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
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.
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).
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.
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.
If you have any questions on this article or would like to propose a subject to be addressed by Synapse please contact us.
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.
12  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  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.