IPPr SCIENCES o ISSUE029 - Ippro LifeSciences Life...new report p4 Latest news Sun Pharma and Merck do an $80 million deal for an investigational therapeutic antibody candidate p4

NY grapples with pharma companiesBut the State of New York believes that generic compe-tition is the reason for the switch.

Its anti-trust lawsuit alleges that because Namenda is protected by a patent that will expire in 2015, Actavis and Forest plan to force patients to switch unnecessar-ily to a very similar drug with a longer patent.

Once patients switch to the new drug, Namenda XR, it’s likely that they will remain on that medication even after the Namenda generics hit the market due to the practical difficulties of switching back, allowing Actavis to insulate its profits from competition, according to the lawsuit.

“A drug company manipulating vulnerable patients and forcing physicians to alter treatment plans unnecessar-ily simply to protect corporate profits is unethical and illegal,” said Schneiderman.

New York state attorney general Eric Schneiderman has blasted pharmaceutical manufacturer Actavis and its recently acquired subsidiary Forest Labora-tories over plans to drop Alzheimer’s drug Namenda.

The state has filed an anti-trust lawsuit against Actavis and Forest in the US District Court for the Southern District of New York, accusing the compa-nies of attempting to continue their monopoly once the patent protecting the drug expires.

Forest managing director Armin Szegedi notified healthcare companies of the discontinuation of Namenda in a letter earlier this year: “We plan to discontinue the sale of Namenda (memantine HCl) tablets in the fall of 2014. The discontinuation of Na-menda tablets is not due to any safety issue. Rather, Forest has made the decision to focus on once-daily Namenda XR capsules.”

AstraZeneca, Eli Lilly develop Alzheimer’s treatmentAstraZeneca and Eli Lilly have joined forces to develop and commercialise an oral beta secretase cleaving en-zyme (BACE) inhibitor currently in development as a potential treatment for Alzheimer’s.

Under the agreement, Eli Lilly will pay AstraZeneca nearly $500 million in de-velopment and regulatory milestone payments, the first $50 million of which is due in H1 2015.

Both parties will share the future costs for the development of commercialisa-tion of AZD3293, as well as net global revenues, once it is launched.

The companies will progress AZD3293 into second and third phase clinical trials to evaluate effectiveness in patents with in early Alzheimer’s disease.

Gilead welcomes generics of Hepatitis C drugGilead Sciences has entered into generic licensing agreements with Indian pharma companies to provide access to Hepatitis C treatment in developing countries.

Seven Indian companies including Mylan and Ranbaxy have signed up to produce generic versions of ledi-pasvir/isofobuvir for distribution in 91 countries.

Under the licensing agreements, the Indian companies will receive a com-plete technology transfer of the Gilead manufacturing process. Licensees will set their own prices, but will pay an undisclosed royalty on sales to Gilead.

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NewsInBrief

New York grapples with pharma companiesContinued from page 1

“Unfortunately, schemes to block competition, without considering the consequences to pa-tients, are a growing trend in the healthcare industry. By standing up to Actavis, we’re send-ing a clear message to all pharmaceutical com-panies: prioritising profits over patients’ rights will not be tolerated.”

Actavis and Forest have not commented publi-cally on the lawsuit..

AstraZeneca and Eli Lilly develop Alzheimers treatmentContinued from page 1

Mene Pangalos, executive vice president, in-novative medicines and early development at AstraZeneca, said: “We are looking forward to working with Eli Lilly, an organisation with ex-pertise in treating Alzheimer’s disease.”

“This alliance moves us one step closer to achieving our goal of making Alzheimer’s dementia preventable by 2025,” said David Ricks, of Eli Lilly.

AZD3293 is an oral, potent and selective small molecule inhibitor of BACE that has been shown in early studies to significantly reduce levels of amyloid beta in the cerebro-spinal fluid of Alz-heimer’s patients and healthy volunteers.

Gilead welcomes generics of Hepatitis C drugContinued from page 1

The countries contain 54 percent of the total global infected population.

Gregg Alton, executive vice president of corporate and medical affairs at Gilead, said: “These agreements are essential to advancing the goals of our humanitarian programme in these countries.”

Mersana receives antibody patent approvalMersana Technologies has a stronger intel-lectual property position, following patent approval from the US Patent and Trademark Office for its next generation antibody drug conjugate (ADC) technologies.

The three patents provide coverage for anti-tumor payloads, encompass Mersana’s Flexi-mer platform to create ADCs with antibody alternatives and provide coverage for Flexi-mer-based ADCs.

According to Mersana, the patents provide the company with expansive IP protection for its platform technologies.

Eva Jack, chief business officer at Mer-sana, said: “We are committed to the on-going advancement of Fleximer-based ADCs to address unmet needs and im-prove patient outcomes.”

Fleximer is Mersana’s antibody drug conju-gate technology based on its biodegradable polymer system.

There’s no system like WIPO’s systems, says GurryIntellectual property systems will be the focus of the World IP Organization (WIPO) for the next six years, according to recently re-elect-ed director general Francis Gurry.

Gurry explained in his first WIPO Assemblies speech since his re-election in May that global patent, trademark and design systems have grown “very significantly” and are “good exam-ples of successful international cooperation”.

He added that WIPO’s global IP systems, such as the Patent Cooperation Treaty, Madrid System for trademarks and Hague System for designs, should be essential priorities of the organisation in the coming six years.

Gurry recommended that the adopted Beijing Treaty on Audiovisual Performances (2012) and the Marrakesh Treaty to Facilitate Ac-cess to Published Works for Persons who are Blind, Visually Impaired or Otherwise Print Disabled (2013), be “converted into acces-sions that bring the treaties into force”.

He also urged member states to move forward with a proposed design law treaty, as well as with work on broadcasting, traditional knowl-edge, traditional cultural expressions, and IP in relation to genetic resources.

US ITC stands by Chinese herbicide decisionThe International Trade Commission (ITC) has denied a plea to block a Chinese herbi-cide from being imported into the US because the patent owner failed to show infringement.

US chemical company FMC Corporation filed a complaint with the ITC on 5 March against Beijing Nutrichem Science and Technology Stock, Summit Agro USA and Jiangxi Heyi Chemicals over the importation of products containing the herbicide sulfentrazone.

FMC alleged that the imported herbicides in-fringe its sulfentrazone patent. The company asked the ITC to block imports.

The ITC’s administrative law judge (ALJ) in-stead issued an initial determination denying FMC’s request on 12 August, because the US company failed to show infringement and that the “technical prong of the domestic industry”

Latest newsIP systems will be the focus of WIPO for the next six years, according to Francis Gurry

p2Latest newsThe ITC denies a plea to block a Chi-nese herbicide from being imported into the US because the patent owner failed to show infringement

p2Latest newsA malware threat is stealing the IP of pharmaceutical companies, says a new report

p4Latest newsSun Pharma and Merck do an $80 million deal for an investigational therapeutic antibody candidate p4

Country profileThe US famously declined Myriad’s BRCA1 and BRCA2 gene patents, but Australia decided to buck the trend

p6Industry eventsAt a loss as to which conference to go to next?

p8People movesAtlas Venture, Marks & Clerk, Kilpatrick Townsend, and more

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requirement, which must be met if infringing products are going to be blocked, would be compromised.

Following a review made at the request of FMC, the ITC found that the ALJ had made no errors of law and that the US company had fai led to prove that i t was enti t led to relief.

A full opinion explaining the ITC’s decision to deny FMC’s review will be published in due course.

Bayer’s goal: life sciencesBayer Pharmaceuticals has decided to focus solely on its life sciences businesses, Health-Care and CropScience, following the separa-tion of its MaterialScience business.

According to reports, the pharmaceutical company will drive the commercialisation of its most successful pharmaceutical products, which includes the cancer drug Stivarga and pulmonary hypertension drug Adempas.

The life sciences arm of Bayer currently ac-counts for around 70 percent of sales and 88 percent of Ebitda before special items.

Bayer CEO Marjin Dekkers said: “Bayer will continue as an enterprise with an attractive and balanced portfolio and a primary focus on organic growth.”

Pharma under threat, says report

A new malware threat, Dragonfly, could be stealing the intellectual property of the pharmaceutical industry, according to a re-port by Belden.

For its recently released report, ‘Defending against the Dragonfly Cyber Security Attacks’, the electronics company tracked and listed the malware that appears to be attacking in-dustrial control systems (ICS).

The Dragonfly malware threat began in late 2010 or early 2011, according to the report.

field for patent protection,” said Michael Gulliford, managing principal at Soryn IP Group and director of patent strategy at Liquid Patent Consulting.

Ankur Desai of Liquid Venture Partners add-ed: “We could not imagine a better partner in launching this game-changing new effort. We take pride in the fact that Liquid Patent Con-sulting will be using the patent process in the right way, to build operating companies from the ground up.”

Sun Pharma and Merck enter $80 million licensing deal

Sun Pharmaceuticals and Merck & Co have entered into an $80 million licensing agree-ment for Merck’s investigational therapeutic antibody candidate tildrakizumab.

The antibody is a treatment for the chronic skin condition plaque psoriasis.

Sun Pharma will pay Merck to acquire world-wide rights to the drug for use in all human indications and will fund all of Merck’s clinical development and regulatory activities.

Under the agreement, Merck is eligible to re-ceive undisclosed payments associated with regulatory and sales milestones.

Sun Pharma will be responsible for subse-quent submissions, pharmacovigilance, post-approval studies, manufacturing and commer-cialisation of the approved product.

“We are pleased to enter into this agreement with Sun Pharma to help realise the potential of tildrakizumab for patients chronic plaque psoriasis,” said Iain Dukes, senior vice presi-dent of business development and licensing at Merck Research Laboratories.

Kirti Ganorkar, senior vice president of busi-ness development at Sun Pharma, added: “This collaboration is a part of our strategy towards building our pipeline of innovative dermatology products in a market with strong growth potential.”

Technology company Symantec reported that it first observed spear-phishing at-tempts in February 2013 that continued through June 2013. In May 2013, a water-ing-hole technique was observed, where websites would redirect visitors to sites hosting malicious content.

It then reported in June 2014 that the attack targeted energy companies, while industrial camera manufacturer Mesa Imaging was the first to have its site compromised in June 2013, by Dragonfly.

Joel Langill, an independent ICS security expert and author of the Belden-commissioned report, found that all of the compromised websites actually belonged to pharmaceutical companies.

Damage to pharmaceutical companies “could include the theft of proprietary recipes and production batch sequence steps, as well as network and device information that indicate manufacturing plant volumes and capabili-ties”, reported Langill.

Eric Byres, chief technology off icer at Tofino Security, a Belden brand, was cited in the report noting the shift of the antici-pated target: “[The] purpose of [Dragonfly] was not causing downtime, but for the pur-pose of intellectual property theft, likely for the purpose of counterfeiting.”

“CIOs and other executives need to know about this attack and be assured that there are techniques and products available to de-fend against it.”

Soryn IP and Liquid Venture launch patent portfolio builderSoryn IP Group and investment banking group Liquid Venture have joined forces to create a new patent portfolio service.

The duo will work together to build patent portfolios for new technology companies un-der the name Liquid Patent Consulting.

“We are excited to announce this unique of-fering, which we believe will level the playing

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CountryProfile

As a rule, if it occurs naturally, it cannot be patented. Such is the argument for genes, but that has not stopped biotechnology com-panies such as Myriad Genetics doing ev-erything they can to protect their inventions. And in Australia, Myriad has succeeded. The Australian Federal Court has, somewhat surprisingly, decided that isolated genes are patentable and upheld Myriad’s patent for the isolated BRCA1 gene.

The BRCA1 and BRCA2 genes, for which Myriad has developed tests, have been iden-tified as responsible for breast and ovarian cancer in women. The company’s Australian patent covers the location (extraction) of the BRCA1 gene. Jason Schigelone, intellectual

property attorney in US firm Brinks Gilson & Lione’s biotechnology and pharmaceuticals practice group, describes the court’s ruling as “a significant win for Myriad and others in the biomedical industry seeking patent pro-tection for isolated DNA”.

In February 2013, Cancer Voices Australia challenged Myriad’s application in the Aus-tralian Federal Court, arguing that Myriad’s claims were invalid on the sole ground that they did not claim to a manner of manufac-ture. But the judge held the view that while DNA “as they exist inside the cells of the hu-man body cannot be the subject of patent, the claims concern DNA which has been ex-tracted from the cells from the human body”.

Cancer Voices appealed against that ruling, but the full bench of the Australian Federal Court dismissed the appeal on 5 September. Adam Denley, senior associate in the life sci-ences sector at Australian firm Freehills LLP, explains the reasoning behind the dismissal.

“The Australian Federal Court was of the view that, even without a change in nucleo-tide sequence, the claimed isolated nucleic acid was chemically, structurally and func-tionally different from what occurs in nature.”

He adds: “While the court stressed that the chemical and physical makeup of the isolat-ed nucleic acid rendered it not only artificial but also different from its naturally occurring

Going it alone: Australia allows isolated gene patentsThe US famously declined Myriad’s BRCA1 and BRCA2 gene patents, but Australia decided to buck the trendTAMMY FACEY REPORTS

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CountryProfilecounterpart, there wasn’t extensive discus-sion on what the exact structural differences were. The functional differences, such as the ability of isolated nucleic acids to be used as primers in diagnostic screening, was more persuasive to the judges.”

Australia “does not support an exclusion from patentability on the basis that some-thing is a ‘product of nature’”, he adds.

The court also noted the subject matter of Myriad’s claims were to a compound, a nu-cleic acid, and not to information.

Myriad has been in court before over its BRCA1 and BRCA2 patent portfolio, most famously in the US. In June 2013, the Su-preme Court found that isolating human DNA from the bloodstream, as Myriad does when isolating the BRCA1 and BRCA2 genes to test for a risk of breast and ovar-ian cancer, is not patentable because nothing new is created.

The Australian Federal Court commented on the way in which the US Supreme Court ruled on isolated genes.

“With respect, [the US] approach is inappo-site in an Australian patent law context. We find the reasoning of the majority in the cor-responding decision in the US Court of Ap-peals for the Federal Circuit persuasive and in accordance with the approach in NRDC (Association for Molecular Pathology v Unit-ed States Patent and Trademark Office and Myriad Genetics).”

Denley says: “The US Supreme Court’s emphasis on the similarity of ‘the location and order of the nucleotides’ between the claimed isolated nucleic acid and the nucleic acid in nature was misplaced. Instead, the emphasis should be on the chemical chang-es in the isolated nucleic acid.”

Patenting genes is clearly a tense subject, with human morality and ethics coming in to play, but as Denley points out, the Austra-lian court considered the patent in black and white. Schigelone explains the different deci-sions in the respective jurisdictions, from an Australian patentee’s firm’s point of view.

“One of the primary differences is how each court viewed the scope of the isolated DNA claims at issue. The full court considered the Australian claims as directed to a nucleic acid compound, and focused on the struc-ture and function of the claimed compound in comparison with its natural counterpart. The full court found that the claimed compound was structurally and functionally distinguish-able and, therefore, patent eligible.”

The differing views in each jurisdiction have raised questions as to what it means to pat-ent a gene. With the decisions in mind, Den-ley considers the Australian Federal Court’s

understanding of what is an “artificially cre-ated state of affairs”, especially now that iso-lated genes have come into play:

“The ‘manner of manufacture’ requirement is the Australian equivalent to 35 USC §101 and Article 52 of the European Patent Con-vention, and essentially defines what is pat-entable subject matter in Australia.”

The common starting point for considering whether claimed subject matter is a ‘man-ner of manufacture’ is the decision by the High Court of Australia in National Research Development Corporation v Commissioner of Patents (1959). The principles in that de-cision can be distilled into two questions, which if both are answered in the affirmative, indicate that the subject matter is patentable.

Denley adds that the Australian Federal Court understands the term as follows: “The principle of intervention of man to produce from, or by means of, a naturally occurring product or the laws of nature, something ar-tificial or of an artificial effect that can bring benefit to mankind.”

It appears that the Australian Federal Court is siding with Myriad for the overall benefit of society. The advantages in identifying and being able to extract a potential can-cer gene may eradicate the life-threatening illness. Denley adds that the ruling will not have any effect on the breast and ovarian cancer testing market.

The US Supreme Court famously denied Myriad’s patent on 13 June, but the biotech-nology company took Ambry Genetics to the US District Court for the District of Utah over infringing BRCA1 and BRCA2 patents on 9 July.

The decision by the Supreme Court did not necessarily close the door on patenting iso-lated DNA per se, adds Schigelone, but rath-er held that claims directed to isolated DNA are not patent eligible simply because they have been isolated.

And while the US denied some Myriad’s patents, it did allow Myriad’s cDNA patents. Schigelone explains: “The Supreme Court distinguished cDNA from isolated DNA on the basis that creation of cDNA results in a molecule that does not occur in nature. The court found that such compounds are patent-able, except for short DNA sequences where the cDNA structure is ‘indistinguishable’ from natural DNA.”

Denley says: “Myriad’s DNA claim fell within the ‘law of nature’ exception and was there-fore not patentable. cDNA on the other hand was considered patent eligible because it was not naturally occurring. In arriving at its decision, the US Supreme Court found the claims were not expressed in terms of chemical composition, nor do they rely on the chemical changes resulting from the iso-lation of a particular DNA section.”

So what will the Australian Federal Court’s de-cision mean for the biotechnology world? Den-ley stresses the benefits for patentees in Aus-tralia: “Patentees may now be more confident to enforce claims directed to isolated nucleic acids on the understanding that those claims cannot be invalidated. However, in practice whether this will occur is unclear.”

The decision will be welcomed by pat-entees with cases that include claims to proteins, peptides, organisms, small mol-ecules, and the Australian Patent Office will allow patent applicants to claim genet-ic material, provided the claimed material is qualified as having been “‘isolated’, or words to that effect.” IPPro

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“ Australia does not support an exclusion from patentability on the basis that something is a product of nature

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IndustryEvents

LES Annual Meeting

Location: San FranciscoDate: 5-8 October 2014www.lesusacanada.org

LES’s 50th Annual Meeting will build upon the 2014 LES theme “Advancing and Enhancing Business Development, Deals & Innovation”, and feature cutting-edge topics addressed by today’s thought leaders, industry experts, and dealmakers. More than 1,000 intellectual property, licensing, business development, and technology transfer professionals will attend the meeting.

London IP Summit 2014

Location: LondonDate: 13-14 Octoberwww.londonipsummit.com

The London IP Summit, now in its third year, is a unique event dedi-cated to bringing together IP owners, experts and investors to address key challenges and operational issues faced by companies and IP professionals today. The summit will provide meaningful and valuable insights in IP generation as well as managing, protecting, enforcing and monetising your intellectual property portfolio, thus creating a plat-form to accelerate industry stakeholders’ collaboration as a vehicle for higher profit generation.

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Industry appointments

PeopleMoves

Editor: Mark [email protected] Tel: +44 (0)20 8663 9620

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Atlas Venture, the Boston-based venture capital firm, has recruited Jason Rhodes as partner in its life sciences investment group.

Rhodes joins from biopharmaceutical com-pany Epizyme, where he served as presi-dent and chief financial officer. Epizyme became a publicly traded company under Rhodes’s leadership.

He has more than 16 years of experience in biotechnology.

Rhodes commented on joining the firm: “I think they [the Atlas Venture’s staff] are very talented and smart people who have a very good strat-egy that has been successful.”

Kilpatrick Townsend & Stockton LLP has added William Leschensky to its Silicon Valley office as counsel.

He previously served as senior counsel at Amgen, through the acquisition of KAI Pharmaceuticals.

At Amgen, he was responsible for intellectual property matters, including patent prosecution, patent strategy, due diligence, client counsel-ling and licensing support.

Carole Bellis, corporate partner in Kilpatrick Townsend’s Silicon Valley office, commented: “We look forward to working with Leschensky and welcome him to the firm.”

Leschensky’s hire follows the appointment of four attorneys to the Silicon Valley office this summer.

Marks & Clerk has promoted four colleagues to partner in its respective offices in Aberdeen, London, Singapore and Paris.

Douglas Rankin, Enrico Priori and Magda-lene Ong are patent attorneys, and Charlie Balme is a solicitor.

Rankin advises engineering companies on IP matters. He has served before the UK IP Office and European Patent Office on both opposition and appeal proceedings.

Balme specialises in the enforcement and com-mercialisation of UK and European Community IP.

He has experience in patent disputes in bio-technology and commercial IP contracts.

Priori focuses on electronics, software, physics and telecommunications-related patents.

Ong has worked on semiconductor fabrica-tion and devices, computers and hardware applications, telecommunications, medical devices, pharmaceuticals, materials and fuel cell technology. She also works on drafting, filing and prosecution of interna-tional patent applications.

Keith Hodkinson, chairman of Marks & Clerk International, said: “We are extremely pleased to welcome these four IP professionals as partners.”

Caldwell Partners has welcomed John Blank as partner into its life sciences and healthcare practice, in Nashville.

He will focus on recruiting board directors, CEOs and senior executives for private equi-ty-backed high-growth healthcare, healthcare technology, managed care and provider ser-vice portfolio companies.

Blank has more than 16 years of experience in the life sciences and healthcare industry and has served in the executive search industry.

“Blank’s addition to our team adds impres-sive and complementary experience covering a huge sector of increasing importance,” said Darin DeWitt, leader of the firm’s life sciences and healthcare practice.

John Wallace, CEO of Caldwell Partners, added: “Blank’s is a results-oriented executive search consultant, and has built a reputation for tireless commitment to client service and superior execution.”

Esperite, a stem cell cryopreservation company, has recruited Thomas Rio Frio as genomics manager for its Genoma business.

Rio Frio joins from Institut Curie in Paris, where he served as the next-generation sequencing platform manager.

Prior to serving at the Institut Curie, he devel-oped several genetic tests for IntegraGen SA in Paris while he worked as a senior geneticist.

Frederic Amar, CEO of Esperite, said: “Rio Frio’s appointment underlines the company’s strategic direction to become a strong player in the fields of proteomics and genomics pre-dictive medicine. His extensive experience is a strong asset for Genoma’s global activities”

Law firm Rimon PC has recruited Robert Lee as its new technologist-in-residence.

Lee focuses on IP protection, angel and venture capitalist financing for high-technology businesses.

He has worked on patents in consumer and enterprise software, electrical engineering, material, medical device and diagnostics, as well as biotechnology and has facilitated angel and venture capitalist financing deals in Silicon Valley.

Lee is also a research fellow in law, science and technology at Stanford University.

He previously served as CEO of Fly Online, a con-sumer travel provider acquired by Travelzoo. IPPro

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