CIPA JOURNAL Incorporating the transactions of the Chartered Institute of Patent Attorneys
November 2016 / Volume 45 / Number 11
IP Futures Sweeping the way forward
Singapore: postgrant amendments Warner-Lambert v Novartis
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Unjustified Threats Bill Litigation Committee
China update: Abuse of IPR Guidelines Toby Mak
Specialist IP tribunals in Pakistan Naeema Sadaf
Six things we love about working in Australia Serena White
07/11/2016 11:32:29
CIPA JOURNAL
CIPA CONTACTS
Editor Editorial Panel
Alasdair Poore David Barron, Paul Cole, Kristina Cornish, Tibor Gold, Alan White Publications Committee William Jones (Chairman) Production Iain Ross, 020 3289 6445 and advertising (iain@ross-limbe.co.uk) Design Neil Lampert Cover design Jonathan Briggs Contact editor@cipa.org.uk Published on behalf of CIPA by Ross-Limbe Communications. The Institute as a body is not responsible either for the statements made, or for the opinions expressed in this Journal. No papers read before the Institute or extracts from its Proceedings may be published without the express permission of the Council and without the simultaneous acknowledgement of their source. CIPA Journal is sent to all members of the Institute as part of the benefits of membership. It is also available on subscription at £130 per annum (plus postage for overseas addresses: Europe £35, Other £70). Individual copies may be purchased at £14 (plus postage for overseas addresses: Europe £4, Other £6). The Editor welcomes the submission of articles, news and correspondence for possible publications including photographs, tables, charts, etc, when appropriate, and any contributions should be sent by email to editor@cipa.org.uk. Iain Ross (iain@ross-limbe.co.uk) will be pleased to discuss any queries regarding submissions and advertising. Copyright in material submitted for publication Material submitted to the CIPA Journal will be accepted for publication on condition that the author, or each of them, grants the Chartered Institute a non-exclusive licence to publish the material: i. in paper form first; and ii. after paper publication, also on its website www.cipa.org.uk, in the members’ area with the ability for members to download them. When sending material, the author(s) should confirm acceptance of this condition and also that the submission is free of any third party rights or other encumbrances. Past contributors The Institute is in the process of putting on its website past articles not covered by an express agreement as set out above. Any contributor wishing to object to their work being treated in this way should write to the editor at editor@cipa.org.uk. Editorial deadline dates for receiving submissions are on the 10th of the preceding month. Please contact editor@cipa.org.uk to discuss any ideas for articles or submissions.
Tony Rollins President
Stephen Jones Vice-President
Andrea Brewster Immediate Past-President
Chris Mercer Honorary Secretary
Committee Chairs Administrators Vicky Maynard; Business Practice (joint with ITMA) Matt Dixon; Computer Technology Simon Davies; Congress Steering John Brown; Constitutional Alasdair Poore; Designs and Copyright David Musker; Education and Professional Standards Simone Ferrara; Exploitation Catriona Hammer; Informals Ben Charig; Internal Governance Bobby Mukherjee; International Liaison Richard Mair; Life Sciences Simon Wright; Litigation Vicki Salmon; PEB Rob Taylor; Patents Tim Jackson; Protected Titles Lee Davies; Media and Public Relations Jerry Bridge-Butler; Regulatory Affairs Chris Mercer; Textbooks & publications Bill Jones; Trade Marks Keith Howick. Membership Team Leader: Dwaine Hamilton Events Coordinators: Kirsty Burls; Johanna Lynch Membership and Events Coordinator: Charlotte Russell Membership Finance Coordinator: Frances Bleach Chief Executive Lee Davies Executive Assistant Gary McFly Head of Media and Public Affairs Neil Lampert Communications Officer Isabelle Wilton Policy Officer Rebecca Gulbul Head of Education Georgina Sear Education Projects Co-ordinator: Angelina Smith Finance Manager Spurgeon Manuel Finance Administrator Andrew Hewitt General enquiries: 020 7405 9450; mail@cipa.org.uk; www.cipa.org.uk
© The Chartered Institute of Patent Attorneys 2016 ISSN: 0306-0314
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Contents 74 43 UP FRONT 2
Council Minutes
Re-examination of patent applications
Lee Davies
Intellectual Property Office FD4 pass rate
ARTICLES
David Musker 10
Unjustified Threats
28
Litigation Committee 14
EPO – fee payments Plant breeding Nagoya – EU Guidance Overseas report
46
Gladys Mirandah and Tai Yoke Yee 19
69 72
The not-so-secret diary
Andrea Brewster
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55
EPO decisions
Bristows 57
Trade marks and other IP
Bird & Bird
EDUCATION 78 80
Institute events East of England
Mathew Leese
PERSONAL 74
Working in Australia
77
Going Remote
Serena White Heather Lane
THE PINKS
Straight allies
Darren Smyth
IP Pro Bono scheme
CIPA press release
Singapore: Warner-Lambert v Novartis
Uma Baskaran, Chow Jian Hong
Cambodia update
IPO decisions
Barker Brettell
The Good Attorney
Jonathan Stafford
Amanda R. Gladwin 18
54
IP tribunals in Pakistan
Naeema Sadaf and H. Zafar Iqbal 43
Life Sciences Committee 17
China update
Toby Mak 38
Life Sciences Committee 16
Clearing the way
Patent decisions
Beck Greener
Liz Cohen and Adrian Chew 32
Patents Committee 15
48
IPReg
NEWS Community Designs
DECISIONS
Manual of Patent Practice
Intellectual Property Office 27
27
7
Online Services and Developments
Intellectual Property Office 26
Chief Executive Report
Lee Davies 5
20
IP Futures
Alasdair Poore 3
28
81 83 84 94
Courses and events Recruitment International Services
NOVEMBER 2016
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07/11/2016 14:18:17
Clear off Is the clearing the way principle still relevant?
Over the last few years the English Patents Court, driven to a large extent by the high prizes at stake in the pharma field, has led the way in innovative approaches to addressing competitors seeking to break into a market developed by the patent holder, leading to concepts such as “clearing the way” before a competitor enters the market and “Arrow”1 declarations where the way is blocked by the spectre of currently not yet granted patents creating further obstacles. Liz Cohen (Associate) and Adrian Chew provide a fascinating insight into some of the unique economic drivers in the UK pharma market which make new competitors want to rush into the patent fray, and how the law is developing as the Patents Court has the opportunity to explore it further.2
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T
he pharmaceutical industry has always relied on patents to protect its investment in new medicines, so it should be of no surprise that around 47% of patent disputes reaching trial in the Patents Court of England and Wales since 2008 have been in relation to the life sciences3. In response, the Patents Court has sought to balance the proper incentives that patent rights provide against the concern that some patentees may gain an unjustified monopoly by maintaining patents that are ultimately found to be invalid and consequently act as a stumbling block for healthy competition. In this article we will consider the role that the “clearing the way” principle has traditionally played in the process for launching a competitor product on the UK market and whether recently reported Patents Court decisions (two decisions in Fujifilm Kyowa Biologics v AbbVie Biotechnology4, and a further decision in Actavis v ICOS5) have the potential to alter this, with consequences which perhaps were not anticipated by the Court in the context in which the decisions were made.
Background It is well recognised that the regulatory requirements for a marketing authorisation (MA) for a new medicinal product are onerous, requiring a large amount of supporting data from clinical trials which are costly, time intensive and uncertain in their ultimate outcome. In the EU, the data submitted to the regulatory authorities in support of an MA is subject to regulatory data protection (RDP) rules6. However, once the period of RDP expires, a third party may rely on the original applicant’s data to support its own MA on the basis that a bioequivalent competitor product will have the same safety, efficacy and bioavailability profile as the original product. RDP often expires before all patent protection covering the medicinal product has expired. Consequently, a third party can obtain an MA to launch a competitor product despite patents protecting the product still being in force, and hence putting them at risk of infringement proceedings and potentially a preliminary injunction or interim injunction (PI) restraining them from offering the competitor product on the UK market, if they launch immediately. www.cipa.org.uk
07/11/2016 14:25:14
ARTICLE
Adding to this complexity is that central prosecution of European patents before the EPO and the use of pan-EU MA procedures creates a multijurisdictional dimension to any launch strategy. Further, the lucrative pharmaceutical market often means that it is rare that only a single competitor will be interested in entering a particular market, and with the rewards stacked towards the first company to launch, competitor products enter into a “race to the market”.
Clearing the way It is a particular quirk of the English NHS drug reimbursement system that once a competing product is launched, there is a window of opportunity for pharmacists to source the cheaper competitor product whilst receiving compensation at the usually higher original product’s reimbursement price. This often results in rapid market uptake of cheaper competitor products with large market gains possible in a short period of time until the price of the original product is lowered. Following the launch of a cheaper competitor product, the drug reimbursement price may eventually be lowered by the NHS to take account of the cheaper competitors, forcing the price of the original product to lower so as to remain attractive to pharmacists. The resulting price competition between competitor product(s) and the original product is often argued to result in an irreversible price spiral which cannot be remedied by the grant of a later final injunction removing the competitor product from the market until after patent expiry, so justifying the grant of a PI preventing the competitor launching at all. Conversely, competitors who wish to enter an existing
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CLEARING THE WAY
market for a particular medicinal product and have obtained an MA to do so, have to balance the risk of not having the ‘first mover advantage’ against being sued for infringement. This is a particular challenge where these patents still have many years to run, particularly if, as recent cases have highlighted, they are still at the application stage. It is against this background of both the patentee and its potential competitor facing irreparable harm if a PI is granted, that the doctrine of “clearing the way” developed in English law, resulting in a rich history of case law which started with Jacob J (as he was then) in Smithkline Beecham v Generics (UK)7. The thinking behind the principle is the Court’s view that a potential competitor is in a position well ahead of launch of a competitor product (in many cases several years ahead) to know whether there are any patents of concern, compared to the position of the patentee whose first indication of a potential competitor launch is public notice of the competitor’s MA grant8. It is therefore incumbent on the competitor to take steps to establish whether its product does or does not infringe a valid patent. If it does not take such steps, this may count against the competitor when the Court is considering whether a PI is appropriate and particularly when considering where the balance of convenience lies. The consequence for competitor companies is that a commercially successful launch of a competitor product is predicated on it resolving any patent issues ahead of launch either by applying for revocation of the patent(s) of concern, or by seeking a declaration of non-infringement in relation to the product which it intends to launch. The Court of Appeal’s decision in Hospira v Novartis9 confirmed that it was not
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China update Competition and anti-trust: NDRC Abuse of IPR Guidelines
Competition and anti-trust issues are becoming increasingly important in relation to IP generally, with issues frequently being raised in the EU in at least two key areas: telecommunications and pharmaceuticals. In the telecoms field, issues such as designating, enforcing and licensing standard essential patents are repeatedly in the news across Europe; and in relation to pharmaceuticals, the EU Commission has had an active interest in “evergreening”, generic product market entry and pay-for-delay agreements, as well as abusive establishment of IPRs. IP practitioners need to keep in mind the impact of what they do in relation to anti-trust laws. This article by Toby Mak (Foreign Member), summarises the Abuse of IPR Guidelines in China. There are close analogies with EU competition law, and this serves as a reminder not just that competition law issues are important in such a major market as China, but also a checklist of points which are equally important in the EU.1
I
n December 2015, the Chinese National Development and Reform Commission (NDRC) published their proposed Abuse of IPR Guidelines (the proposed Guidelines) for consultation. Compared to the draft Guidelines (published in October 2015) there were many significant changes. Some readers may not be familiar with the Chinese NDRC, which manages many economic functions of the State Council, including: formulating and implementing strategies of national economic and social development, annual plans, medium and long-term development plans; monitoring macroeconomic and social development trends and providing forecasts. One of its key responsibilities is the enforcement of the Chinese Anti-monopoly Law, particularly issues regarding standard essential patents. The proposed Guidelines are intended to provide guidance on when enforcing IP, particularly patents, would be considered to violate the Antimonopoly Law. However, as the reader will see below at times the guidance is less than clear. The Guidelines start with an explanation that the purpose of the Anti-monopoly Law is to maintain market competition, motivate innovation, and enhance technology dissipation and utilization, while intellectual property law’s goal is to protect and encourage innovation so as to enhance market competition. The Guidelines then state that the Anti-monopoly Law is not applicable to the enforcement of IP unless the enforcement of IP violates its original goal (i.e. to protect and encourage innovation), which could eliminate and/ or restrict competition. The Guidelines then provide a very comprehensive set of rules that try to provide better certainty and reasonable expectations on when enforcement of IP would be considered as violating the Anti-monopoly Law. The Guidelines have the following sections that are directly relevant to IP: 1. Basic questions. 2. IP agreements that may eliminate and/or restriction competition. 3. Concerning Acts of Abuse of Dominant Market Position of IP.
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www.cipa.org.uk
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CHINA UPDATE
Basic questions
COMPETITION
•
This section states that the following principles should be considered when analyzing whether the enforcement of IP violates the Anti-monopoly Law: • • •
•
Characteristics of IP should be considered together with standards on types of assets other than IP. IP owners will not be considered as being dominant by simply owning IP. Acts should be analyzed on a case-by-case basis, thoroughly considering how the enforcement of IP affects competition and innovation. Facts, evidence and reasons of enforcing IP provided by IP owners should be thoroughly considered.
Market definition is essential to the determination of antimonopoly activities. The Guidelines specifically state that as IP can be used in products and services and can also be the object of trade itself, only analyzing the product and/or services market cannot fully evaluate the influence of IP on competition. Therefore, the relevant technology market should also be involved, including influence on research investment and/or innovation activities. More specifically, the relevant technology market refers to the market formed due to competition between the technology in question and ‘substitutable’ technology. The Guidelines state that the following factors should be considered in determining “substitutability”: • • • • •
nature of the technology; use of the technology; the level of licence fees; remaining term of IPRs applicable to the technology; the possibility and costs of switching to “substitutable” technology.
The Guidelines then set out the following factors which are to be considered when performing a competitive analysis.
“Number share” (why suddenly change to number share? Interesting……) of the relevant technology in the replaceable IP.2
Analysis on elimination and/or restriction of competition by the enforcement of IPRs • • • • •
Elimination or obstruction to existing and potential competition in the relevant market. Control of resources like key technologies, setting or raising barriers to entry in the relevant market. Restricting technology innovation, promotion and development. Restricting the development of industry. Restrictions on levels of production, coverage of territory and customer groups.
Promotion of innovation and enhancement of efficiency by enforcement of IPRs • • •
•
Causal relationship with promotion of innovation and enhancement of efficiency. Levels of promotion of innovation and enhancement of efficiency. Whether serious restrictions on competition in the relevant market, or hindrance to innovation of other operations would be imposed. Whether consumers could enjoy benefits from the promotion of innovation and enhancement of efficiency.
IP agreements that may eliminate and/or restrict competition The Guidelines state that it is more likely for IP agreements between competitors to eliminate and/or restrict competition than those between non-competitors. The Guidelines also specifically identify the following factors covering various types of agreements to be considered in evaluating whether competition would be eliminated and/or restricted. On the other hand, the Guidelines accept that these agreements generally benefit competition by enhancing efficiency and, in particular, reducing transaction costs.
Analysis on competition in relevant market • • • • • •
Market status of IP owner, competitors, and trading partners. Concentration of the market. Ease of entering the market. Reliance on IP by the trading partner. Characteristics and development of the industry. Technology status of the relevant market, including technology developments, availability of substitutable technology and IP owners’ market share.
Agreements between competitors Joint development • • •
Whether the development of new technology or products in an unrelated field is restricted. Whether cooperation with third parties to develop new technology or products in an unrelated field is restricted. Whether ownership and enforcement of IP derived from new technology or products in an unrelated field is restricted.
Calculation of market share
Patent pools
•
•
•
Share of licensing income of the relevant technology in the relevant market. Share of products/services using the relevant technology in a downstream market.
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•
Whether the pool is formed by inter-changeable technologies. Whether members of the pool are restricted to licensing patents only within the pool. NOVEMBER 2016
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Specialist IP tribunals in Pakistan Naeema Sadaf and H. Zafar Iqbal discuss the impact of new specialist intellectual property tribunals in Pakistan.
W
orldwide, the concept of establishing special intellectual property (IP) courts and tribunals has emerged as one of the strategies to deal with the complex and technical nature of IP litigation; and Pakistan is no exception. In the last three decades, IP infringement proceedings had been receiving a secondary treatment before the regular courts in Pakistan. This has resulted in a substantial backlog of IP cases in the courts. On the other hand, since at least 2000, various conflicting provisions in the TRIPs-compliant IP laws of Pakistan, especially the patent law, have resulted in an increased number of IP cases being litigated and consequently disorderliness in the courts. The situation was inflamed when, by the end of 2014, about 70% cases in pharmaceutical and biotechnology patent disputes, badly needed the specific expertise and detailed attention of the specialized judges. In September 2015 and in response to these perceived problems, the Federal Government of Pakistan, by a gazette notification, has constituted IP tribunals as a specialized substitute for the District Courts. The very aims and objectives behind conceptualizing and constituting IP tribunals was thus to create a judicial mechanism that can address the technical and complex nature of IP laws; ensure adjudication of IP cases with speed, economy, consistency, predictability and quality; and in parallel to reduce the litigation burden (caseloads) on the regular courts. The IP tribunals were created by the Intellectual Property Organization of Pakistan Act, 2012 (the Act). Section 18(1) states that: “All suits and other civil proceedings regarding infringement of intellectual property rights shall be instituted and tried in the tribunal”.
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Section 18(2) goes on to state that: “the tribunal shall have exclusive jurisdiction to try any offence under intellectual property laws”. In terms of section 17(3) and (4) all proceedings before the tribunal are deemed to be judicial proceedings within the meaning of sections 193 and 228 of the Pakistan Penal Code1 and that no court other than a tribunal can have or exercise any jurisdiction with respect to any matter to which the jurisdiction of the tribunal extends under the Act.
Editor’s summary Specialist IP jurisdictions are becoming an increasing focus worldwide (see June [2016] CIPA 63). The authors explain Pakistan’s new specialist IP tribunals, which have exclusive first instance jurisdiction in civil IP infringement matters, as well as certain criminal IP matters. This article provides details of the new jurisdiction and expresses the authors reservations about the lack of a requirement to appoint judges with specialist IP experience to preside, especially in relation to the handling of patent cases which are already creating a significant backlog in Pakistan, and the risk of a backlog of cases on appeal being created, as well as a continuing need to address administrative procedures relating to IP.
www.cipa.org.uk
07/11/2016 14:52:18
ARTICLE
PAKISTAN
Composition of the IP tribunals
Procedure before the IP tribunals
In contrast to the regular courts, IP tribunals are specialized courts with independent judicial power to adjudicate disputes and administer justice concerning infringement of intellectual property rights (IPRs) exclusively. IP tribunals have all the trappings of a regular court except they have specialized jurisdiction and are not a part of the regular court system. They can exercise jurisdiction within the territorial limits defined by the Federal Government2 and hold sittings at a place within their territorial jurisdiction as determined by the Federal Government. Whilst, the Federal Government may establish as many tribunals as it considers necessary to exercise jurisdiction under the Act3, so far only three tribunals have been established; one for each of the two provinces of Punjab (Lahore) and Sindh (Karachi); and one for Islamabad (capital). Each tribunal consists of a presiding officer, appointed by the Federal Government after consultation with the Chief Justice of High Court concerned4. To preside over an IP tribunal, a person must have either served as a judge of High Court; a District and Session Court; or be an advocate qualified for appointment as a judge of the High Court. Being specialized tribunals, and, one might presume a presiding officer must either be a specialist or at least have adequate legal training and experience in IP law. Instead, however, within the meaning of the Act5, a presiding officer does not need to be an IP specialist or have any legal training and experience in IP: it is enough if they have a suitable qualification and experience in law. This is confirmed from two of the three appointments made so far. The District and Session Judge, and the Judge Accountability Court-II are both lacking the required experience and knowledge needed to preside over the complex IP matters especially the patent infringement proceedings.
The Act6 empowers the Organization (IPO-PK) to prescribe rules, subject to the approval of the Federal Government, for carrying out the purposes of the Act. However, no special rules for dealing with the IP litigation within the special jurisdiction of the tribunals have been prescribed so far. On the other hand, section 17(2) envisages that in all matters with respect to which the procedure has not been provided for in this Act, the tribunal shall follow the procedure laid down in the Code7. This suggests that for IP suits and other civil proceedings before the tribunal, there is no shift or change in the normal rules of evidence and the civil procedure, previously followed by the regular courts. The tribunal has the power to summon witnesses; to examine them on oath; order the discovery and production of any document or material objects; to receive evidence on affidavits; to issue commissions for the examination of any witnesses or documents; and to exercise jurisdiction with respect to any matter to which the jurisdiction of the tribunal extends under the Act. However, when trying an offence under IP laws, the tribunal is directed to hear the proceedings from day to day and dispose of the same in 90 days8. This shift from the “periodic hearings” provided under the normal rules of the Criminal Procedure Code to the so-called “continuous hearings” apparently seems to remedy the delays in the decision-making process but from the practical side, managing an increasing number of offences – especially under copyright, and trade mark law – seems difficult to achieve by a single judge.
IP experts for technical assistance The law governing IPRs is complex, but the technology involved is even more so – especially in the areas of biotechnology, cell biology, and electronics. Judges frequently deal with difficult questions of scientific or technical nature to which they generally have no training. Consequently, during trials, the role of expert witnesses have particular significance. In many situations, taking advantage of the claims language, especially in the cases of widely drawn generic claims, expert witnesses often present contradictory positions that inevitably may challenge having one acceptable answer. In order to address these complexities, tribunals are authorised to seek the assistance of experts, experienced in the technical aspects of IPRs. Nevertheless, this technical assistance does not discharge the ultimate responsibility of a judge to decide the matter on merit. Volume 45, number 11
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Transfer of proceedings: Power to proceed de novo Since the date of constitution of the IP tribunals, all suits or other proceedings relating to IPRs, pending in any court within the jurisdiction of a tribunal, have been transferred to the tribunals. And since then all transferred proceedings are being heard and disposed of by the tribunals from the stage the proceedings had reached prior to the transfer. In transferred proceedings, the tribunals are not bound to recall and rehear any witnesses, and may act on the evidence already recorded or produced before a court from which the proceedings have been transferred 9. This suggests that tribunals are given the liberty either to hear or recall any witness previously heard or called by the District Court to proceed with and decide any matter de novo. However, to the extent of decisions of High Court deciding a question of law or which is based upon or enunciates a principle of law10, these are binding on tribunals and they cannot deviate unless the decision is incorrect in its underlying legal approach. NOVEMBER 2016
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SINGAPORE
WARNER-LAMBERT v NOVARTIS
Warner-Lambert v Novartis The Singapore High Court refuses post-grant amendments of method of treatment claims to Swiss-style claims in Warner-Lambert Company LLC v Novartis (Singapore) Pte Ltd [2016] SGHC 106. By Uma Baskaran and Chow Jian Hong.
T
his case is an opposition by Novartis (Singapore) Pte Ltd (“Novartis”) to a post-grant amendment application for a patent by Warner-Lambert Company LLC (“WLC”). The matter was heard by Justice George Wei in the High Court of Singapore. WLC filed an amendment to its Singapore Patent SG 61244 (“SG Patent”) several years after grant. The amendment involved, inter alia, a change of claim category from Method of Treatment (“MoT”) to Swiss-style claims.
Background WLC’s SG Patent claims a method of treatment of pain using a therapeutically effective amount of pregabalin. Novartis had applied for a product licence with the Singapore Health Sciences Authority in respect of its pregabalin product. As a requirement under section 12A(3)(a) of the Medicines Act, Novartis served a notice on WLC that the SG patent would not be infringed by acts for which the product licence was sought. WLC opposed Novartis’ product licence application claiming that the SG Patent would be infringed. Novartis sought to revoke the patent on the ground that the granted claims were invalid as they claim a method of treatment, which is not patentable under the Singapore Patents Act (SPA). Subsequently, WLC applied to amend the SG Patent’s MoT claims to Swiss-style claims. The SG Patent was a national phase application based on a PCT application filed on 16 July 1997 claiming priority from a corresponding US application filed on 24 July 1996. The SG Patent was granted in Singapore on 23 May 2000. At the time of grant of the SG Patent, patents were granted under a self-assessment system in Singapore. Although there was an option of requesting for a search and examination, most of the Singapore patents were granted without substantive examination. There were two main issues in this case: 1. Whether the proposed amendment from an MoT claim to a Swiss-style claim post-grant would extend the scope of protection conferred by the patent. 2. Whether the court should exercise its discretion to disallow the proposed amendments on the ground that there was unreasonable delay on the part of WLC in seeking the amendments. 46 CIPA JOURNAL
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Extension of the scope of protection Similar to many jurisdictions, post-grant amendments are fairly restrictive in Singapore. No amendment of the specification of a patent shall be allowed if the amendment would result in the specification disclosing any additional matter – section 84(3) (a) SPA – or if the amendment would extend the protection conferred by the patent – section 84(3)(b) SPA. In Singapore, methods of treatment are excluded from patentability as method of treatment claims are deemed to be incapable of industrial application under section 16(2) SPA. However, under section 16(3) of the Singapore Patents Act, a substance or composition is considered to be industrially applicable even if its intended purpose is for use in the method of treatment. Furthermore, section 14(7) SPA provides that a new use of a known substance or composition will be new if this use does not form the part of the state of the art. These provisions allow the claims drafted in Swiss-style format – i.e. claims directed to a use of a known compound or a composition – to be eligible for a grant of a patent in Singapore. The new therapeutic use is regarded as conferring novelty on the process of manufacture. In practice, during prosecution – i.e. before the grant of a patent – claims directed to method of treatment are usually amended to a Swiss-style claim format in order to overcome the exclusion under section 16(2) SPA. In this case, WLC applied for a post-grant amendment of an MoT claim to a Swiss-style claim. A key question therefore was whether such an amendment from an MoT claim to a Swiss-style claim, post-grant, would amount to an extension of the patent’s scope of protection under section 84(3)(b) SPA. Novartis argued that the proposed amendment would extend the scope of protection conferred: 1. by changing the category of claim from a method of treatment to a method of manufacture; and 2. by deletion of the crucial step of “administering a therapeutically effective amount of a compound. www.cipa.org.uk
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SINGAPORE
The judge held that a mere change in a category of claim did not necessarily mean that the scope of protection had been extended. The judge held that a useful test of determining whether the scope of protection was being extended was: whether a matter which fell outside the scope of the claims (properly interpreted) and was hence not an infringing act on its own (preamendment), now falls within the claims such that it becomes an infringing act (post-amendment). A “purposive approach” was to be adopted in construing the patent claims. Section 66(1)(b) and (c) SPA sets out what constitutes an infringement of a process patent. The judge applied section 66(1) (b) SPA to determine what would constitute an infringement of the granted MoT claims and the amended Swiss-style claims to ascertain if there was an extension of scope of the claims. The judge determined that:
WARNER-LAMBERT v NOVARTIS
It was held that the technical subject-matter and contribution over which the protection claimed by a Swissstyle claim was different from that of an MoT claim. The post-grant amendment of an MoT claim to a Swiss-style claim would extend the protection conferred by the patent by bringing into its scope the step of manufacturing the medicament. Singapore has not aligned its laws to the UK’s or EPO’s position on medical use claims. The examination guideline issued by the Intellectual Property Office of Singapore (IPOS) in 2014 clarifies the issue on medical use claims and Swissstyle claims: • •
•
•
•
Novartis will infringe the granted claims if it offers or provides treatment of pain in Singapore by administering a therapeutically effective amount of pregabalin. On the other hand, Novartis will infringe the amended claims if it uses pregabalin in the process to manufacture the medicament for treating pain. Novartis will also be infringing section 66(1)(c) SPA if it disposes uses or imports a product obtained directly from that manufacturing process.
The judge was of the view that the manufacture of the medicament was not an activity that fell within the scope of the granted patent. While both the MoT claims and the Swissstyle claims were connected by the objective of treating pain, the granted MoT claims were targeted towards a different activity (the act of administering the compound to treat pain) as opposed to the Swiss-style claims (which are targeted at making a compound for the purposes of administration). As WLC had chosen to claim the administration of the compound for treating pain, and not the manufacturing process that produced the compound for that use in the granted claims, the judge held that WLC should not be allowed to extend the protection conferred by the patent by bringing into its scope the step of manufacturing the medicament. The judgment also elaborated on whether secondary or indirect infringement should be taken into account in determining whether the scope of the patent has been extended. Singapore Patent law does not provide for indirect or secondary infringement. It is governed by the common law position on joint tortfeasorship on proof of a common design to procure or actually participate in acts of infringement. The judge held that it would not be appropriate to take into account secondary or indirect infringement when determining the extension of scope of protection conferred by the patent. Any further act which attracted additional liability should be disregarded while ascertaining the extension of scope of the proposed amendments as they do not fall within the scope of the claims as granted. Volume 45, number 11
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• •
Swiss-style claims are not related to method of medical treatment claims; European-style second medical use claims are not related to Swiss-style claims; method of treatment claims are not related to first medical use claims; and EPO second medical claims are in a format corresponding to a Singapore first medical use claim.
Therefore, care should be taken while amending MoT claims to Swiss-style claims even before the grant of a patent, particularly, when relying on a corresponding granted patent.
Unreasonable delay in seeking the amendments The court held that WLC had many opportunities to amend its patent pre-grant and post-grant. The reason for its inaction or delay in seeking amendments was not adequately explained. The court therefore exercised its discretion to disallow the amendments because they were sought after a lengthy and inexplicable delay. This is a landmark judgment based upon which the IPOS later reviewed its practice on the assessment of post-grant amendments under the SPA. The review introduced additional grounds to assess the post-grant amendments including: a. Whether relevant matters are sufficiently disclosed. b. Whether there was any unreasonable delay in seeking amendments. c. Whether the patentee has gained an unfair advantage obtained by delaying amendments which are known to be needed. In conclusion, the application to amend the patent in suit was dismissed with costs to Novartis. WLC has appealed against the judgment to the Court of Appeal. Jian Hong Chow (lawyers@mirandahlaw.com) is an associate (and Advocate and Solicitor in Singapore) at mirandah law llp and Uma Baskaran (singapore@mirandah.com) is a patent specialist (and Registered Indian Patent Agent) at mirandah asia (singapore). NOVEMBER 2016
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INSTITUTE EVENTS
Institute Events For more information and to book onto any event please see the CIPA website or email cpd@cipa.org.uk
Wednesday, 16 November 2016 Conference
Do Patents have a ‘Chilling Effect’ on the Incentives for Research and Development? Time: 18:00–19.30pm Location: UCL Cruciform Lecture Theatre, UCL Main Campus, Gower Street, London, WC1E 6BT A patent is a grant of the exclusive right for a novel, non-obvious invention. The value of patents to society lies in the incentives they provide to research and develop useful inventions. Today many are prepared to argue that patents retard research and development and so hold back economic progress. This conference will examine the arguments and evidence on both sides of this debate. The four panelists have a maximum of 15 minutes to speak. A Q&A session will follow.
Speakers: The Rt. Hon. Sir Robin Jacob, Nikolaus Thumm, John Howells, David Rosenberg, Robert Pocknell
Prices: £30 (£25.50 CIPA members)
Thursday, 17 November 2016 Social
Monday, 21 November 2016 Seminar
Patent Case Law London Time: 12:30–17:00pm Location: The Royal College Of Surgeons, 35-43 Lincoln's Inn Fields, London, WC2A 3PE This seminar will focus on interesting patent decisions to have come from UK and US courts, and the EPO Boards of Appeal in 2016. This seminar will also be held in Bristol and Manchester. CPD: 3; Prices: £234 (members £156)
Wednesday, 23 November 2016 Webinar
The Unified Patent Court Past, Present and Future
Join us for an opportunity to network with other IP professionals over drinks. Please note, booking is mandatory and drinks tokens will be distributed on arrival. FREE for CIPA members, register at www.cipa.org.uk/whats-on/events/
Monday, 28 November 2016 Seminar
Time: 12:30–13:30pm
CIPA/ITMA New Students Induction Day
Please join us for this webinar, in which speakers Pippa Allen and Leythem Wall will give a brief overview of the Unitary Patent and UPC systems, where the UPC stands now in light of ‘Brexit’, your representation rights, and what paths lie ahead.
Time: 09.15am-16.50pm Location: CIPA, 95 Chancery Lane, London, WC2A 1DT
CPD: 1; Prices: £72 (members £48)
York Happy Hour Time: 18.00–19.30pm Location: Royal York Hotel, Station Road, York, YO24 1AA
else from the IP professions who has an interest in our work. The event will likely start in the late afternoon/early evening, and will include updates on IP Inclusive projects; a chaired discussion on bringing more BAME (black, Asian and minority ethnic) professionals into IP; and a chance to share experiences and suggestions. We will finish with refreshments and informal networking. More details will follow, but for now, please save the date. If you haven't already done so, sign-up to the IP Inclusive Charter for Equality, Diversity and Inclusion, which has a fantastic 76 signatories already!
Thursday, 24 November 2016 Reception
IP Inclusive Reception Time: 17.00pm Location: Carpmaels & Ransford LLP, 1 Southampton Row, London WC1B 5HA The reception will be an opportunity to bring together the EDI officers of all the IP Inclusive Charter signatories, as well as task force members and anyone
If you have joined the profession in the last 18 months, then our induction day is for you! This day will be a chance to learn more about CIPA, ITMA and IPReg and will include: • an introduction to the commercial context of the IP attorney’s work; • basic business practice, including professional ethics and client care; • an overview of CIPA Informals; and • an introduction to the training and qualification systems for both patent and trade mark attorneys. It is also an excellent opportunity for trainees to meet and share experiences, particularly for those based outside London. Prices: £36 (member rate)
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Monday, 28 November 2016 Seminar
EVENTS
particularly for those based outside London.
Winchester Happy Hour
Patent Case Law Bristol Time: 12:30–17:00pm Location: Mercure Brigstow Hotel, 5-7 Welsh Back, Bristol, BS14SP This seminar will focus on interesting patent decisions to have come from UK and US courts, and the EPO Boards of Appeal in 2016. This seminar will also be held in London and Manchester. CPD: 3; Prices: £234 (members £156)
Monday, 5 December 2016 Seminar
CIPA New Students Induction Day
Prices: £36 (member rate)
Wednesday, 7 December 2016 Social
CIPA Christmas Happy Hour 2016 Time: 18.00–21.00pm Location: The Fable, 52 Holborn Viaduct, London, EC1A 2FD Join us for this merry opportunity to network with other IP professionals over festive drinks. Please note, booking is mandatory and drinks tokens will be distributed on arrival. FREE for CIPA members, register at www.cipa.org.uk/whats-on/events/
Time: 9.15am-16.50pm Location: CIPA, 95 Chancery Lane, London, WC2A 1DT If you have joined the profession in the last 18 months, then our induction day is for you! This day will be a chance to learn more about CIPA, ITMA and IPReg and will include: • an introduction to the commercial context of the IP attorney’s work; • basic business practice, including professional ethics and client care; • an overview of CIPA Informals; and • an introduction to the training and qualification systems for both patent and trade mark attorneys. It is also an excellent opportunity for trainees to meet and share experiences,
Monday, 12 December 2016 Seminar
Patent Case Law Manchester Time: 12:30–17:00pm Location: DoubleTree by Hilton Hotel Manchester, M1 3DG This seminar will focus on interesting patent decisions to have come from UK and US courts, and the EPO Boards of Appeal in 2016. This seminar will also be held in London and Bristol. CPD: 3; Prices: £234 (members £156)
London Hilton on Park Lane
Join 600 guests from across the entire legal profession to enjoy ITMA's ever popular afternoon of networking, drinks and traditional three-course Christmas meal. For more details see: www.itma.org.uk/calendar/event/view?id=110
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Time: 18.00–19.30pm Location: The Green Man, 53 Southgate Street, Winchester, SO23 9EH Join us in the South of England for after work drinks and a chance to network with other CIPA members. Please note, booking is mandatory and drinks tokens will be distributed on arrival. FREE for CIPA members, register at www.cipa.org.uk/whats-on/events/
Monday, 23 January 2017 Seminar
ECF Everything
ITMA London Christmas Lunch 9 December 2016
Thursday, 19 January 2017 Social
Time: 16.15–19.15pm Location: CIPA, 95 Chancery Lane, London, WC2A 1DT The seminar will inform about the reasons, aims and implementation of the Early Certainty initiatives at the EPO. Further recent developments at the EPO will also be addressed. This event will be followed by drinks and nibbles. Speakers: Heli Pihlajamaa, Director of Patent Law at EPO, John Beatty, director Practices and Procedures Management at the EPO CPD: 2; Prices: £156 (members £102)
Reporters Needed! CIPA is looking for volunteers to report on regional CIPA events. If you are interested, please contact cpd@cipa.org.uk.
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