS

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PharmaFuture

The pharmaceutical industry is much young-er than most people think. Although the big companies were founded in the 19th cen-tury, modern drugs companies as we know them essentially grew out of the chemical industry after the Second World War, pro-pelled by a series of blockbuster discover-ies: antibiotics, tranquillizers, pain killers, the contraceptive pill. The genomics revolu-tion of the 1980s continued the rapid pace of innovation as engineered insulin opened up new fields of discovery.

Unfortunately, as far as innovation in the pharmaceutical sector is concerned, the pace of progress has ground to a halt. De-spite exponential growth in computing power and practically all inputs to the R&D process, the number of new drugs discovered has flat-lined. In real terms, success in discovery of new drugs has plummeted and ‘Big Pharma’ is almost standing still.

Just look at the pharmaceutical industry’s productivity rate, which is generally estimat-

ed at around 2 percent in R&D. It’s the only industry where a 98 percent failure rate is considered a success.

But the situation is worse than that. In ad-dition to the collapse in R&D productivity, many drugs have ended their patent life over the past decade and have not been replaced with new ones, steadily eroding corporate profits. Since 2010, more than $90 billion of revenues have been lost by the industry as Pfizer, Eli Lilly, BMS, GlaxoSmithKline

Evolve or dieTimes have changed dramatically and the organisations that grew out of vast chemical companies need to change in response, says Dr Chris Donegan of EverEdge IP

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(GSK), Novartis, AstraZeneca, Merck, Sanofi Aventis, Johnson & Johnson and Forest Lab-oratories have all fallen off the ‘patent cliff’. For example, Pfizer’s sales of Lipitor were $11 billion in 2010, but today, after patent ex-piry, they have fallen to $2 billion.

In the absence of new innovation, the in-dustry has adopted aggressive strategies to defend ageing drugs. Patent life exten-sions, such as Janssen’s recent Zytiga fil-ing, seek to eke out a few more years of exclusivity that can be worth several billion dollars. Pfizer, which is reeling from the Lipitor patent expiry, is already fighting a losing battle to defend its erectile disfunc-tion drug Viagra, having settled with Teva Pharmaceuticals and agreeing to a launch of its generic in 2017.

To compensate for this plateau, pharm companies are restructuring. Consolida-tion was the first step, with acquisitions counting for two thirds of all sales growth in the industry since 1995. Pfizer acquired Warner Lambert, Pharmacia and Wyeth in a decade and restructured its R&D ac-tivity multiple times, cutting 5 percent off its workforce since 2011 while closing its huge R&D facility in Sandwich, Kent, where Viagra was discovered.

Stock buy-backs have been widespread and therapeutic areas have been narrowed as companies seek dominance in key areas. This is exemplified by GSK’s asset swap with Novartis in April, when it sold its cancer busi-ness for $16 billion and acquired Novartis’s vaccine division for half that amount.

The recent interest in tax-driven mergers (inversions), such as the failed $53 billion Shire/Abbie Vie transaction or the £70 billion Pfizer/AstraZeneca acquisition, are another way to boost corporate earnings in the ab-sence of new drug revenues.

Other strategies to improve productivity and generate value include tie-ups with academ-ic institutions. AstraZeneca, for example, had more than 500 collaborations in force over the past few years.

This can be highly valuable for both the pharmaceutical company and the universi-ties as illustrated by the $14.55 million roy-alty buy-back in October by genetic analysis company Sequenom of IP rights from Oxford University’s ISIS Innovation. The MRC Labo-ratory at Cambridge is another generating more than £300 million in royalties over the past decade from this type of collaboration.

The intensity of corporate activity is evi-dence that big pharmaceutical companies are struggling to remain relevant as R&D engines. Small molecule chemistry has de-livered the low hanging fruit and it is difficult for pharmaceutical companies to make the next leap. The next big wave is expected

to be in biologics and the products of gene mapping, but the high level of investment in genetics and computational biochemistry is yet to produce answers. It is still early days in those fields.

Pharmaceutical companies have also moved towards collaboration, sharing the financial burdens of R&D costs, much in the same way that movie studios get cold feet half way through creating the summer blockbuster. The risk sharing between Fox and Para-mount on Titanic has the exact same pur-pose as Lilly, Merck or GSK’s joint R&D ven-tures with Piramal Healthcare and Ranbaxy Laboratories, or Eli Lilly and Astra Zeneca’s partnering on Alzheimer’s.

This risk sharing approach has also opened the door to external investors such as TPG-Axon, which wish to participate in R&D risk in exchange for revenue participation. This is a growing area of IP investing, which was also pioneered in motion pictures where co-investment financing of hugely expensive movies is commonplace.

So-called ‘orphan drugs’, which treat rare diseases that affect relatively small numbers of people and so have been neglected his-torically, are another area of focus. They are interesting from a risk management perspec-tive because instead of having one block-buster drug, dozens of smaller drugs are de-veloped that avoids putting all the R&D eggs in one basket. Also, drugs for niche diseas-es, which usually do not have an alternative therapy, are highly profitable and subject to lower margin pressure.

There are inherent disadvantages, however, in building business on orphan drugs. In the long term, charging hundreds of thousands of dollars for drugs that affect only small numbers of people or offer marginal ben-efit in terms of quality of life is unlikely to be viable. Another problem is scale. At the moment, the scale of pharmaceutical companies is so vast that it takes a billion in revenue for a drug to be relevant. Major restructuring of the pharmaceutical industry is inevitable. The reality is that Big

Pharma needs more inventiveness and huge integrated R&D operations are hard to man-age for creativity. There are tens of thou-sands of people in laboratories, and that’s not typically how creativity happens, instead it happens in small concentrated cross-functional groups of people. In this respect, multidisciplinary networks show promise for the future, together with greater use of open source or crowdsourced research, which is something that Eli Lilly pioneered with its In-nocentive spin out.

The life expectancy of an S&P 500 company has fallen from 61 years in 1958 to 18 years today. The last decade has seen an unprec-edented acceleration in the time it takes for companies to rise and fall as their inventive-ness failed. This point is amply illustrated by the meteoric rise to dominance of Google, Apple, Facebook, Amazon and Alibaba and the equally rapid decline of Nokia, BlackBer-ry, Kodak and Motorola.

The very same driving forces that affected these companies now buffet the pharma-ceutical industry. Changing technology, de-mographics, regulation, innovation and busi-ness models are driving change and new entrants to the industry may come from sur-prising places, such as the technology world, and not just generic companies migrating up the value chain.

This future trend can be seen in AbbVie and Google-backed Calico’s decision to work on an R&D collaboration. The companies plan to discover, develop and bring to market new therapies for patients with age-related dis-eases, including for neurodegeneration and cancer. The companies are co-investing up to $1.5 billion and will share costs and profits equally. Calico will also set up an R&D facil-ity in the San Francisco Bay Area as a result of the partnership.

Whatever the eventual model of success, what is certain is that Big Pharma will look very different in 10 years. The winners will be those who evolve, since the status quo is no longer a viable strategy for survival. IPPro

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“ The reality is that Big Pharma needs more inventiveness and huge integrated R&D operations are hard to manage for creativity

The 2014 CIPA Life Science Conference

Location: Sutton Coldfield, UKDate: 20-21 Novemberwww.cipa.org.uk

The CIPA Life Sciences Conference is the UK’s premier annual educa-tional and networking event for patent and IP professionals active in the pharma, medical technology and biotechnology sectors. Over nearly two decades the conference has provided unrivalled expert insight into the latest developments in patents, regulatory and IP law in the global life science industry. Most importantly, the event provides a friendly envi-ronment for in-house and private practice professionals to network and share experiences.

Competition Law in the Pharma Sector

Location: Brussels, BelgiumDate: 27 November www.ibclegal.com

The pharmaceutical sector is still facing tough times. Recently the European Commission imposed a fine of 427 million € on Servier and several other pharmaceutical companies for breaching EU com-petition law rules.

Keeping up to date and evaluating the practical impact of recent case law and policy decisions is crucial to avoiding unnecessary costs and fines.

IndustryEvents

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Industry appointments

PeopleMoves

Editor: Mark Dugdalemarkdugdale@ipprolifesciences.com Tel: +44 (0)20 8663 9620

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Copyright © 2014 Black Knight Media Ltd. All rights reserved.

The White House has nominated deputy direc-tor Michelle Lee to lead the US Patent and Trademark Office (USPTO) on a full-time basis.

Lee has acted as director since January. She joined the agency to set up and lead its Silicon Valley office.

She has served at the USPTO for more than two years. Lee joined the agency from Google where she was the deputy general counsel and head of patents and patent strategy.

Her nomination as head of the USPTO is sub-ject to congressional approval.

“Lee is a proven leader with strong management skills, having ably led the PTO since January,” said Penny Pritzker, US commerce secretary.

“She brings decades of legal, technical and business experience in delivering real results for our nation’s innovators.”

The director role was vacant at the USPTO fol-lowing the resignation of Teresa Stanek Rea in September 2012.

She was leading the agency after David Kappos left his role earlier that year. He has since joined Cravath, Swaine & Moore.

Stanek Rea also moved into private practice, joining Crowell & Moring LLP in late 2013.

Kilpatrick Townsend & Stockton LLP’s Ted Davis has been elected chair of the Ameri-can Bar Association Section of Intellectual Property Law.

Davis focuses his practice on domestic and international litigation and client counselling in trademark, copyright, false advertising, and unfair competition law.

He has particular experience in trade dress disputes and with large-scale trademark clear-ance and registration projects.

Davis previously served as vice-chair and prior to that, as section financial officer for six years. He has also been chair of the trademarks divi-sion and unfair competition division.

He will assume his role of chair for the 2015-16 year period.

Jones Day has recruited Cristiana Spotoni as partner in its life sciences and healthcare prac-tice office in Brussels. Katherine Llewellyn has also joined as associate.

Spotoni has previously advised clients on biotechnology, pharmaceuticals and medical devices. She also manages and coordinates multi-jurisdictional assignments.

Prior to working in private practice, she spent

two years with the Council of the EU and the European Commission in Brussels.

James Dutro, healthcare and life sciences practice leader at Jones Day, said: “Spotoni offers a superb range of experience in life sciences and government regulation. She is an important addition to our thriving global life sciences team.”

Carpmaels & Ransford LLP has recruited Camilla Balleny, a life sciences litigator, in its litigation team.

Balleny previously served at Pinsent Masons. Her colleague Lucy Sewter, a spe-cialist life sciences legal specialist, has also joined the firm.

Both Balleny and Sewter join Carpmael’s IP litigation specialists Ian Kirby and Jonathan Day, who arrived from Arnold & Porter LLP last month.

The team will develop the firm’s litigation practice in London.

The firm has worked on complex and commercially significant cases, including longstanding clients Novartis and Johnson & Johnson. IPPro

Got a hire, promotion or new office to shout about? Let us know:

tammyfacey@blackknightmedialtd.com

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