Patents & Trademarks
The ins and outs of patents & trademarks in United Kingdom. Prepared in association with Clyde & Co, a leading law firm in United Kingdom, this is an extract from The Pharma Legal Handbook: United Kingdom, available to purchase here for USD 99.
1. What are the basic requirements to obtain patent and trademark protection?
There are 2 types of UK patents: a national patent applied for at (and granted by) the UK Intellectual Property Office (UKIPO) and a European patent applied for at (and granted by) the European Patent Office (EPO). An application can also enter the UKIPO or EPO routes in the national/regional phase of an application filed at the World Intellectual Property Organisation (WIPO) under the international procedure (i.e. under the Patent Co-operation Treaty 1970 (PCT)).
European patents and the EPO are provided for by the Convention on the Grant of European Patents 1973 (EPC). There are 38 contracting states to the EPC, which include all EU countries plus others such as Norway, Switzerland and Turkey. There are also extension states and validation states and, in addition, a European patent designating the UK can be used as the basis for a Hong Kong patent. The EU itself is not a party to the EPC and a European patent is not an EU right.
Under the EPC system, the EPO provides a central examination procedure for a European patent application. Upon filing an application is deemed to designate all contracting states but the applicant can subsequently decide which contracting and extension states it would in fact like the European patent to be validated in upon grant. The patent then takes effect as a bundle of national patents in those countries. For example, if an applicant were to include the UK as one of the designated countries, and attend to the necessary formalities, the patent will be granted as a European patent (UK), be registered at the UKIPO and give essentially the same rights as a national UK patent.
The basic requirements for a patent application filed at either the UKIPO or the EPO are that it meets the criteria for patentability (discussed in Question 60 below), designates the inventor and comprises a specification describing the invention, claims, any drawings referred to in the specification (or claims) and an abstract. The specification must disclose the invention in a manner clear and complete enough for the invention to be performed by a person skilled in the relevant art. The claims must define the subject matter for which protection is sought, be clear and concise, be supported by the specification and relate to a single inventive concept only. The appropriate fee must also be paid.
In addition, SPCs may be obtained that extend the protection for an authorised medicine (or plant protection product) for up to 5 years beyond the 20 year life of a patent (with possible further paediatric extension of up to 6 months) . SPCs are governed by EU Regulation 469/2009/EC and are intended to compensate a patent owner for regulatory delay in obtaining authorisation for a protected product. SPCs covering the UK, i.e. based on either a UK patent or a European patent designating the UK, are applied for to (and granted by) the UKIPO. The criteria, and length of SPC are discussed in the answer to Question 3 below.
(ii) Trade Marks
There are also 2 types of UK trade marks: national marks filed and registered at the UKIPO and EU trade marks filed and registered at the European Union Intellectual Property Office (EUIPO) (formerly known as OHIM). The EUIPO and EU trade mark are established by EU legislation and so, as an EU right, the trade mark takes effect in all countries of the EU upon registration (i.e. there is no ability similar to that for European patents to select specific countries).
A UK or EU trade mark can also be obtained through the international (Madrid) system that applies to countries that have signed up to the Madrid Protocol. International applications are made to WIPO and must be based on an existing trade mark application or registration in a member country.
The basic requirements for a trade mark application at either the UKIPO or the EUIPO are that it gives the name and address of the applicant, contains a statement of the goods and services in respect of which the mark is intended to be used (following the Nice Classification) and a representation of the mark. The appropriate fee must also be paid. The Nice Classification arranges goods and services by class. Generally the more classes applied for, the higher the fee.
2. What agencies or bodies regulate patents and trademarks?
As said in the answer to Question 1 above, the bodies that oversee the filing, examination and grant of patents are the UKIPO, EPO and WIPO and the bodies that oversee the filing, examination and registration of trade marks are the UKIPO, EUIPO and WIPO.
As discussed further in the answer to Question 60, the UKIPO, EPO and EUIPO also have a role in post-grant/registration challenges to the validity of patents and trade marks and the UKIPO also has jurisdiction over infringement, entitlement and other disputes relating to patents and trade marks.
Decisions of the EUIPO can be appealed to the EU’s General Court with final appeal to the Court of Justice of the European Union (CJEU). Decisions of the UKIPO can be appealed to the Chancery Division of the High Court of the Royal Courts of Justice or, in the case of trade marks, to an Appointed Person (typically a senior barrister who practises in trade mark law). Proceedings concerning the validity, infringement, entitlement and other matters concerning patents and trade marks can also be brought directly in the High Court in either the Intellectual Property Enterprise Court (IPEC), for less complex disputes between SMEs, or the Patents Court or Intellectual Property List of the Chancery Division.
3. What products, substances, and processes can be protected by patents or trademarks and what types cannot be protected?
The criteria for patents are that, to be patentable, the claimed invention must be new, involve an inventive step, be capable of industrial application and not consist of excluded subject matter. Excluded subject matter is given in the Patents Act 1977 as discoveries, scientific theories, mathematical methods, aesthetic creations, mental acts, methods of playing games or doing business, computer programs, the presentation of information, and methods of treatment or diagnosis (on human or animals). The invention must also not be contrary to public policy or morality. Similar exclusions apply under the EPC to patent applications filed at the EPO.
In addition, Articles 1 to 11 of European Directive 98/44/EC on the legal protection of biotechnological inventions (the “Biotech Directive”) exclude the following from being patentable inventions:
- the human body, at the various stages of formation and development and the discovery of simple elements from it, such as the sequence (or partial sequence) of a gene;
- processes for cloning human beings;
- processes for modifying the germ line genetic identity of human beings;
- uses of human embryos for industrial or commercial purposes;
- processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial benefit to man or animal (and animals resulting from such processes); and
- any variety of animal or plant (or essentially biological process for their production) not being a microbiological process or other technical process or the product of such a process.
However, the Biotech Directive also says that inventions concerning plants or animals may be patentable if their techniques are of general applicability and that elements isolated from the human body (or otherwise produced) by means of a technical process can be patented.
These provisions of the Biotech Directive have been incorporated into the UK’s Patents Act 1977 by amendment.
All of these exclusions have implications for the patents that can be obtained in the pharmaceutical and medical device industries. As regards pharmaceuticals, there is generally little difficulty over protecting new chemical entities and the EPO (and UKIPO) have employed a legal fiction to allow patents for second medical uses of known drugs (now formalised by the revised text for the EPC known as EPC 2000). Similarly, new dosage regimes are treated as novel (rather than being excluded as methods of treatment) although they tend to run into difficulty in meeting the inventive step requirement. As regards biotech, the UKIPO’s examination guidelines note that it is established practice that a natural substance isolated for the first time, and which has no previously recognised existence, is patentable and does not lack novelty. This covers, for example, claims to newly isolated DNA sequences and antibodies (though they may be subject to objections of lack of inventive step if their isolation was no more than routine laboratory practice).
The patentability of human embryos and stem cells has been a contentious area. The CJEU held in Brüstle v Greenpeace (C-34/10; 2012) that cells that are capable of commencing the process of development of a human being are included in the term “human embryo” and are therefore unpatentable. However, since then it has been held by the CJEU in International Stem Cell Corp v Comptroller General of Patents (C-364/13; 2014) that a method of producing human embryonic stem cells from parthenogenetically-activated oocytes was patentable as the oocytes were not within the definition of “human embryo” if they were inherently incapable of developing into human beings. This decision has since been followed by the EPO in allowing stem cell related patents.
Regarding the exclusions from patentability of mental acts, computer programs and the presentation of information, all of which are of particular relevance to medical devices, the exclusions only apply “as such”. That is, if an invention includes features that go beyond the excluded subject matter then that invention may be patentable (assuming it fulfils the other patentability criteria). In practical terms this means that, when examining an application, the UKIPO or EPO are looking, respectively, for a technical effect or for technical features that solve a technical problem that takes the invention outside the exclusions and so makes it patentable. Further, the exclusion of methods of treatment and diagnosis does not prevent a claim directed to a substance or device used in that method from being patentable.
The three key requirements for the grant of an SPC in the UK are that the medicinal product is covered by a basic UK patent or European patent (UK) that is in force at the time of application, that the product has a valid marketing authorisation to place the product on the market in the UK (which must be the first such authorisation) and that there is no pre-existing SPC. An SPC cannot be obtained for a medical device certified by a CE mark only. The length of the SPC is calculated as the period from the filing date of the basic patent application to the date of the first marketing authorisation for the protected product in the EU, less 5 years, and subject to a cap of 5 years.
(ii) Trade Marks
To be registerable, a trade mark must not:
- be devoid of distinctive character;
- be descriptive of the goods or services listed in its specification (i.e. it must not relate to, for example, the quality, intended purpose, geographical origin of the goods);
- be a generic term for the goods or services;
- consist of or contain a protected emblem (e.g. the Royal arms or, if misleading or grossly offensive, the national flags of the constituent parts of the UK);
- be identical or confusingly similar to a trade mark already registered in the UK (or EU for an application for an EU trade mark);
- take advantage of or be detrimental to the reputation of an earlier well- known trade mark already registered in the UK (or EU); or
- be liable to have its use prevented by virtue of earlier third party rights (such as unregistered trade marks, copyrights or design rights).
Whereas the UKIPO and EUIPO will examine a trade mark in respect of the first 4 grounds (“absolute grounds” for refusal of registration), they will leave the owners of the earlier rights to raise the others (“relative grounds”). This can be by means of an opposition, filed following publication of the application for the trade mark, or by subsequent proceedings for cancellation (i.e. revocation or invalidation). An additional absolute ground for refusal is that a mark is applied for in bad faith (e.g. because the applicant knows that the rights to or in the mark belong to another or because it has no genuine intention to use the mark at all or across the full scope of the goods and services applied for).
With respect to allowable names for a branded medicine, EU Directive 2001/83/EC requires that an invented name should not be liable to cause confusion in print, handwriting or speech with the common name for that or for any other medicine and should not be misleading with regard to the therapeutic effects, composition and/or safety of the product. The risk of confusion is assessed by reference to factors such as the product’s characteristics (e.g. indications, route of administration, strength) and the patient population. Additionally, the invented name should not be derived from the medicines International Non-proprietary Name (INN) or contain the INN stem (published by the World Health Organisation).
Medicines may also be known by their generic name. If an INN exists for the active ingredient, that should be used exactly as published. If not, then the common name in the UK (i.e. its British Approved Name published in the British Pharmacopeia) should be used.
The MHRA is responsible under delegated powers for assessing the acceptability of names for medicines in the UK, e.g. upon an application for a new marketing authorisation. Similarly the proposed name for a drug is assessed by the (Invented) Name Review Group within the EMA for applications for marketing authorisations under the CP. Both the MHRA and the EMA have issued detailed guidance on the above and other considerations in naming medicines.
There are no specific restrictions on the trade marks that can be used in respect of medical devices, though they are subject to general consumer legislation such as the requirement under the Consumer Protection from Unfair Trading Regulations (2008/1277) that they should not create confusion with products, trade marks or trade names of competitors.
4. How can patents and trademarks be revoked?
Granted UK patents and European patents designating the UK may be revoked through proceedings brought in the UKIPO, IPEC or Patents Court at any time post-grant. In addition, European patents may be revoked centrally through opposition proceedings brought in the EPO within 9 months of grant.
The grounds for revocation set out in the Patents Act 1977 are:
- that the claimed invention in the patent consists entirely of excluded subject matter (as discussed in the answer to Question 3 above).
- non-entitlement – the patent was granted to a person not entitled to it.
- lack of novelty (or anticipation) – the claimed invention is not new. The UK and the EPO apply worldwide novelty such that any prior public disclosure (whether as a document or a prior use) anywhere in the world of the invention claimed in a patent will invalidate that patent if the disclosure is enabling (i.e. contains sufficient teaching to enable the skilled person in the relevant field to put it into practice).
- lack of inventive step – the claimed invention is obvious. A claimed invention must be inventive over the prior art when considered by the skilled person in light of the common general knowledge in the field. If not, it will be vulnerable to revocation.
- insufficiency – the patent’s specification does not disclose the invention clearly enough and completely enough for it to be performed by the person skilled in the art. This is known as “classic” insufficiency. In recent years sufficiency has been extended to include where the invention claimed in the patent is not plausible, lacks technical contribution to the art or the skilled person is not able to reproduce the invention over the whole scope of the claim (this last is known as “Biogen” insufficiency).
- added matter – the subject matter of the patent extends beyond what was clearly and unambiguously disclosed, either explicitly or implicitly, in the application for the patent as filed.
- extension of scope of protection – an amendment to the patent’s claims post-grant has had the impermissible effect of broadening them.
- double-patenting – the Comptroller of the UKIPO is required under the Patents Act 1977 to revoke a UK patent where a European patent (UK) is granted protecting the same invention, to the same applicant (or successor in title) and with the same priority date. Double-patenting may also be raised in proceedings before the court.
Similar grounds for revocation are available under the EPC save for non-entitlement and double-patenting. However, an objection of double-patenting can be considered in an EPO opposition as it is assumed that an applicant has no legitimate interest in having 2 patents for the same invention.
(ii) Trade Marks
The grounds for invalidation of a registered trade mark mirror the grounds for refusal of registration set out in the answer to Question 3 above. While anyone can apply for invalidation of a mark on absolute grounds, only the owners of the earlier rights (or other person with an interest such as a licensee) can apply under the relative grounds.
In addition to grounds for invalidation, there are the following grounds for revocation:
- there has been no genuine use of the mark for 5 years from the date of registration or for a subsequent continuous period of 5 years;
- due to the proprietor’s acts or inactivity the trade mark has become the common name in the trade for the products or services it covers (i.e. has become generic); and
- the mark is liable to mislead the public, particularly as to the nature, quality or geographical origin of the goods or services covered.
The grounds for invalidation must exist from the date of application for the mark and accordingly it leads to a mark being removed from the EU or UK trade mark register as if it had never existed. In contrast, the grounds for revocation can only arise after a mark is registered and so the revocation of a mark takes effect from the date of the application for revocation.
Invalidation and revocation of a registered trade mark can be in whole or in part (e.g. where a mark has been used for only some of the goods and/or services it covers, the mark may be partially revoked in respect of the unused goods and/or services). The proprietor of an invalidated or revoked EU trade mark may apply for the mark to be converted to a national mark in those EU countries where the grounds of objection do not apply.
Proceedings for cancellation of an EU trade mark must be brought in the EUIPO, unless they are in the form of a counterclaim to a claim for infringement, in which case they can be heard in a designated Community trade mark court (the IPEC and Chancery Division of the High Court are so designated). If proceedings for cancellation of an EU trade mark are already in being before the EUIPO, then a Community trade mark court must stay an infringement action until the cancellation proceedings are concluded. Similarly, the EUIPO should stay cancellation proceedings before it where validity is already in issue before a Community trade mark court (though it may continue the proceedings at the request of one of the parties).
Proceedings for cancellation of a UK registered trade mark can be brought in the UKIPO, IPEC or Chancery Division (Intellectual Property List).
5. Are foreign patents and trademarks recognized and, if so, under what circumstances?
Foreign patents, including European patents that do not designate the UK, do not have any protective effect in the UK in the sense of allowing the proprietor to bring proceedings for infringement of the patent by acts carried out in the UK. However, foreign patents remain items of property that are recognised by English courts, for example in the context of entitlement disputes, and agreements concerning them are also recognised and are justiciable in the UK where jurisdiction clauses and rules allow. By way of example, in a recent case this led to the English court determining whether a licensee’s product infringed a US patent and so whether it should pay royalties.
(ii) Trade Marks
The position on foreign trade marks is similar to that for patents described above save that international marks designating the EU or UK are recognised and enforceable in the UK and that a foreign mark may acquire goodwill in the UK (e.g. through imports or internet sales). If there is sufficient goodwill, based on a genuine market for the goods in the UK, then the owner of the mark may use the tort of passing off to prevent a third party from using the mark (or a similar one) in circumstances such that consumers may be deceived into thinking that the third party’s goods are those of the trade mark owner or are endorsed by or otherwise associated with the trade mark owner.
6. Are there any non-patent/ trademark barriers to competition to protect medicines or devices?
Leaving commercial factors aside, and compliance with laws and regulations in areas such as product safety, the main non-IP barriers to competition relate to medicines and are the data and marketing exclusivity periods discussed in the answer to Question 6 of Regulatory, Pricing and Reimbursement Overview. As said there, these exclusivity periods protect branded medicines from generic entry for up to 11 years from the date of their approval. However, a generic company can avoid these periods by applying for a marketing authorisation based on its own clinical data (if the expense of doing this is commercially worthwhile).
7. Are there restrictions on the types of medicines or devices that can be granted patent and trademark protection?
See the answer to Question 3 above.
8. Must a patent or trademark license agreement with a foreign licensor be approved or accepted by any government or regulatory body?
No. It makes no difference under the Patents Act 1977, the Trade Marks Act 1994 or any other legislation concerning patents and trade marks in the UK if a licensor is a foreign person or entity. Approval from appropriate bodies may be required by a licensor to enable it to conduct business in the UK and by a licensee dealing with a licensor that is subject to sanctions or is (or is owned by) a politically exposed person. However, these points are outside the scope of this Chapter.
It is, though, worth noting that a patent or trade mark licence may be registered at the UKIPO in order to protect the licensee’s interest in the event of subsequent conflicting licences being granted by the licensor. Also for patents, where the licence is exclusive and has not been registered within 6 months of being entered, the exclusive licensee will not be allowed to recover its costs of any successful infringement action from the losing party for the period prior to registration. There is a similar rule in respect of trade mark licences except that it applies to non-exclusive as well as exclusive licences. Also, a licensee (whether exclusive or non-exclusive) cannot bring proceedings for infringement of a UK trade mark in the first place until the licence has been registered at the UKIPO (though this restriction does not apply to licensees of EU trade marks).