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Medical use

Second medical use

8.130 Second or subsequent medical uses of a substance or composition may only be claimed in the form of “Swiss-type” claims. This form of claim, first allowed by the Swiss Patent Office in response to a lack of provision in the legislation for the protection of second medical uses of a substance or composition, were also deemed allowable by the Enlarged Board of Appeal in G 05/83, and subsequently by the Patents Court in John Wyeth’s and Schering’s Applications [1985] RPC 545. As stated in G 05/83:

“… it is legitimate in principle to allow claims directed to the use of a substance or composition for the manufacture of a medicament for a specified new and inventive therapeutic application, even in a case where the process of manufacture as such does not differ from known processes using the same active ingredient.”

8.131 “Swiss-type” claims are regarded as purpose limited process claims whereby the claim is directed to the use of the substance for the manufacture of a medicament for a specified medical use. Hence, “Swiss-type” claims are not restricted to second or subsequent medical uses of a substance or composition and can be used even when the first medical use of a compound is not previously known.

8.132 This practice of using a “Swiss-type” claim format for second medical uses differs  from that of UK and Europe. Since the implementation of the EPC 2000, Applicants  within contracting member states have been able to protect inventions relating to second and subsequent medical uses through a more direct claim form: “substance X for use in the treatment of disease Y”. However, without similar provisions in the Singapore legislation, such claims cannot be construed as providing the same limitations of being specifically directed to the treatment of disease Y in Singapore.

8.133 Normally, “for” is interpreted as “suitable for”. However, in a “Swiss-type” claim, “for” is interpreted as “suitable and intended for” treatment of the indication specified. In Warner-Lambert Company, LLC v Actavis Group Ptc EHF & Ors (Rev 1) [2015] EWHC 72, Arnold J. (citing Actavis v Merck and Birss J. in Hospira UK Ltd v Genentech Inc.), noted that a “Swiss-type” claim is directed at the manufacturer and that the intention of the manufacturer in the production of the pharmaceutical product is key.

8.134 Second medical use claims can only derive novelty from their intended use if the use is in a method of treatment excluded under Section 16(2). This means that “Swisstype” claims are not allowable for the new use of a known substance in a non-medical method. In Commonwealth Scientific & Industrial Research Organization’s Application BL O/248/04, the method of follicle ablation on sheep was considered as a method of maintaining hygiene, even though the consequence of wool removal results in a reduction of conditions favourable for balanitis and blowfly strike occurrence. However, this reduction of favourable conditions was not directly linked to a therapeutic activity of follicle ablation. Therefore, the method was considered a nontherapeutic method and consequently was not entitled to protection in the form of a “Swiss-type” claim.

8.135 An application may include both “Swiss-type” claims and non therapeutic claims (e.g. use of the compound for cosmetic purposes) on condition that the therapeutic and nontherapeutic methods are supported and distinct. As stated by the Hearing Officer in Commonwealth Scientific & Industrial Research Organization’s Application BL O/248/04:

“… an application may include both claims to the second medical use of a compound for therapeutic purposes, and claims to non-therapeutic methods of using the compound, providing the therapeutic and non-therapeutic methods are distinguishable and both methods are fully supported by the application as filed. On the other hand, if the therapeutic and non-therapeutic aspects cannot be distinguished, or if the non-therapeutic effect is merely a secondary consequence of the therapy, then the invention is unpatentable, regardless of the wording used …”

8.136 Although the Enlarged Board of Appeal in G 05/83, referred only to “therapeutic” methods, second medical use claims may be used to protect the use of a known substance or composition in any method excluded under Section 16(2) of the Patents Act, on condition that the specified medical use is new and inventive. In T 655/92 NYCOMED/Contrast agent for NMR imaging OJEPO 1998, 17, a “Swiss-type” claim was allowed for the use of a known compound, previously used as a medicament, as a reagent in a diagnostic method performed on the human body. The allowed claim reads:

“Use of a magnetically responsive material for the manufacture of a diagnostic contrast agent for use in a method of in vivo nuclear magnetic resonance imaging of a subject, said agent comprising particles of a matrix material having a diameter of up to 10 micrometres and having enclosed therein a said magnetically responsive material the magnetic responsiveness of which is such that said particles are magnetically localisable and such that said particles in said nuclear resonance imaging of said subject cause relaxation time changes resulting in a visualisable ‘black hole’ contrast effect.”

8.137 The following are examples of suitably drafted second medical use claims:

(vi) Use of compound X in the manufacture of a medicament for the treatment of disease Y.
(vii) Use of compound X in the manufacture of a pharmaceutical composition for treating disease Y.

8.138 Unsuitably drafted second medical use claims include, but are not limited to:

(viii) Use of compound X for the treatment of disease Y.
(ix) Compound X for use in the treatment of medical condition Y.

Claim (viii) is interpreted as a method of medical treatment and would lack industrial application.

Claim (ix) is consistent with current second medical use forms accepted by UK IPO and EPO. However, under present Singapore practice, it is construed as a claim to a first medical use and accordingly, the claim lacks novelty if compound X is a known medicament as the specific use is not considered to be limiting. Nonetheless, if a previous medical use is not known then such claims are allowable, provided that there is evidence in the specification supporting the claimed use.

8.139 T 1075/09 LABORATOIRES SERONO provides a further example of suitably and unsuitably drafted “Swiss-type” claims. In T 1075/09, a claim to the combined use of two hormones was drafted in a way such that one of the hormones was interpreted as a second medical use while the other, as a therapeutic method. The claim in question relates to the new use of luteinising hormone (LH) and included the phrase “wherein folliculogenesis is induced by the administration of follicle stimulating hormone (FSH)”. This phrase was considered as a method of administering follicle stimulating hormone and so the claim was interpreted as encompassing a method of medical treatment. On the other hand, the claim “The use of FSH and LH in the production of a medicament for inducing paucifolliculogenesis or unifolliculogenesis … wherein the FSH is for inducing folliculogenesis and the LH is to be administered subsequent to FSH …” was found to be allowable. Thus, the wording of claims relating to combined treatments needs to be checked to ensure that a method of treatment by therapy is not included in the scope of the claims.

8.140 Another example of a Swiss-type claim that is not properly formatted is seen in BGH/Carvedilol II [2006] X ZR 236/01. The claim reads:

“Use of carvedilol for the production of a medicament for the reduction of mortality … wherein the medicament is administered in starting dosage of …”

The phrase “wherein the medicament is administered” was considered a therapeutic procedure for the treatment of the human body and thus was not considered a proper “Swiss-type” claim.

A suitable rectification would be to replace the phrase “wherein the medicament is administered” with “wherein the medicament is to be administered” such as in the claim below:

(x) Use of a compound X in the manufacture of a medicament for the treatment of disease Y wherein the medicament is to be admininstered at a daily dosage of Z mg.

Novelty and inventive step assessment of second medical use claims

8.141 As in the case of a first medical use claim, a disclosure of an activity that merely suggests that a substance or composition can be used for the claimed therapy, or that discloses in vitro testing for such a use in a non-patent document would not anticipate a second medical use claim for the same proposed medical use, if the document did not explicitly or implicitly disclose the use of the substance or  composition for theclaimed therapy. Mere assertion or assumption of a therapeutic use of a compound based upon in vitro testing is not sufficient to destroy the novelty of the claim. This is primarily because the disclosure in the non-patent document may not be enabling, and moreover, following the directions in the document would not necessarily infringe a claim to a therapeutic use. Nonetheless, such documents would form the basis of a strong inventive step argument. Summarizing the disclosure requirement, Lord Hoffamn in SmithKline Beecham’s (Paroxethin Methanesulfonate) Patent [2006] RPC 10, stated:

“Anticipation requires prior disclosure of subject-matter which, when performed, must necessarily infringe the patented invention.”

8.142 However, patent documents which disclose the substance or composition for treatment of the claimed disease, but without providing actual clinical data may still be cited as a prior art for novelty. This is because even if the document does not disclose actual clinical use, by following the directions in the document, the skilled person would still infringe the patent. Similar to first medical use, the onus is on the Applicant to challenge whether the disclosure in the prior art document constitutes an enabling disclosure.

8.143 Likewise, experimental data demonstrating the efficacy of the treatment for the claimed ailment using the substance or composition on animals would constitute anticipation of the medical use claim. If, on the other hand, and as pointed out in T 715/03 PFIZER, the document does not indicate the use of the substance or composition for the treatment of the claimed disease, but merely mentions the completion of Phase I or commencement of Phase II trials, without providing any results on therapeutic efficacy, then this will not necessarily constitute evidence of therapeutic use. This is because Phase I trials merely assess the safety of the drug and Phase II trials indicate the efficacy of the drug but not necessarily its therapeutic effect. Nevertheless, this would again be a strong basis for an argument under inventive step. However, the Examiner should consider such disclosure on a case-bycase basis, taking into account the intention of the trials and what is known regarding the substance or the composition under trial before making a decision on whether a novelty or an inventive step objection is warranted.

8.144 In the case whereby the substance or composition has been used to treat a related condition, the inventiveness of the claim may be questioned. However, T 913/94 EISAI/Medicament for gastritis [2001] EPOR 362 stated that even if the diseases have a common origin, causative factors or mechanism, this may not necessarily mean that the claim lacks inventiveness. If the severity of the symptoms of the disease indicated in the prior art document is greater than the claimed disease, this would strongly imply that the same agent will similarly be effective for the latter condition. More often than not, these cases may need to be individually dealt with by the Examiner on a case-bycase basis.

8.145 For a new use of a known substance or composition to be recognized asinventive, the specification needs to provide reasons not previously known or recognised as to why the claimed substance or composition is likely to be effective for the new use. It was stated in Teva v Astrazeneca [2014] EWHC 2873:

“Where, as here, a patent is sought in relation to a new use of an existing drug or combination of drugs, patent protection will only be justified if the patentee discloses sound reasons, not recognised or known before, for thinking that new use will be effective to secure the object for which it is put forward.”

8.146 Typically, the answer to the final question of the Windsurfing test determines the inventiveness of new medical uses of known substances or composition. The question may be along the lines of: Is it obvious to try to use the said substance or composition for the claimed purpose? In this instance, obviousness is only found where it is considered as obvious to try with a reasonable or fair expectation of success. This is particularly so in the area of pharmaceuticals and biotechnology as a means of minimizing deterrence to research. The Court of Appeal in MedImmune v Novartis [2010] EWCA Civ 1234, [2013] RPC 27 provides some guidance on this:

“Whether a route has a reasonable or fair prospect of success will depend upon all the circumstances including an ability rationally to predict a successful outcome, how long the project may take, the extent to which the field is unexplored, the complexity or otherwise of any unnecessary experiments, whether such experiments can be performed by routine means and whether the skilled person will have to make a series of correct decisions along the way.”

Although this case did not relate to medical use claims, this approach was validated by the Court of Appeal in Regeneron Pharmaceuticals v Genentech [2013] EWCA Civ 93 in relation to a second medical use claim.

The new use

Treatment of a new disease or condition

8.147 Typically, a second medical use claim is used to protect the use of a substance or composition in the treatment of a different disease. An example of this would be aspirin, which was originally used as an antipyretic and analgesic, and was subsequently found to be useful as an anticoagulant, and later as an anti stroke medication and an anti-ischaemic. Hence, a claim based on a new medical use of a known substance or composition may claim novelty in the form of a “Swiss type” claim. Guidance on evaluating novelty for this form of claims may be taken from the decision in Schering A.G.’s Application [1985] RPC 553:

“… a second pharmaceutical use invention, which is also referred to as the second medical indication, that is to say an invention based on the discovery that a drug already known for a particular medical activity (or activities) has another useful medical activity unconnected with the first and which had not previously been expected.”

8.148 In a scenario where the new use is the treatment of a specific form of a disease, the novelty of such a second medical use claim may vary depending on the facts of the case. In most cases, a general disclosure of a class of diseases, does not anticipate a claim to a specific disease within that class. Nonetheless, a novelty objection may be made in instances where the prior art document discloses a class of diseases which appear to encompass the specific disease claimed, and either the specific disease is referred to in the prior art document as being treatable with the claimed substance or it may be reasonably implied that the prior art document does disclose the treatment of the specific disease. The onus will be on the Applicant to argue whether the prior art document constitutes an enabling disclosure for the specific disease claimed. In T 1001/01, a “Swiss-type” claim to adenocarcinoma of the ovary was judged as novel over the prior art document which disclosed experimental data employing a metastatic reticulum cell sarcoma arising from the ovary of a C57BL/6 mouse. The Technical Board of Appeal was convinced by the Appellant’s arguments and evidence that the preclinical model using metastatic reticulum cell sarcoma could not serve as a model for adenocarcinoma of the ovary which is of epithelial origin and has a glandular growth pattern. Additionally, the Board reasoned that the skilled person would be able to distinguish when an ovarian cancer is an adenocarcinoma of the ovary and therefore the novelty of the claim over the prior art document was acknowledged.

New mode and dosage of administration

8.149 The mode of administration may play a critical role in a medical treatment and can serve as a distinguishing feature over the prior art documents. In T 51/93 SERONO, the administration of human chorionic gonadotrophin in the treatment of male sexual disorders or infertility by a subcutaneous route was considered to confer novelty over the prior art documents which disclosed administration via an intramuscular route. In this case, the Applicant demonstrated that the subcutaneous route provided the advantages of reduced nerve lesions and the option of self administration. Nevertheless, it should be noted that the claim must be appropriately drafted such that the claimed mode of administration is directed at the manufacturer and not at the medical practitioner. If the claim is drafted such that it is deemed to be directed to a medical practitioner then it will be considered as a medical method of treatment and thus lack industrial application. Although second medical use claims may be defined in part by their modes of administration, defining the use in these terms alone (e.g. for enteral administration) without further specifying any actual therapy, is not considered to define a new medical use and so in such cases, the claim would be construed as a substance or composition “suitable for” such a use (T 1278/12 N.V. Nutricia).

8.150 Second medical use claims which are distinguished from the prior art documents by the dosage regime used are allowable, on the condition that the claimed dosage regime is novel and inventive. In Actavis v Merck [2008] RPC 26, the dispute centered around the second medical use of finasteride at a new daily dosage of about 0.05 mg to 1.0 mg for the treatment of androgenic alopecia. Finasteride was a known drug for treating prostate conditions and had been previously proposed as a treatment for androgenic alopecia at a dosage of at least 5 mg. Thus, the new feature in the claim was a lowered dosage of finasteride for the treatment of androgenic alopecia. In this case, the Court of Appeal overturned the decision of the Patents Court in Actavis v Merck [2007] EWHC 1311 and held that a second medical use claim in the form of a new dosage regime was allowable. Additionally, after much deliberation, Jacob LJ acceded to Merck’s argument that based on the state of knowledge of the skilled person at the priority date of the document, it would not have been obvious to the skilled person to reduce the dosage range for the treatment of androgenic alopecia.

8.151 However, in most cases, a new dosage regime is generally presumed as lacking inventiveness unless there is a clear technical prejudice pointing away from the claimed dosage regime. Therefore, typically, such dosage regimes will be considered obvious as investigation of dosage regime is regarded to be a routine practice in the art. This point was highlighted in Actavis v Merck [2008] EWCA Civ 444:

“Only in an unusual case such as the present (where … treatment for the condition with the substance had ceased to be worth investigating with any dosage regime) could specifying a dosage regime as part of the therapeutic use confer validity on an otherwise invalid claim.”

New patient group

8.152 A second medical use claim may, for novelty and inventive step purposes, rely solely on the patient group to be treated. This is despite the known association of the claimed substance or composition and the disease to be treated.

8.153 The new patient group must consist of a distinctly different group of patients from those treated in the prior art. Furthermore, there must be a functional relationship between the particular physiological or pathological status of this group of patients and the therapeutic or pharmacological effect achieved. Guidance is provided by the Technical Board of Appeal in T 233/96 MEDCO RESEARCH:

(1) The new patient group must be clearly distinct from the patient group treated in the prior art and these 2 groups must not overlap;
(2) The distinction must not be arbitrary and must be based on a functional relationship between the physiological or pathological characteristics of the new group and the therapeutic effect.

An example of a non-overlap of the new patient group with the known patient group would include the therapeutic application of a vaccine known for the treatment of sero-negative pigs, to a new and different class of the same animal, sero positive pigs in T 19/86 DUPHAR/Pigs II OJEPO 1989, 24. As stated by the Board of Appeal:

“… Such a new use is not only valuable in cases where a novel area of therapeutic use, i.e. a novel medical indication, is provided but also in those cases where a novel class of animals, which previously did not respond to a medicament, is cured or protected against a disease. The question whether a new therapeutic use is in accordance with the decision Gr 05/83 should not be answered exclusively on the basis of the ailment to be cured but also on the basis of the subject (in the present case the new group of pigs) to be treated.”

8.154 A second medical use claim directed to the use of a substance or composition in the manufacture of a medicament for the treatment of a disease in a specific patient group will not be considered novel if the same substance or composition has already been used to treat the same group of patients, amongst others. Mere discovery that a treatment is particularly effective in one sub-group of patients does not render a claim novel if it is explicitly or inherently implied from the prior art documents that the same substance has been used to treat the same disease in this patient group. The identification of this sub-group of patients is considered a mere discovery of an advantage to an already known treatment. For example, in Bristol-Myers Squibb v Baker Norton Pharmaceuticals [1999] RPC 253, it was decided that new information of an advantage or how a treatment worked did not constitute an invention if this information did not lead to a new use. This decision was upheld in the Court of Appeal in Bristol-Myers Squibb v Baker Norton Pharmaceuticals [2001] RPC 253.

New mechanism or technical effect

8.155 Second medical use claims distinguished solely by a different mechanism of action or technical effect, but used for the same therapeutic purpose as the prior art will lack novelty. The mere discovery of how a treatment works is inconsequential.

8.156 This interpretation is based by the decision of the Patents Court in the earlier discussed Bristol-Myers Squibb v Baker Norton Pharmaceuticals [1999] RPC 253. As stated by Jacob J:

“All you have is more information about the old use. In due course no doubt more information about the exact mode of action of Taxol will emerge. No one could obtain a patent for its use simply by adding ‘for’ at the end of the claim and then adding newly discovered details of the exact mode of action.”

8.157 This conclusion was followed by the Patents Court in El-Tawil v The Comptroller General of Patents [2012] EWHC 185 where the decision of the Hearing Officer in the rejection of claims relating to a mechanism of action of a known treatment was upheld. Furthermore in Actavis UK Ltd v Jassen Pharmaceutica NV [2008] EWHC 1422, a second medical use claim relating to the use of an agent for potentiating the effects of blood pressure reducing agents having adrenergic and/or vasodilating activity was concluded as merely providing more information about the mechanism of action of a known treatment. It was stated:

“I think that all that is done here is to explain why the results that would be obtained with compound 84 are as good as they are.”

8.158 The newly discovered mechanism or technical effect is insufficent on its own in confering novelty to a second medical use claim. As stated by Floyd J in Actavis UK Ltd v Jassen Pharmaceutica NV [2008] EWHC 1422:

“In my judgement, merely explaining the mechanism which underlies a use already described in the prior art cannot, without more, give rise to novelty.”

Hence, the discovery of a new technical effect has to be associated with some other feature of the treatment which is clearly distinguishable over the prior art document such as a new therapeutic use, patient group or clinical situation in order to fulfil novelty.

8.159 A claim defined in mechanistic terms does not necessarily mean that the claims are unclear. In Regeneron Pharmaceuticals Inc. and Bayer Pharma AG v Genentech Inc. [2013] EWCA Civ 93, the phrase “non-neoplastic disease or disorder characterised by undesirable excessive neovascularisation” was deliberated. Floyd J held that there was no difficulty in identifying treatable diseases characterised by undesirable excessive neo-vascularisation. It was stated:

“There was no evidence that the skilled addressee would have any difficulty in determining whether a given disease would fall within the terms of the claim as I have construed them.”

8.160 Examiners should therefore consider such claims on a case-by-case basis and in relation to what is generally known about the mechanism of action being claimed and its relationship with specific medical conditions. Nevertheless, even if the condition to be treated defined in mechanistic terms is considered to be clear, the Examiner should ensure that such claims are supported and that there is a clear indication that all conditions which fall under the scope of such a mechanism would in fact be treatable by the claimed composition.

New advantage to known use

8.161 Claiming an unexpected advantage to a known treatment is not considered as a new therapeutic use, although it may form the basis of such a use. In Bristol Myers Squibb v Baker Norton Pharmaceuticals [1999] RPC 253, the invention lay in the unexpected discovery that a shorter infusion time of Taxol of 3 hours versus a 24 hour period led to a lessening of neutropenia (white blood cell count). The court found that the Applicant was simply seeking to protect new information (i.e. lessening of neutropenia) regarding the known use of Taxol for treating the same disease over the same infusion duration. As stated by Jacob J:

“… there is a big difference between new information that a prior proposal previously thought unworkable in fact works and new information to the effect that a prior proposal has an additional advantage.”

Level of efficacy of treatment

8.162 Generally, the sole feature of an improved level of efficacy over an existing treatment will not confer novelty to the claim. Moreover, lack of clarity may be raised as the claim is defined in terms of a desired outcome. In T 315/98 STERLING/  (+) ibuprofen, 2000, the “hastened onset” of pain relief was not considered to be a new medical use when the substance was already known for its analgesic properties. The fact that the prior art document did not expressly mention hastened onset did not automatically establish novelty of the claimed use. Both the patent in suit and prior art document referred to the same racemate of ibuprofen as a basis for comparing the pharmacological activity of the S(+)enantiomer. Additionally, both referred to pharmacological activity in the form of analgesic response. Hence, it was held that the reference in the prior art document to S(+)ibuprofen in higher concentrations reaching the site of action more quickly with a higher activity means nothing else than hastened onset of analgesia. Accordingly, it was concluded that the pharmacological effect of S(+)ibuprofen as claimed was disclosed in the prior art document.

8.163 Claims defining a level of efficacy of treatment were also discussed in Hospira v Genentech [2015] EWHC 1796. The patent claimed the use of an antibody in combination with a taxoid to treat breast cancer wherein the clinical benefit was measured by time to disease progression, which is one of several parameters used generally to determine the efficiacy of anti-cancer treatments. It should be noted though for this case, the claimed level of efficacy of treatment was not critical for the establishment of novelty as it could not be established from the prior art documents that this combination of drugs had been used to treat cancer. Thus, the patent was in fact, revoked on grounds of inventive step. However, in general, if a claim defines a level of efficacy and the prior art documents disclose the actual treatment with the same agent for the same purpose applied in the same manner, it would be reasonable to assume that the efficacy achieved in the prior art documents would be similar if not the same as that of the application in question.

Co-administration

8.164 It is common to combine two or more known substances or compounds for use as a medicament. Such compositions comprising two or more agents for the treatment of a disease may claim novelty in the form of a second medical use claim on condition that the stated combination has not previously been used for the specified disease or condition. In Actavis UK Ltd v Janssen Pharmaceutica NV [2008] EWHC 1422, the use of one steroisomer of blood pressure drug, nebivolol, to potentiate the bloodpressure reducing effects of other agents, including one of its other stereoisomers, was anticipated by the use of a racemic mixture for the treatment of hypertension.

8.165 The inventiveness of claims of this type will require determining whether the claim relates to a single or a plurality of inventions. If the two (or more) components simply perform their usual function in the body and there is no synergy between them, then the claim would be considered as relating to two separate inventions and there is no inventiveness in combining them. This practice finds support in the judgement by the House of Lords in SABAF v MFI Furniture Centres [2005] RPC 10 whereby the judge held that the design was obvious, involving essentially only the collocation of two known features. Evidence of this synergistic effect must be provided at the time of filing; any evidence provided post-filing cannot be used to demonstrate inventiveness in this situation. As stated in Glaxo Group’s Patent [2004] RPC 43:

“If a synergistic effect is to be relied on, it must be possessed by everything covered by the claim, and it must be described in the specification. No effect is described in the present specification that is not the natural prediction from the properties of the two components of the combination.”

8.166 Moreover, evidence of unexpected synergy between the claimed components does not render a combination inventive if this combination was obvious to the skilled person. In particular, if it is known to combine two categories of active agent, it is unlikely that the substitution of a newer, more effective agent of one or other category in the combined preparation be considered as inventive. The patents in both Glaxo Group’s Patent [2004] RPC 43 and Richardson-Vicks’ Patent [1995] RPC 568 were revoked on these grounds.

8.167 If the synergy of the combined components is no greater than the equivalent prior art combination, then this synergy does not equate to evidence of inventiveness in this combination. In T 492/99 NIPRO, it was determined that there was no advantage of the combined anti-inflammatory agent claimed in the main request over the state of the art and therefore it was held that the claim in question did not involve an inventive step.

8.168 However, in Schering-Plough Ltd v Norbrook Laboratories Ltd [2005] EWHC 2532, even though the combination was prima facie obvious, inventiveness was  acknowledged because technical prejudice pointed away from the combination inquestion. The inventive concept was the use of a long-acting anti microbial with an anti-inflammatory in a combination therapy. Combination products are single products designed to administer two therapeutic agents in the same dose whilst in concurrent  therapy, the two drugs are administered separately but at the same time.The common general knowledge consisted of (i) a combination treatment of a short acting antimicrobial with an anti-inflammatory, and (ii) a concurrent therapy of long-acting antimicrobial and an anti-inflammatory. In view of this, the idea of combining the two products was prima facie obvious. However, the underlying issue was whether this combination therapy retained the long-acting effect of the anti microbial after administration which forms the basis of the technical prejudice. On the basis of expert evidence, the High Court was satisfied that the data in the patent showed that the longacting antimicrobial effect of Norbrook’s long acting oxytetracycline product was retained when formulated together with flunixin in a single product and that this was an unexpected benefit.

Use in treatments performed outside the body

8.169 Therapeutic treatments such as dialysis where blood or tissue is treated outside of the body and thereafter returned to the patient are considered to be methods of treatment by therapy and therefore unpatentable. It therefore follows that an invention relating to the use of a known substance or composition for such an ex vivo treatment could be protected under a second medical use claim. For example, in T 2003/08 EDWARDS LIFESCIENCES, a “Swiss-type” claim directed the use of an agent for treating a pathological condition by removal of immunoglobulins from plasma ex vivo before reinfusion was allowed.

Support for second medical use claims

8.170 Second medical use claims have to be supported by adequate evidence in the specification as filed that it is (or at least likely to be) effective for the specified use. The second medical use claims in Hoerrmann’s Application [1996] RPC 341 and McManus’s Application [1994] FSR 558 were rejected for this reason. As stated by the Hearing Officer in Hoerrmann’s Application [1996] RPC 341:

“… unless there is some indication in the description of applications of this type of tests, however rudimentary, demonstrating that the invention has been carried out in an effective manner then the application must fail for lack of support for the invention claimed.”

8.171 The mere assertion that tests had been carried out is insufficient. In Consultant Suppliers Ltd’s Application [1996] RPC 348, a mere statement in the specification that the claimed invention has been tested in the absence of any details of this test was deemed to lack support. Similarly, in Prendergast’s Applications [2000] RPC 446, it was stated that full, detailed, rigorous and conclusive testing of a drug for its ability to treat a condition is not necessary but there must be at least some evidence that it would in fact work. It was held that tests showing that the known substance or composition works in the proposed new circumstances are an essential part of the description if second medical use claims are to be adequately supported. As stated by the Patents Court:

“… where you have a claim for the use of a known active ingredient in the preparation of a medicament for the treatment of a particular condition, the specification must provide, by way of description, enough material to enable the relevantly skilled man to say this medicament does treat the condition alleged … pure assertion is insufficient.”

8.172 Similar to a first medical use claim, support for a second medical use claim must be found in the specification as filed. As such, an objection to a lack of support cannot be overcome by later-filed evidence. As stated in T 0609/02 SALK INSTITUTE FOR BIOLOGICAL STUDIES:

“Sufficiency of disclosure must be satisfied at the effective date of the patent, ie on the basis of the information in the patent application together with the common general knowledge then available to the skilled person. Acknowledging sufficiency of disclosure on the basis of relevant technical information produced only after this date would lead to granting a patent for a technical teaching which was achieved, and, thus, for an invention which was made, at a date later than the effective date of the patent.”

It was further added by the Technical Board of Appeal in T 0609/02:

“Once this evidence is available from the patent application, then post published (so-called) expert evidence (if any) may be taken into account, but only to backup the findings in the patent application in relation to the use of the ingredient as a pharmaceutical, and not to establish sufficiency of disclosure on their own.”

8.173 In Commonwealth Scientific & Industrial Research Organization’s Application BL O/248/04, the application was not considered to have provided support for the treatment of both the diseases, blowfly strike and balanitis in sheep and related animals, as claimed. The tests included in the application relates solely to blowfly strike with no data provided to demonstrate that balanitis may be treated by a similar method. Thus, the “Swiss-type” claims relating to balanitis were deemed unsupported by the description as filed.

8.174 However, if the evidence in the application shows an effect on a common underlying mechanism behind a broader class of diseases, then a correspondingly broad claim may be considered to be supported. In American Home Products v Novartis [2001] RPC 8, Aldous LJ states:

“Thus if the patentee has hit upon a new product which has a beneficial effect but cannot demonstrate that there is a common principle by which that effect will be shared by either products in that class, he will be entitled to a patent for that product but not for the class, even though some may subsequently turn out to have the same beneficial effect … On the other hand, if he has disclosed a beneficial property which is common to the class, he will be entitled to a patent for all products of that class (assuming them to be new) even though he has not himself made more than one or two of them.”

8.175 Further guidance may be found in Agency for Science, Technology and Research’s Application BL O/221/13 and G W Pharma’s Application BL O/237/12. Although not drafted as a “Swiss-type” form of second medical use claim, the decision in Agency for Science, Technology and Research’s Application in terms of support for second medical claim is still relevant. In Agency for Science, Technology and Research’s Application, it was held that experimental data performed solely on breast cancer cells made it plausible that the claimed agents could treat any cancer characterised by the over-expression of a particular protein called VHZ. On consideration of information presented, the Hearing Officer concluded that it was credible that at the priority date the skilled addressee could have expected from reading the application that anti-VHZ agents could be used to treat not only breast cancer but the other claimed cancers.

8.176 On the other hand, in G W Pharma’s Application BL O/237/12, there was no teaching in the application that the provided in vitro evidence was related to the mechanism underlying prostate cancer, which was the claimed use. Moreover, in view of the state of the art, there was no teaching that suggested any correlation existed between the provided in vitro evidence and prostate cancer. Accordingly, the claims were concluded to lack support.

Kit of parts/Set of instructions

8.177 Combined preparations of individual components may be protected as a kit of parts, provided that the components form a functional combination through a purpose directed application. Such claims may be defined in terms of simultaneous or sequential administration or at particular time intervals. Claims in this form was discussed in T 09/81 ASTA/Cytostatic combination OJEPO 1983, 372, where the invention related to a combined preparation containing an oxazaphosphorin cytostatic agent and the sodium salt of 2-mercapto-ethane-sulphonic acid as therapeutic active ingredients. The co-administration of sodium 2-mercapto-ethane sulphonate ceased the severe side effects caused by cytostatic agents. Individually, these two components were known medicaments, however these two components had never been used together to provide a joint effect and were also unknown as a single composition. The claim in question read:

“Products containing an oxazaphosphorin cytostatic agent and the sodium salt of 2-mercapto-ethane-sulphonic acid as a combined preparation for simultaneous, separate or sequential use in cytostatic therapy.”

8.178 As indicated in the claim, the components were not necessarily present as a single composition, and as such the components may be used separately or sequentially. It was held by the EPO Board of Appeal that the combined preparation of an oxazaphosphorin cytostatic agent and the sodium salt of 2-mercapto ethane sulphonic acid was novel and inventive but needed to be drafted specifying its purpose in the form of a medical use claim in order to distinguish it from a medical kit, collection or package containing the two agents together for their known independent uses. Hence, such claims are allowable provided that the pack is stated to be for the method in which the invention resides and that the pack is novel and not obvious for any other application.

8.179 A claim to a pack containing a known substance with instructions describing the new use would normally be construed as directed to a pack containing the known substance since instructions are not considered to make a technical contribution to the claim.

8.180 However, in the case where the actual contribution resides beyond mere instructions, the claim may be patentable. For this, the claim must define the functional relationship between integers in the kit that necessarily provides the invention. In Organon Laboratories’ Application [1970] RPC 574; [1970] FSR 419, a claim in relation to a pack containing two types of contraceptive pills arranged in a distinct order with instructions for its use was granted under the old UK law (1949 Act). Although packs containing contraceptive pills in a given order were known, the claim was allowed on the basis that the particular order of arranging the pills in this case was novel and not obvious from the prior art as it was based on a new and inventive method of contraception.