Life Sciences Spotlight: Chinese regulatory enforcement action not slowing down; patent strategies and loyalty discounts; and more download
DLA Piper has released the fourth edition of Life Sciences Spotlight, which discusses developments in the sector across the Asia-Pacific region.
The allegedly unfair behaviour of a competitor does not justify exclusionary practices against it download
Cegedim, in a dominant position on the market of medical information databases, has been heavily sanctioned by the French Competition Authority.
AstraZeneca has failed to prevent generic companies from selling competing generic versions of its Crestor cholesterol drug. Minter Ellison represented Watson and Ascent in this matter.
Life Sciences Spotlight: Chinese regulatory enforcement action showing no signs of slowing down; and more download
Welcome to the fourth edition of Life Sciences Spotlight.
Our firm has extensive experience advising Swiss companies and subsidiaries of international groups on life sciences and healthcare matters.
On 1 August 2014, the FDA released draft guidance that would exempt from premarket 510(k) review many low-risk medical devices
Allen & Overy has won a spot alongside a raft of US giants to advise on Walgreen’s £5.6bn acquisition of its remaining stake in Alliance Boots.
Reed Smith has advised alongside a raft of European firms on Swedish pharmaceuticals company Meda’s acquisition of its Italian rival Rottapharm for £1.8bn.
Servier and other French pharmaceutical manufacturers have received fines for conspiring to keep generic medicines off the market.
The Irish Commercial Court has handed down judgment in Holloway and Others v Damianus BV and Others — otherwise known as the Omega Pharma case.
European Commission fines Servier and five generic companies for curbing entry of cheaper versions of cardiovascular medicine download
The European Commission has imposed fines totalling €427.7m on the French pharmaceutical company Servier and five producers of generic medicines.
Yana Dianova of GRATA took part in the meeting of the Expert Council for Competition Promotion in Social Sphere and Health?are.
DLA Piper has announced that Shane Albright has joined the firm’s corporate and finance practice as a partner in the Silicon Valley office.
Addleshaw Goddard’s Manchester M&A team has acted on key north-west deals totalling more than £860m in the last three weeks alone.
Khaitan & Co has advised Rexam on the India leg of the transaction in relation to sale of its containers and closures division of its healthcare business to Berry Plastics Group.
Khaitan & Co has advised Meiji Seika Pharma Co in relation to its acquisition of Medreich India and its subsidiaries.
Shoosmiths’ Adam Dowdney has advised the shareholders of Softbox Systems on the strategic majority investment by US private equity firm Great Point Partners.
The recovery in global M&A markets is developing a broader base, according to Allen & Overy’s latest M&A Index.
Shoosmiths has advised SAL and REC shareholders on their sale to Concept Life Sciences.
Antitrust and competition enforcement is changing fast: our report for multinationals from three global conferences download
The world of antitrust/competition enforcement is changing more rapidly than ever. This evolving environment presents new challenges for companies.
Herbert Smith Freehills and Slaughter and May are advising on the proposed takeover of Dublin-based Shire, by US drug manufacturer AbbVie.
The government has been consulting on broadening the scope of the Bolar exemption.
Irina Kirichenko gave a presentation titled ‘Forensics in the disputes on intellectual property rights protection in the field of pharmaceuticals’ at IPF 2014.
At Kemp Little, we have helped to drive the adoption of technology and data analytics as well as providing advice to life science companies supplying the sector.
Penningtons Manches’ life sciences team has won GLE’s award for Life Sciences Law Firm of the Year in England 2014 in the Client Choice category.
As spending on pharmaceutical R&D continues to soar, executives, shareholders and analysts alike are entitled to ask: what value are we getting for our investment?
Freshfields has swept the board in Thomson Reuters M&A rankings for the first half of 2013, coming top among all UK-based firms for global, European and UK-related M&A.
The Ely Lily case highlighted the impact a judicial decision can have on a business. But what of the wider impact a judge can have on the economy as a whole?
Shoosmiths has advised the shareholders of Orion Clinical Services on its merger with Simbec Research.
Amy Jensen Cunniffe has joined DLA Piper’s government affairs and healthcare public policy and regulatory practices as a senior policy adviser in Washington DC.
DLA Piper has advised Parnell Pharmaceuticals Holdings (PARN) in its initial public offering on NASDAQ.
Gateley has advised on the admission to trading of German biopharmaceuticals company Biofrontera on AIM.
Cleary Gottlieb Steen & Hamilton and Wachtell Lipton Rosen & Katz, alongside Irish heavyweights A&L Goodbody and Arthur Cox, are leading on the mammoth $42.9bn (£25.3bn) merger of medical technology giants Medtronic and Covidien.
Penningtons Manches has advised Adaptimmune, a biotechnology company, on its multi-million-dollar strategic collaboration and licensing agreement with GlaxoSmithKline (GSK) for the development and commercialisation of its lead clinical cancer programme.
Wragge Lawrence Graham & Co has advised biopharmaceutical company arGEN-X on its first collaboration with Bayer and on a strategic alliance with Shire.
New Thalidomide compensation bid download
Eight victims of the Thalidomide drug have filed papers at the High Court seeking compensation 50 years after they were born.
Khaitan & Co has advised Elder Pharmaceuticals in relation to the sale of some of Elder’s branded domestic formulations business in India and Nepal to Torrent Pharmaceuticals.
Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use has been published in the Official Journal of the European Union.
Penningtons Manches has advised Evotec in its acquisition of all shares in Euprotec, a UK-based specialist contract research organisation.
KPMG has launched a virtual R&D centre that will serve as a global innovation hub with the aim of incubating and developing data-driven business solutions.
Pillsbury has announced that for 2014, Chambers USA has ranked 86 individual Pillsbury lawyers, with 12 partners recognised in two or more categories for a total of 98 individual lawyer rankings.
Stephenson Harwood has advised on the two recent reverse takeovers of Feedback and Rex Bionics.
Conyers has provided Cayman law advice to Lombard Medical on its $55m US IPO and the listing of the company’s ordinary shares.
Foresight is an easy-to-use legal calendar that outlines major cases, government policy and forthcoming legislation right through to 2017.
In a recent Technical Board of Appeal decision, the European Patent Office has shed some light upon the boundaries of the prohibition against double patenting.
Nicholas Braslavsky QC and Andrew Grantham from Kings Chambers were recently successful in the Court of Appeal in the landmark decision of Webster v Liddington.
SeaLife Pharma has been named ‘Best start-up from the Biotech sector’ at the Biotech Venture Lounge and has received a comprehensive package from Wildgen.
New patent law proposals laid in Parliament could result in clinical trials being brought back to the UK.
Jonathan Brook has joined Eversheds as a partner in the law firm’s London litigation team.
Khaitan & Co has advised Exal Corporation on its complete buy-out of Mankind Pharma’s stake in Casablanca Industries Private.
On 28 November 2013, the European Commission announced a proposal for a directive on trade secrets and confidential information.
Chambers & Partners has published the latest Chambers Europe 2014 guide. Wierzbowski Eversheds has been recommended in numerous fields of law.
A raft of US firms, including Fried Frank Harris Shriver & Jacobson and Sullivan & Cromwell, have stepped up to advise on the $14.2bn acquisition of Merck’s consumer care business by Bayer.
The Employment Appeal Tribunal (EAT) has offered guidance on how employment tribunals should approach whistleblowing claims.
Bristows associates Dominic Adair, Jeremy Blum and Adrian Sim have been promoted to the partnership.
Attorneys from Dacheng’s Zhoushan office have advised Zhejiang Hailisheng Biotechnology Co on its new third board listing.
Technology businesses should be aware that the European Commission has revised the rules on how EU competition law affects technology licensing agreements.
Skadden Arps Slate Meagher & Flom and Freshfields Bruckhaus Deringer have scooped key roles on Pfizer’s proposed multi-billion dollar takeover of UK pharmaceuticals rival AstraZeneca.
DLA Piper has announced that Ben Boyd and Mary Gately have been named co-managing partners of the Washington DC office.
In food marketing litigation, class certification is a major hurdle for would-be class plaintiffs, but a recent case may have lowered the bar with a flexible approach to class certification.
The European Parliament has published its resolution on the proposal for a Regulation of the European Parliament and Council on trials on medicinal products for human use.
Cleary Gottlieb Steen & Hamilton and White & Case are advising on the £7.9bn ($13.4bn) acquisition of orthopaedic manufacturing company Biomet by Zimmer, the manufacturer of the ‘zimmer frame’.
Latest news — April 2014: the training of UPC judges; local and regional UPC divisions announced; and more download
The Preparatory Committee has now formulated a number of categories of suitability of the candidates, including those with training needs.
On 28 November 2013, the European Commission announced a proposal for a directive on trade secrets and confidential information.
The life sciences team at Penningtons Manches has recently worked alongside Evotec’s general counsel on the company’s research alliance with Panion.
The European Medicines Agency launched a new post-marketing surveillance system in the autumn called the ‘Black Triangle’ scheme.
The Court of Justice of the European Union has made its ruling in the case AstraZeneca AB v Comptroller General of Patents, Designs and Trade Marks.
There are a few developments in this year’s Budget that are of particular interest for those operating in the life sciences sector.
On 2 April 2014, the European Parliament voted in favour of the implementation of a new Clinical Trials Regulation.
Italy’s highest administrative court has ruled that Pfizer’s use of patents and SPCs relating to Xalatan/latanoprost in Italy constituted an abuse of its dominant position.
DLA Piper has announced that Lisa Haile and Mark Fowler have been named to the Daily Journal’s 2014 list of ‘Top Intellectual Property Lawyers’.
Dare to share? Proposed new directive should help protect your confidential information when doing business in Europe download
The European Commission’s new directive should help businesses to stop others from obtaining, disclosing or using their trade secrets in the EU without their permission.
Norwich Pharmacal relief — obtaining information relating to a BVI company from its registered agent download
This briefing note deals with the circumstances in which and methods by which non-public information about a BVI company can be obtained by a third party.
The MHRA offers useful guidance on the difference between apps that are regulated as medical devices and those that are related to healthcare but do not qualify.
Whether you are in pharmaceuticals, veterinary drugs, medical devices, diagnostics, biotechnology, life sciences research, plant biology, crop science, agriculture, or ‘border’ products such as nutraceuticals, food supplements and food products — Dentons knows your business.
That science and new scientific developments are a vital part of our modern society is reflected in one of the changes brought in by the new Defamation Act 2013.
Parmjit Singh, head of the India business group at Eversheds, has commented following Sun Pharmaceuticals’ acquisition of Ranbaxy.
Eversheds partner Richard Lewis has commented on Sun Pharmaceuticals’ acquisition of Ranbaxy.
Hogan Lovells has advised Actavis on its acquisition of Silom Medical Company for approximately $100m in cash.
Stephenson Harwood has advised Lansen Pharmaceutical Holdings on the acquisition of the rights to sell Sicorten Plus in China from Novartis.
At IBB, we are passionately committed to helping businesses develop a bespoke IP strategy to protect your property and build your commercial success.
Covington & Burling has advised new client Horizon Discovery on its admission to the Aim market, as the biotech market continues to pick up in the UK.
DLA Piper has secured the dismissal of patent infringement claims against subsidiaries of St Jude Medical, a global medical device manufacturer, by Volcano Corp.
Lookalikes: a wealth of confusion… brand-owners vs own-branders | competition law vs law of unfair competition download
Lookalikes are an age-old problem as brand-owners try to protect their brands from copying or leveraging by retailers or others.
The Federation of American Societies for Experimental Biology (FASEB) has released recommendations regarding response to threats by animal rights extremists.
Conyers Dill & Pearman’s British Virgin Islands office has recently added four attorneys to its corporate and litigation practices.
At a time when well-known names are disappearing from the high street as a result of retailers going into administration, the spectre of corporate insolvencies has never loomed larger.
This year is already shaping up to be a big year in the world of patents, with a number of Full Federal Court decisions due to be handed down on important issues.
The European Commission’s first decisions on ‘pay-for-delay’ arrangements attempt a tricky balancing of competing legal and policy objectives.
Edward Cooper and Jill Carey discuss how businesses can avoid certain pitfalls when renewing a commercial lease.
Ian McEwan and Jill Carey provide a summary of the issues that should be taken into account by a company when planning an exit strategy.
Penningtons Manches has advised Oxford Gene Technology on its acquisition of Cytocell.
Gateley’s Manchester corporate team has advised on a recent deal that saw oncology business Incanthera acquire University of Salford spin-out Onco-NX.
The FDA has distributed a revised draft guidance document titled ‘Distributing Scientific and Medical Publications on Unapproved New Uses — Recommended Practices’.
The pharmaceutical industry is one of the key business sectors for Ilyashev & Partners.
Schoenherr’s regulatory expertise and longstanding experience is recognised as the standard bearer for regulatory-related advice.
Schoenherr’s IP practice group has long-standing experience and an outstanding reputation in trademark, design, patent, copyright and unfair competition matters.
Our core practice is advising and representing clients on transactions and complex corporate and commercial matters.
Bristows partner Hazel Grant has identified the issues that pharmaceutical manufacturers might face to comply with the UK Data Privacy Act in a interview with BMI System.
Animal welfare: recent EU conference — mid-term review of the strategy for the welfare of animals 2012–15
The conference on the achievements of the EU strategy for the welfare of animals 2012–15: mid-term review took place on 12 February 2014.
One of the EPO Boards of Appeal has ruled on the highly debated issue of human stem cell patentability under the European Patent Convention.
FDA revises forms for submission of patent information to the Orange Book: Federal Circuit decision alters patent term adjustment download
Two recent developments will affect the listing of patent information with pharmaceutical products approved by the US Food and Drug Administration.
California GCI’s coming priority products list and the DTSC Strategic Plan — what do they mean for you? download
The highly anticipated next step in California’s Green Chemistry Initiative (GCI) is the planned April 2014 release of the list of ‘priority products’.
NYAG forges new ground in scrutiny of pharmaceutical agreements with first-filer exclusivity no-challenge settlement download
NYAG has reached a settlement with two drug manufacturers regarding allegations that an agreement between the firms not to challenge each other’s eligibility for regulatory exclusivity was anti-competitive.
A team of attorneys from Dacheng’s Wuhan office has advised Ferguson (Wuhan) Biotechnologies on its application for a listing at the NEEQ system.
Eversheds’ Madrid office has successfully represented pharmaceutical company MSD Spain in a landmark patent dispute.
Fundraisings of early-stage life science companies can be complicated affairs from the point of view of actually securing the funds from investors in the first place.
The articles of association are a contract between the company and each shareholder and between the shareholders themselves.
A life sciences company raises funds either by issuing shares or by borrowing money from individuals, venture capital bodies or lending institutions.
A number of life sciences industry bodies have jointly published a report entitled ‘From vision to action: delivery of the strategy for UK life sciences’.
Two new references have been made to the CJEU asking for preliminary rulings on issues under Regulation (EC) No 469/2009.
It is common in investments for life sciences companies for a term sheet to be put in place between the investors and the founders that sets out the key terms of the investment.
This case relates to an application for payment of damages, further to a cross-undertaking on a preliminary injunction.
One innovative deal structure is geographical licensing. While apparently simple on the face of it, the devil is in the detail.
Hogan Lovells has continued the expansion of its Los Angeles office with the addition of healthcare litigation partner Michael Maddigan.
French firms Bredin Prat and Darrois Villey Maillot Brochier, alongside Switzerland’s Homburger and Orrick Herrington & Sutcliffe, have taken lead roles on L’Oréal’s buyback of €6.5bn in shares from Nestlé.
Hogan Lovells has announced the further expansion of its New York office with the addition of corporate partner Adam Golden.
As test results from a public laboratory in West Yorkshire find more additives in food products, Eversheds’ health and safety partner David Young considers the consequences.
Pharmaceutical sector update download
The latter half of 2013 proved to be an interesting period for the pharmaceutical sector from a competition law perspective.
Wragge & Co’s life sciences team has brokered a licensing agreement between AstraZeneca and a partnership of Belgian life sciences research institutes.
Federal judge limits antitrust scrutiny of pharmaceutical reverse payments to settlements involving monetary transfers download
A judge held that only patent settlements involving a reverse monetary payment will be subject to antitrust scrutiny under the framework articulated by the Supreme Court last year in FTC v Actavis.
Allen & Overy has advised Rexam, a global beverage can maker, on the sale of the bulk of its healthcare business to Montagu Private Equity for $805m.
The Administrative Decisions Tribunal has upheld an employee’s claims of indirect racial discrimination because the employer’s selection criteria excluded members of a certain race.
Health, Pharmaceutical and Biotechnology Alert: HRSA issues letter discussing ADAP 340B rebates; proposed rule expected download
On 3 February 2014, the Office of Pharmacy Affairs posted a letter to its 340B drug pricing program website discussing 340B rebates paid to AIDS Drug Assistance Programs.
Health Alert — 3 February 2014 download
DLA Piper has released the 3 February 2014 issue of its Health Alert, which focuses on judgments, legislation and reports in the health sector.
The National Academy of Sciences is set to present its 2014 Public Welfare Medal to Hogan Lovells partner John E Porter.
Health Alert — 28 January 2014 download
DLA Piper has released the 28 January 2014 issue of its Health Alert, which focuses on judgments, legislation and reports in the health sector.
Taylor Wessing has launched its third Cambridge newsletter, providing legal news and updates for companies in Cambridge and the surrounding areas.
There were developments last month in the ongoing discussions around the need for greater regulation of cosmetic medical devices.
Draft social media guidance download
After four years of waiting, the Food and Drug Administration has released its draft social media guidance.
The first preliminary injunction decision in Germany relating to a ‘bio-better’ type drug has been made in Amgen v Teva in the Düsseldorf District Court.
This unusual application related to proceedings to revoke a European patent and a declaration that an SPC based upon it would not be valid.
The CJEU delivered three important rulings on the application of the supplementary protection certificate regulation 469/2009/EC on the same day.
Compensating employee inventors download
In the life sciences industry, highly skilled people are employed in the research and development of drug candidates and other advancements associated with therapy.
A Düsseldorf court has referred questions to the CJEU on the supply of substances by a third party to a company that intends to use the substance for obtaining a marketing authorisation.
On 9 December 2013, the European Commission published its report on the monitoring of patent settlements from January to December 2012.
Taylor Wessing’s lawyers from Austria, Germany and the UK explain their respective national approaches to the issue of ex-employees in possession of trade secrets.
New research suggests that athletes using steroids for only a short period could gain an unfair advantage over ‘clean’ competitors for up to 10 years.
Inward investment to Ireland is rising, just the tonic for its law firms
DLA Piper has represented Arsenal Capital Partners in its purchase of Certara, a biopharmaceutical service provider.
CJEU referral of the Düsseldorf Court of Appeal regarding third-party supply for Bolar exemption purposes download
A Düsseldorf court has referred questions to the CJEU on whether the supply of patent-protected substances by a third party to a generic company is covered by the Bolar exemption.
DLA Piper advised on more than 20 significant inbound and outbound US transactions that closed last year on behalf of Israeli institutional investors and companies.
Collyer Bristow has announced that it has recruited intellectual property specialist Tim Bamford from Withers, where he had been a partner since 2005.
French pharmacists can now substitute a biosimilar for the prescribed (reference) biological medicine as long as the prescribing physician has not marked the prescription as ‘non-substitutable’.
Conyers Dill & Pearman has advised Hony Capital Fund V and New Good Management on the $495m privatisation of Simcere Pharmaceutical Group by way of merger.
Addleshaw Goddard has announced the arrival of commercial litigation expert Bill Gilliam, previously head of Eversheds’ health and life sciences practice.
Bristows has appointed partner Rosemary Choueka and announced the promotion of three associates to the partnership next May.
DLA Piper has announced that Wayne P Bunch Jr has joined the law firm’s franchise and distribution practice as a partner in the Houston office.
Hogan Lovells has announced the promotion of 29 new partners, effective 1 January 2014.
Astrazeneca Insurance v XL Bermuda and Ace Bermuda was the first case in which the English courts had been asked to consider the proper interpretation of a ‘Bermuda Form’ policy.
Foreign companies operating in certain complex or sensitive industries in China need to do more than instil an anti-corruption policy.
Federal Circuit limits ITC authority to remedy patent infringement claims based on induced infringement download
A limited exclusion order under section 337 may not be predicated on a theory of induced infringement when the subject imported product did not directly infringe before or at importation.
Appleby has acted as Cayman counsel for Consun Pharmaceutical Group in relation to its listing on the Main Board of the Hong Kong Stock Exchange on 19 December 2013.
The Hong Kong office of Eversheds has advised BOCI Asia in connection with the HKD1.09bn initial public offering (IPO) of Consun Pharmaceutical Group.
On 12 December 2013, the OFT announced that a £380,000 settlement had been agreed in relation to a market sharing cartel involving two pharmaceutical suppliers.
On 5 December 2013, the Court of Justice of the European Union published its decision on the appeal of the European Medicines Agency.
The Court of Justice of the European Union has released a ‘reasoned order’ in the GSK Biologicals SA case (C-210/13).
The High Court has ruled that there was no need for Doncaster Pharmaceuticals Group to rebrand its imported products as Regurin in order to gain effective access to the market.
Personalised medicine is a very promising and cutting-edge approach that Taylor Wessing recently discussed from a patent law perspective in its Synapse October edition.
In regulating the pharmaceutical industry, legislators have to balance a number of competing interests.
Eversheds has advised Milan-based Recordati Spa on the acquisition of 67 per cent of shares in Tunisian pharmaceutical company Opalia Pharma.
On 12 December, the Court of Justice of the European Union (CJEU) delivered three important rulings on supplementary protection certificates under Regulation 469/2009/EC.
Allen & Overy has advised German pharmaceutical and chemical group Merck on its £1.6bn takeover offer of Luxembourg-based AZ Electronics Materials.
The Düsseldorf Court of Appeal has referred questions to the CJEU on whether the supply of patent-protected substances by a third party to a generic company is covered by the Bolar exemption.
The Australian High Court has delivered its first judgment that directly considers the patentability of methods of medical treatment.
Allen & Overy (A&O), Ashurst and Clifford Chance have advised on German drugs and chemicals group Merck’s £1.6bn acquisition of AZ Electronic Materials.
Pharmaceutical sector — clarification on approach to market definition for prescription medicines download
A recent decision by the Court of Appeal provides useful guidance on the correct approach to defining the market in relation to pharmaceutical products.
The considerable duration of EPO proceedings will continue to point in favour of refusing a stay of English proceedings in most cases.
The European Medicines Agency is currently developing a policy on the proactive publication of clinical-trial data.
Pharmaceutical benefit assessments play an increasingly important role in refunds by the national health services.
Incubators are not often commonly associated with corporates or business enterprises, yet young companies can benefit greatly from a period of ‘incubation’.
In September 2012, the European Commission adopted a proposal for a regulation on in vitro diagnostic medical devices.
Simon Crossley of Eversheds has commented in response to calls from the pharmaceutical industry that the number of medicines being blocked from the UK market by NICE is too high.
Eversheds has been appointed as legal adviser to the Cell Therapy Catapult, a UK centre of excellence in cell therapy, following a competitive pitch process.
The Advocate General’s opinion in Georgetown University has been released. It fails to recommend whether or not more than one SPC can be granted based on the same patent.
Despite 20 states allowing the use of medicinal marijuana and two more allowing recreational marijuana use, employers remain unaffected.
Allen & Overy (A&O), Osborne Clarke (OC) and Proskauer Rose have taken mandates advising on the $1.7bn (£1bn) sale of Swiss pharmaceutical giant Novartis’ transfusion diagnostics unit to Spanish plasma therapies company Grifols.
Antitrust agencies amend premerger notification rules to clarify reporting of acquisitions of pharmaceutical patent rights download
The new rules may cause an uptick in premerger notification filings in the pharmaceutical industry.
The FTC has announced final changes to certain HSR rules regarding acquisitions of exclusive patent rights in the pharmaceutical industry.
The FTC has announced revisions that clarify the types of patent licenses in the pharmaceutical industry for which a filing must be made before such licenses may become effective.
Eversheds Ireland has played a key role in the takeover by Endo Health Solutions of Paladin Labs Europe for approximately £1.1bn.
Allen & Overy has advised Husky Injection Molding Systems on its acquisition of Schöttli Group. The sale is expected to close in early December.
Simon Crossley from Eversheds believes the deal should be a good outcome for industry and government.
The 2014 edition of Chambers UK has recognised Pillsbury’s outsourcing and information technology practice and several partners.
On 23 September 2013, the Italian Supreme Court decided on the so-called ‘galenical exemption’ provided by Italian laws as a limitation to the enforceability of pharmaceutical patents.
The specialist pharmacy team at Sintons has overseen the £37m management buyout transaction of pharmaceutical wholesaler DE Group.
Corporate lawyers from Hogan Lovells’ Silicon Valley office have helped Five Prime Therapeutics to finance its operations and to enter the public market.
Copyright litigation update: copyright register has ‘right to weigh in’ before registration is invalidated download
The 7th Circuit has held that a district court had committed legal error in invalidating a copyright registration without first consulting the Register of Copyrights.
Eversheds has commented on proposed new laws governing medical devices being debated in the EU parliament.
The provisions proposed by the European Commission in its regulation target better supervision of the accreditation bodies.
Medicinal products may be protected by a paediatric extension, which extends the lifetime of a supplementary protection certificate by a further six months.
The number of candidates entering and progressing through the product pipelines of some leading originator pharmaceutical companies has diminished.
The European Parliament and the European Council have adopted a new customs regulation, replacing Regulation 1383/2003/EC.
Hogan Lovells has hired partner Eduardo Ustaran to join its global privacy and information management practice.
Conyers has provided Bermuda legal advice to Bank of America in connection with a $3.1bn sale and repurchase agreement related to the acquisition by Amgen of Onyx Pharmaceuticals.
Offering healthcare solutions at consumers' fingertips? What you should know about FDA regulation of mobile medical apps download
More than two years after the FDA issued draft guidance on ‘mobile medical applications’, the agency recently issued its final guidance.
Hogan Lovells has announced that Michael Kasser has joined the firm as a regulatory specialist in its food, drug, medical device and agriculture group.
On 27 September, the PhRMA filed suit against the HHS challenging the 340B orphan drug final rule.
Lawyers handling our pharmaceuticals and healthcare practice have acquired massive expertise in advising a large number of pharmaceutical and biotechnology companies and medical devices manufacturers.
The ECJ held that the TRIPs (Trade-Related Aspects of Intellectual Property Rights) agreement falls within the field of the ‘common commercial policy of the union’.
The CJEU has given judgment in case C-109/12, which concerns some practical effects of the borderline between medicinal products and medical devices.
The US Food and Drug Administration (FDA) issued the final unique device identifier (UDI) rule on 24 September 2013.
On 23 September 2013, the FDA released the long-awaited mobile medical applications final guidance.
On 2 July, the National Development and Reform Commission (NDRC) announced an investigation into the prices charged by 60 foreign and domestic drug makers.
On 1 August 2013, Shanghai Higher People’s Court made a final judgment on the Rainbow v Johnson & Johnson case.
ENVI has voted to approve a suite of amendments to the draft European legislation governing medical devices.
New Third Circuit decision toughens standard for class certification when information about individual consumers is lacking download
A recent decision has toughened the standard for class certification when information about individual consumers is lacking.
A federal judge has largely denied a series of motions seeking dismissal of various ‘pay-for-delay’ claims brought by direct and indirect purchasers involving AstraZeneca’s Nexium drug.
Two deals this year have propelled the Irish pharmaceuticals sector back into the spotlight
Investigations have recently been reported into allegations that millions of pounds worth of bribes have been paid to boost drug sales in China.
Under the ‘sunset clause’, any marketing authorisation for a medicinal product that has not been marketed for three years will cease to be valid.
Pharmaceuticals company Lundbeck has been the subject of two important decisions in recent weeks.
Second medical use patents download
Patent cliffs remain one of the biggest issues facing the pharmaceutical industry.
DLA Piper has published the second issue of its Life Sciences Spotlight publication for 2013.
The future of DNA patents download
The US Supreme Court has ruled that certain patent claims owned by Myriad Genetics are invalid as products of nature.
DLA Piper has released the Q3 2013 edition of its Intellectual Property and Technology News — EMEA.
US private equity firm Bain Capital has recently acquired an 80 per cent stake in blood products company Plasma Resources UK for £230m.
Macfarlanes, Peters & Peters and Taylor Wessing will do battle with Herbert Smith Freehills in a multi-million pound case that pitches the NHS against pharma giant Reckitt Benckiser Group in January.
Insights on drafting pharmaceutical patents from the Supreme People’s Court’s Annual Report of Intellectual Property Cases download
In April 2013, the Supreme People’s Court issued the Annual Report of Intellectual Property Cases, which included 34 typical intellectual property and competition cases.
Health Alert — 12 August 2013 download
The 12 August 2013 issue of DLA Piper’s Health Alert is available now.
Following the surprise doping scandal involving Godolphin stables in Newmarket, Sheikh Mohammed Bin Rashid Al Maktoum has moved swiftly in response to the findings of the BHA.
Sullivan & Cromwell and Dillon Eustace have taken the lead roles for US pharmaceutical company Perrigo as it acquires Irish-headquartered biotechnology company Elan.
A wind of change in Hungarian pharmaceutical regulations — a welcome breeze of fresh air or an unpleasant gale? download
On 8 July 2013, a new Hungarian law entered into force affecting the pharmaceutical sector.
DLA Piper wins the M&A Advisor Healthcare/Life Sciences Deal of the Year (under $250m) award.
Over the past 10 months, Grant Thornton and DLA Piper have launched a successful life sciences boardroom lunch series.
Over the past few years, the European Commission has been investigating perceived anti-competitive practices in the pharmaceuticals sector.
Health Alert — 22 July 2013 download
The 22 July 2013 issue of DLA Piper’s Health Alert is available now.
The implementing decree regulating the online sale of medicines was published on 23 June 2013 and enters into force on 12 July 2013.
The regulation of similar biological medicinal products (‘biosimilars’) is governed by article 10(4) of Directive 2001/83 as amended, supplemented by the annex to the directive.
The draft EC data protection regulation proposes a number of changes to the EU data protection regime.
Negotiating a good patent licence is a challenging business at the best of times.
Patent infringement by pre-expiry offer to supply a product after the patent has expired is an area of acute difficulty in Austria.
In France, two sets of rules apply to the enterprises operating in the medical sector when dealing with health professionals, their organisations and healthcare institutions.
SPC protection for combinations download
It has proved very difficult to interpret the legislation governing supplementary protection certificates (SPCs) as regards combination drugs.
DLA Piper in Ukraine has been highly ranked in a number of sectors by legal magazine Gvardia.
Our dedicated healthcare team delivers pragmatic advice to healthcare operators, professionals and businesses.
The OIG has released an advisory opinion approving a proposed arrangement by a manufacturer to establish a tiered rebate programme for its customers.
We have unparalleled experience in these areas.
The Supreme Court has changed the interplay between the national court and the EPO when considering a defendant’s liability to pay damages.
The current regulation block-exempting certain categories of technology licensing agreements from the competition rules on anti-competitive agreements is due to expire on 30 April 2014.
Supreme Court in Actavis: analyse reverse-payment settlements' anticompetitive effects case by case download
The Supreme Court in FTC v Actavis held 5-3 that reverse-payment settlements of Hatch-Waxman Act litigation must be analysed under the rule-of-reason standard on a case-by-case basis.
A federal jury in New York has found Hebei Welcome Pharmaceutical Co and its parent liable for agreeing with other Chinese manufacturers to fix prices in the vitamin-C market.
The US Supreme Court ruled in Federal Trade Commission v Actavis that antitrust challenges to pay-for-delay agreements between drug makers should be analysed under the ‘rule of reason’.
On 17 June, the Supreme Court finally weighed in on the issue of pharmaceutical patent settlement agreements involving so-called ‘reverse payments’.
The Supreme Court has issued its decision in FTC v Actavis on the antitrust analysis of reverse-payment settlements of Hatch-Waxman Act litigation.
A recent survey of sales and marketing executives at large pharmaceutical companies shows that one in four interactions with doctors, healthcare providers and patients in the US is now digital.
Compulsory licensing of patents download
The availability of compulsory licences in respect of patents, especially in relation to pharmaceutical patents, has been the subject of considerable attention lately.
Another reference has been made to the Court of Justice of the European Union for a preliminary ruling on the patentability of stem cells.
R&D capital allowances download
R&D capital allowances (formerly scientific research allowances) are available for qualifying capital expenditure incurred for research and development.
With Google Glass creating interest in the media, attention is shifting to the possibility of a new generation of technology that is not just portable but wearable.
On 13 June 2013, the US Supreme Court ruled that certain patent claims owned by US biotech company Myriad Genetics are invalid as products of nature.
Novartis has been awarded an interim injunction against Hospira to prevent sales of generic zoledronic acid in the UK despite Novartis’s patents having been declared invalid by the English High Court.
Transparency of clinical trials data download
This document contains an overview of current rules on access to clinical trials data, an overview of the anticipated legislative changes and a summary of the issues that the new regulation may bring.
Chambers USA 2013 recognises Hogan Lovells’ practice areas and lawyers.
Mills & Reeve has advised Sphere Fluidics on its recent £1.65m series A funding from a syndicate of investors.
The Court of Appeal has allowed Novartis’s application for a preliminary injunction against Hospira.
NCTM has advised the management of DOC Generici on its acquisition by Charterhouse Capital Partners.
The Court of Appeal has confirmed that the English court has cross-border non-infringement jurisdiction.
Taylor Wessing has released the May 2013 edition of its Cambridge Technology and Life Sciences Update.
Taylor Wessing has added a fresh batch of data-protection-focused content to its Global Data Hub site.
Health Alert — 6 May 2013 download
The 6 May 2013 issue of DLA Piper’s Health Alert publication is available now.
Health Alert — 13 May 2013 download
The 13 May 2013 issue of DLA Piper’s Health Alert publication is available now.
Healthcare advertising in the UAE download
Many changes are afoot in respect of healthcare and pharmaceuticals in the UAE. There is a real push to improve standards relating to health and medicine across the board.
DLA Piper has advised Healthcare Buying Group on its acquisition of DBG (UK) from Synova Capital.
Patients First and Foremost, the government’s initial response to the Francis Report, was published just before Easter.
This article offers some simple tools to help guide compliance officers, executives, new lawyers and others in evaluating whether Stark may prohibit a proposed or existing arrangement.
The spring 2013 issue of Walker Morris’s Procurement Update covers topics such as the EU procurement reforms, the Utilities Directive and NHS healthcare services.
The Life Sciences Law Review explores legal issues of special interest to pharmaceutical, biotechnology and medical device companies in 27 jurisdictions.
OIG’s ‘Special Fraud Alert on Physician-Owned Entities’ is the strongest statement to date that investing in or doing business with a POD is a significant Antikickback law risk.
The government has launched a consultation on whether NHS organisations should be made subject to compulsory data protection audits.
A raft of Irish, UK and US firms have won roles on the battle for control of Irish biotechnology company Elan, which yesterday rejected an offer from Royalty Pharma.
Henry Carr QC, sitting as a deputy High Court judge in the Patents Court, has made only the second reference to the CJEU for a preliminary ruling on the patentability of stem cells.
This briefing is intended to cut through the pages of small print and to see where CCGs will stand in the new world order when it comes to planning and securing services for patients.
In Resolution v Lundbeck, Arnold J has allowed Resolution Chemicals Ltd to pursue its own revocation proceedings against Lundbeck’s SPC/GB02/049 protecting escitalopram.
Taylor Wessing has released the April 2013 edition of Synapse, its publication dedicated to law for life sciences.
Hogan Lovells’ global life-sciences practice has been placed in band one for the second year running in the Chambers and Partners Global 2013 rankings.
Mourant Ozannes has advised a consortium of investors on the £700m sale and leaseback of 12 UK private hospitals from the Spire Healthcare Group.
The US Food and Drug Administration is undergoing a major culture change, and nowhere is that impact being felt more than in the food industry.
The latest issue of Data & Information E-Alerts is available now from Addleshaw Goddard.
Interpretation of section 25 of the Self Regulation Code of Marketing Communication.
The CMS provides stakeholders with the opportunity to comment on certain aspects of the Sunshine final rule that were not raised in the proposed rule.
Comparative advertising in the UAE.
Arnold J says the SPC system is dysfunctional as it cannot be applied consistently by local patent offices.
This month on Synapse, Taylor Wessing discusses the impact of insolvency on licensors and licensees in the life sciences sector.
Medical device alert download
The US FDA has issued new draft guidance on distinguishing medical device recalls from product enhancements.
Taylor Wessing discusses injunctions against pharma patent infringement.
Chinese SOE unable to extricate itself from US antitrust litigation against vitamin C exporters download
Judge’s decision illustrates the risks that Chinese parent companies face when doing business in the US through affiliates.
The Curtis Life Sciences group provides a wide range of legal services to clients in the life sciences sector, including manufacturers, funds and institutions.
Our pharma team is highly knowledgeable about the process of development, testing and commercialisation of pharmaceutical products and their entire lifecycle.
China trade marks — inclusion of retail and wholesale services relating to medicines and pharmaceuticals download
The China Trade Marks Office recently announced that from 1 January 2013 it is accepting applications to register trade marks in relation to retail or wholesale services for pharmaceutical, veterinary and sanitary preparations and medical supplies only in class 35.
Welcome to the Fall/Winter 2012 issue of our China Life Sciences Newsletter, a periodic update on key developments, companies, and people in the dynamic China life sciences industry.
The heart of a marketing authorisation application is the pre-clinical and clinical data that proves the drug’s safety and efficacy.
On 6 December 2012, the EU Court of Justice dismissed AstraZeneca’s appeal of the General Court’s judgment in AstraZeneca v Commission.
The general counsel of Swiss generic drugmaker Actavis is to step down from the role as US rival Watson Pharmaceuticals acquires the company for €4.25bn (£3.4bn).
Weight Watchers has launched a tender process for a UK and Europe healthcare panel as the slimming group prepares to expand its business of working with state and commercial organisations in the sector.
US firms Latham & Watkins, Skadden Arps Meagher & Flom, Sullivan & Cromwell and Weil Gotshal & Manges have all won roles advising on Valeant Pharmaceuticals’ $2.6bn (£1.6bn) acquisition of dermatology drugmaker Medicis Pharmaceutical.
Field Fisher Waterhouse (FFW) has launched a representative office in Silicon Valley in a bid to clinch work originating in the Californian technology hub.
Clifford Chance and Linklaters were part of a string of City firms advising on private equity group Cinven’s £465m acquisition of generic drugs company Mercury Pharma from HgCapital.
FCPA update — July 2012 download
In this issue: the SFO’s latest bribery related settlement; The difficulty of recovering damages from the government when an FCPA prosecution misfires; German High Court ruling on pharmaceutical industry and doctors.
Novartis has announced the results of its first panel review since the company’s $40bn takeover of Alcon, with three magic circle firms – Allen & Overy, Freshfields Bruckhaus Deringer and Linklaters – securing spots on the global roster along with two US firms.
The Royal Pharmaceutical Society (RPS) is looking to put together its first legal panel, with the move coming shortly after the arrival of its first general counsel.
Hogan Lovells has boosted its global life sciences practice with the hire of partner Carla Schoonderbeek and her team of five associates from NautaDutilh.
CMS Cameron McKenna and Freshfields Bruckhaus Deringer secured prize mandates on the €9.6bn (£8.4bn) sale of Swiss drug company Nycomed to the Japanese Takeda Pharmaceutical Company.
A quartet of international firms has scooped lead roles as French pharmaceutical giant Sanofi-Aventis finalised its $20.1bn (£12.47bn) acquisition of US company Genzyme.
Despite global economic conditions, deal-making by large pharmaceutical companies has remained relatively buoyant, say Daniel Pavin, Grant Castle and Alexandra Pygall.
The UK life sciences industry is a world leader, but the lack of appetite from domestic investors is potentially threatening the development of life-saving medicines, says Simon Wallwork
Beachcroft is to install a healthcare consultancy unit after appointing the former chair of the Healthcare Commission Sir Ian Kennedy as a consultant.
Kurt Geiger general counsel Suzanne Smith is to leave the company to return to the pharmaceuticals sector, joining global biotechnology corporation Genzyme.
Willkie Farr & Gallagher has advised US dermatology company Stiefel Laboratories on its $3.6bn (£2.5bn) takeover by pharmaceutical giant GlaxoSmithKline (GSK)