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3. Dr Coco Pops is a junior house doctor at WestHampton Hospital.

All employees contracts contain the following clause: any and all inventions made by an employee whilst employed by the Hospital Trust shall belong to the Hospital Trust absolutely. Dr Pops was experimenting with the therapeutic use of honey in an attempt to improve healing rates of some of her patients. She started off applying honey directly to the wounds of patients on one of the wards. Initial results were impressive with healing rates improving significantly. Dr Pops then started experimenting with different types of honey. She discovered that honey produced by the Apis mellifera species of bee was the most effective, nearly tripling the healing rate. By April 2011 it was apparent that using raw honey on wounds was impractical for a number of reasons: First honey is runny at body temperature and so is difficult to retain at the wound site. Second, many wounds exude moisture which dilutes the honey, reducing its effectiveness and making it even harder to contain. Therefore Dr Pops sought methods of improving her treatment. At the suggestion of her brother, Dennis, she tried making a jelly out of the honey this could then be moulded to fit the wound site. On 2 January 2013 Dr Pops was granted a patent on the use of honey in the treatment of infections in wounds. The patent contains the following claim: a medical composition for dressing wounds comprising the combination of honey from the bee species Apis Mellifera with one or more natural based gelling agents, wherein the amount of gelling agent is such that the resulting composition is in the form of a flexible sheet or a pliable putty that can be readily moulded to fit the wound to which it is to be applied, and wherein at least 50% (by weight) of the composition is honey. Dr Pops wound dressing OhHoney went on sale on 2 February 2013 and was a great success. However, last month Bandico (a large pharmaceutical company) started selling honey-based wound treatments. Their current product comprises honey derived from the Apis mellifera sicula bee (a sub-species Apis mellifera) which is held, in liquid form, in a flexible silica pad. The silica pad ensures that it does not escape the wound site but is chemically inert and does not interact with the honey in any way. Bandico is also intending to launch a new product in which different honeys are blended with gelatine (a gelling agent) before injection into the silica pad. The total composition of the pad by weight is 30% honey, 30% gelling agent and 40% silica. Gelico Inc. is advertising the fact that its gelatine products can be blended with honey to make a do-it-yourself version of OhHoney at a fraction of the cost. Dr Pops is considering instructing her solicitors to send a letter to Bandico and Gelico Inc. stating that she intends to take any steps necessary to ensure the offending products are withdrawn from the market. Advise Dr Pops in respect of ALL of the following: (a) whether she has standing to bring an action for patent infringement; (b) whether any of Bandicos or Gelico Incs activities infringe the patents claims; (c) of any other matters you feel Dr Pops should be aware.

(a) STANDING
To have standing to bring an action for patent infringement, Dr Coco Pops has to be the owner of the patent. Dr Pops was entitled to make her application for a patent alone: s7(1) Patents Act 1977 (PA). Patents are only granted to certain people, namely the inventor or those claiming through him: s7(2) PA. By making the application, it was presumed that she was entitled to the patent grant and she alone was successfully granted the whole of the patent on 2nd January 2013: s7(4) PA. [Time limit for challenging patent ownership? 2 year period in s37(5)] However, her ownership of the patent is vulnerable to challenges: 1) from her brother Dennis and 2) from her employer Hospital Trust who may bring legal action to the Comptroller even after the patent has been granted; the Comptroller has the power to, inter alia, grant either of them joint or exclusive proprietorship of the patent and to refer the matter to the courts: s39. The onus of establishing the contrary position is on the challengers: s7(4). CHALLENGE FROM DENNIS Her brother will claim that he is the sole inventor (ie. actual deviser of the invention) and therefore entitled to the patent exclusively: s7(3) PA, or failing which, that he is a co-owner of the patent.: s36 PA. Whether the courts will deem him to be the sole actual deviser will turn on whether Denniss idea to make a jelly mould out of honey was the only inventive concept in the patent: IDA Ltd v University of Southampton. This is disputed as Dr Pops contribution to the composition was key to the inventive concept (a particular medical composition) of the patent, evident from the stipulation that at least 50% (by weight) of the composition is honey, distinguished from the mere simple and routine experimentation and verification in the IDA case. He will face difficultly proving that Dr Pops did not contribute to the inventive concept at all, and therefore, may have to settle for being named as a joint inventor: Yeda Reserarch v RhonePoulenc Rorer International. This will not affect her standing to bring infringement actions as she is entitled to the same rights of an undivided share: s36 PA. CHALLENGE FROM HOSPITAL TRUST Her employer will claim that it owns her patent exclusively. It will rely on the terms of the contract, or failing which, the right of an employer: s39 PA. First, it is established common ground that the relevant provisions of the PA apply to this invention as Dr Pops was mainly employed in the UK when she made it: s43. Her employer will attempt to enforce the term in its employment contract with Dr Pops that the invention, made while employed by the Hospital Trust, belong[s] to the Hospital Trust absolutely. The courts will refuse to enforce this as it is not possible to diminish the employees rights over their invention below that granted by s39: s42(2). The Hospital Trust will have to base its claim on s39(1)(a) or (b) which grants the invention belonging to the employer if certain circumstances are proven. Under s39(1)(a), the Trust will have to prove that the invention was made during the course of the normal or specifically assigned duties of the employee and that the circumstances were such that an invention could reasonably be expected to result from the carrying out of those duties. To establish the normal or specifically assigned duties of their employee, the Trust may adduce evidence of Dr Pops job description imposing duties of study and research or practical evidence that this was required of her (such as scheduled research time), though this is unlikely as she was only a junior house doctor: LIFFE v Pinkava distinguished. Furthermore, there is established authority that a doctors duty to treat her patients does not include the duty to devise new, better ways to treat those patients; she was not acting under normal duties when

she invented the OhHoney, the fact that the research would aid her duties notwithstanding: Greater Glasgow Health Boards Application. Even assuming that the invention was made during the course of the employees duties, it is dubious whether the circumstances were such that there could be a reasonable expectation of a invention to result from the carrying out of employee duties. The relevant circumstances are those surrounding the making of the invention, not her general circumstances carrying out her duties, so it is essential information but unknown if at the point she made her invention it was during her own spare time at home or the course of duties at the hospital: Greater Glasgow. If she had done so at home, they would likely have nothing to do with carrying out of her duties as employee, presenting another barrier to the Trusts contention of her entitlement. The Trust are unlikely to rely on s39(1)(b) as she was only a junior house doctor, indicating that she was not hired to invent (as considered above), and she is unlikely to have been under a special duty to further their interests; this obligation is more likely to exist at higher levels of management (e.g. directors): Re Harris. As the employees invention does not belong to the Trust, the invention will be presumed to belong to the employee inventor: s39(2); she has standing to bring actions for infringement.

(b) INFRINGEMENT
BANDICO The onus is on Dr Pops to show that Bandicos two products fall within her patent claim, interpreted in light of the description, drawings and context: s125(1) PA, each considered separately as each is a separate cause of action for infringement. To determine whether it falls within the claim, the test is what the skilled addressee would understand the patentee to have used the words in the claim to mean: Kirin-Amgen. This interpretation will balance between combining a fair protection for the patentee with a reasonable degree of certainty for third parties, meaning the claim is neither to be treated literally nor only as guidelines: s125(3) PA. The skilled addressee is someone in the field interested in the technology and techniques: Technograph & Mills v Rockley. Despite his excellent common general knowledge of the art, he shares the common prejudices of his trade: Rockwater v Technip France. Here, the skilled addressee is someone skilled in producing medical compositions for dressing wounds. Current Product Both are medical composition[s] for dressing wounds. However, the current product is a composition in the sense that it combines distinct parts to form a whole, whereas the patentees product uses composition in the sense of a mixture or compound. It seems likely that the skilled addressee would have understood the patentee to have used the words in the claim to mean only a mixture/compound in the context of the claim, namely the purpose to create a jelly mould. This distinguishes the product. The product has honey from the bee sub-species Apis Mellifera sicula, whereas the claim stipulates honey from the bee species Apis Mellifera. This latter language can have a looser meaning to include the minor variants: honey from the bee species Apis Mellifera including the honey from sub-species of Apis Mellifera. However, the skilled addressee may also have assumed that the patentee had good reason to restrict his patent so, possibly because it was not obvious if the variant of sub-species honey would have any material effect upon the way the

invention worked. It would depend on the state of knowledge concerning the different efficacy between species and sub-species honey on wound treatments, but it seems unlikely that it was common knowledge. The courts may choose to distinguish the claim from the product on this description. It also does not comprise a combination [] with one or more natural based gelling agents. Rather, it is a silica pad which contains the honey and never interacts with it, rather than being combined with it. The change to a silica pad container seems to have no material effect on the way the invention works, and it would have been obvious to a person skilled in the art that a silica pad container would work the same way. Therefore, the reader would have understood that the patentee had some reason to confine his claim to combinations with gelling agents in its conventional meaning, and not in a generic sense that would include silica pad containers. This provides the strongest distinction between the product and the claim. Both are compositions in the form of a flexible sheet [] that can be readily moulded to fit the wound to which it is to be applied. It is unknown whether at least 50% (by weight) of the composition is honey in the current product. It is harder to interpret numbers purposively, and it is clear that a significant deviation from the 50% requirement would bring the product beyond the claim. If the skilled addressee would have treated the products composition as majority honey, then it would suffice to bring it under the claim: Improver v Remington. The current product is unlikely to infringe the patent. If the current product does infringe, Bandico infringes by making, disposing, offering to dispose, using, and keeping, and possibly importing: s60(1)(a) PA. New Product Different honeys are used. This may distinguish it even further from the claim because it is harder to interpret the term to mean honey from any bee species. If the different honeys are not sufficient to distinguish it, the new product is similar to the claim to the extent that it is a medical composition for dressing wounds comprising the combination of honey [] with one or more natural based gelling agents, wherein the amount of gelling agent is such that the resulting composition is in the form of a flexible sheet, the addition of silica notwithstanding. However, unlike the claim, it does not have at least 50% (by weight) of the composition as honey. It is harder to interpret numbers purposively, and it is clear that a 30% is a significant deviation from the 50% requirement. The skilled addressee would not have treated the products composition as majority honey, bringing it beyond the claim: Improver v Remington. The new product is unlikely to infringe the patent. If the new product does infringe, Bandico infringes by making, offering to dispose, using and keeping: s60(1)(a) PA. It cannot claim the defence of experimentation under s60(5)(b) PA because in its production it is simply testing the commercial viability, not to test a new hypothesis: Monsanto v Stauffer. It may argue that it infringed innocently: s62 PA, but this is extremely difficult to prove especially as Bandico is a large pharmaceutical company which could

easily have discovered that there was a patent for honey-based wound treatments and it only started selling after the great success of OhHoney. GELICO Gelico infringes Dr Pops patent through secondary infringement, ie. while the patent is in force and without the proprietors consent, he supplies or offers to supply to people not entitled to work the invention with means relating to an essential element of the invention for putting the invention into effect: s60(2) PA. Clearly, the gelling agents are an essential element of the composition. By promoting the fact that it can be blended with honey, they also fulfil the requirement of knowledge that the means are suitable and intended to put the invention into effect in the UK: Grimme v Scott. No actual infringing adaptation need be shown, the expectation of a future intention of a future buyer is sufficient for Gelico to be a secondary infringer. They may argue that the product they supply is a staple commercial product which is commonly available, qualifying for protection under s60(3) PA. However, advertising that their products can be used to make infringing adaptations is inducement to infringe, denying them the defence. Dr Pops can bring an action for secondary infringement against Gelico: s69 PA. Damages will be backdated to the publication date of 2nd Jan 2013. Dr Pops has to be wary because the alleged infringers will seek to invalidate the original patent as a form of defence: s74 PA. The court may also revoke the patent on grounds that it was granted to a person not entitled to that patent: s72(1)(b) PA. If they are not found guilty of infringement, the aggrieved party may also retaliate by bringing an action for groundless threats of litigation proceedings: s70 PA. Dr Pop may seek to rely on the defence that they did not know and had no reason to suspect their patent was invalid: s70(2A). Word Count: 2088

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