1 ` PATENT AND PHARMA UPDATE Our regular patent and pharma update aims to keep you informed of recent developments in United Kingdom and European law relating to patents and the pharmaceutical industry. 1. Regeneron's transgenic mice patents held invalid for insufficiency by English Patents Court Regeneron Pharmaceuticals Inc v Kymab Ltd & Anor  EWHC 87 (Pat), 1 February 2016 • Regeneron's patents concerning transgenic mice models have been held invalid for insufficiency as they did not enable a skilled person to perform the invention across the breadth of the claims without undue burden or inventive skill. • The Judge confirmed that while a patent may be sufficient if a skilled person could perform it by taking ordinary steps of trial and error, a patent would not be sufficient if a skilled person would need to conduct prolonged research, enquiry or experiment in order to perform it. • The Judge also made clear that parties should not use the circulation of draft judgments as an opportunity to re-argue their case or make further submissions. The Court circulates draft judgments in order for the parties to correct obvious or typographical errors. Regeneron claimed that Kymab had infringed its patents, EP (UK) 1 360 287 and a divisional EP (UK) 2 264 163, concerning transgenic mice that can be used as platforms for therapeutic antibody discovery. Kymab counterclaimed for revocation of the patents alleging that the patents were invalid for insufficiency (amongst other grounds). The crux of the patented inventions lay in using bacterial vectors with human immunoglobulin gene fragments (LTVECs or large targeting vectors for eukaryotic cells) to replace homologous gene fragments in mouse embryonic stem cells (ES cells). The resultant "reverse chimeric" B cells would produce antibodies with human variable gene segments and mouse constant gene segments, which would later be manipulated for various therapeutic applications. Henry Carr J decided that all strains of Kymab's mice would infringe at least the '287 patent, if it were to survive the invalidity challenges mounted by Kymab. In relation to insufficiency, Henry Carr J stressed the requirement that the scope of claims be limited to the extent of the actual technical contribution to the art. Accordingly, it was important for the patent to give the skilled person sufficient guidance to perform the invention over the whole range claimed without undue burden. Although the patent need not set out every detail necessary for the performance of the invention and could require ordinary steps of trial and error by the skilled person, prolonged research, enquiry or experiment was not to be expected for the performance of the invention. The claimed method in its preferred embodiment would have required about 150 kb of mouse genomic sequence to be replaced with 75 kb – 300 kb of human sequence. The expert evidence was that, at the priority date, insertions and deletions MAY 2016 London Table of Contents 1. Regeneron's transgenic mice patents held invalid for insufficiency by English Patents Court 1 2. English Patents Court grants Actavis pan-European declarations of non-infringement for its lung cancer treatment 2 3. English Patents Court refuses Janssen's application to stay proceedings pending EPO opposition decision 2 4. Medac's methotrexate formulation patent found invalid by the English Patents Court 3 5. English Court of Appeal declares patent obvious by considering information "the skilled person would ask"4 6. Grant of MA with post-authorisation conditions can define the start of the 10 year data exclusivity period 5 7. American Science & Engineering's mobile X-ray backscatter inspection system patent held valid by the English Patents Court 5 8. GSK and generics fined £45 million for anti-competitive 'pay-for-delay' agreements 6 9. Key points from featured decisions related to patents 7 10.Key points from featured decisions on issues other than patents 9 11.Contacts 10 RELATED LINKS > Herbert Smith Freehills > The Unified Patent Court and the Unitary Patent 2 of this size could not have been performed without undue burden and without needing inventive skill. On this basis, Henry Carr J held that the patents were invalid for insufficiency and allowed Kymab's counterclaim for revocation. After the Court circulated a draft judgment to the parties for the correction of obvious errors, Regeneron made submissions regarding what it considered were "material" omissions in the judgment. The Judge rejected these submissions and held that a draft judgment was circulated primarily to ensure correction of "typographical or other obvious errors", but not to allow parties to re-argue the case, repeat submissions made at the hearing or deploy fresh ones. 2. English Patents Court grants Actavis pan-European declarations of non-infringement for its lung cancer treatment Actavis UK Ltd & Ors v Eli Lilly & Co (Rev 1)  EWHC 234 (Pat), 12 February 2016 • Arnold J has granted declarations of non-infringement in favour of Actavis in relation to the UK, French, Spanish and Italian designations of Lilly's patent concerning a lung cancer treatment. • The judgment provides a useful practical example of how the court will apply the test for indirect infringement where a generic supplies a medicine that does not directly infringe a patent, but a person administering the medicine would infringe a patent. • The judgment makes clear that the burden for avoiding infringement should not lie solely with the potentially infringing party – the patentee may also be expected to take appropriate measures to police its own patent. Lilly has marketed pemetrexed disodium as ALIMTA, a cancer treatment, since 2004. Alimta is marketed as a freeze-dried powder with instructions to reconstitute it, and then dilute it, in a 0.9% solution of sodium chloride. In June 2015, the Court of Appeal upheld the High Court's decision that Actavis' proposed pemetrexed diacid product would not directly infringe Lilly's patent, EP (UK) 1 313 508, but reconstitution and/or dilution of Actavis' product in normal saline would cause Actavis to indirectly infringe ( EWCA Civ 555, permission to appeal this decision at the Supreme Court has been granted). A separate "dextrose remission" issue was remitted to the High Court and this is the subject matter of the present proceedings. In December 2015, Actavis launched its rival liquid pemetrexed diacid product in the UK and plans to follow suit in France, Spain and Italy later this year. This product does not require reconstitution and must only be diluted with 5% dextrose solution as per its Summary of Product Characteristics (SmPC). Actavis sought declarations of non-infringement in relation to the UK, French, Spanish and Italian designations of the patent for its liquid product. The question for the Court was whether Actavis would indirectly infringe the patent by supplying pemetrexed diacid with instructions to dilute only with dextrose solution. Lilly argued that Actavis knew, or it would be obvious to a reasonable person to know in the circumstances, that its product would be diluted with saline by some customers. Arnold J disagreed with Lilly. It was highly unlikely that customers would dilute Actavis' product with saline in error. Further, pharmacists would not deliberately deviate from the SmPC, using saline instead of dextrose solution, at least until some reliable stability data was available for Actavis' product in saline. This was unlikely for three main reasons: • Actavis had undertaken not to make any stability data for its product in saline available and there were no incentives for customers or third parties to carry out their own stability studies, since the stability of Actavis' product in dextrose was sufficient. Actavis also informed any researcher who contacted them for stability data that using saline was forbidden. • Even with stability data for the Actavis product in saline, there would be no motivation to depart from the SmPC specifications. Lilly attempted to argue that Actavis' product in dextrose would be harmful to diabetics by raising their blood glucose levels, hence motivating the use of a different diluent. However, on evidence, the impact of administering Actavis' product diluted with dextrose on diabetics was minimal. • Actavis had taken, or was going to take, a number of additional steps to prevent its product being diluted in saline, such as writing to relevant competent authorities explaining that its product should not be diluted with saline. Lilly complained that such a letter was a misleading threat. Arnold J did not agree and commented that Lilly was not only "merely seeking to place the entire burden of enforcing the Patent on Actavis" by not taking any steps of its own, but also complaining that Actavis was "going too far in attempting to safeguard Lilly’s rights" which was a "remarkable attitude". Arnold J therefore granted the declarations of non-infringement, but gave the parties liberty to apply in the event of a material change in circumstances. This means that Lilly can seek appropriate relief should evidence come to light that Actavis' product is being diluted in saline before the expiry of the patent. 3. English Patents Court refuses Janssen's application to stay proceedings pending EPO opposition decision Eli Lilly And Co. v Janssen Sciences Ireland UC  EWHC 313 (Pat), 18 February 2016 • The Patents Court has refused to stay Lilly's claim in the English Court for a declaration of non-infringement and revocation of Janssen's solanezumab antibody patent pending an EPO decision on the validity of the patent. 3 • The Court emphasised the need to achieve a balance of justice between parties in the circumstances, which in this case favoured the continuation of the English proceedings so that Lilly could obtain commercial certainty as to whether its product infringed Janssen's patent. Lilly applied to the Patents Court for a declaration of non-infringement in respect of its product solanezumab, an antibody proposed to be used in the treatment of Alzheimer's disease, and to revoke Janssen's divisional patent, EP (UK) 2 305 282. Janssen applied for a stay of the English proceedings pending a decision in EPO Opposition Division proceedings. Hearing Janssen's stay application, Rose J emphasised the need to "achieve a balance of justice between the parties having regard to all relevant circumstances of the case", in particular, whether any commercial certainty could be achieved "sooner rather than later" by accepting or rejecting the stay application. A declaration of non-infringement granted by English courts (since national courts have exclusive jurisdiction in infringement matters) would provide some certainty to Lilly that its product was not within the patent's claims. More importantly, Rose J held that Lilly needed the declaration to determine when it should apply for a marketing authorisation and launch its product. It was unlikely that Janssen would be able to launch its own product or apply for an SPC before patent expiry, which would mean that Janssen would not be able to apply for an SPC based on the patent. However, if Lilly obtained a marketing authorisation for its product before patent expiry and the product fell within the scope of the patent, Janssen could use Lilly's marketing authorisation to support an SPC application. Therefore, if Lilly applied for a marketing authorisation and launched its product before the Court decided whether it infringed, Lilly was exposed to the risk that Janssen would obtain an SPC and make Lilly pay royalties under it if Lilly's product was found to infringe. Janssen added to the uncertainty by not specifying what a reasonable royalty rate would be. For these reasons, the Court dismissed Janssen's stay application and allowed the English proceedings to continue. The Court accepted but was not persuaded by Janssen's arguments that the EPO proceedings would conclude before the English proceedings and that there would be wasted costs. Nor was the Court persuaded to stay the English proceedings on the basis of undertakings offered by Janssen to: (1) support any application by Lilly to accelerate any appeal from the EPO Opposition Division decision; (2) not seek a preliminary or final injunction against Lilly and its licensees or customers for infringement during the patent or the SPC term; and (3) seek no damages other than on a reasonable royalty basis should the patent be held valid. 4. Medac's methotrexate formulation patent found invalid by the English Patents Court Accord Healthcare Ltd v medac Gesellschaft Für Klinische Spezialpräparate Mbh  EWHC 24 (Pat), 13 January 2016 • Medac’s patent for a new dosage form of methotrexate (RASUVO) has been found invalid for lack of inventive step. • Medac found itself in an obviousness-insufficiency "squeeze" by submitting that the invention involved an inventive step because data extraneous to the patent suggested that higher concentrations of methotrexate may cause side effects. The Court indicated that if the invention did involve an inventive step on this basis, it was not sufficiently disclosed in the patent. • Birss J indicated that having no satisfactory answer to the question "if it was obvious, why was it not done before?", could provide decisive support to a patentee's position that the invention involved an inventive step. However in this case, such "secondary evidence" put forward by medac was not strong enough to overcome Accord's obviousness case. Medac owned a patent, EP (UK) 2 046 332, for the use of a formulation of methotrexate with a concentration of about 50mg/ml for subcutaneous injection to treat inflammatory autoimmune diseases (eg rheumatoid arthritis or psoriasis). The point of the invention was to reduce pain by reducing injection volume by increasing methotrexate concentration. Accord challenged the validity of the patent on the grounds of obviousness and insufficiency. The identity of the skilled person was an important issue as it affected the obviousness assessment. Birss J preferred Accord’s evidence that the skilled team consisted of a clinician and a formulator, over medac's evidence that the skilled person was a clinician alone. The Judge concluded that formulation was "at the heart of the matter", with the patent "plainly" addressed to a clinician-formulator team working in a pharmaceutical manufacturer. Medac's only expert, a clinician, had accepted that the patent was directed to the industry. Birss J pointed out that although the skilled person in the context of obviousness is not necessarily the same as the skilled person from the point of view of reading and implementing the patent (sufficiency), here they were the same. Accord argued that the invention was obvious over the common general knowledge alone and over a prior art publication known as Russo, which reported a study of the tolerance of parenteral higher dose methotrexate in children with juvenile chronic arthritis. On the evidence, Birss J held that the reference to "parenteral" administration in Russo covered subcutaneous administration. As regards the dosage, the skilled team would have arrived at the claimed invention by optimising a putative methotrexate formulation to minimise pain in light of Russo. Birss J dismissed Accord's submission that the invention was obvious in light of the common general knowledge alone. The Judge said that the present case illustrated the problems with such arguments, "that the combination of features relied on is always and necessarily one created with hindsight knowledge of the invention, and worse, is one which the person attacking 4 validity has not been able to find as a pre-existing combination in the concrete prior art. If they had they would have relied on that concrete prior art." Medac adduced evidence that the invention involved an inventive step because it had not been carried out before, in spite of the prior art. While Birss J acknowledged that such "secondary" evidence could be powerful in the right circumstances, he decided that it did not overcome Accord's strong obviousness evidence in this case. Medac also tried to establish an inventive step by arguing that the skilled person would have concerns about administering methotrexate at the claimed higher dose due to side effects. Accord argued that this would expose medac to a squeeze on its inventive step. If the invention did involve an inventive step on the basis of the side effect point, the patent would become liable to an insufficiency attack as it lacked any information or reference to methotrexate side effects at the claimed dose. According to Birss J, there is nothing in the patent "on which a skilled reader could base a view about the credibility of whether 50 mg/ml subcutaneous methotrexate does or does not have a side effect problem". He further distinguished medac's patent from the patent in suit in the recent judgment in Actavis v Eli Lilly  EWHC 3294 (Pat) (see section 2 above). In that case, although that patent contained no experimental data, it did contain relevant information and reasoning which made it plausible that the drug could be used as a treatment for the disease. 5. English Court of Appeal declares patent obvious by considering information "the skilled person would ask" Richter Gedeon Vegyeszeti Gyar RT v Generics (UK) Ltd (t/a) Mylan  EWCA Civ 410, 26 April 2016 • The Court of Appeal has upheld the High Court decision that declared Gedeon's single dose contraceptive patent invalid for obviousness. • Under limited circumstances, an obviousness assessment could include the skilled person notionally possessing information that could be obtained from a third party, if it was obvious for the skilled person to ask the third party for such information. • The Court of Appeal has, however, cautioned against the use of this approach in all patent cases. Gedeon held a patent, EP (UK) 1 448 207, for a 1.5 ± 0.2 mg single application dose of levonorgestrel (trading under various brand names). The drug was already known as an emergency post-coital contraceptive, but was administered in two doses of 0.75 mg taken 12 hours apart. Hence, the patent contribution was for a single dose which would have significant compliance advantages. At first instance, Sales J held the patent invalid for lack of inventive step over a paper published in 2000, Killick. This paper reported that a single dose of 1.5 g (not mg) was as effective as a two-dose levonorgestrel regimen. On the evidence, the Court found that a skilled person would have clearly realised that the dose reported in Killick was erroneous as it was "too massive to be credible". However, the skilled person would still not know what the correct dose reported was. Sales J held that the skilled person would have asked Killick’s author for the actual dose reported and would have found it to be 1.5 mg (the claimed dose). Thus, the patent was obvious. On appeal, Gedeon asserted that the Judge had erred in law because the skilled person would not know through its own knowledge or through the common general knowledge the correct dose in Killick. Since the skilled person would obtain the correct dose only by asking Killick’s author, Gedeon contended that Sales J had wrongly attributed the private knowledge of a third party to that of the skilled person in holding the patent obvious. The Court of Appeal disagreed with Gedeon. An assessment for obviousness was not limited by the knowledge notionally within the head of the skilled person. For instance, if the skilled person, informed by the state of the art, would find it obvious to look up certain information, then that information too could be considered in determining whether the skilled person would find the claimed invention obvious. Similarly, it would be no different for the skilled person to correct the dosing error in Killick by asking Killick's author for the actual dose reported. This dose correction would render the patent obvious over Killick. Therefore, the Court of Appeal comprising Sir Robin Jacob (whose last decision this was), Floyd LJ and Arnold J unanimously agreed with Generics UK and upheld the first instance decision that invalidated the patent. However, the Court of Appeal also cautioned that including information obtained by the skilled person from third parties in an obviousness assessment was possible in this case only because: • there was a “clearly obvious error” in the prior art; • there was a clear source to ask what the correct dose was; and • the source would give a clear and unambiguous answer to correct the prior art dose error. 5 6. Grant of MA with post-authorisation conditions can define the start of the 10 year data exclusivity period Accord Healthcare Ltd & Anor v Astellas Pharma GmbH & Anor  EWHC 3676 (Ch), 16 December 2015 • The Chancery Division of the English High Court has granted Accord a declaration that the marketing authorisation (MA) for bendamustine obtained by Astellas in Germany in 2005 was granted in accordance with European Directive 2001/83/EC (the MA Directive), despite the fact that the MA had to go through a process to make it compliant with EU law and that the MA imposed post-authorisation conditions on Astellas. • Accord could therefore rely on the German MA's pre-clinical and clinical data in its application for a UK MA for generic bendamustine, as the 10 year data exclusivity period had expired. • Although a UK MA granted by the MHRA should have been challenged by a judicial review, the High Court allowed this case to proceed as both parties stressed the importance of obtaining a speedy declaration on disputed issues from the English court, and the MHRA or other third parties had not objected to the case proceeding. Accord's product is a generic version of Astellas' branded bendamustine chemotherapy drug sold as RIBOMUSTIN, and more recently as LEVACT. The MA Directive allows a generic pharmaceutical company to obtain an MA based on the preclinical and clinical data of an already authorised reference product after a "data exclusivity period" has passed since the grant of the reference product's MA. In the present case, the relevant exclusivity period was 10 years. Accord sought declarations that Astellas' data exclusivity period for bendamustine began in July 2005 when Astellas obtained an MA in Germany for Ribomustin. Astellas disagreed, claiming that the German MA was not granted in accordance with the MA Directive as the MA was conditional upon the pharmaceutical quality of the product and that these conditions were imposed because of "serious deficiencies" in the dossier submitted by Astellas. The Court found in favour of Accord and declared that the German MA for Ribomustin did make it a reference medicinal product within the meaning of the Directive despite the conditions. First, there were repeated references in the MA Directive to post-authorisation conditions on MAs. Second, a situation where the authority was obliged to grant an MA "but was wholly unable to impose conditions on the quality of the product being authorised would be surprising and would require considerable justification". Further, the conditions did not indicate any "serious deficiencies" with the German MA application. As a result of the Court's decision, the data exclusivity period due to Astellas had expired, and it would not be able to challenge the UK MA granted to Accord for bendamustine in November 2015 on the basis that Accord used Astellas' data during the exclusivity period. Morgan J expressed concern about the unusual procedure adopted by the parties to resolve their dispute surrounding the grant of a UK MA. He noted that "the appropriate way for Astellas to challenge that decision was to seek judicial review". However, he was convinced that the present proceedings should continue since (1) the parties were united in stressing the importance of the proceedings continuing, as an English court declaration on the issues would be beneficial before other European courts where Accord's MA was being challenged by Astellas, and (2) third parties, such as the MHRA, had not objected to the proceedings. 7. American Science & Engineering's mobile X-ray backscatter inspection system patent held valid by the English Patents Court American Science & Engineering Inc v Rapiscan Systems Ltd  EWHC 756 (Pat), 11 April 2016 • American Science & Engineering's (ASE) patent for a mobile inspection system using X-ray backscatter technology has been found to involve an inventive step and therefore to be valid. • The judgment is a reminder that evidence from the point of view of hindsight will not support an obviousness attack. • Solicitors must carefully instruct experts to exclude any knowledge of the claimed invention when considering whether it would have been obvious for a skilled person to reach the claimed invention based on the prior art. • A party seeking to rely upon secondary evidence of fact to show why a purportedly obvious invention was not carried out prior to the patent has the burden of proving the existence and the relevance of that fact. Here, it was not enough for Rapiscan to simply state that the invention had not been carried out earlier because of existing patent protection. ASE was the proprietor of a patent claiming an inspection system using X-ray backscatter imaging primarily for use in remote sensing and screening of persons and enclosed objects, EP (UK) 1 558 947. Rapiscan admitted that it infringed the patent if it was valid, however counterclaimed for revocation arguing that the patent was obvious over a prior art publication. The patent disclosed the use of a mobile X-ray scanner for covert imaging under three circumstances: (i) the "drive-by" mode, where the scanning vehicle was moving past the target to be scanned; (ii) the "drive-past" mode, where the scanning vehicle was stationary as the target moved past it; and (iii) the scanning vehicle overtaking the target while both were in motion. Arnold J made some general comments on the parties' instructions to their respective expert witnesses. While ASE's solicitors had asked its expert to consider obvious developments of the prior art before showing him the patent, Rapiscan's solicitors had asked its expert to consider the question of obviousness after showing him the patent. Although according to 6 Arnold J, neither method was wrong per se, Rapiscan's expert had looked at the obviousness question without excluding knowledge of the claimed invention and therefore did not avoid hindsight. Arnold J accepted ASE's contention that the claims were not obvious over the prior art publication, Swift, which disclosed a "drive-by" mode of scanning wherein the driver/occupants of the target vehicle had to leave the target before scanning could occur. On the facts, changing the Swift system into the claimed covert system of scanning without the knowledge of the target occupants would have been obvious only with hindsight. Rapiscan's submission that it would be obvious to convert the Swift system to a "drive-past" covert scanning system was also tainted with hindsight. As secondary evidence that the invention was non-obvious, ASE asked the rhetoric question as to why the invention had not been carried out before, if Rapiscan was correct that the invention was obvious. In response, Rapiscan submitted that ASE had patent protection for X-ray backscatter systems which precluded the carrying out of the invention and that the burden lay upon ASE to prove otherwise. Arnold J found this to be an "extraordinary submission" and stated that a party wishing to rely upon a fact (such as patent protection) to explain why the invention was not carried out before the patent had the burden of proving the existence and relevance of that fact. 8. GSK and generics fined £45 million for anti-competitive 'pay-for-delay' agreements Final infringement decision, Paroxetine investigation: anti-competitive agreements and conduct, Case reference: CE/9531-11, UK Competition and Markets Authority, 12 February 2016 • The UK Competition and Markets Authority (CMA) has fined GlaxoSmithKline plc (GSK), Generics (UK) Ltd (GUK) and Alpharma Ltd a total sum of £45 million for entering into 'pay-for-delay' agreements. The GSK fine is the highest ever competition fine imposed on a pharmaceutical company by UK authorities thus far. • The anti-competitive practices took place during 2001-2004 and were found to have caused the delayed entry of generic paroxetine in the UK market, which helped the sales of GSK's own branded paroxetine, an anti-depressant drug. • GSK was also found to have abused its dominant position in the market, although further details of the abuse will become evident only when the decision is published once the CMA has dealt with confidentiality issues. • As the EU Commission and national competition authorities become increasingly vigilant in their aim of preventing anticompetitive practices, pharmaceutical companies should rigorously assess their commercial arrangements for compliance with competition law. In 2001, GSK held patents in relation to paroxetine and its branded version of paroxetine, SEROXAT, was highly successful in the market. Various generic pharmaceutical companies, including GUK and Alpharma, were attempting to enter the UK market for paroxetine. GSK challenged the entry of generics by claiming that its paroxetine patents were infringed, and both GUK and Alpharma individually entered into settlement agreements with GSK before litigation was commenced. These agreements are purported to have contained terms to prohibit the independent entry of GUK or Alpharma paroxetine generics into the UK market. After an investigation following an EU Commission reference in 2010, the CMA found that: • The GSK-GUK and the GSK-Alpharma Agreements delayed the entry of the respective paroxetine generics into the market, in an infringement of Chapter I of the Competition Act 1998. • GSK also infringed Chapter II of the Competition Act 1998 by making cash payments and other 'value transfers' to GUK and Alpharma, such as by offering distributorship positions to these companies and permitting limited volumes of these companies' products in the market in place of GSK products (thereby effectively transferring some component of GSK's profit margin). • A third company, Norton Healthcare Ltd, did not infringe the Competition Act 1998 prohibitions by virtue of its GSK Agreement due to an exemption under the Vertical Agreements Exclusion Order (in force until 2005). Consequently, the CMA has fined GSK £37.6m and GUK and Alpharma, their parent companies or their successor companies, a total of £7.4m. The fine on GSK is the highest the CMA has imposed on a single company and is also the largest competition fine imposed on a pharmaceutical company. GSK has publically said that it disagrees with the decision and is considering an appeal. 7 9. Key points from featured decisions related to patents Patentee / patent no. Other party/ies Product Court Judge Legal issue Outcome Decisions related to pharmaceutical patents Eli Lilly & Co EP (UK) 1 313 508 Actavis UK Ltd, Actavis Group EHF, Actavis Group PTC EHF, Medis EHF, Actavis Deutschland GMBH & Co. KG, Medis Pharma GMBH, Medis Pharma France SAS, Actavis France SAS, Actavis Spain SA, Actavis Italy SPA A Socio Unico ALIMTA powder for reconstitution (pemetrexed disodium, a chemotherapeutic treatment for lung cancer) High Court (Patents Court) Arnold J Declaration of non-infringement Whether Actavis should be granted a declaration of non-infringement on the basis that its generic product does not require reconstitution with saline Declarations of non-infringement granted to Actavis, but Eli Lilly has liberty to apply if there is a material change in circumstances. Janssen Sciences Ireland UC EP (UK) 2 305 282 Eli Lilly & Co Solanezumab, an antibody that Eli Lilly proposes be used in the treatment of Alzheimer's disease High Court (Patents Court) Rose J Stay of proceedings Whether Janssen should be granted a stay of the English proceedings pending the decision of the EPO Opposition Division Stay refused. English proceedings to go ahead. medac Gesellschaft Für Klinische Spezialpräparate Mbh EP (UK) 2 046 332 Accord Healthcare Ltd METOJECT syringe (methotrexate to treat rheumatoid arthritis) High Court (Patents Court) Birss J Patent validity Whether medac's patent containing Swiss and second medical use claims was invalid for obviousness Claims were obvious in view of a prior art journal article. Richter Gedeon Vegyeszeti Gyar RT EP (UK) 1 448 207 Generics (UK) Ltd Levonogestrel, an emergency post-coital contraceptive, sold under various brand names Court of Appeal Sir Robin Jacob, Floyd LJ, Arnold J Patent validity Whether the Patents Court was correct in deciding the patent obvious over a prior art publication Patents Court decision invalidating the patent upheld. In assessing obviousness, the skilled person would find it obvious to ask the author of a prior art publication for information to correct a clearly obvious error in the prior art disclosure. 8 Patentee / patent no. Other party/ies Product Court Judge Legal issue Outcome Decisions related to patents other than pharmaceutical patents American Science & Engineering Inc EP (UK) 1 558 947 Rapiscan Systems Ltd Mobile inspection system using X-ray backscatter imaging High Court (Patents Court) Arnold J Patent validity Whether patent was obvious over prior art publication Patent was not obvious over prior art publication and was valid. Regeneron Pharmaceuticals Inc EP (UK) 1 360 287 EP (UK) 2 264 163 Kymab Ltd, Novo Nordisk A/S Transgenic mice that can be used as platforms for therapeutic antibody discovery High Court (Patents Court) Henry Carr J Patent validity Whether the patents were invalid for insufficiency Patents invalid for insufficiency. 9 10. Key points from featured decisions on issues other than patents Supplier of branded product Suppliers of generic product Product Court / Authority Judge Legal issue Outcome Astellas Pharma GmbH Napp Phamaceuticals Limited Accord Healthcare Ltd Intas Phrmaceuticals Limited LEVACT, previously sold as RIBOMUSTIN (bendamustine, a chemotherapy drug) High Court (Chancery Division) Morgan J Marketing authorisations Whether an authorisation for bendamustine obtained by Astellas in Germany in 2005, had been granted in accordance with Directive 2001/83/EC so that Accord could rely on that authorisation as a reference product in its application for a UK marketing authorisation for generic bendamustine Accord granted a declaration that the authorisation obtained by Astellas in Germany in 2005, had been granted in accordance with Directive 2001/83/EC. GlaxoSmithKline plc Actavis UK Limited, Xellia Pharmaceuticals ApS, Alpharma LLC SEROXAT (paroxetine, an antidepressant) UK Competition and Markets Authority N/A Anti-competitive conduct in patent settlements Whether "pay for delay" agreements and value transfers made towards settlement of patent disputes between GSK and generics in 2001-2004 were anticompetitive. The CMA imposed fines totalling £44.99 million on the companies directly involved in the infringements. GSK’s total fine is £37,606,275. In respect of Alpharma’s infringement, total fines of £1,542,860 have been imposed. 10 11. Contacts Jonathan Turnbull (Senior Associate) T +44 20 7466 2174 Jonathan.Turnbull@hsf.com Krishna Kakkaiyadi (Associate, India) T +44 20 7466 2979 Krishna.Kakkaiyadi@hsf.com Grace Pead (Associate, Australia) T +44 20 7466 7518 Grace.Pead@hsf.com If you would like to receive more copies of this briefing, or would like to receive Herbert Smith Freehills briefings from other practice areas, or would like to be taken off the distribution lists for such briefings, please email email@example.com. © Herbert Smith Freehills LLP 2016 The contents of this publication, current at the date of publication set out above, are for reference purposes only. They do not constitute legal advice and should not be relied upon as such. Specific legal advice about your specific circumstances should always be sought separately before taking any action based on the information provided herein.