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)