Patent and trademark firm Harrison Goddard Foote (HGF) has recruited AstraZeneca’s Principal Patent Attorney as its new Patent Director.

Mike Nelson has joined HGF’s pharmaceutical team, based in its Leeds office, where his industry experience will assist clients in building a commercial development strategy around their patents and brands.

HGF covers intellectual property (IP) protection for new drug molecules, formulations, drug delivery technologies and life cycle management.

Jonathan Couchman, a partner at HGF, commented: “In pharmaceuticals, we are one of a few European IP firms able to provide high level commercial and technical excellence to the industry, and with Mike Nelson we can build further on this existing platform, especially in commercial strategy.”

“HGF is currently one of the fastest growing intellectual property specialists in the UK,” said Mike Nelson. “This growth stems from its proactive approach and understanding of its client’s business needs. Together with the considerable technical expertise and industrial experience of its attorneys, HGF provides clients with an unrivalled intellectual property service.”

HGF advises on all aspects of IP from its offices in Aberdeen, Glasgow, Edinburgh, Leeds, London, Birmingham, Oxford, Manchester, Sheffield and York. It has six specialist business groups including pharmaceuticals.

Sanofi has lost a legal appeal against the decision that Roche and Biogen Idec did not infringe its patent for biologic drug development.

Roche’s Genentech business and biotech specialist Biogen Idec did not steal Sanofi’s IP for genetic medicine to develop the cancer drugs Avastin and Rituxan, a US appeals court determined.

The decision reflects the growing commercial potential of biologics and the tense relationship between big pharma and the biotech sector.

The dispute began in 2008, when Genentech cancelled its long-standing licensing agreement with Sanofi. The genetic medicine specialist was acquired by Roche in 2009.

Sanofi claimed that Genentech and Biogen Idec had used its proprietary techniques to enhance gene expression, improving the efficiency of drug production.

However, the US court upheld the previous decision that in both cases, the drug production methods were different from those covered by Sanofi’s patent.

Avastin and Rituxan, both cancer drugs, are among Roche’s best-selling products: Rituxan achieved sales of $6.6bn, and Avastin $5.81bn, in 2011. Avastin is marketed by Roche, while Rituxan is co-marketed with Biogen in the US.

According to Sanofi spokesperson Carrie Brown, the company is “currently evaluating its options and next steps.”

The European biosimilars market is expected to reach nearly $4 billion by 2017 after the expiration of patents and other intellectual rights opens new opportunities, a new report predicts.

Frost & Sullivan’s Analysis of European Biosimilars Market predicts the industry will record annual growth of more than 50% in the next five years as physicians and patients search for cheaper medication.

Srinivas Sashidhar, a Frost & Sullivan Research Analyst, says the next decade “opens up opportunities for biosimilars to enter the market and increase industry competition”.

The report notes that the biosimilars manufacturing industry is at a nascent stage. The market earned revenue of around $172 million in 2010, research found.

However, while there are plenty of opportunities for growth, the market will require sizeable investment – especially smaller firms. Complex production processes, expensive materials and rigorous clinical trials require significant investment, the report adds.

“The need for considerable financial outlays will hinder the entry of small biotech firms in particular,” warns Mr Sashidhar. “On the other hand, specialty pharmaceutical companies with biotech expertise and financial capabilities are well positioned to venture into the biosimilars market.”

Another obstacle the market faces is high manufacturing costs. But, the report says, viable prospects for licensing agreement between companies should overcome this. “Access to sales and marketing capabilities can be achieved through collaborations between pharmaceutical companies and specialty biotech firms with technical expertise,” said Sashidhar. “Companies can build sales and marketing capabilities in-house and ensure effective marketing support for the commercialisation of biosimilars.”

If the market is to realise its potential in the next decade, the report advises effective sales communication to the scientific community, coupled with continuous promotional activities as well as close and constant interaction with doctors and pharmacists.

AstraZeneca will share intellectual property with UK medical researchers, giving them free access to 22 of its compounds.

The company’s agreement with the Medical Research Council (MRC) has been heralded as “the start of a new era in medical discovery”, offering a new model for partnership between industry and the academic field.

AstraZeneca will retain rights to the composition of the compounds, but new research findings using them will be owned by the academic bodies responsible for them.

The MRC, a publicly-funded body, will judge clinical research proposals that involve using the compounds to investigate new treatment opportunities. It will select the best proposals and award up to £10 million in total to them.

The approved research must not duplicate existing studies or contribute directly to AstraZeneca’s R&D – though the company may choose to work with the researchers directly.

According to MRC Chief Executive Sir John Savill, “The initiative marks a new era in medical discovery, open innovation and public-private collaboration.”

His comment refers to the concept of open innovation developed by US researcher Henry Chesbrough: a collaborative process involving experts from different sectors.

David Willetts, Minister for Universities and Science, said the deal would “give our world-leading research base new insights into disease and encourage the development of groundbreaking new treatments. This will keep the UK at the very forefront of biomedical research and drive growth and innovation in our life sciences industry.”

Pharma companies can only obtain one Supplementary Protection Certificate (SPC) per patent, the EU Court of Justice (CJEU) has ruled.

The new ruling clarifies existing regulations, whose disputed application had led to uncertainty about the patent status of combination drugs and multivalent vaccines.

Pharma companies in the EU will now be less able to use SPCs to extend patent life by gaining additional exclusivity for altered products.

As a result, companies may see an increase in biosimilars and generics being released by competitors at the point of patent expiry.

According to the CJEU verdict, an SPC:

• can only be granted for active ingredients that are specified in the claims of the underlying patent

• is permitted for multi-ingredient products only if each ingredient is patent-protected

• can be granted only once for each basic patent.

Jonathan Radcliffe of global law firm Mayer Brown commented that the ruling “cuts directly across current patent office and industry practice across Europe, where multiple SPCs are being granted out of the same basic patent despite the prohibition against doing so”.

However, Will James of UK law firm Marks & Clerk pointed to the value of the ruling for pharma companies: “The CJEU rulings have confirmed a relatively broad scope of SPC protection covering all combinations of a particular active ingredient with others, providing that the active ingredient is supported by the underlying patent.”

The decision arose partly from the recent case brought by UK pharma company Medeva, which was refused SPCs for combination vaccines that brought together patented and non-patented active ingredients.

The Medeva case was referred to the CJEU – whose new ruling means that an SPC can be granted for a product with additional active ingredients only if these were specified in the original patent.

In the pharmaceutical industry one of the biggest challenges is to manage large events which require certain levels of privacy, whilst also ensuring they are hosted in professional and accessible venues. Simon Hunter shares his knowledge on how to make the most of your venue and event.

A high profile venue is a prominent, well known, iconic space which has a range of facilities to offer, and a reputation for hosting annual industry exhibitions or summits for international brands.

Discretion and privacy are key attributes of hosting events at high profile venues. If there are well-known guests present or sensitive intellectual property being shared – a new scientific discovery or drug, for example, then this kind of venue is ideal.

 

Experience pays

Other advantages of high profile venues include a proven track record in hosting different sizes of events in-house. For example, Chelsea Football Club manages fixtures attracting 42,000 guests who need to be managed onsite and this translates to the events team and experienced in-house security. The higher profile the venue or the bigger the event brand, the more strategies will already be in place which can help.

With regards to security, trust the staff and the in-house teams; they will have the benefit of experience organising private events, managing arrangements for high profile guests, and advising on the best way to utilise facilities. A good venue will take you through all stages of the event and should ask in advance of any special requirements, schedules or VIP attendees.

Ensure that all channels of communication are left open during the event itself so that staff  know of any last minute alterations. This will also guarantee that event organisers look professional, with the additional help of the venue’s catering, service and after-care.

 

Deciding outcomes

Knowing your audience and the objectives you want to achieve from any event will be a great help in selecting a venue. It is therefore vital to outline these clearly before approaching any venues for suggested briefs. Following this, there are some useful points to bear in mind which will make selecting a suitable venue easier.

Consider the components of your event to make sure you select somewhere that can accommodate them all. For example, consider whether the event will be an annual conference with a gala dinner and accommodation; whether you need separate facilities for VIP guests; and the possibility of needing to bring in equipment for demonstrations or exhibitions.

Venues which offer numerous events spaces, like a music venue, accommodation, restaurants and an exclusive spa can be ideal for organisers wishing to combine many activities within one event. It will also reduce the need for a separate transport budget to transfer guests from between conferences and seminars, for example.

Every event organiser should be constantly focussed on how to get maximum results for minimum cost. Look for a venue that whilst impressive, offers a range of packages and choose the one that suits your audience and your budget.

 

Simon Hunter is the Head of Venue at Chelsea Football Club.

Intellectual property (IP) is a major asset of any medtech company. Bruce Dean and Joanna Westwood discuss how you can not only protect your IP, but maximise its value.

                        
           Bruce Dean                                                      Joanna Westwood 

All businesses own intellectual property (IP) in one form or another. For many organisations, especially for R&D-driven businesses, establishing IP rights is a way to protect the substantial investments made in R&D and brand development. However, IP rights are more than just defensive rights: they are a valuable commercial asset that, with the right strategy and advice, can be used to improve revenue steams, attract investment and add value to a business.

Medtech companies have great potential to exploit every aspect of intellectual property protection. The industry’s value to the UK economy is well known. Medtech provides over 120,000 jobs, and contributed over £10 billion to the UK economy in 2008. Given the sector’s strong reliance on high-quality research, IP protection is key to making the most of medtech innovation in the current climate.

Types of protection

To see how your intellectual property can be of most value to your business, it’s a good idea to look first at the different forms of IP that are out there. There are several types of IP protection that can be used alone, or in combination, to enhance the value of your business. The four most common types are listed below.

Perhaps the form of IP that people are most familiar with is trademarks. These protect any marks that identify a product as originating from a particular company, which may be logos, words, shapes or slogans. One of the key advantages of trademarks over other forms of intellectual property protection is their duration, which can last indefinitely. As such, trademarks can be extremely valuable for preserving a market share after patent protection expires. The patent on Viagra ceased many years ago, but the trademark continues to preserve the product’s market share.

Another relatively well-known type of IP is copyright. This protects artistic works such as art, literature and music. Copyright is often overlooked by companies with significant R&D interests, especially in the pharmaceutical and medical technology industries. However, copyright is a valuable tool, particularly for the protection of software and some CAD/CAM technologies.

Many people are also familiar with patents, which are used to protect inventions (the way something works). These offer a fixed-term monopoly (usually for 20 years) to anyone who develops something new and inventive with an industrial application. Patents represent one of the most critical forms of protection in the medtech sector, as its products are typically of a technical nature.

A further, lesser-known type of IP is design rights. These cover the aesthetic look and external form of a product. Design rights can be very useful as they can be obtained very quickly, are significantly less costly than many other forms of protection, and can last for up to 25 years.

All of these types of protection have value and can be used to help businesses in various ways.

Don’t tip your hand

In order for someone to obtain patent protection, their invention must be new – i.e. it must not have been disclosed anywhere. All too frequently, patent attorneys receive urgent requests to file a patent application as soon as possible due to a recent or imminent disclosure.

Often companies looking to attract investment for new innovations disclose their products to would-be investors, and in so doing unintentionally disclose the entire invention, preventing protection from being obtained (and almost certainly ending any chance of attracting investment). Similarly, research can often be disclosed unwittingly at exhibitions and trade fairs or through posters and academic papers, as well as talks during conferences.

Unfortunately, such disclosures often prevent protection from being acquired, leaving competitors free to copy the new products.

The companies that are most successful at generating value from their IP implement an efficient product and invention management process. It is important to identify innovation early, to assess its value in relation to the current state of the market and to manage disclosures.

Patent attorneys can be of great assistance even in the very early stages of development. Often, inventors and those closest to the R&D process do not immediately see the commercial potential of new inventions, or may consider advancements to be trivial. An invention may appear obvious to its creator, but in reality be quite distinctive: something that demonstrates the ‘inventive step’ required for the idea to gain patent protection.

In industries where new developments are constantly being produced, catching inventions early can ensure not only that you are the first to reach the market, but also that you are not excluded from marketing your product by rival businesses patenting in the same area.

Early identification of the products with the greatest commercial potential also allows refinement of the R&D process, so that investment is not wasted in technical fields that have already been extensively studied and, in many cases, well protected.

Most companies involved in research and development understand that for innovation to be successful there must be a planned route to disclosure. Once the internal disclosure has been made, the next step is to assess the commercial potential of the product. It is then possible to decide what IP protection is most appropriate and cost-effective for your product before seeking that protection. Only when the applications are filed should you proceed to make any commercial or academic disclosures.

In order to encourage innovation and an efficient disclosure strategy, many companies operate invention reward programmes, providing incentives to individual inventors to develop patentable products. The reward can vary from a few hundred to several thousand pounds depending on the success of the invention.

Making IP pay

When intellectual property rights have been established, a number of options are available to exploit them. This is arguably the most important stage of the process, as it is where the company realises the value of its R&D and IP investment.

First, intellectual property rights can be sold outright. This offers a quick solution to recoup outstanding (often significant) costs incurred during the R&D procedure, and can be an effective way to generate capital.

Alternatively, it is possible to license IP rights to third parties – either to one specific party exclusively, or to many different parties. An exclusive licence offers a higher royalty as only one party is entitled to exploit the invention, whereas multiple licences can often provide greater market coverage. Finding licensees can often be a favourable option in situations where a particular innovation has specific manufacturing requirements and the owner of the IP rights does not have the necessary infrastructure to commercialise the invention on a profitable scale.

There are also many ways to use your intellectual property beyond the sale or licensing of rights. Being the proprietor of IP rights allows you to prevent third parties from exploiting your innovation without your permission, allowing you to market your product without fear of third parties copying your inventions. If any competitors attempt to undermine your monopoly, you have the power to launch proceedings against them, stop the sale of their products and receive compensation.

Developing a strong patent portfolio is also an excellent way to attract investment, as it demonstrates that the company is actively engaged in R&D and has a sound commercial outlook.

Legal support

It is not uncommon for companies to keep external IP advisors at arm’s length from researchers and inventors, in order to avoid perceived disruptions to research activities. Large, well-established companies such as pharmaceutical companies, who are well versed in IP rights, often operate their own in-house teams to manage an effective IP strategy, allowing a close bond to form between IP advisors and research teams.

Most small and medium-sized medtech companies do not have such internal resources. Many are also wary of seeking external advice for fear of excessive cost. However, in nearly all cases, the losses made as a result of poorly-planned IP protection are significantly greater, as lack of protection can compromise your right to market your products exclusively and hamper efforts to recoup R&D investments.

The most successful SMEs maintain a close relationship with their IP advisors. Engaging in regular discourse means that their technologies are well understood by their IP team, ensuring a good standard of protection.

Ultimately the most successful approach to managing innovation is to develop an organised IP strategy that identifies innovation early, and to maintain regular dialogue with your legal advisors. In particular, effective IP management systems involve researchers and attorneys who share a passion for a specific field of technology. Seeking advice within a well-maintained relationship enables medical technology companies to avoid the pitfalls of IP and realise the value of their innovation.

Bruce Dean and Joanna Westwood are patent attorneys for Withers & Rogers, working in the chemical and medical technology sectors.