Patent restrictions on drug trials in the UK will be lifted, making it easier for new drugs to be compared with the standard treatment.

The new exceptions enable companies to trial a new drug or a generic version against an established brand without violating its patent.

The changes to the Patents Act could both strengthen the UK as a base for pharmaceutical R&D and improve the medical value of clinical trial findings.

Life science industry trade associations have welcomed the new regulations for the boost they offer to innovative drug development, despite potential losses to established brands.

An Intellectual Property Office consultation showed overwhelming industry support for both changes to the patent law: the ‘research exception’ for trials of new drugs and the ‘Bolar exception’ for trials of generic drugs.

Not only does the rule that head-to-head clinical trials infringe patent make it harder to establish new drugs, it has also led to widespread criticism of clinical trials that compare a new drug with placebo – which no doctor prescribes.

Most EU countries exempt clinical trials from patent infringement, and the UK law has been a barrier to clinical trial work in the UK.

“The Government is keen to create a supportive environment for pharmaceutical research and development in the UK,” said Lord Younger (pictured), Minister for Intellectual Property.

“Helping the industry get their products to market as quickly as possible will benefit patients, the industry and the economy.”

Stephen Whitehead, CEO of the ABPI, commented: “This is a welcome development that will make the UK a more attractive place in which to conduct clinical trials, which in turn will encourage pharmaceutical companies to continue operating here.”

The European Parliament has voted for measures to speed up patient access to generic medicines.

The proposal to shorten the period for decisions on pricing and reimbursement of generic drugs from 180 days to 60 days was backed by 559 votes to 54.

Some member state governments are expected to resist the change, which could enable generic drug manufacturers to negotiate higher prices.

The deadline for new (branded) drugs would remain set at 180 days from regulatory approval, under rules that date back to 1989.

Bulgarian MEP Antonyia Parvanova, an architect of the new legislation, commented: “It is unacceptable that delays in the pricing and reimbursement of medicines can sometimes reach more than 700 days.”

The draft legislation would also require national health systems to publish an annual list of medicines available within each system and their prices, as well as the names and declarations of interest of the experts consulted.

While accepting that pricing and reimbursement are national responsibilities, the European Commission has stated the legislation will clarify these procedures and help to avoid unnecessary delays in access to generic drugs.

The proposed change may favour generic drug manufacturers in terms of pricing negotiations, as well as making the ‘patent cliff’ steeper for branded drugs.

Glenmark Generics (Europe) Ltd (GGEL) has launched a generic version of Glaxo’s successful anti-malaria drug Malarone in the UK, following the revocation of Glaxo’s patent.

The High Court determined that Glaxo could not block the launch of generic atovaquone proguanil, with the presiding judge saying the case was “obvious”.

The drug brought Glaxo £17.76m in the UK in 2012, a sizeable market that Glenmark is set to undercut.

Malarone is indicated for the prevention and treatment of acute, uncomplicated p.falciparum malaria, especially in patients resistant to treatment. It is recommended by the UK’s Malaria Reference Laboratory.

The mosquito that transmits malaria is not found in the UK, but prevention and treatment in people travelling to tropical regions can be necessary.

Rahul Garella, Glenmark’s Senior Vice President Europe, said: “Atovaquone proguanil is a well-established treatment for malaria. Doctors, pharmacists and consumers, in particular travellers, need to be made aware that there is now a first-class quality generic option available which can offer a more competitive solution.”

GGEL is based in the UK and sells, directly and through distribution partners, in the UK, Ireland, Germany, the Netherlands, Denmark and Sweden, with more than 300 generic drugs approved for sale in Europe.

It is the European arm of Glenmark Generics Ltd (GGL), which aims to be a leading global supplier of generic drugs and active ingredients. GGL is a subsidiary of the Glenmark Pharmaceuticals group, based in India.

Rosemont Pharmaceuticals, the leading UK supplier of liquid oral medicines, has been acquired by US company Perrigo.

The merger will enable Perrigo, a major supplier of over the counter (OTC) products, to add a range of liquid-form drugs to its generic prescription drugs portfolio.

Leeds-based firm Rosemont, sold for £180m, has seen its business grow dramatically in recent years due to the ageing population.

Its liquid formulation versions of widely-prescribed drugs such as metformin target paediatric patients and people suffering from dysphagia (which affects many elderly patients), with net sales of £40m in 2012.

Perrigo will benefit from the UK firm’s niche market, an area of critical medical need with demographic factors driving an increase in its size; and from the opportunity to expand its range of generic prescription medicines in the UK and Europe.

Joseph C. Papa, CEO of Perrigo, said: “We continue to focus on expanding our international footprint and view the acquisition of Rosemont as an opportunistic next step given our existing presence in the UK.

“Similar to Perrigo’s position in the niche US extended topical generic prescription market, Rosemont is the number 1 player in the niche specialty UK oral liquid formulations market.

“This transaction represents another step forward executing our strategy to make quality healthcare products more affordable for consumers around the world.”

Based in Michigan, Perrigo is the world’s largest manufacturer of OTC pharmaceuticals for the store brand market, as well a major supplier of generic prescription drugs.

The global market in statins, once the pharmaceutical industry’s lead blockbuster products, is predicted to decline by 40% in the next five years.

The forecast by GBI Research of a negative CAGR of 7.2% up to 2013 for the cholesterol-lowering drugs is based on prospects of generic erosion, weak pipelines and failing prescriber confidence.

The decline in the statins market shows that the shift of healthcare towards prevention and management of long-term conditions is not without pitfalls for the pharma industry.

Statins, which lower cholesterol levels by targeting an enzyme in the liver, have been hailed as ‘wonder drugs’ that could radically reduce the global incidence of cardiovascular events.

Routinely prescribed for ‘high-risk’ patients such as people with high blood pressure or diabetes, statins have also been linked to reduced risk of bowel cancer and reduced death rate from influenza.

However, their global market declined from $23.7 billion in 2004 to $20.5 billion in 2011 (a negative CAGR of 2.5%), due largely to patent expiry.

The report predicts a much steeper decline in the statins market over the next five years, for four reasons:

• Patent expiry – the generic share of the statins market is predicted to grow from 11% in 2011 to 34% in 2018.

• Austerity health budgets – spending on prevention is likely to be cut back.

• Weak product pipelines – the ‘me-too’ nature of most statins betrays a lack of potential for innovation.

• Increased use of alternative drugs.

Medical writer Ben Goldacre has argued that the marketing of statins in terms of relative risk reduction glossed over the low absolute risk reduction they offer, and left the products open to a backlash over side-effects.

Statins are associated with both symptomatic side-effects (including digestive disorders) and potential ones (including increased risk of type 2 diabetes).

As the overall statins market declines, the report says, individual products will struggle to gain or keep a place within it: “The global statins market has reached the competitive stage of its lifecycle, with many branded and generic drugs competing with each other on price.”

US generic drug company Watson Pharmaceuticals has taken the name of its recently acquired subsidiary, Actavis.

The company, which is now the world’s third largest manufacturer of generic drugs, has launched a new global website.

Actavis now has two business strands: Actavis Pharma makes and sells generic and biosimilar medicines while Actavis Specialty Brands makes and sells branded drugs in specialist areas.

The company, which has operations in 60 countries worldwide, achieved $8bn revenue in 2012.

Paul Bisaro, President and CEO of Actavis, said: “Today marks an historic day for Actavis and a milestone in our evolution into a global pharmaceutical leader. While we have been operating as one company since last year, today we unite all of our 17,000 employees under a single name.”

The new Actavis logo was designed by Lippincott, a leading brand development agency. The company’s press release explains that its green colour “reflects growth – a fundamental foundation for Actavis and its future – and a commitment to be an environmentally responsible company.”

Actavis is based in New Jersey, USA, with international headquarters in Zug, Switzerland. Its UK operation is based in Barnstaple, Devon.

The company’s Actavis Pharma business manufactures and sells generic, branded generic and legacy brands and OTC products, and is ranked in the top 10 in 33 global markets.

Its Actavis Specialty Brands business manufactures and sells a portfolio of about 40 products with applications in urology and women’s health.

The NHS Commissioning Board has identified the enforcement of generic prescribing as one of its key priorities for 2013.

A study commissioned by the Board found the NHS could save £200m per year by replacing two branded statins with generic alternatives, and annual savings of up to £1bn could be achieved across all prescribing.

The study recommends that GPs with expensive prescribing habits should be required to explain their decisions to the CCG – thus potentially creating conflicts between CCGs and pharmaceutical companies.

An embargo on branded drugs where generic versions exist could also see deep erosion of the specialised biopharmaceuticals market by biosimilars.

Branded drugs are often more recognisable, easier to swallow and even easier to digest than generic alternatives – but they can cost up to 25 times as much.

Open Health Care UK and data research company Mastodon C analysed the prescribing of two statins across the country. Many GPs were still prescribing branded versions, despite the availability of generics.

The Board’s Medical Director, Sir Bruce Keogh (pictured), said: “Variation in prescribing habits costs the NHS millions of pounds a year. Sharing of information will help clinicians understand whether they are over- or under-prescribing.

“This will focus minds in a way that will not only improve the quality of treatment for patients but also reduce cost and free up money for reinvestment.”

According to experts cited by The Independent, two mechanisms underlie the over-prescribing of brands: GP practices with on-site pharmacies have an incentive to prescribe branded drugs as they generate more profit; and hospitals buy branded drugs in bulk, reducing the cost but creating an ongoing patient expectation.

Open Health Care UK and Mastodon C will develop software to help the new CCGs target local GPs whose prescribing practices are expensive.

AstraZeneca has lost its appeal to the European Court of Justice against a €52.5m fine for its tactics to delay generic versions of Losec (omeprazole).

The company was fined by the European Commission in 2005 for manipulating regulatory approval in order to block generics.

According to the Commission, AZ launched a tablet version of the ulcer drug in 2001 and asked for the capsule’s authorisation to be withdrawn.

As a result, generic companies planning to launch their own capsule versions of omeprazole were blocked.

The Commission also claimed that AZ had deceived patent offices, courts and lawyers in several EU states over the date of Losec’s authorisation.

Losec, a proton pump inhibitor, was the world’s best-selling drug in 2000, but its European patent expired in 2001.

The European Commission commented that the appeal decision would prevent other companies from misusing drug regulatory procedures in order to protect their drug patents.

According to Ana Nicholls, Healthcare Analyst at the Economist Intelligence Unit, “This case exposed some of the strategems that pharma companies have used to delay the launch of cheaper generic versions of their drugs.

“By upholding the ruling, the court confirmed that pharma companies have to stamp out these practices or risk a substantial fine.”

Jonas Koponen of London law firm Linklaters commented that the decision was representative of “the European Commission’s policy of removing obstacles to competition from generics”.

Johnson & Johnson has said it will not enforce patents on its HIV drug Prezista (darunavir) in Africa and other poor regions of the world.

The decision will ensure that many patients have access to cheaper generic versions of the drug.

However, J&J insists that generic darunavir must be of high quality, and reserves the right to enforce its patents if this is not the case.

The company has declined to join the new Medicines Patent Pool, which aims to accelerate generic drug production.

J&J came second in the Access to Medicine Index 2012, which scores major pharmaceutical companies on the access to their drugs in poorer countries – seven places higher than its 2010 placing.

Multiple generic manufacturers will now be able to produce generic darunavir for sale in sub-Saharan Africa and other ‘least developed countries’.

The drug is a second-line therapy for patients who have developed resistance to the standard antiretroviral drugs. Demand for it in Africa is increasing rapidly.

Paul Stoffels, J&J’s Head of Pharmaceuticals, said that competition between generic manufacturers would drive down the price of darunavir.

Indian pharmaceutical companies would be particularly quick to bring out generic versions of the drug, he predicted.

Stoffels defended the decision to stay out of the Medicines Patent Pool: “We want to reserve the right to reinforce patents if people are not providing the right quality of product, for example by bringing products to market that under-dose.”

The restrictions on use of existing drugs in pharmaceutical R&D could be lifted under new laws proposed by the Intellectual Property Office (IPO).

The IPO’s proposed amendments to the Patents Act would rule that the use of a branded drug in a clinical or field trial does not infringe copyright.

This would make it easier for companies to compare a new drug to a branded product that is not their own, or to test a combination of the two drugs.

Current UK law allows limited use of patented drugs in tests required for the regulatory approval of generic drugs, but not of new brands.

The aim of the proposals, now out for consultation, is to create a better environment for pharmaceutical R&D in the UK.

IPO Chief Executive Sean Dennehey said: “Previous discussions with the pharmaceutical industry revealed a widespread appetite for change in the way UK patent law treats clinical or field trials.

“This consultation now offers a formal opportunity to shape the patent infringement provisions so that they can better support growth in this key industry sector.”

The consultation will run for eight weeks, until 19 December.