UK: Life Sciences Issues In Corporate Transactions – Part 1

Last Updated: 16 June 2016
Article by Colin McCall

Introduction

High research costs, complex regulatory requirements and dwindling opportunities for developing small-molecule targets: these are some of the factors blamed for the difficulties encountered by some branded pharmaceutical companies in recent years when trying to bolster the number of candidates entering and progressing through their product pipelines. At the other end of the medicinal product life cycle, many of the blockbuster drugs that have dominated the market in the last decade now have generic competition.

The life sciences industry is one of the most highly regulated industry sectors there is and the level of regulatory burden continues to grow. Indeed, one report by the Progressive Policy Institute1 suggests that the regulatory burden on the life sciences industry, at least in the United States, has risen by 40% since 2000 alone. This increasing burden continually raises the bar for companies trying to bring new medicinal products to market and new medicinal product approvals are more and more difficult to achieve.

This trend shows no sign of letting up. For instance, greater transparency in Europe as regards clinical trials is required under the new Clinical Trials Regulation, which stipulates that the results of a clinical trial must be made available within a year of the trial finishing. With this greater requirement for transparency in the results of clinical trials it is likely that there will be pressure for evidence of superior comparative efficacy of new medicinal products over existing treatments before a marketing approval will be granted. Given that, according to one report, only around 10% of new medicinal products that are granted marketing approval are deemed superior to existing treatments2 it is likely that new approvals are going to be even thinner on the ground in the future.

There is a similarly increasing regulatory burden on the medical devices industry also, especially in the wake of the PIP scandal, with the EU currently in the process of revising the regulatory framework in respect of medical devices and in vitro diagnostic medical devices. In particular it has been suggested that these new regulations should require some form of pre-marketing approval process akin to the clinical trials required for medicinal products. Until there is agreement on the new regulations there is considerable uncertainty regarding the level of regulatory burden in the sector for the future.

Further difficulties have, of course, come from the worst economic downturn in living memory, with ensuing pressures on costs. As a result of these pressures, some companies are moving away from reliance on the traditional small-molecule pharmaceutical business model and are attempting to broaden the nature of their product offerings to, among other things, branded generic products, biologicals and medical devices. There have been other developments: the acquisition of small research companies with promising drug candidates has become an attractive alternative to conducting early-stage development in-house. Interest has also turned to divestment of certain business operations and the efficiencies brought by cooperation and collaboration with third parties.

This diversification of the traditional, small-molecules industry may have actually sustained it through the downturn. Indeed, this is the view of a major report prepared by Battelle and the Biotechnology Industry Organization in 2012 (the Battelle Report)3, which attributes the resilience of the bioscience industry in the United States to its diversity. However, innovation in this field is not restricted to the United States and Europe. For example, although it has been known for many years as a centre of generic drug production, India is now seeing a number of novel drug research projects coming to fruition4, with more anticipated to follow in the coming years. Also, new levels of deal making within the sector in 2014 are attributed to a desire for efficiency, productivity and the need to reshape businesses after retrenchment over the last few years5.

With the time and money that is being invested in the sector and the potential commercial rewards at stake, how do those making that investment and others depending on the success of a life sciences business ensure that the innovations at the centre of their businesses provide a return for them? Furthermore, in such a competitive sector, what is to ensure that the technology being developed by one enterprise is not being appropriated by another? The answer is that where there is innovation, especially when it has a prospect of commercial application, there is intellectual property and, in particular, patents.

IMPORTANT IP RIGHTS IN THE LIFE SCIENCES

Patents

Patenting a technology provides exclusivity against competitors. Even though patents cannot guarantee that an innovation will be commercially successful, they do ensure, if properly managed, that the rewards of a successful invention flow to the patent owner. Indeed, as the Battelle Report states, the industries in the biosciences sector are among those with the highest levels of patenting and this, says the report, is key to their competitive advantage in the marketplace.

The importance of patents is further explained by another report, published in January 2014 by University College London's School of Pharmacy and co-written with the London School of Economics (the UCL Report)6. The UCL Report examines patient interests in medicines and biomedical innovation, and the extent to which these are served by IP rights and patents in particular. As the UCL Report points out, the market value placed on medicines is not a reflection of simply the cost of raw materials and manufacture, but of the scientific challenges and material costs of their development. These include the preclinical developments and clinical trial costs of not only successful drugs but also those of drug candidates that never make it to market. The UCL Report supports the estimate that the costs of developing an innovative medicine to market are in excess of $1 billion. Hence, as the UCL Report notes, patents do not just enable rewards for innovations that are already available; patents are also important to secure the willingness of investors to continue to put large sums of money towards innovations for the future.

Patents in themselves are key, but there is more to the development of successful products than ensuring exclusivity. As the UCL Report explains, patents are recorded as a property right on a register, allowing the owner to share that information in the patent with the public at large without losing their claim to it. But, importantly for the purpose of commercial activity, this also allows patents to be dealt in as an asset with third parties, as with any other property right, or to enable the proprietor to collaborate with third parties to share the technology for the advancement of the interests of both. The fundamental ways in which this is achieved are by patent assignment, by which rights to a patented technology are transferred from one owner to another, and by licence, in which certain rights to the patent can be granted in a controlled way to one or more third parties without ownership itself being transferred. Both methods allow the proprietor to ask for money by way of exchange; thus the patent is monetised, without a single product having been sold or, necessarily, developed.

Given the importance of patents to the sector, when looking at a commercial transaction, it is important to identify whether or not the patent portfolio is secure, whether pending applications (if an early stage investment or acquisition) will proceed to grant and underlying issues that may affect patentability and as a result exclusivity. The following are examples of such issues that are specific to the life science sector, with comment also on enforceability, as the way to protect exclusivity granted by patents is through litigation in the courts.

Patentability of gene-based inventions

Ever since the adoption of Directive 98/44/EC (the Biotechnology Directive) in 1998, which was then incorporated into the Implementing Regulations of the European Patent Convention (EPC), the position as to whether biological inventions are capable of being patented in Europe has been settled. In particular Article 3(2) of the Biotechnology Directive and Rule 27 of the EPC confirm that patents are available for isolated biological material even if occurring previously in nature and plants and animals are patentable per se provided that the technical feasibility of the invention is not limited to a particular plant or animal variety. Further, Article 5 of the Biotechnology Directive and Rule 29 of the EPC confirm that gene sequences can be patented so long as the industrial applicability of the sequence is disclosed in the application for a patent.

However, as a result of recent case law in the United States, there is a very different approach in the United States to the patentability of gene sequences. The cases are, firstly, Association for Molecular Pathology v Myriad Genetics, Inc.7 regarding Myriad Genetics' patents in respect of the BRCA1 and BRCA2 genes (specific mutations that indicate an increased risk of breast and ovarian cancer), in which the US Supreme Court ruled that patents are not available for inventions that claim isolated but naturally occurring DNA. Furthermore, the even more recent Federal Circuit Court of Appeals case of University of Utah Research Foundation et al. v Ambry Genetics Corp.8, again in relation to Myriad's BRCA1 and BRCA2 patents, has gone further and clarified that man-made versions of naturally occurring DNA are also ineligible for patentability.

Patentability of stem cell-based inventions

In the United States, patents in respect of stem cells and in particular human embryonic stem cells have long been available. However, this position may be in doubt following the Supreme Court decision in Myriad, since if naturally occurring DNA is exempted from patentability then the same may be said to be true for naturally occurring stem cells as well.

On the other hand, in Europe, uses of human embryos for industrial or commercial purposes are expressly not patentable, as provided by Article 6(2)(c) of the Biotechnology Directive and Rule 28 of the EPC. Furthermore, a landmark European Patent Office ruling on the patentability of stem cells was issued in the WARF/Thomson case9, stating that an invention that necessarily involves the use and destruction of human embryos is not patentable. At that time, the only source of human embryonic stem cells was the destruction of a blastocyst (a pre-implantation embryo), precluding patentability for all stem cell-based inventions. The judgment of the Court of Justice of the European Union (CJEU) in its Brüstle decision10 stated that stem cells obtained from the destruction of human embryos directly, or indirectly (ie, from publicly available cell lines), are unpatentable, thus making the patenting of stem cell-based inventions in Europe problematic.

Since then, however, stem cell technology has moved on such that other non-embryo destructive methods of generating human stem cells are available. This means that patents for stem cell-based inventions should now be available in Europe. This is so especially in light of the recent ruling by the CJEU11 on a referral from the United Kingdom in the case of International Stem Cell Corporation v Comptroller General of Patents,12 which stated:

in order to be classified as a "human embryo", a non-fertilised human ovum must necessarily have the inherent capacity of developing into a human being. Consequently, the mere fact that a parthenogenetically-activated human ovum commences a process of development is not sufficient for it to be regarded as a "human embryo".

Accordingly, cells and inventions that require human embryonic stem cells should no longer be barred from patentability on the basis of Article 6(2)(c)of the Biotechnology Directive. However, the date from which applications for such patents will be allowable is likely to be the date on which stem cells derived from such technology were publicly available, with applications filed prior to that date likely to continue to be unallowable.

Second Medical Use Patents

A claim to a known substance or composition for a second or subsequent medical use is patentable in principle in Europe if the substance or composition has not previously been used for that specific purpose. However, actually enforcing second medical use patents in Europe has proven problematic, especially with the increase in off-label prescribing in Europe. Some argue that the carve-outs that generic firms use in the summary of product characteristics labels submitted in the marketing authorisation process to avoid second medical use patents ignore market realities and that even if a generic drug is formally approved only for unpatented uses, doctors may still prescribe for the patented indication, and pharmacists may nonetheless substitute the generic for all indications once it becomes available.13 However, in the United Kingdom14 and in Germany15 the courts have taken the approach that such skinny labelling is enough to avoid infringement of second medical use patents. Indeed, the courts require that there is an intention by the generic manufacturer that their product is used for the patented indication. But a recent case in the Netherlands16 held, in finding infringement of a second medical use patent, that a generic firm supplying product way in excess of the amount required to treat the condition for which it is approved indicates knowledge that the product would be used for the infringing second medical use.

Accordingly, there is no widespread harmony in Europe on the issue of infringement of second medical use patents. Even with convergence of interpretation on the law between the member states, there are still the widely differing healthcare systems in Europe to consider. Where the intention and/or knowledge of the manufacturer is concerned, a finding of infringement in any European member state may depend on factors such as procurement and prescribing practices, in particular the frequency and known acceptability of off-label prescribing, together with policies on substitution and interchangeability. However, as a means of protecting Pfizer's second medical use patent rights in respect of the use of pregabalin for pain relief, the UK High Court has recently17 ordered the UK National Health Service to issue central guidance that when the drug pregabalin is prescribed for pain relief that the prescription must indicate LYRICA (the brand name) and not the generic pregabalin.

Freedom to operate

Given that the cost of developing new life sciences technologies or developing new products to the point of authorisation is prohibitively expensive without an absolute monopoly on the right to exploit the technologies or products it is hard to underestimate the value of acquiring strong IP rights in order to protect investments and to ensure ongoing returns. Furthermore, as a result of the huge sums involved and the disastrous consequences of early competition the life sciences industry is a highly litigious one in the field of intellectual property with a high degree of willingness among IP asset owners to litigate in order to protect them. Accordingly, before acquiring a company in this sector on the basis of its IP assets it is extremely important as part of the due diligence process to ensure that the target company has freedom to operate in respect of its present business activities as well as those it intends to pursue in the future, or at least to assess its scope of freedom to operate by assessing the relevant IP landscape. Failure to conduct a freedom to operate search could lead to wasting resources on an enterprise that may later be adversely affected as a result of infringing third party intellectual property and, in some cases, in respect of which there could be payment of significant damages. Conducting such a search early in the transaction process may identify third-party rights that may prove problematic, thereby identifying rights that either need to be licensed or worked around. This helps to further gauge the cost of acquiring the company and can also prevent wasted transactional costs, both in terms of time and money, if any third-party rights prove insurmountable.

Supplementary protection certificates

The system of supplementary protection certificates (SPCs) was introduced in 1993 under Council Regulation (EEC) No 1768/92 (now Regulation 469/2009/EC) (SPC Regulation) as a means to effectively extend the patent term of protection for particular medicinal products.

The purpose of this legislation is to remedy the common problem that the term of patent monopoly for many medicinal products can be significantly eroded by the time the patentee or their licensee has to wait for the grant of a marketing authorisation. The result can be that there is little or no patent monopoly left on the product by the time it reaches the market, limiting the commercial return on the product and thus undermining the investment made in it.

Calculation of duration of SPC

The SPC Regulation seeks to address this problem by providing up to five years further monopoly protection for specific patented products. The precise period of extension is the period between the date on which the application for a basic patent was lodged and the date of the first authorization to place the product on the market in the Community, less 5 years, and subject to a cap of a maximum of 5 years duration.

The formula provides that a patentee does not obtain an extension of its patent monopoly if it has only been eroded by five years or less by the wait for the grant of marketing authorisation. For example:

  • A patent filed on November 1 2005 and marketing authorisation granted on November 1 2010: the patent expires on October 31 2025 with no further SPC protection.
  • A patent filed on November 1 2000 and marketing authorisation granted on November 1 2010: five years' SPC protection commencing on November 1 2020.18
  • A patent filed on November 1 1995 and marketing authorisation granted on November 1 2010: five years' SPC protection commencing on November 1 2015.

Eligibility for SPC

In order to obtain an SPC, there are three key conditions that must first be satisfied. The conditions are found in Article 3 of the SPC Regulation:

  • Protection by a basic patent in force

    The product must be protected by a basic patent in force (Article 3(a)). The purpose of this provision is to reflect the intention of the SPC legislation to prolong monopoly protection for products that are already patented;
  • A first authorisation

    A valid authorisation to place the product on the market as a medicinal product must have been granted (Article 3(b)). This must be the first authorisation to place the product on the market as a medicinal product; and
  • No pre-existing SPC

    The product must not have already been the subject of an SPC (Article 3(c)). The purpose of this provision is to prevent further SPCs for modifications of the same product. For example, it is unlikely that a new formulation of an active ingredient that is already the subject of an SPC can be subject to a further SPC, because a "combination of active ingredients of a medicinal product" used in the definition of 'product' in Article 1(b) excludes situations in which only one ingredient has therapeutic effects and the other, such as an excipient, only improves the therapeutic efficacy of the first substance.

If these conditions are satisfied, the legislation provides SPC protection for specific patented products. It does not prolong the patent protection itself, so that many other potential products that fall within the scope of protection of the patent are not covered by the additional SPC protection.

However, it has proved difficult to interpret the SPC Regulation, especially as to the degree to which the underlying patent must identify the product to be protected and as regards combination drugs. This is widely thought to be because the SPC Regulation was drafted to deal only with those drugs comprising single, small molecule active ingredients and patents that covered them alone. Indeed, a number of issues under the SPC Regulation have been, and continue to be, referred to the CJEU. This reflects the problems that are being encountered with applying the SPC Regulation to modern pharmaceutical developments and the regime implemented by the SPC Regulation has been the subject of judicial criticism for this reason.

Availability of SPCs for combinations

Many drugs, including vaccines, oncology therapies, anti-asthmatics and hypertensives are administered as combinations of active ingredients. This is due to a number of different reasons ranging from policy to synergistic interaction. Combination drugs may also require substantial investment, even when one or both components have themselves been available as separate treatments for many years. In many circumstances, this has led those that manufacture and sell such drugs to seek SPCs to preserve protection and thus protect the investment in the drug from generic competition.

It has proved very difficult to interpret the SPC Regulation as regards combination drugs. The key questions that have arisen for combination products under Article 3 are whether a marketing authorisation for a hypothetical product A+B+C is capable of constituting a "valid authorisation" of product A alone, for the purposes of Article 3(b)? Or can it serve only as an authorisation for A+B+C?

Alternatively, an applicant might seek an SPC to protect product A+B+C, so that its SPC application reflects the marketing authorisation instead of the patent. In this situation, does a hypothetical patent covering A alone protect the combination product A+B+C for the purpose of Article 3(a)?

To answer these questions, a large number of cases were referred by national courts to the CJEU.

Principal among these references was the case of Medeva BV's SPC Applications,19 which concerned five SPC applications for a variety of combination vaccines, all of which had been refused.

Under Article 3(a) of the SPC Regulation the CJEU ruled that an SPC cannot be granted for a combination product that is not "specified" in the wording of the claims of the basic patent. Hence, an application for an SPC on product A+B+C must be supported by a patent claim that specifies A+B+C.

Under Article 3(b) in Medeva, the CJEU ruled that the SPC need only be sought for one or more of the products for which the marketing authorisation has been granted. In other words, an SPC can be sought for product A only, based on a marketing authorisation for A+B+C.

If an SPC can only be obtained for product A alone, because it is only A that is specified in the basic patent, how does this affect the SPC proprietor's ability to enforce its SPC for A against third-party use of a combination product such as A+B+C? This question has also been resolved by the CJEU, in Novartis v Actavis.20

As a result of the CJEU ruling in Novartis v Actavis, the owner of an SPC for A would be able to enforce that SPC against a product comprising A in combination with other active ingredients.

This is important for proprietors of combination drugs, given the Medeva ruling. It confirms a wide scope of enforcement of an SPC for A (against A+B+C, etc), compensating for the fact that the SPC may need to be limited to one active ingredient if that is all that is covered by the basic patent.

Availability of more than one SPC under the same basic patent

In the case of Georgetown University v Octrooicentrum Nederland,21 the key question was whether several products covered by one patent (eg, active ingredient A alone, the combination of active ingredients A+B, the combination of active ingredients A+B+C, etc) were each capable of SPC protection.

According to the CJEU's ruling, it is possible, in principle, on the basis of a patent that protects several different products, to obtain several SPCs in relation to each of those different products. Each of those products should, however, be protected as such by that basic patent in accordance with Article 3(a) and be contained in a medicinal product and subject to an MA.

Paediatric extensions

A further six-month extension to the SPC is available if an agreed research and development (R&D) programme aimed at ensuring that the necessary data are generated determining the conditions in which a medicinal product may be authorised to treat the paediatric population, known as a paediatric investigation plan (PIP), is executed with the results of the PIP included in the summary of product characteristics.

Since 2007, following the Paediatric Regulation (Regulation (EC) 1901/2006), agreement of the PIP with the Paediatrics Committee of the European Medicines Agency has been compulsory for all applications for a marketing authorisation whether for new medicinal products or for new indications for medicinal products already authorised for other indications. However, the Paediatrics Committee may agree a waiver of the requirement to submit the results of the PIP if the medicine is likely to be ineffective or unsafe in the paediatric population, if the disease to be treated only occurs in the adult population or if the medicine does not represent a significant therapeutic benefit over the existing treatments for paediatric patients. It is also possible for the measures set out in the PIP to be deferred, for instance, if it is appropriate for studies to be carried out only on adults first.

It is not necessary for the product actually to be indicated for use in the paediatric population (if, for example, the results show that that would not be appropriate) for the six-month extension to be applied, this six-month extension to the SPC applies to all indications for the product. Furthermore, the existence of this six-month paediatric extension to an SPC has meant that applying for zero-term or even negative-term SPCs (ie, for products that receive marketing approval within the period of four-and-a-half to five years after filing the basic patent) can be worthwhile since while the SPC itself for such zero-term or negative-term periods will confer no additional monopoly protection, the six month paediatric extension that can be added to these zero-term or negative-term periods will do (provided any negative-term SPC is less than six-months of course).

CONFIDENTIAL INFORMATION

A life sciences company will, in the course of developing its technology or products, generate information that has a commercial value. This information for as long as it remains secret is known as confidential information or a trade secret. Keeping the information confidential will be valuable as a means of maintaining a competitive advantage over others operating in the field for a number of reasons, including:

  • In order to obtain a patent in respect of a new invention that new invention must not be disclosed to the public (even if the disclosure is made by the inventor himself) prior to the filing date of the patent application.
  • Much developed know-how will not be of itself patentable, such as formulae and other technical data, but may be of technical importance.
  • Methods developed may show best practice, for example, in terms of efficiency or cost effectiveness, as to how to work a particular technology or manufacture a particular product.
  • The information can show that a particular method of trying to do something is in fact an "evolutionary dead-end". Other researchers in the field would benefit from this knowledge since they could avoid expending resources in pursuing such methods.

Clearly, the value of confidential information to the innovator will diminish as soon as that information ceases to be confidential or secret and becomes publicly available to all. However, in order to exploit confidential information and trade secrets it is sometimes necessary to disclose it to others. Such disclosure can be protected by the law of confidence, enabling a person to disclose secret information to a recipient in confidence, thereby imposing an obligation on the recipient to maintain the secrecy of the information.

While the patent system provides a time-limited monopoly right in return for a public disclosure of the invention, confidential information can remain secret indefinitely. Accordingly, it can be tempting to rely on the confidential nature of the invention rather than applying for patents. However, most inventions, once marketed, are capable of being reverse engineered and in the absence of patent protection such reverse engineering by a competitor is perfectly permissible.

Nevertheless, confidential information is a vital asset for a life science company and needs to be approached carefully both in transaction diligence and in the transaction documents.

DATA AND MARKET EXCLUSIVITY IN EUROPE

Regulatory approval for medicinal products requires applicants to provide information about the efficacy and safety of their product to regulatory authorities. The first applicant for approval of a new medicinal product must provide a substantial body of data relating to the product (including the results of preclinical tests and clinical trials).

The regulatory regime permits generic companies, who subsequently wish to gain their own approval for the same drug substance, to rely on information filed by the innovator company that made the first application. In order to be able to benefit from the data provided by the innovator in their regulatory filings for that medicinal product – the 'reference medicinal product' – a generic company must show that their product has the same qualitative and quantitative composition as that product and that it is bioequivalent.

Accordingly, data exclusivity is a form of product exclusivity in Europe with a subsequent period of market exclusivity being allied to that period of data exclusivity. The rationale for granting data and market exclusivity is to compensate the innovator company for the investment it has put into developing the new medicinal product and to generating the data required to obtain a marketing authorisation and is separate to patent and SPC protection.

For marketing authorisation applications made from November 2005 onwards, the period of data exclusivity in Europe has been harmonised as eight years from the date of first authorisation in Europe. For marketing authorisation applications made before November 2005, the period of data exclusivity varies between EU member states and is either 6 or 10 years. During the period of data exclusivity the innovator's preclinical and clinical trials data may not be referenced in the regulatory filings of any other company for the same drug substance.

For marketing authorisation applications made from November 2005 onwards, there is an additional period of two years of market exclusivity. This is the period of time during which a generic company may not market an equivalent generic version of the originator's medicinal product (although their application for authorisation may be processed during this period, such that they are in a position to market their product on the expiry of this additional two-year period). An additional one year of market exclusivity may be obtained if, within the eight-year data exclusivity period, the innovator company is granted another marketing authorisation for a new indication for the relevant medicinal product that brings significant clinical benefit over existing therapies.

In this way the regime ensures that generic competition can be prevented for up to 11 years following the first grant of a marketing authorisation regardless of the patent position in respect of the relevant medicinal product.

TRADEMARKS AND DESIGNS

While perhaps not so immediately obviously valuable in the life sciences industry, both trademark rights and design rights can assist in maintaining market share after patent expiry. For instance, Pfizer has numerous trademark and design rights in respect of its Viagra product, in each of the name, the colour and the shape of the product. Design rights are even more important in the medical devices industry, where they can protect features that are not purely functional in nature.

Part 2 of this article will be published in the February edition of Synapse.

Footnotes

1. See www.progressivepolicy.org/wp-content/uploads/2014/10/2014.10-Carew_FDA-Regulation-in-the-Data-Driven-Economy.pdf

2. JC Van Luijn, FW Gribnau and HG Leufkens, Superior efficacy of new medicines? European Journal of Clinical Pharmacology (2010) 66: 445-8.

3. Battelle/Bio, State Biosciences Industry Development 2012.

4. See Amy Kazmin, Indian pharmaceutical groups shed copycat image, Financial Times, July 22 2013.

5. Andrew Ward, Pharma deals reach new level of intensity, Financial Times, May 1 2014.

6. Mari Lundeby-Grepstad and David Tordrup (LSE), and Tinas Craig and David Taylor (UCL School of Pharmacy), Patients' needs, medicines innovation and the global public's interests, January 2014.

7. 133 S. Ct. 2107 (2013).

8. No. 2014-1361 (Fed. Cir. Dec. 17, 2014).

9. EPO G 0002/06 (Use of embryos/WARF) of 25.11.2008.

10. C-34/10.

11. C364/13

12. [2013] EWHC 807 (Ch).

13. 'Off-label' use usually means the use of a drug for an unapproved indication, age group, dosage or way of administration while 'cross-label' use means the use of a drug for an approved and patented indication, age group, dosage or way of administration that is not mentioned on the label instructions. In this regard, the often-used term 'skinny labelling' refers to label instructions that do not mention the patented use, but only the uses that are already off-patent.

14. Warner-Lambert Company LLC v Actavis Group PTC EHF & Ors [2015] EWHC 72 (Pat).

15. Düsseldorf Court of Appeal, docket number 2 U 54/11, 31 January 2013 – Cistus Incanus; Düsseldorf District Court, docket number 4a O 145/12, 14 March 2013 – Chronic Hepatitis C.

16. Novartis AG v Sun Pharmaceutical Industries (Europe) BV C/09/460540 / KG ZA.

17. HC-2014-001795 Warner-Lambert Company LLC v National Health Service.

18. Whether the period of SPC protection ends at 23:59 on October 31 or 23:59 on November 1 depends on the country whose patent office granted the SPC (eg, the United Kingdom, Switzerland, Spain and the Netherlands adhere to the former, and Germany, Poland, Austria and Sweden adhere to the latter expiry dates).

19. C-322/10, 24 November 2011.

20. C-442/11, 9 February 2012.

21. C-484/12, 12 December 2013.

This article is an extract from the Life Sciences chapter of Intellectual Property Issues in Corporate Transactions, published by Globe Law and Business, December 2015.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

Authors
 
In association with
Up-coming Events Search
Tools
Print
Font Size:
Translation
Channels
Mondaq on Twitter
 
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
 
Email Address
Company Name
Password
Confirm Password
Position
Mondaq Topics -- Select your Interests
 Accounting
 Anti-trust
 Commercial
 Compliance
 Consumer
 Criminal
 Employment
 Energy
 Environment
 Family
 Finance
 Government
 Healthcare
 Immigration
 Insolvency
 Insurance
 International
 IP
 Law Performance
 Law Practice
 Litigation
 Media & IT
 Privacy
 Real Estate
 Strategy
 Tax
 Technology
 Transport
 Wealth Mgt
Regions
Africa
Asia
Asia Pacific
Australasia
Canada
Caribbean
Europe
European Union
Latin America
Middle East
U.K.
United States
Worldwide Updates
Check to state you have read and
agree to our Terms and Conditions

Terms & Conditions and Privacy Statement

Mondaq.com (the Website) is owned and managed by Mondaq Ltd and as a user you are granted a non-exclusive, revocable license to access the Website under its terms and conditions of use. Your use of the Website constitutes your agreement to the following terms and conditions of use. Mondaq Ltd may terminate your use of the Website if you are in breach of these terms and conditions or if Mondaq Ltd decides to terminate your license of use for whatever reason.

Use of www.mondaq.com

You may use the Website but are required to register as a user if you wish to read the full text of the content and articles available (the Content). You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these terms & conditions or with the prior written consent of Mondaq Ltd. You may not use electronic or other means to extract details or information about Mondaq.com’s content, users or contributors in order to offer them any services or products which compete directly or indirectly with Mondaq Ltd’s services and products.

Disclaimer

Mondaq Ltd and/or its respective suppliers make no representations about the suitability of the information contained in the documents and related graphics published on this server for any purpose. All such documents and related graphics are provided "as is" without warranty of any kind. Mondaq Ltd and/or its respective suppliers hereby disclaim all warranties and conditions with regard to this information, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Mondaq Ltd and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use or performance of information available from this server.

The documents and related graphics published on this server could include technical inaccuracies or typographical errors. Changes are periodically added to the information herein. Mondaq Ltd and/or its respective suppliers may make improvements and/or changes in the product(s) and/or the program(s) described herein at any time.

Registration

Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:

  • To allow you to personalize the Mondaq websites you are visiting.
  • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our information providers who provide information free for your use.

Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.

If you do not want us to provide your name and email address you may opt out by clicking here .

If you do not wish to receive any future announcements of products and services offered by Mondaq by clicking here .

Information Collection and Use

We require site users to register with Mondaq (and its affiliate sites) to view the free information on the site. We also collect information from our users at several different points on the websites: this is so that we can customise the sites according to individual usage, provide 'session-aware' functionality, and ensure that content is acquired and developed appropriately. This gives us an overall picture of our user profiles, which in turn shows to our Editorial Contributors the type of person they are reaching by posting articles on Mondaq (and its affiliate sites) – meaning more free content for registered users.

We are only able to provide the material on the Mondaq (and its affiliate sites) site free to site visitors because we can pass on information about the pages that users are viewing and the personal information users provide to us (e.g. email addresses) to reputable contributing firms such as law firms who author those pages. We do not sell or rent information to anyone else other than the authors of those pages, who may change from time to time. Should you wish us not to disclose your details to any of these parties, please tick the box above or tick the box marked "Opt out of Registration Information Disclosure" on the Your Profile page. We and our author organisations may only contact you via email or other means if you allow us to do so. Users can opt out of contact when they register on the site, or send an email to unsubscribe@mondaq.com with “no disclosure” in the subject heading

Mondaq News Alerts

In order to receive Mondaq News Alerts, users have to complete a separate registration form. This is a personalised service where users choose regions and topics of interest and we send it only to those users who have requested it. Users can stop receiving these Alerts by going to the Mondaq News Alerts page and deselecting all interest areas. In the same way users can amend their personal preferences to add or remove subject areas.

Cookies

A cookie is a small text file written to a user’s hard drive that contains an identifying user number. The cookies do not contain any personal information about users. We use the cookie so users do not have to log in every time they use the service and the cookie will automatically expire if you do not visit the Mondaq website (or its affiliate sites) for 12 months. We also use the cookie to personalise a user's experience of the site (for example to show information specific to a user's region). As the Mondaq sites are fully personalised and cookies are essential to its core technology the site will function unpredictably with browsers that do not support cookies - or where cookies are disabled (in these circumstances we advise you to attempt to locate the information you require elsewhere on the web). However if you are concerned about the presence of a Mondaq cookie on your machine you can also choose to expire the cookie immediately (remove it) by selecting the 'Log Off' menu option as the last thing you do when you use the site.

Some of our business partners may use cookies on our site (for example, advertisers). However, we have no access to or control over these cookies and we are not aware of any at present that do so.

Log Files

We use IP addresses to analyse trends, administer the site, track movement, and gather broad demographic information for aggregate use. IP addresses are not linked to personally identifiable information.

Links

This web site contains links to other sites. Please be aware that Mondaq (or its affiliate sites) are not responsible for the privacy practices of such other sites. We encourage our users to be aware when they leave our site and to read the privacy statements of these third party sites. This privacy statement applies solely to information collected by this Web site.

Surveys & Contests

From time-to-time our site requests information from users via surveys or contests. Participation in these surveys or contests is completely voluntary and the user therefore has a choice whether or not to disclose any information requested. Information requested may include contact information (such as name and delivery address), and demographic information (such as postcode, age level). Contact information will be used to notify the winners and award prizes. Survey information will be used for purposes of monitoring or improving the functionality of the site.

Mail-A-Friend

If a user elects to use our referral service for informing a friend about our site, we ask them for the friend’s name and email address. Mondaq stores this information and may contact the friend to invite them to register with Mondaq, but they will not be contacted more than once. The friend may contact Mondaq to request the removal of this information from our database.

Emails

From time to time Mondaq may send you emails promoting Mondaq services including new services. You may opt out of receiving such emails by clicking below.

*** If you do not wish to receive any future announcements of services offered by Mondaq you may opt out by clicking here .

Security

This website takes every reasonable precaution to protect our users’ information. When users submit sensitive information via the website, your information is protected using firewalls and other security technology. If you have any questions about the security at our website, you can send an email to webmaster@mondaq.com.

Correcting/Updating Personal Information

If a user’s personally identifiable information changes (such as postcode), or if a user no longer desires our service, we will endeavour to provide a way to correct, update or remove that user’s personal data provided to us. This can usually be done at the “Your Profile” page or by sending an email to EditorialAdvisor@mondaq.com.

Notification of Changes

If we decide to change our Terms & Conditions or Privacy Policy, we will post those changes on our site so our users are always aware of what information we collect, how we use it, and under what circumstances, if any, we disclose it. If at any point we decide to use personally identifiable information in a manner different from that stated at the time it was collected, we will notify users by way of an email. Users will have a choice as to whether or not we use their information in this different manner. We will use information in accordance with the privacy policy under which the information was collected.

How to contact Mondaq

You can contact us with comments or queries at enquiries@mondaq.com.

If for some reason you believe Mondaq Ltd. has not adhered to these principles, please notify us by e-mail at problems@mondaq.com and we will use commercially reasonable efforts to determine and correct the problem promptly.