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UK court tells NHS to use Lyrica brand have expired. But a second patent protecting pregabalin’s use in the treatment of neuropathic pain is under Swiss patent claim. Actavis holds a patent for its drug Lacaent, which it plans to launch in the UK. The drug treats generalised anxiety disorder, neuropathic pain and epilepsy. Also in January, Warner-Lambert wrote to the NHS asking it to issue guidance to doctors about the using the Lyrica brand name, but the NHS said it would only do so following a court order. In its March decision, Justice Arnold ensured that the order complied with Article 3 of the Enforcement Directive and explained that guidance by the NHS is “the most efficacious, dissuasive and cheapest solution to the problem, which confronts Warner-Lambert”. The UK High Court has ordered the National Health Service (NHS) to ensure that UK doctors use the Lyrica brand name when prescribing the pain relief drug. Justice Richard Arnold issued the order against the NHS following litigation between Warner-Lambert, a member of the Pfizer group, which currently markets Lyrica (pregabalin), for indications including the treatment of pain, and generic manufacturer Actavis. Justice Arnold denied Warner-Lambert interim relief in the UK in January, over generic competition from Actavis, based on a Swiss form claim. Warner-Lambert’s basic composition patent and supplementary protection certificate for pregabalin Federal Circuit overturns erroneous damages The Court of Appeals for the Federal Circuit has overturned a $102 million award in the patent infringement case between NuVasive and Medtronic Sofamor Danek and its associated unit, Warsaw Orthopedic. The court upheld a September 2011 verdict of patent infringement but it found that the damages award was erroneous. Warsaw Orthapedic originally accused Medtronic of infringing its patents covering implants that can be inserted trans- laterally between adjacent vertebrae, a plate and screw system used to stabilise vertebrae in the cervical spine and a tissue rectractor. A jury in San Diego found NuVasive liable and awarded damages of $102 million to Medtronic for lost profits and the sale of conveyed products and royalties. But it also held that Medtronic infringed a patent belonging to NuVasive, which sought damages of $600,000. AbbVie does $21 billion deal for Pharmacyclics AbbVie has entered an agreement to acquire Pharmacyclics and its asset Imbruvica (ibrutinib), which treats hematologic malignancies, for $21 billion. Under the agreement, AbbVie will pay $261.25 per share comprised of cash and AbbVie equity. Imbruvica is a Bruton’s tyrosine kinase (BTK) inhibitor approved for use in four indications to treat three different types of blood cancer. It is currently approved in more than 40 countries. readmore p2 readmore p2 readmore p2 If you’d like to find out more about the IPPro brand, send an email to Carlos Northon at: [email protected] ipprolifesciences.com ISSUE039 11.03.2015 WEDNESDAY

ISSUE039 WEDNESDAY 11.03... · for Pharmacyclics. AbbVie has entered ... Graham and Co, wrote in an analysis that the ... The case will be returned to the district court

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UK court tells NHS to use Lyrica brandhave expired. But a second patent protecting pregabalin’s use in the treatment of neuropathic pain is under Swiss patent claim.

Actavis holds a patent for its drug Lacaent, which it plans to launch in the UK. The drug treats generalised anxiety disorder, neuropathic pain and epilepsy.

Also in January, Warner-Lambert wrote to the NHS asking it to issue guidance to doctors about the using the Lyrica brand name, but the NHS said it would only do so following a court order.

In its March decision, Justice Arnold ensured that the order complied with Article 3 of the Enforcement Directive and explained that guidance by the NHS is “the most efficacious, dissuasive and cheapest solution to the problem, which confronts Warner-Lambert”.

The UK High Court has ordered the National Health Service (NHS) to ensure that UK doctors use the Lyrica brand name when prescribing the pain relief drug.

Justice Richard Arnold issued the order against the NHS following litigation between Warner-Lambert, a member of the Pfizer group, which currently markets Lyrica (pregabalin), for indications including the treatment of pain, and generic manufacturer Actavis.

Justice Arnold denied Warner-Lambert interim relief in the UK in January, over generic competition from Actavis, based on a Swiss form claim.

Warner-Lambert’s basic composition patent and supplementary protection certificate for pregabalin

Federal Circuit overturns erroneous damages

The Court of Appeals for the Federal Circuit has overturned a $102 million award in the patent infringement case between NuVasive and Medtronic Sofamor Danek and its associated unit, Warsaw Orthopedic.

The court upheld a September 2011 verdict of patent infringement but it found that the damages award was erroneous.

Warsaw Orthapedic originally accused Medtronic of infringing its patents covering implants that can be inserted trans-laterally between adjacent vertebrae, a plate and screw system used to stabilise vertebrae in the cervical spine and a tissue rectractor.

A jury in San Diego found NuVasive liable and awarded damages of $102 million to Medtronic for lost profits and the sale of conveyed products and royalties.

But it also held that Medtronic infringed a patent belonging to NuVasive, which sought damages of $600,000.

AbbVie does $21 billion deal for PharmacyclicsAbbVie has entered an agreement to acquire Pharmacyclics and its asset Imbruvica (ibrutinib), which treats hematologic malignancies, for $21 billion.

Under the agreement, AbbVie will pay $261.25 per share comprised of cash and AbbVie equity.

Imbruvica is a Bruton’s tyrosine kinase (BTK) inhibitor approved for use in four indications to treat three different types of blood cancer. It is currently approved in more than 40 countries.

readmore p2

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If you’d like to find out more about the IPPro brand, send an email to Carlos Northon at: [email protected]

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UK court tells NHS to use Lyrica brandContinued from page 1

The NHS must issue guidance to general practitioners and pharmacies in the UK, explaining that pregabalin “should only be prescribed for the treatment of neuropathic pain under the brand name Lyrica”.

Christopher Freeth, associate at Wragge Lawrence Graham and Co, wrote in an analysis that the decision it is a “bold and pragmatic” step by Justice Arnold, because it addresses the enforcement of Swiss-form second medical use claims.

“This decision indicates that the courts are not afraid to extend the use of the inherent jurisdiction beyond that seen in cases of more blatant infringement of IP rights to deliver a practical solution to a commercial dispute,” added Freeth.

“The decision marks a major change in how second medical use claims will be enforced but there is likely more to come yet; this is surely a case the life science industry will be keeping a close eye on for some time to come.”

Federal Circuit overturns erroneous damagesContinued from page 1

The Federal Circuit has now found the $102 million damages award to be incorrect because Medtronic cannot recover damages for lost profits or for the sale of conveyed products.

The case will be returned to the district court to determine a correct damages award, based solely on a reasonable royalty.

Alex Lukianov, chairman and CEO of NuVasive, said: “We are very pleased with today’s legal ruling.”

“By limiting the damages to only a reasonable royalty, we believe our overall exposure has been reduced from the current amount we have accrued. We look forward to the upcoming retrial.”

AbbVie does $21 billion deal for PharmacyclicsContinued from page 1

“Imbruvica has demonstrated strong clinical efficacy across a broad range of hematologic malignancies and raised the standard of care for patients,” said Richard Gonzalez, CEO and chairman of AbbVie.

“Team Pharmacyclics is honored to join the AbbVie organisation.”

Together and as one, our focus remains to create a remarkable difference for patients around the world,” said Bob Duggan, chairman and CEO of Pharmacyclics.

USPTO ends SAWS programmeThe US Patent and Trademark Office (USPTO) has cancelled its Sensitive Application Warning System (SAWS), after a review concluded it offered “minimal benefit” to applicants.

The programme was introduced in 1994 by the agency to deal with patents that related to what it deemed ‘sensitive’ matter.

It was also used as a quality assurance programme, so the “highest quality patents” were issued by the agency.

Usually more than one patent examiner would address the application and it would take considerably longer for a patent concerning sensitive matter to be granted.

But the patent process has changed since then and following the USPTO’s review of the SAWS system in January, it decided to retire the programme

As part of its enhanced patent quality initiative, the agency said it would seek public input into whether the current examination process offers enough in the way of establishing the quality of patents.

AZ completes purchase of Actavis respiratory portfolioAstraZeneca has finalised its deal to buy the Actavis’s respiratory business in the US and Canada.

AstraZeneca will pay $600 million up front and low single-digit royalties above a certain threshold.

Under the agreement, AstraZeneca will own the development and commercial rights in the US and Canada to Tudorza Pressair (aclidinium bromide inhalation powder), a long-acting muscarinic antagonist for chronic obstructive pulmonary disease and Dalliresp (roflumilast).

The acquisition builds on the agreement for Almairall’s respiratory portfolio in 2014 and extends the company’s commercialisation right in the US for both Tudorza Pressair, and Duaklir, Genuair.

AstraZeneca has also paid Actavis an additional $100 million for consents and approvals for amendments to ongoing collaborations between the two parties.

Stem cell patent challenge stopped dead

The US Supreme Court has declined to hear a consumer advocacy group’s challenge of a stem cell patent, following a Federal Circuit ruling that it lacked legal standing to do so.

Latest newsNew pharma company targets untreated diseases

p4Latest newsEuropean patent applications increase 3.1 percent, hitting a new high p5Latest newsMylan completes purchase of Abbott’s non-US developed markets branded generics business

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Technology insightYour genetic makeup make you who you are, but what if you could change it? p7

Venture financingThe CJEU provides yet more clarification on stem cell patents in Europe

p8People movesNew appointments at Nutter, CohnReznick, Fried Frank, and more p10

IPProINBRIEF

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NewsInBrief

The country’s top court refused Consumer Watchdog’s petition without comment on 23 February, leaving intact the Court of Appeals for the Federal Circuit’s holding that the non-for-profit group cannot challenge an administrative decision to uphold the patent on human embryonic stem cells.

The Federal Circuit held in June 2014 that Consumer Watchdog was entitled to take part in an administrative review of the patent, but could not appeal the US Patent and Trademark Office’s (USPTO) decision to uphold the patent, because the group was not directly harmed.

Consumer Watchdog filed a petition with the Supreme Court in October last year, arguing that the Federal Circuit’s ruling directly contravened presidential and congressional intent to provide for court appeal of administrative responses to requests in any field, and to empower the public to seek revocation of invalid patents.

The consumer advocacy group sought to challenge the Wisconsin Alumni Research Foundation’s (WARF) patent in 2006 through re-examination, because it believed the patent to be invalid and would stunt stem cell development if it went unchallenged.

The USPTO did reject the patent, but the foundation narrowed its claims and promised to give more favourable licensing terms.

WARF was eventually awarded the modified patent, which now covers only embryo-derived stem cells, and excludes cells derived by re-programming.

New pharma player to target untreated diseasesA new pharmaceutical company has launched after acquiring three treatments from Retrophin.

Turing Pharmaceuticals has launched to focus on diseases and conditions for which there are no treatments.

The three assets purchased from Retrophin include an unnamed intranasal formulation of ketamine, Syntocinon, which is an oxytocin nasal solution, and Vecamyl, which are mecamylamine hydrochloride tablets.

Martin Skreli, executive chairman of Turing, who left Retrophin to set up the new company, said: “Our goal is to build a diverse portfolio and pipeline of therapies that can make a significant difference to patients.”

The new intranasal formulation of ketamine is being developed for a variety of psychiatric indications. It is also working on a novel delivery mechanism.

Turing’s further plans to start a development programme for Syntocinon to address multiple indications across several therapeutic areas.

Per Falk, executive vice president and chief scientific officer at Ferring, added: “Our portfolio of peptide therapeutics make us an attractive partner for companies like CTCBIO to collaborate on new approaches for oral drug delivery of peptides and proteins.”

People picking up a patent or twoThe average fee paid for a patent in 2014 indicates that prices are rebounding following declines in 2012 and 2013, according to brokerage firm IPOfferings.

The IPOfferings Patent Value Quotient for 2014, which covered 32 patent transactions across all technologies, showed that the average price paid per patent is up on previous years.

The report showed that, on average, $251,007 was paid for a patent in 2014, an increase of 10 percent from 2013. The median outlay dropped 27 percent to $123,444.

This dichotomy is due to patents selling over a broader price range and the marketplace continuing to adjust to recent court rulings, explained IPOfferings.

“We talk to sellers and buyers of patents every day—that’s our business—so we know that demand for quality intellectual property was leveling off and starting to improve throughout 2014. As a result, the numbers in the Patent Value Quotient were not a surprise to us,” commented Rich Ehrlickman, founder and president of IPOfferings.

“The Patent Value Quotient for 2014 shows that demand for quality patents is strong across all technologies and at many price points.”

For the 32 patent transactions reported for 2014, the average price of a patent ranged from $10,000 for a semiconductor portfolio to $1,663,270 for a natural language portfolio.

The Patent Value Quotient covered the sales of more than 2,800 issued US patents, from four single-patent transactions to two 900+ patent portfolios.

Athersys and Chugai agree over cell therapy treatmentBiotechnology company Athersys and Chugai Pharmaceutical have entered a licence agreement to develop and commercialise a cell therapy, MultiStem for a type of stroke in Japan.

MultiStem cell therapy is Athersys’ product currently under evaluation in second phase clinical studies for the US, Japan and Europe. It is aimed at treating ischemic stroke, which is characterised by the sudden loss of blood circulation to the brain.

Athersys will receive $10 million in cash from Chugai and subsequent payments over the

Vecamyl, meanwhile, is the company’s first Food and Drug Administration-approved product and revenue stream.

The new pharmaceutical company plans to acquire and advance the development of external compounds while pursuing internal drug discovery through proprietary R&D. It has also acquired two unnamed early-stage compounds to be developed for various orphan drug indications.

Sharing is saving, says WIPOInternational research agreements for the treatment of tropical diseases have doubled thanks to World Intellectual Property Organization’s (WIPO) IP sharing royalty-free service, Re:Search

By the end of 2014, 82 collaborations were in place between 94 members, including 38 new agreements, according to WIPO.

Merck and biotechnology company Kineta were some of the companies that joined WIPO Re:Search in 2014.

WIPO director general Francis Gurry said: “We are hopeful that these positive results will continue to grow in the coming years and lead to outcomes to alleviate the huge burden of neglected tropical diseases on already vulnerable populations.”

“We are extremely proud of what our members have accomplished through WIPO Re:Search to date,” added BIO Ventures for Global Health president Jennifer Dent.

“With 82 agreements established, WIPO Re:Search is poised to have an important impact on filling the pipelines for these devastating neglected diseases.”

Organisations can use WIPO Re:Search to share compounds, expertise and know-how without having to pay patent royalties.

Ferring bags novel drug delivery techFerring Pharmaceuticals has signed an agreement with South Korean company CTCBIO for the rights to a novel oral drug delivery technology.

The companies will collaborate to develop prototype formulations for in-vitro and in-vivo testing and any work required to manufacture the technology.

“Keeping the active pharmaceutical ingredient stable and secure is critical,” explained Dr Jeon Hongryeol, vice president of CTCBIO.

“This technology makes this possible and is particularly useful for hydrophilic macromolecules like peptides and proteins while offering the advantage of oral administration.”

NewsInBrief

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NewsInBrief

length of the agreement. Chugai will develop and commercialise MultiStem for ischemic stroke in Japan, whilst Athersys will focus on product supply.

Tatsuro Kosaka, president and COO at Chugai, commented: “By combining Chugai’s strong expertise in biological pharmaceuticals, we hope to bring MultiStem to the Japanese healthcare system as a new treatment modality during the critical phase of ischemic stroke.”

“We are excited to be working with Chugai in this important area,” said Dr Gil Van Bokkelen, CEO at Athersys.

Using MultiStem has shown to reduce inflammation and immune system modulation.

Preclinical studies show that a single dose of MultiStem therapy provides significant improvement in patients.

EU patent applications soarEuropean patent filings increased 3.1 percent in 2014, hitting a new record high of more than 274,000 in a single year.

European Patent Office (EPO) statistics revealed on 26 February that 2014 filings

The Netherlands bagged a 9.1 percent increase in filings, while the UK and France enjoyed increases of 4.8 percent and 4 percent, respectively.

Traditionally lower filing countries such as Poland saw European patent applications increase 21.5 percent.

Around two-thirds of filings at the EPO last year came from countries outside of Europe.

The US accounted for the largest share with 26 percent, followed by Japan, China and South Korea with 18, 9 and 6 percent, respectively.

With an increase of 18.2 percent, China continued its rise in filings from previous years, while Japan suffered a decrease of -4.4 percent in 2014.

Amarin and Eddingpharm join over fatty acid drugBiotech therapeutics, Amarin and pharmaceutical company Eddingpharm have entered an agreement to develop and commercialise Vascepa (icosapent ethyl), a drug that helps to remove triglycerides from the blood, in China, Hong Kong and Taiwan.

Under the agreement, Eddingpharm will develop and commercialise activities in

surpassed 2013’s, when the office received 266,000 applications.

The agency also granted 64,600 European patents last year.

“Demand for patent protection in Europe has been growing steadily, and is up for the fifth year in a row,” said EPO president Benoȋt Battistelli. “Europe continues to strengthen its key role as a global hub of technology and innovation for a growing number of companies from around the world.”

“The rise in patent filings originating from Europe underlines the importance of patent-intensive industries as a solid base for the European knowledge economy: they foster Europe’s competitiveness, economic strength and employment.”

The 38 member states of the European Patent Organisation consolidated their 35 percent share of total filings at the EPO last year, with applications from Germany accounting for 11 percent, France 5 percent, the Netherlands 3 percent and the UK 2 percent.

The 1.2 percent increase in the volume of filings from the 38 member states in 2014 was based on varied trends in individual countries.

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NewsInBrief

each country and be responsible for the associated expenses.

Amarin will provide development assistance and be responsible for supplying finished and later bulk product.

Eddingpharm will make upfront and milestone payments of up to $169 million and royalties on net sales of Vascepa.

Xin Ni, founder, chairman and CEO of Eddingpharm, said: “We are delighted that Amarin has entrusted Eddingpharm to develop and commercialise Vascepa in China. Vascepa has significant commercial potential in the rapidly growing Chinese market. Together with Amarin, we are committed to bringing this medicine to millions of patients in the region.”

The Chinese pharma market has reportedly been growing at 20 percent over the past 10 years and is the third largest in the world.

“Vascepa has the potential to occupy a leading position in the substantial worldwide market for prescription omega-3 products,” commented John Thero, president and CEO of Amarin.

“We are very pleased to be collaborating with Eddingpharm. Eddingpharm has established development and regulatory capabilities and an impressive commercial organisation that has launched many innovative products in China.”

include the new indication for the treatment of metastatic pancreatic and breast cancers.The drug will treat patients who are not candidates for curative surgery or radiation therapy.

The decision follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) and a randomised study where patients treated with Abraxane had a significantly higher response rate.

Tuomo Pätsi, president of Celgene in Europe, the Middle East and Africa, said: “At Celgene, we are pleased that the European Commission’s approval of Abraxane in non-small lung cancer allows patients in Europe who have been diagnosed with this devastating disease to access this innovative nanotechnology medicine.”

“The expanded application of Abraxane across three difficult to treat tumors—breast, pancreatic and lung cancers—reinforces the value Abraxane provides and our commitment to advance transformational science, the world over.”

“There is a large unmet need for a high-quality, well-studied and differentiated prescription grade omega-3 product in the Chinese market,” added Ni.

Mylan completes Abbott purchase

Mylan has completed its acquisition of the non-US developed markets branded generics business of Abbott Laboratories.

Mylan initially entered the agreement to acquire the generics side of Abbott’s business in 2010, for an estimated $5.3 billion in shares.

Along with the assets, Mylan will also gain a portfolio of more than 100 specialty and branded generic pharmaceutical products.

Heather Bresch, CEO of Mylan, said: “These new assets will build upon our exceptional existing global platform and the strong growth strategy already in place.”

EC approves new path for AbraxaneThe European Commission has approved Celgene International’s Abraxane (nabpaclitaxel) for a new use in the treatment of non-small lung cancer.

Marketing authorisation for Abraxane has been updated across 28 EU member states, to

Send all of your breaking news to:[email protected]

NewsInBrief

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TechnologyInsight

Gene technology is having its moment in the sun. The potential applications of gene technology are many, from manipulating genes to better understand suitable therapies for treating cancer, to creating an embryo with the genetic code of three parents.

Genetically modified foods are everywhere, but gene manipulation can now also be used to keep crops pest-free.

An impressive example of how far gene technology has come is 23andMe, whose genetic tests are now being advertised on TV to the general public in the UK. Based on the fact that DNA is made up of 23 different chromosomes, it offers users a tool that allows them to understand their own genetic traits.

This area of biotechnology is certainly en vogue and it’s gathering pace by the day. Numerous companies are teaming up and entering licensing agreements with one another to explore the potential of gene technology.

At the end of January, AstraZeneca promised to collaborate with four research companies using 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.

Universities have also jumped on the gene bandwagon, with the Massachusetts Institute of Technology and the Broad Institute signing an agreement with Editas Medicine for access to intellectual property for genome editing technology.

Pharmaceutical giant Pfizer has thrown its weight behind gene technology, too. It agreed in December 2014 to collaborate with Spark Therapeutics over gene therapy technology. Their aim is to find a treatment for the blood clotting disease Haemophilia B.

A spokesperson from Pfizer explains where the technology is, how it arrived in Pfizer’s lap, and where the company expects it to go next.

Where is gene therapy technology at, generally, in terms of its usefulness?

Gene therapy often uses specially adapted viruses (viral vectors) to carry genetic material into host cells. These specially adapted viruses can introduce genes, which are encoded to produce a particular behaviour or effect in the cell—a procedure of significant interest to scientists exploring therapies for diseases, which are caused by genetic problems. There are a number of viral vector systems being developed throughout the industry and the most common of these are based on adeno-associated virus (AAV). To date, we are aware that one product has been approved by the European Medicines Agency for use in humans. As of June 2012, more than 1,800 gene therapy clinical trials had been completed, were ongoing or had been approved worldwide.

How did the technology come about, and where does Pfizer see the technology going in the future?

The fundamental understanding of the biology of rare diseases, coupled with advances in the technologies to disarm viruses and gene therapy, offers a meaningful opportunity to develop potential gene therapies for a number of debilitating or even fatal disorders.

Although it is difficult to make any predictions on how the technology will actually develop over the course of time, our hope for the future is a deeper understanding of the mechanisms that could bring about true disease modification for those suffering from devastating diseases.

To this end, Pfizer has entered into a global collaboration with Spark for the development and potential commercialisation of SPK-FIX, a development programme advancing proprietary, bio-engineered AAV vectors for the potential treatment of Haemophilia B. Spark will be responsible for conducting all first- and second-phase studies while Pfizer will assume responsibility for pivotal studies,

any regulatory approvals and potential global commercialisation of the product.

We have also established a gene therapy group within our rare disease research unit in the UK. This group will be led by Professor Michael Linden who has joined Pfizer from his current position at King’s College London for a two-year secondment to lead our research.

What sort of IP does Pfizer own around gene therapy? How important has obtaining protection been to innovating in this area?

IP is clearly an important consideration in any drug discovery area. Issued patents and published patent applications are publicly disclosed at the appropriate time.

Thus, any IP that Pfizer may own in the area will eventually be contained within publicly available documents.

How will the deal with Spark help to innovate in this area?

Pfizer has a long-standing commitment to the haemophilia community and has been providing haemophilia products to patients for more than 17 years.

The agreement with Spark offers an important expansion of Pfizer’s commitment to the haemophilia community and could pioneer a potential new treatment technology for patients suffering from Haemophilia B.

How important is collaboration to gene therapy?

We see collaboration in this area as critical to success. In rare disease in particular, the challenges are far too great for anyone to go it alone.

We will continue to look at identifying the best science, either within Pfizer or beyond our walls, so that we can explore unique potential treatment options for patients. IPPro

Good fit: Pfizer buys into gene therapyYour genetic makeup makes you who you are, but what if you could change it?

TAMMY FACEY REPORTS

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VentureFinancing

In what it claims to be the first-of-its-kind report, the Biotechnology Industry Organization (BIO) has compiled a study on venture financing over a 10-year period to discover how therapeutic innovation is being financed.

Access to early-stage financing has been cited as the lifeblood of biotechnology innovation and BIO’s study, Venture Funding of Therapeutic Innovation, sought to present a decade of venture funding of drug R&D.

According to James Greenwood, president and CEO of BIO, funding is imperative for new ventures, which demand large and long-term investment.

Both Greenwood and Cartier Esham, BIO’s executive vice president for emerging companies, claim it is important for BIO to understand investor trends to determine where scientific or policy issues may affect the maintenance of a pipeline of innovative medicines.

BIO completed an extensive study, which broke down financing by disease area and novelty of research. More than 1,200 US drug companies in receipt of $38 billion of venture capital over 10 years, between 2004 and 2013, were examined.

Four databases were combed, including BioCentury and Evaluate Pharm, which helped BIO to investigate investor trends, examine investment in specific therapeutic areas and identify early-stage venture equity financing.

There were interesting results, with 78 percent of US venture capital for therapeutics, contributing to novel drug R&D. But BIO also found that total venture funding of drug R&D dropped 21 percent, from $21.5 billion to $16.7 billion over a five-year period following the financial crisis in 2008.

Further results of the study included disease funding seeing a large increase over the

past decade in terms of money raised and companies funded.

However, oncology was the most funded disease by a wide margin. It accounted for 24 percent of all investment in the last 10 years, with over $9 billion being invested.

Neurology and infectious disease had 12.1 percent and 10.9 percent investment, respectively.

According to the report, oncology is a “very diverse” set of hundreds of different diseases and biotechnology has been at the “cutting edge of new breakthroughs to meet unmet medical needs in this area”.

Investments over the last 10 years have led to the advancement of immuno-oncology, targeted antibodies, and selective kinase inhibitors.

“The field is on the brink of making biomarker-defined, patient-stratified medicine a reality,” according to the report.

Follow the moneyBIO’s first-of-its-kind investigation into venture financing in therapeutic innovations reveals where the money has been, and where it needs to go for future R&DTAMMY FACEY REPORTS

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VentureFinancing

Since 2004, nearly 85 percent of oncology investment has gone towards R&D, as opposed to improving former regimes.

The report stated that oncology could serve as a benchmark by which other disease areas should be funded: significant amounts of funding, high levels of innovation, and a broad diversity of companies.

The second most-invested area is neurology, according to the report. Venture funding of companies with lead programmes in neurology reached just over $4.6 billion over the last 10 years and accounted for 12 percent of total venture capital raised.

But there was a significant decline when BIO compared funding in the five-year windows—from $2.8 billion in 2004-2008 to only $1.7 billion in 2009-2013, a decline of 40 percent.

Funding for novel R&D in neurology dropped by 56 percent and the number of companies financed in neurology reached 40 per year, while investment dropped over the latest five-year period. BIO believes that this indicates that companies are receiving smaller amounts of funding.

The third most invested area is infectious disease (ID). They include viral, bacterial, fungal, and parasitic infections.

There is a “high demand for novel drugs” in these areas to “reverse disease progression within patients and to stop the wider spread throughout the population”, found the report.

“In antibiotics there has been a rise in strains resistant to older therapies, making the need for novel drugs highly important.”

Venture funding for ID totalled $4.6 billion over the last 10 years, and accounted for 11 percent of total venture capital raised.

However, it has dropped over the five-year windows, from over $2 billion to less than $1.5 billion (-33 percent).

In contrast, diabetes, psychiatry, gastrointestinal, respiratory and cardiovascular diseases have seen a decline in novel drug R&D venture funding, making up less than 10 percent of the total.

Cardiovascular indications, such as heart failure, acute coronary syndrome, atherosclerosis, hypercholesterolemia, and hypertension received total venture funding of $2.4 billion over the last 10 years, and accounted for 6 percent of total venture capital raised.

But funding has dropped 27 percent over the five-year windows, from over 1.4 billion to less than $1.0 billion.

In terms of psychiatry, venture funding of companies with lead programmes in psychiatric diseases was just under $900 million over the last 10 years, and accounted for only 2 percent of total venture capital raised. This is five times less than neurology.

Funding for psychiatry has also dropped over the five-year windows, from more than $588 million to less than $302 million (-49 percent).

Novel R&D for this group dropped even more (-56 percent), from $465 million to $203 million.

“There is a still an unmet medical need in many of these disorders, and the funding levels do not point to a strong investment in future breakthroughs,” said the report.

For disease-specific increases or decreases in financing over the time period, BIO found the most notable decreases were in endocrine (-60 percent), psychiatry (-56 percent), gastrointestinal (-49 percent), respiratory (-41 percent), and neurology (-39 percent).

Greenwood hopes the report will help inform future policy work and provide “industry, policymakers, and other stakeholders with a comprehensive view of the investment environment”. IPPro

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Nutter McClennen & Fish has appointed Lana Gladstein as partner in its intellectual property practice group.

Gladstein’s practice focuses on strategic uses of IP for biotech and pharma companies, including patent litigation and contested proceedings at the US Patent and Trademark Office (USPTO).

She also represents clients in licensing and contract disputes and aided cases at the US Court of Appeals for the Federal Circuit.

She joins Nutter from Pepper Hamilton in Boston, where she served as partner.

Deborah Manus, managing partner of Nutter, commented: “Gladstein is a terrific addition to Nutter. She brings legal expertise that is highly valued by clients.”

CohnReznick has expanded its technology and life sciences practice in Austin where new partner Christopher Thomas will take the lead.

The practice includes a combination of local and national professionals who will provide accounting, tax, and advisory services to technology and life sciences companies in the Austin area.

Thomas commented on the expansion: “I am very excited to be taking the lead on this initiative and we look forward to making a positive impact, not only on the local tech and life sciences markets, but on the Austin community as a whole.”

Fried, Frank, Harris, Shriver & Jacobson has added Jeffery Lewis as partner to its litigation practice in New York.

Lewis focuses on patent litigation and also handles trademark matters.

He represents both plaintiffs and defendants in a range of technology-related sectors, but focuses primarily on pharmaceuticals, chemicals, biotechnology and life sciences.

Prior to joining the firm, he was a partner at Patterson Belknap Webb & Tyler, where he served as head of the patent group.

David Greenwald, chairman of Fried Frank, commented: “[He] brings a rare combination of thought leadership, technical skill and stature in his field that will complement many practices across the firm.”

Jonathan Losk has joined Knobbe Martens Olson & Bear as a partner in the firm’s Los Angeles office.

Losk previously worked at medical device company St. Jude Medical, where he held

various roles, including chief patent counsel and director of strategic innovation.

Losk focuses on the medical device, electronics, communications and computing industries, helping clients to develop strategic patent portfolios.

He has particular experience in securing patents in the cardiac rhythm management, heart failure, and neuromodulation markets.

David Weiss, managing partner of the Knobbe Martens Los Angeles office, said: “Losk’s unique combination of skills—having served as both chief patent counsel and vice president of the electrical engineering department at St. Jude Medical, will be a tremendous asset to our team and our clients.”

Thomas Moga has joined LeClairRyan as shareholder in the firm’s IP and technology team.

In his new role, Moga will primarily be based in the firm’s Detroit office, while also working out of its Washington DC office.

He is an experienced patent prosecutor in the mechanical, chemical, biochemical and pharmaceutical arts and focuses his practice on IP and international business transactions.

His experience includes the development of domestic and foreign patent portfolios, the acquisition of registrations for trademarks and copyright, licensing, litigation, dispute resolution and mediation, and policy development.

Venable has promoted attorneys Vincent Verrocchio and Lars Genieser to counsel as part of a 10-attorney promotion drive.

Verrocchio has represented clients in all aspects of litigation matters, including patent and trademark infringement.

His practice covers all aspects of trial and appellate litigation in state courts, federal courts and arbitrations.

Genieser focuses his IP prosecution practice on pharmaceutical, chemical, mechanical and medical technologies of domestic and foreign clients.

He actively manages complex international patent portfolios for new therapeutics in preparing and prosecuting patent applications.

Brian Schwalb, vice chairman of Venable, said: “These senior associates have done consistently outstanding legal work.” IPPro

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