Eli Lilly is handed another win in its efforts to keep generics companies selling ALIMTA competing drugs off the market
We have reported previously on the litigation in multiple jurisdictions regarding Eli Lilly’s patents covering ALIMTA, its blockbuster drug used for the treatment of mesothelioma and certain lung cancers. The latest instalment comes by way of Federal Circuit decision Eli Lilly and Co v. Apotex, Inc. (Fed. Cir. 2020).
There is a strict difference between statutory patent law and the guidelines in place for patent examination. Nevertheless, where there exists no contradiction with the patent law, Examiners and Judges will use the guidelines as a key reference guide in their decision-making process. As such, the recent revisions to the Chinese guidelines will be of interest to parties prosecuting and litigating patents in China.
It is a well-established principle in many legal systems that an appeal court/tribunal should generally not overturn findings of fact made at first instance (or at least should only do so in limited circumstances). The EPO Boards of Appeal had also previously overturned first instance findings of fact only under certain conditions. However, in this case, the Board considered that they were competent to do so, even outside circumstances set out in previous EPO case law.
Although the UK left the EU on 31 January 2020, as a result of the transition period there have been few changes to intellectual property. However, when the transition period ends on 31 December 2020, there will be significant changes for holders of EU intellectual property rights. This article provides a brief summary with some key take-home points for right holders.
Eli Lilly and Company v Fresenius Kabi Nederland B.V. - Hague Court of Appeal on the Dutch Approach to Equivalence in Patent Infringement cases
In another case in the Pemetrexed saga, the Hague Court of Appeal has overturned the earlier decision of the District Court and set the Dutch approach to equivalence in Patent Infringement cases.
The US Federal Circuit importantly considered the “broadest reasonable interpretation” of the claim “in light of the specification”. Whilst the claims did not explicitly state that the native heart valve remained, this was clear from the full specification and therefore the broadest reasonable interpretation of the claim was limited to situations where the native valve remained.
T844/18 Confirms Legal Certainty in the EPO’s Consistent Interpretation of the Priority Provisions in Art. 87(1) EPC
In this decision, the EPO’s Technical Board of Appeal Board confirmed the EPO’s long-standing practice in interpreting Paris Convention Art. 4(A) and EPC Article 87(1).
For a valid claim to priority under the European Patent Convention (EPC), the later application has to be filed by the same applicant or the same applicants (meaning all of the applicants, omitting none) who filed the earlier application. Thus, for a first filing by multiple applicants but a subsequent application by only one or some of those applicants it has to be shown that the priority right held jointly by the multiple earlier applicants had been transferred to the sole applicant or the group of applicants.
SPCs and Orphan Drug Exclusivity are different regimes which provide market exclusivity for medicinal drug products. Under both regimes, an extension of the term of exclusivity can be obtained by conducting paediatric testing of the product. While an SPC may not benefit from this “paediatric extension” when the product in question is also the subject of an orphan medicinal product designation, this Dutch court case addresses the question of whether the SPC term can be extended for a product that used to be (but is no longer) designated as an orphan medicinal product.
Demonstrating that a company has no genuine intention to use a trade mark that it has applied to register is not easy, but Full Colour Black have managed to convince the EUIPO Cancellation Division.
The UK Supreme Court has confirmed that the English High Court is a suitable forum for setting the terms of worldwide FRAND licences.
TRANSLATION REGIME REDUCES COST OF POST-GRANT VALIDATION OF EUROPEAN PATENTS. Following the ratification by France of the London Agreement on the application of Article 65 EPC, a new era of reduced translation costs for European patents entered into force on 1 May 2008.
European patents cannot be opposed on the ground that the claims are unclear. In this case, the opponents argued that unclear features of the claims resulted in the claims being excessively broad and therefore insufficient. However, contrary to the Opponents’ argument that the unclear features must be considered as a whole, the Board of Appeal considered that for a fair and objective approach, each issue must be considered on a one-by-one basis.Read more
The sale of counterfeit goods is a significant problem on online marketplaces such as Amazon®, eBay® and Alibaba®. Solutions are available directly though these companies, though they vary in the degree of proactivity taken and their accessibility to businesses of different sizes.Read more
In an eagerly awaited decision, the CJEU has confirmed that Supplementary Protection Certificates (SPCs) are not available for new therapeutic applications of previously approved active ingredients.Read more
The US Supreme Court has confirmed that trade marks consisting of a generic word followed by “.com” can in principle be registered. In the case of USPTO v Booking.com, the Supreme Court held that of utmost importance was whether consumers would recognise the trade mark as being indicative of a specific source of goods/services.Read more
CJEU confirms that copyright can subsist in products whose shape is, at least in part, necessary to obtain a technical result
In the context of a referral from the tribunal de l’entreprise de Liège in Belgium, in its latest judgment the CJEU considered the question of whether copyright exists in technical designs.Read more
The UK Supreme Court has confirmed that in order to meet the requirement of sufficiency, a patent must enable a person skilled in the relevant art to make (at least substantially) all embodiments that fall within the scope of the claims. A patent which claims products which could not be made at the priority date of the patent will not be held sufficient, even if such products embody the inventive advance of the patent. The full judgement can be found here.Read more
Is the Enlarged Board to be followed in preference to the Rules of the EPC, and are claims to plants produced by essentially biological processes considered allowable under the EPC?Read more
The CJEU have looked at the meaning of the trade mark “Fack Ju Göhte” and found that its true meaning, and whether this phrase is registerable as a trade mark, must be based on the meaning understood by the population of people the phrase is intended for.Read more
Following its Preliminary Ruling in the Teva case, the CJEU has now issued further guidance on the criteria that must be met when assessing whether a product is protected by a patent according to the EU SPC Regulation.Read more
The European Patent Office (EPO), UK Intellectual Property Office (UKIPO) and EU Intellectual Property Office (EUIPO) have all announced general extensions to time limits as a result of the worldwide disruption caused by the COVID-19 outbreak.
These extensions have important implications for not only right holders but also third parties.
In this case, the Federal Circuit upheld the Patent Trial and Appeal Board’s claim construction based on a submission made by the patentee during pre-grant prosecution.
This case serves as a reminder of the importance of defining potentially unclear or ambiguous terms in patent specifications and also the implications of file wrapper estoppel in the US.
Claims directed to second (or further) medical uses of known compositions or substances are commonly prosecuted and granted before the European Patent Office. However, the patentability of new uses of known non-medical product is less commonly addressed. Although in 1989 the Enlarged Board of Appeal confirmed that patents could be obtained for new uses of known (non-medical) products (See Decisions G 2/88 and G 6/88), this has been questioned in more recent years.
In this case, the Technical Board of Appeal has confirmed that claims directed to new uses of known non-medical products may be patentable and have clarified the approach that should be taken when assessing the novelty of such claims.
CAFC decision in Illumina, Inc. v. Ariosa Diagnostics, Inc., offers a glimmer of hope in diagnostic arena
Inventions in the medical diagnostics arena often face significant hurdles with respect to establishing patent eligibility in the US. At the core of many diagnostic inventions is the detection of newly discovered ‘natural phenomenon’ using widely known techniques. Unfortunately, no matter how great the practical benefit of the claimed invention, under established case law, if a claim related to a judicial exception such as a law of nature or natural phenomenon does not recite additional elements that are deemed to amount to significantly more than the judicial exception, the patent will likely fall under 35 U.S.C. § 101.
Earlier this month, the U.S. Court of Appeals for the Federal Circuit (CAFC) issued its judgement in Illumina, Inc. v. Ariosa Diagnostics, Inc. and if the judgement stands, it may offer diagnostic companies a new way of navigating 35 U.S.C. § 101 - by way of method of preparation claims.
Broad and lengthy trade mark specifications often stifle competition by preventing trade marks from being used in connection with goods/services which are not being provided by other parties under the same or a similar mark. While non-use provisions go some way to tackle broad registrations, third-parties must wait 5 years following registration before they can attack a registration on this ground. In this case, the CJEU clarifies which grounds for invalidity can be used against broad specifications within 5 years from registration.Read more
The USPTO regularly raises objections under §101 USC 35 that inventions aren’t patentable because they are directed to a law of nature. It is unusual for these to arise for mechanical inventions but that is the logic underlying a recent US Federal Circuit decision.Read more
In a recently issued Decision, the Board of Appeal have confirmed a referral to the Enlarged Board on double patenting. The principles of double patenting appeared to have been settled in G 1/05 and G 1/06 in which it was noted that an applicant can have “no legitimate interest” in a second patent to the same subject matter. However, a question has now been referred in relation to double patenting arising from internal priority, where the additional patent term could give rise to “legitimate interest”.Read more
After months of uncertainty, it is now clear that the UK will leave the EU at 11pm on 31 January 2020. But what does this mean for intellectual property right holders? This article provides a brief summary with some key take-home points for right holders.Read more
EPO Technical Board of Appeal Upholds Opposition Division’s Decision Regarding Settled Law on the Right to Claim Priority
On 16 January 2020, The EPO Technical Board of Appeal upheld long-standing EPO law and practice regarding the right to claim priority and found the Broad Institute’s CRISPR/Cas9 patent EP2771468 to lack priority from its first, second, fifth and eleventh priority filings. As an aside, the Broad Institute’s patent EP2771468 is revoked. As a fundamental, we now know why the law is settled, and this explanation should cement EPO practice under the Paris Convention.Read more
The CJEU have recently offered clarification regarding the scope of protection offered by Community Plant Variety Rights regarding to what extent acts relating to harvested material from protected varieties constitute an infringement and the level of protection provided to right holders during the period of provisional protection after publication of the Plant Varity Right application but prior to its grant.Read more
The revised Rules of Procedure of the Boards of Appeal (RPBA) are set to come into force on 1 January 2020. One of the aims of the revised RPBA is to reduce the likelihood of ping-ponging between the Boards of Appeal and the departments of first instance, and consequent undue prolongation of the entire proceedings before the EPO. To that end, Article 11 of the revised RPBA states that the Boards of Appeal shall not remit a case to the department of first instance, unless there are “special reasons” for doing so. Article 11 of the revised RPBA further states that “fundamental deficiencies” in the first instance proceedings will as a rule constitute “special reasons” but the precise ambit of the phrase “fundamental deficiencies” remains to be seen. In the case at hand, notably decided prior to the revised RPBA coming into play, incorrect use of discretion by the Opposition Division was held to be enough for remittal to be ordered.Read more
Delays in obtaining a granted US patent, resulting from the filing of a Request for Continued Examination (RCE), are not eligible for Patent Term Adjustment (PTA), but when in prosecution does this PTA exclusion expire?Read more
The Unitary Patent System of the European Union is a project designed to replace the bundle of national patents that arise upon grant of the European patent application with a single patent right covering all of the states of the European Union. This offers significant advantages in terms of the cost and convenience of securing EU-wide patent protection.Read more
EPO remains strict when it comes to establishing “special circumstances” for rectification of a priority claim post publication
The present case serves as a reminder that in order to correct a priority claim post publication “special circumstances” must exist and if they don’t, the request to correct the priority claim will be denied.Read more
US Federal Circuit applied the Doctrine of Equivalents in an infringement action relating to the drug “pemetrexed”. We have previously reported similar cases in the UK and Italy where a doctrine of equivalents was invoked and consider the contrasting approach in the US.Read more
The Enlarged Board of Appeal (EBA) of the European Patent Office (EPO) was asked questions following EPO Technical Boards of Appeal (TBA) decision T 831/17 as to whether (i) an obviously inadmissible appeal gives the appellant a right to oral proceedings and (ii) whether the appointment of oral proceedings in Haar (i.e. outside Munich, the main EPO site) is compatible with the European Patent Convention (EPC). The short answers to these questions is, unsurprisingly perhaps, “no” and “yes”, respectively.Read more
The President of the European Patent Office (EPO) asked a question of the Enlarged Board of Appeal (EBA) as to whether an appeal that was filed after the deadline should be considered as being (i) not filed or (ii) inadmissible. They have now replied in decision G 1/18. The short answer is that such appeals are considered to be “not filed” and therefore in such cases the appeal fee will be reimbursed.Read more
While it may seem sensible for UK infringement proceedings to be stayed in view of parallel EPO opposition proceedings, given that a decision by the EPO to revoke the patent would render the entirety of the UK proceedings redundant and a waste of the court’s and parties’ time and resources, this case highlights the importance of prompt resolution of patent infringement cases as a matter of public interest.Read more
Does the development and testing of a prototype in a private garden that is nevertheless open to public viewing amount to a public disclosure? This was the situation considered by Mr Justice Nugee.Read more
On 5 July 2019, in opposition proceedings before the EPO, the claims of a further Broad Institute patent, namely EP2898075, were scrutinized, and only after amendment to deal with added subject matter and lack of clarity objections, were they found to meet the requirements of the EPC.Read more
EPO decision T 0725/14 highlights the importance of understanding the wording of an assignment – if you don’t, priority could be lost.
The validity of a priority claim is fundamental for many patent proprietors, who file priority applications and then publish their invention before filing a subsequent application which claims priority from the initial application. In order for a priority claim to be valid, chain of title must be maintained. Failure to timely maintain chain of title between priority applications and subsequent priority claiming applications can lead to loss of priority entitlement.Read more
Currently, there exists conflicting case law on the issue of double patenting at the EPO. The Board of Appeal in T 318/14 seeks to gain some clarity on double patenting issues by referring certain questions to the Enlarged Board of Appeal.Read more
By referring two questions to the Enlarged Board of Appeal, the President of the EPO has attempted to gain some clarity as to whether plant products produced by essentially biological processes are patentable. A significant issue at hand, however, is whether these questions will be deemed admissible.Read more
The UK Supreme Court has recently issued guidance on the factors that should be considered when assessing the obviousness of an invention under Section 3 of the UK Patents Act in its judgement in Actavis v ICOS.Read more
Eli Lilly And Company v Genentech, Inc – Can third party MAs be used by Patentees to seek SPC protection? Referral to the CJEU
The question of whether a Patentee can obtain a Supplementary Protection Certificate (SPC) for a product for which the Marketing Authorisation (MA) has been issued to a non-related third party has been considered again and this time a referral on just that point has been made to the CJEU.Read more
Eli Lilly And Company & Ors v Genentech, Inc – Both Warner-Lambert Plausibility Test and Actavis Infringement Test Applied
Following the highly anticipated decisions in Warner-Lambert v Generics Ltd with regards to plausibility and Actavis v Lilly in relation to infringement, the UK High Court has now considered both tests in present case.Read more
Can a claim be interpreted under the doctrine of equivalents to cover the prior art, and if so can a product that is an obvious modification of the prior art infringe the claims? These were questions considered by HHJ Hacon.Read more
Following the Prime Minister’s second defeat at getting her EU withdrawal deal accepted, the outcome of Brexit still remains uncertain. However, the UKIPO are continuing to update their guidance on the effect of Brexit on IP so that UK rights holders can prepare, as much as possible, for all outcomes.Read more
This article looks at the case of Regen Lab v Estar  EWHC 63 (Pat) and provides an analysis of the Doctrine of Equivalents (i.e. through the Actavis questions) when applied to numerical limitations.Read more
In the US a patent cannot validly be issued for a product that was “in public use, on sale, or otherwise available to the public” before the filing date of the patent. The US Supreme Court has now ruled that the term “on sale” covers a sale agreement that remains secret or where the fact of the sale was made public but no details of the invention were disclosed.Read more
Can you patent a genetically modified organism? While Article 53(b) EPC is clear that essentially biological methods of producing an organism, i.e. crossing and selection, are not patentable there has been ongoing debate as to whether the organisms resulting from these methods are patentable. However, while the EPC defines what is patentable in EPO countries the EU also issues directives (e.g. the Biotech Directive) that affect what is considered patentable in the EU. This has led to the legal ambiguity considered in T 1063/18.Read more
In this case, Novartis were awarded a preliminary injunction on the basis of their European patent which had been considered invalid for adding matter by the EPO Opposition Division (although this decision is under appeal). The UK judge considered the test used by the EPO to assess added matter was too strict and considered that, from a UK perspective, the claims had basis in the application as filed.Read more
EPO Issues Decision in Opposition Proceedings against Broad Institute Patents EP2784162 and EP2896697
Last week, in sequential hearings, two of the Broad Institute’s CRISPR/Cas9 Patents went under the hammer of one of the EPO’s Opposition Divisions. On 14th February 2019, the European Patent Office Revoked EP2784162. On 15th February 2019, the European Patent Office maintained EP2896697 albeit with a significantly narrowed scope.Read more
The CJEU firmly distinguishes between approval in accordance with the Medicinal Products Directives and approval in accordance with the Medical Devices Regulation. As such, medical devices are not able to benefit from SPCs.Read more
We had previously reported that in Fresenius v Eli Lilly, a case having significant similarity to Actavis v Eli Lilly in the UK, the Court of Milan had issued a decision that there was no infringement, in contrast to the UK decision. The Appeal Court in Milan has now overturned this decision, and concluded that there is infringement, bringing the Italian Courts into agreement with the UK Court.Read more
The Supreme Court has issued the final word in the long running Warner-Lambert v Actavis and Mylan dispute, dismissing Warner-Lambert’s appeal and confirming the role of plausibility in the assessment of sufficiency in patent applications.Read more
If an alleged copyright infringer shares an internet connection with a family member can the family member legally refuse to supply evidence that they are not the infringer? CJEU decision C-149/17 speaks to this point and considers the overlap of the strong protections afforded to copyright by the InfoSoc and Enforcement Directives with the right to family and private life under the EU Charter of Fundamental Rights .Read more
Lord Kitchen, now elevated to the Supreme Court, along with Lord Floyd and Lord Longmore, has issued a judgement in which he has followed the approach to infringement set out in the Supreme Court Decision in Actavis v Lilly and found infringement on the basis of equivalence.Read more
Following a referral to the CJEU the Patents Court has now issued its decision on the validity of Gilead’s SPC for a combination of two active ingredients. Arnold J has indicated that as the combination of actives did not embody the technical contribution of the patent and the second active was not even mentioned in the patent, the SPC was invalid.Read more
While the consensus appears to be that a “No Deal” Brexit is best avoided, the government is now considering and addressing the possibility. Accordingly, the government has now issued guidance notes on how a no deal Brexit might affect intellectual property rights.Read more
New technologies such as CRISPR/Cas9 have enabled genetic modification of plants without introducing exogenous (foreign) genes from other organisms. It was thought that such “gene-edited” plants were distinct from genetically modified organisms (GMO) and indistinguishable from natural mutant plants. However, the CJEU in decision C‑528/16 have found this not be the case.Read more
This judgement provides some guidance on the UK approach to determining the novelty of overlapping ranges. Whilst the judge in this case was reluctant to fully adopt the EPO “serious contemplation” test, the basic principles of assessing novelty appear to mirror those used at the EPO.Read more
How independent does an intervener have to be for an intervention to be admissible? In the case that an opposition is filed by a straw man (i.e. on behalf of a party but in the name of their representative), is an intervention filed by the party behind the straw man opponent admissible? This decision should lead parties wishing to oppose a European patent to choose the identity of the opponent carefully and also provides a warning to proprietors about instituting infringement proceedings whilst EPO proceedings are ongoing.Read more
The UK Intellectual Property Office (UKIPO) is seeking views and evidence on a proposed new exception from infringement of Supplementary Protection Certificates (SPCs), which protect medicines. The European Commission proposes a new exception to permit manufacture of protected medicinal products in the EU for export outside of the EU.Read more
Almost all businesses have trade marks of some kind. Be these their company name, product name or logo, they are all valuable ways for companies to indicate the origin and/or quality of their goods and services to their consumers.Read more
Significant Development with respect to Brexit Withdrawal Agreement – What Does This Mean for Owners of EU Trade Marks and Community Designs?
On 19 March 2018, the UK and EU Commission announced that agreement has been reached on the vast majority of the provisions dealing with trade marks and designs.Read more
The European consensus on the patentability of dosage regimes is not shared throughout the national laws of all of the individual member states. Thus, in some member states, it is unclear whether granted claims to dosage regimes can be enforced against infringers. This article sheds some light on the position in the UK and now also in France.Read more
The CJEU previously decided that the date of notification of first marketing authorisation to an applicant and not the date of the decision itself sets the duration of a supplementary protection certificate (SPC). Accordingly, the term of some SPCs is incorrect. However, in decision C 492/96 (Incyte) the CJEU found that the SPC holder can apply for correction of the SPC term as long as the SPC has not expired.Read more
European Commission Draft Withdrawal Agreement Explicitly Addresses Intellectual Property Rights - What Does This Mean for Owners of EU Trade Marks and Community Designs?
On 28 February 2018, the European Commission published the draft Withdrawal Agreement between the European Union and the United Kingdom of Great Britain and Northern Ireland.Read more
In R 1/15, the Enlarged Board of Appeal found that the Patentee’s right to be heard had been violated and as a consequence the decision of the Technical Board of Appeal was annulled and the case was sent back to the Technical Board of Appeal to be reheard.Read more
The Enlarged Board of Appeal has clarified that the appropriate test for determining the allowability of undisclosed disclaimers is as set out in G 1/03. As well as endorsing this test, the Board also provided some further guidance in the area of disclaimers.Read more
The European Patent Office on 17th January 2018 revoked the first of the Broad Institute’s CRISPR/Cas9 patents, its validity having been challenged by 9 parties on multiple grounds.Read more
Following the UK Supreme Court judgement in Actavis v Eli Lilly (commented on in our earlier article), the Court of Milan have also handed down a judgement concerning the scope of protection of Eli Lilly's patent relating to its pemetrexed product. The Court of Milan took an opposing view to the UK Supreme Court regarding whether alternative salts of pemetrexed disodium could be considered to fall within the scope of Lilly's patent claim.Read more
Following amendments of the European Union Trade Mark Regulation further changes came into force on 1 October 2017. Probably the most significant of these changes is the abolishment of the requirement for graphical representation of a trade mark. Other changes include the introduction of a Certification mark and various procedural changes.Read more
The planned changes to Section 70 of the UK Patents Act 1977 look to clarify the existing law surrounding threats, ensure adequate protection for more vulnerable businesses and end the tactic of suing legal representatives. Furthermore, the new law is set to bring consistency across many IP rights, including registered trade marks and registered designs.Read more
It may be thought necessary, during the course of a legal dispute, for a claimant to seek interim relief by way of an injunction. This is usually the case when the claimant feels that the defendant’s actions may, if not stopped, cause irreparable damage to the commercial activities of the claimant. However, on the basis that interim injunctions severely curtail a defendant’s rights, and are usually granted before the merits of the respective parties’ arguments have been fully considered at full trial, the claimant is required to give a cross-undertaking in damages, which can be enforced against the claimant if at full trail the court finds that the injunction was incorrectly granted and as a consequence the defendant has incurred losses.Read more
Patent rights are crucial value drivers for individuals and technology companies, large or small. This article presents a selection of best practice pointers under the law of the European Patent Office (EPO) on how to get the most out of patent applications, especially the “first filing” that establishes a priority date for and sets the framework for future patent rights.Read more
In accordance with Canadian patent law it was necessary to a patent to fulfil any promise set out in the specification, a Doctrine which came from an interpretation of the requirement for a patent to be “useful”. The Canadian Supreme Court have now held this Doctrine to be unsound – for a patent to be “useful” it must be capable of actual relevant use but does not have to demonstrate every promise contained in the specification.Read more
The Supreme Court has issued an important decision on whether literal infringement is required or whether an equivalent will infringe. The tests set down under the Improver case have been reconsidered and modified, with guidance given in particular to the proper application of the third question.Read more
The cost of litigation is capped at the Intellectual Property Enterprise Court (IPEC) in order to ensure access to justice for smaller parties such as SMEs. However, proceedings can be transferred to the High Court where costs are much higher. In this case the IPEC decided that access to justice by the SME bringing the claim would be prejudiced by being transferred to the High Court largely because of the increased costs and decided that the case should be heard by the IPEC.Read more
Following the Decision of the Enlarged Board of Appeal at the EPO in G1/15 regarding partial priorities, the EPO Technical Boards of Appeal have started applying the principles from this decision when deciding whether claims should be entitled to partial priority. This case sets out a two-step test which we expect to be used by future Boards of Appeal when examining partial priorities.Read more
The European Patent Convention allows European patent applications to be re-established where they have been deemed withdrawn as a result of failing to meet a time limit set. In order for the request for re-establishment to be effective, the request must be filed in time and the time limit must have been missed despite all due care.
As renewal fees may be paid by anyone (not only professional representatives before the EPO), renewal fee deadlines may be missed as a result of a breakdown in communication between the European representative, the applicant and another third party who may be responsible for the payment of the renewal fee.
This case looks at the standards docketing systems used by applicants should meet to ensure that their application can be re-established in the case of a missed renewal fee.Read more
In T 1852/13, the so-called ‘essentiality test’ was analysed in detail. Questions were raised as to whether this test is in compliance with the Gold Standard for assessing added subject-matter following claim amendments.Read more
Having already made a referral to the CJEU in Teva v Gilead regarding the criteria for a combination product to be protected by a basic patent in force (according to Article 3(a) of the SPC Regulation) Arnold J was asked again to consider this question, but this time in relation to Markush structures encompassing a number of chemical species.Read more
Entitlement to priority in an invention is a fundamental right in the patent system in the UK, Europe and globally. It is therefore essential that the requirements for using an applicant's priority right are well understood that each of the jurisdiction in which they are applied. In case T 577/11 the Technical Boards of Appeal (TBA) of the European Patent Office (EPO) have confirmed existing EPO practice regarding the transfer of priority rights to a successor in title. These provisions are stricter than those in other jurisdictions, notably the USA, and we have seen priority rights lost as a result of the differing formal requirements.Read more
The High Court has now proceeded to full trial, following on from the guidance of the Court of Appeal that stated Arrow Declarations were to be issued only in exceptional circumstances and not merely as a means to determine whether it is likely that a pending application will lead to a valid, granted patent.Read more
In a decision that explores the boundaries of the terms ‘descriptive’ and ‘acquired distinctiveness’, the High Court ruled that IWATCH cannot be registered for a smartwatch.Read more
With UK ratification of the UPC Agreement now in sight, it is important for proprietors of European patent applications and patents to prepare for the fast-approaching changes to European patent litigation. In other words, now is the time to start considering whether you want to opt out your European applications / patents from the jurisdiction of the UPC.Read more
The EPO Enlarged Board of Appeal (EBA) have given their decision in case G 1/15 and have found that a first patent application that is published is not novelty destroying when cited against a further application that claims priority from the first application. In short, there is an antidote to ‘poisonous’ priority applications.Read more
Cybersquatters are individuals or companies who purchase domain names with the intention of selling them on to a party with an interest in the domain name at an extorted price. The World Intellectual Property Office (WIPO), along with other dispute resolution service providers, offers a system that allows complainants to have domain names cancelled or transferred from cybersquatters or other individuals/companies who have clearly purchased domain names for unjust reasons.Read more
The Court of Justice of the European Union (CJEU) has answered the question of whether the Enforcement Directive (2004/48) prevents Member States from providing in their national legislation the possibility of awarding punitive damages in IP cases.Read more
The Unified Patent Court (UPC) Preparatory Committee have issued a statement indicating that they are currently working under the assumption that the UPC will become operational in December 2017.Read more
In October 2016, we reported the decision Fujifilm Kyowa V Abbvie  EWHC 2204 (Pat) where Arnold J refused to strike out Fujifilm’s claim for an Arrow declaration in the ongoing litigation between these two parties. Since then, this decision has been appealed to the Court of Appeal and AbbVie have taken further steps to try and avoid a full trial on the matter.Read more
The European Patent Office have recently updated their practice regarding the evidence required to successfully record a change of ownership on the European Patent Register. From now on, assignment documents will need to be signed by or on behalf of both the assignor and assignee.Read more
The EPO have recently updated their Internal Guidance to Examiners regarding the patentability of inventions relating to the use of human embryonic stem cells. There has been and will be, however, no formal announcement. Subtle media releases are not new, of course. Tech giant Google® is well known for ‘soft’ launch of its products: there is no fanfare heralding release of its latest app, it just arrives and news gets around; you pick it up on social media or second hand from your 11-year old child.
Enlightened by this tech vernacular the EPO stem cell practice change has just happened and the news is gently disseminating: a new, morally acceptable source of human embryonic stem cells has now been identified, and can be referred to in patent applications relating to this subject matter with an effective filing date on or after 5 June 2003 to avoid an objection of lack of morality under Art 53(a) EPC.
The recent ‘Cancer Immunotherapy Pilot Program’ initiated by the United States Patent and Trademark Office (USPTO) represents a way of expediting prosecution of patent applications relating to cancer immunotherapy.Read more
In Decision T 1691/15, the Board of Appeal admitted that it does not perform checks to ensure that, where necessary, non-public parts of the file are made public during Opposition Proceedings. It appears that such an exercise would help mitigate problems that may arise when exchanges with the EPO are withheld from the other parties in Opposition Proceedings.Read more
Arrow Declarations are declarations regarding the validity of subject-matter (rather than specific patents) and provide accused infringers of legal certainty that their proposed activities will not fall within the scope of any valid patent that may be granted in the future.
In Fujifilm Kyowa v AbbVie, Mr Justice Arnold refused to strike out Fujifilm’s request for an Arrow Declaration based on “bad faith” acts carried out by AbbVie in previous proceedings before the UK Court.
The UKIPO has announced patents rule changes effective 1 October 2016 and 6 April 2017. These changes are intended to increase legal certainty and procedural flexibility and to reduce the administrative burden on patent applicants and owners.Read more
G 2/12 and G 2/13 confirm that the rights of the traditional plant breeder may, in some cases, be diminished as a result of a valid plant patent being in force, but were these decisions really unexpected?Read more
The CJEU has ruled that market holders may be forced to stop allowing market traders who infringe trade marks from renting pitches in their markets.Read more
In a notice on 2 October 2015 the President of the EPO announced that all proceedings before the EPO Examining and Opposition Divisions in which the decision depends entirely on the outcome of G1/15 would be stayed until the decision in G1/15 is issued.Read more
With the average duration of opposition proceedings in 2015 being 26.1 months, the EPO has announced its new streamlined opposition proceedings. The aim is to reduce the duration of opposition proceedings in straight-forward cases to 15 months. These changes take effect on all pending and new oppositions from 1 July 2016 onwards.Read more
The question as to whether disclosure orders should be given in cases where inventive step of a patent is challenged is notorious. Disclosure is often of little assistance but presents a great burden for the patentee. Will the judgement in Positec v Husqvarna however be a turning point for disclosure orders and result in such orders being given in fewer obviousness cases?Read more
Patent prosecution takes a long time, but how long is just too long for an applicant to reasonably bear? The EPO Technical Boards of Appeal recently decided that for one case the answer was 12 years.Read more
The Supreme Court has now published its Judgement in the case of PMS International Group v Magmatic Limited ( UKSC 12), better known as the “Trunki” case after the well-known children’s ride-on suitcase manufactured by the appellant. The Supreme Court upheld the Court of Appeals decision that PMS’s “Kiddee case” product did not infringe the Community Registered Design (CRD) owned by Magmatic. This Judgement highlights the importance of the drawings of a CRD in defining the precise scope of protection that the applicant seeks. In this article we consider some practical advice for applicants preparing drawings for a CRD.Read more
A new amended trade mark Regulation brings substantial changes to trade marks in Europe. The most obvious change will to the name of the Office which becomes the European Union Intellectual Property Office, and the mark, which now becomes the European Union Trade Mark. Other significant changes are to the fee structure and the interpretation of the specifications of goods and services.Read more
In a recent article on this website we examined the case of Actavis vs Lilly and the “plausibility” test for sufficiency of disclosure used in that case. We noted that that this was a departure from the test for sufficiency that has been used previously and that this case is likely to be appealed. A recent decision that uses a more usual test for sufficiency, and which does not refer to Actavis vs Lilly, has now been published – Regeneron vs Kymab ( EWHC 87 (Pat)). In this article, we consider the differing effects of these two approaches to sufficiency.Read more
Under Article 112a EPC a party to appeal proceedings may file a petition for review of the decision by the Enlarged Board of Appeal. One instance is where a fundamental procedural defect occurred during the appeal proceedings and the petitioning party was adversely affected as a result of the decision.Read more
The Japanese Supreme Court has decided that a Patent Term Extension may be allowed based on any substantially new marketing authorization for a product covered by that patent. This is a significant broadening of the range of medical patents eligible for extensions of term.Read more
One of the cornerstones of contract law in the UK is that for a contract to be valid, there must be sufficient consideration. Whilst it has generally been held that for a valid assignment of a patent or patent application consideration is also necessary, the judgement in Wright Hassall LLP v Horton Jr has seemingly removed this requirementRead more
An attempted squeeze argument based on the plausibility test in obviousness and sufficiency has led to a decision that these tests are not the same. For obviousness the test is whether something is obvious to try with a fair expectation of success. For a patent to be sufficient it simply has to be credible.Read more
Patenting of stem cell technologies has been dogged by their controversial origin but technological developments and guidance from recent judicial decisions have answered and overcome many of these difficulties. In particular the European Patent Office, United States Patent and Trademark Office, Japan Patent Office and State Intellectual Property Office of China have published guidelines covering patenting of stem cell technologies in the light of recent decisions. We now see a patent landscape where stem cell technologies and related therapies can, with very few exceptions, be protected via patents, provided the appropriate form of claim wording is used.Read more
The long awaited Decision of the Actavis v Warner-Lambert trial was published on 10th September 2015, following various hearings regarding interim injunctions including one appeal to the Court of Appeal. This decision is critical to interpretation of second medical use claims in the UK courts, though it seems inevitable that this Decision will be further appealed.Read more
Disclaimers are negative claim features that exclude specific subject matter from the scope of a claim. It is rare that a patent specification will contain specific support for omitting a feature, and hence there are generally two types of disclaimer in European practice...Read more
Following two UK High Court cases relating to infringement of Swiss-form medical use claims, the UK Court of Appeal have given their interpretation of these claims. If this interpretation is followed in the full trial scheduled for later this year, this could see manufacturers of treatments for non-patented indications having to enter into strict agreements with pharmacists regarding the dispensing of their products.Read more
The Supreme Court has considered, and reaffirmed, current UK law and practice concerning goodwill in a trade mark despite developments in other common-law jurisdictions.Read more
The Preparatory Committee of the Unified Patent Court have released a Consultation Document regarding Court fees as well as proposed schemes to offer fee reductions to small and medium-sized businesses and non-profit organisations.Read more
ARE PLANTS MADE BY ESSENTIALLY BIOLOGICAL PROCESSES PATENTABLE? New and inventive plants may be patented at the EPO, but there are exceptions. Two recent EPO decisions, “Tomatoes II” and “Broccoli II” complete a series of referrals that seek to clarify what the statutory exceptions mean …Read more
A NEW PROSECUTION OPTION FOR PCT APPLICATIONS AT THE EPO. Until recently, the only option for filing argumentation on a PCT application was to enter the application into International Preliminary Examination. It is now possible to file argumentation in response to a search report issued on an earlier European patent application when filing a new PCT application at the EPO that claims priority from the earlier application. This gives potential for significant acceleration to grant…Read more
An updated set of Guidelines has been issued by OHIM, with the main amendments being to include the new change in practice on black and white marks, and the new indication that additional evidence of use submitted after the deadline may in certain circumstances be accepted.Read more
The “Hague System” allows many national and regional design registries to cooperate to register and protect industrial designs in their territories. The EC has long been a member. The USA and Japan were, however, most notable non-member countries. Their accession to the Hague Union widens and strengthens the Hague System as a route for efficient International registration of Industrial designs.Read more
JOIN US ON WEDNESDAY 25 MARCH 2015 FROM 5.15PM IN LONDON, WC1R 4PJ. You are invited to join an open discussion on The Patentability of Human Embryonic Stem Cells in Europe with leading patent attorney experts. This discussion will be chaired jointly by Nick Bassil of Kilburn & Strode, George Schlich of Schlich Ltd and Dan Wise of Carpmaels & Ransford.Read more
Following our article on the Unitary Patent System (UPS) and whether to opt in or out, we have received a number of enquiries from our client in this regard. Although some critical details of the new system are still yet to be decided we have put together some of these queries together with our answers.Read more
TRANSLATION REGIME REDUCES COST OF POST-GRANT VALIDATION OF EUROPEAN PATENTS. Following the ratification by France of the London Agreement on the application of Article 65 EPC, a new era of reduced translation costs for European patents entered into force on 1 May 2008.
In case C-364/13 the CJEU have decided that human parthenotes are not “human embryos” because they are incapable of commencing the process of development into a human being. Therefore parthenotes are a legitimate source of human embryonic stem cells for use in patentable technologies.Read more
MORALLY ACCEPTABLE SOURCES OF HUMAN EMBRYONIC STEM CELLS (hESCs): EMBRYOS THAT NEVER WERE, OR COULD NEVER BE. The Advocate General’s Opinion in C 364/13, if followed, improves the position for pioneering inventions based on hESCs in Europe...Read more
NEW “SAFE HARBOUR” LEGISLATION. In order to market a generic version of a medicinal product, after the expiry of any patent protection on the original product, its manufacturer needs to obtain regulatory approval. For a generic product...Read more
NO MORE BIOPIRACY = NO MORE PLANT BREEDERS? The Nagoya protocol is an international agreement aimed at protecting against "biopiracy". Biopiracy is the evil sibling of bioprospecting. Bioprospecting is the search for existing genetic resources ...Read more
A SINGLE PATENT RIGHT ENFORCEABLE THROUGHOUT THE EU. Currently a European patent application is searched and examined centrally by the European Patent Office (EPO). However, once the application is allowed the granted European patent does not automatically come into force in all of the EPO member states...Read more
WHETHER TO OPT OUT? The “European Patent with Unitary Effect”, otherwise known as the “Unitary Patent”, is a single patent that will cover all participating Member States of the European Union. We provide below some pointers as to whether patent owners should opt in or out of the new system...Read more
SUPPLEMENTARY PATENT PROTECTION IS EXTENDED. A recent decision by the Courts of Justice of the EU (CJEU) has expanded the scope for granting supplementary protection certificates for patented products. The court's interpretation of the term 'product' in the SPC regulation opens the door for SPCs to be granted to second medical uses of...Read more
NO END TO THE WAITING? On 11th April 2013 the European Brüstle patent (EP 1040185) was revoked, but the EPO did so without considering morality issues; sadly, therefore, we are no closer to resolving the patentability of human stem cell inventions in Europe. As the EPO has not gone beyond...Read more
NEW FEATURES OF THE AMERICA INVENTS ACT. The Leahy-Smith America Invents Act (AIA) was passed 16 September 2011 and is now coming into force. The intention of the AIA is to streamline the patenting process and to reduce legal costs. In addition the US Congress has taken this opportunity to bring US patent law into closer conformity with patent...Read more
THE DEATH OF STEM CELL PATENTS? The Court of Justice of the European Union (CJEU) has issued its much anticipated ruling in the case of Brüstle v. Greenpeace e.V. (C-34/10). Ever since, a rash of hastily written stories has appeared in the news trumpeting the death of stem cell patents, lamenting their passing and predicting the destruction...Read more
OBVIOUS TO TRY ATTACK REQUIRES A REASONABLE EXPECTATION OF SUCCESS. In the UK Patents Court on 21 December 2011, J Floyd held that Merial's patent EP (UK) 0 881 881 was inventive despite the claimed invention being obvious to try and there being no evidence that the technical effect was difficult to achieve. The case hinged on whether the skilled team would have a basis for predicting...Read more
UPDATE ON ACCEPTABLE CLAIM LANGUAGE IN EUROPE. If the filing date of your application falls after human ES cell lines are accepted as being publicly available then there seems no need to disclaim any subject matter in claims directed at or using human ES cells or human pluripotent stem cells. Any reference in the description to use of human embryos must...Read more
THE WARF DECISION - THERE IS MORE TO AN IMMORAL INVENTION THAN ITS CLAIMS. G02/06 - the decision re patentablity of human embryonic stem cells in Europe (the WARF decision) is out: the Enlarged Board of Appeal (EBA) has held that the WARF invention required, at the time of filing, destruction of an embryo. Whatever the claims covered, this inevitable embryo destruction meant the application had to be refused...Read more
COMMENT ON AND PREDICTION OF THE DECISION RE PATENTABLITY OF HUMAN EMBRYONIC STEM CELLS IN EUROPE. Following the EPO hearing on 24th June 2008, we now wait for the key biotech patentability decision in case G 02/06 before the EPO’s Enlarged Board of Appeal (EBA). It’s an important one. And it’s about time. The decision is said to be due out before the EPO summer holidays...Read more
UK PATENTS COURT REJECTED CLAIM DIVERGES FROM EPO APPROACH. A recent decision from the UK Patents Court appears to have the closed the door on second medical use claims for known therapeutic applications where novelty hinges on a dosage regime. The decision was handed down by Mr Justice Warren in Actavis UK Ltd v Merck & Co Inc  EWHC 1311 (Ch) and shows a divergence...Read more
RARE DECISION ON OBVIOUSNESS REFLECTS A MORE BALANCED APPROACH. The US Supreme Court has recently issued its first decision in respect of the issue of obviousness for many years (KSR Int’l Co. v. Teleflex Inc., No. 04-1350 (April 30, 2007)). Although the effect of this decision is yet to be seen in the lower US courts and in the practice of the USPTO, the KSR decision...Read more
EXAMINATION OF HUMAN EMBRYONIC STEM CELL INVENTIONS IN EUROPE. It is now a little over a year since the decision of the CJEU was handed down in the case of Brüstle v. Greenpeace e.V. (C-34/10)1. This decision was a disappointment to many in the legal and scientific communities because of its apparent restriction on the scope of patentable inventions in the human ...Read more
A PLEA TO THE CJ NOT TO FOLLOW THE OPINION (article as originally published in in the April 2011 issue of the CIPA Journal) | The background and the Opinion explained ...Read more
GOOD NEWS - NO SIGNIFICANT ADDITIONAL BURDENS. A number of rule changes affecting patent practice before the European Patent Office (EPO) have been introduced or are shortly to be introduced with implementation dates falling between October 2010 and April 2012. The rule changes appear not to impose any significant additional burdens on the applicant...Read more
THE SO-CALLED "EDINBURGH PATENT" HAS BEEN MAINTAINED IN AMENDED FORM. The Appeal Proceedings are over, and the patent has been maintained in amended form - in the same form as approved during the opposition proceedings in 2003. The patent was granted in 2001 and alleged by many to relate, intentionally or otherwise, to human cloning. This latter concern was rapidly...Read more
GENE PATENTS ARTICLE FROM NATURE REVIEWS. "ICOS" and "Agrevo" are well-known decisions from the European Patent Office relating to patentability, inter alia, of gene sequences, especially in cases where at the time of filing there is incomplete information about the function of the sequence or of polypeptides encoded thereby. In 2002, it was felt that the...Read more