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METHOD OF TREATMENT INVENTIONS UNDER THE EPC:
WHAT KIND OF PROTECTION CAN YOU GET?
Introductory Comments
The methods excluded by Article 52(4)EPC are the result of policy. The intention protection, Article 52(4) of the European surgery or therapy and diagnostic methodsfrom patent protection. Article 52(4) EPC, General Considerations
Methods for treatment of the human or animal body by surgery or therapy and hence, should be narrowly construed and
diagnostic methods practiced on the regarded as inventions which are sus- ceptible of industrial application within the constitute a surgical or diagnostic method.
The following comments shall giveguidance to the reader as to what should Article 52(4) EPC thereby provides one of treatment of the human or animal body.
According to ample case law of the Boards European patents shall be granted for any inventions which are susceptible of indus- must not contain a single therapeutic step trial application, which are new and involve (cf. also section 2.2 infra for the definition of “therapeutic“) in order not to violateArticle 52(4) EPC .3, 4 It is noted that Article 52(4) EPC by way oflegal fiction excludes method of treatment performed by a medical practitioner oranother person having medical knowledge or under the supervision of such a person is not sufficient to decide whether the
method step is objectionable under Article
An invention shall be considered as sus- ceptible of industrial application if it can be performed or used in any kind of industryincluding agriculture. 2Decision of the Enlarged Board of AppealG 5/83; cf. O.J. EPO 1985, 64 3Decision of the Technical Board of Appeal T 1Decision of the Technical Board of Appeal T 4Decision of the Technical Board of Appeal T GRÜNECKER, KINKELDEY, STOCKMAIR & SCHWANHÄUSSER
indication. In Decision T 385/86 the Board well as the alleviation of the symptoms of with the human or animal body susceptibleof industrial application is patentable if it prophylactic treatment. Thus, therapeutic pointing to a method of treatment excluded from patentability by Article 52(4) EPC is if (prophlyaxis) or restoration (therapy) of the method has to be performed by or
Types of Treatment excluded by
Article 52(4)
should be encompassed by the exclusionfrom patentability by Article 52(4) EPC. In diagnosis which are basically independent restrict each other. According to case law, their exclusion from patentability requires with and are often indistinguishable from treatments by surgery, therapy or diagno- impossible and undesirable to distinguish thus not excluded from patentability.7 In i.e. healing or cure and mere relief. Thus, line with this, the treatment of body tissues the treatment of menstrual discomfort was and therefore excluded from patentability thereon are not excluded by Article 52(4) discussed in the following - an AppealBoard came to a different conclusion.
Meaning of “Therapy“ as defined
by European Case Law
There is an increasing interest noticeablefor the use of pharmaceutical compo- In a first definition by an Appeal Board, the sitions comprising a therapeutically active ingredient for non-therapeutical purposes.
curative treatment in the narrow sense as e.g. the use of the drug seldinafil(VIAGRA) for increasing the sexual vitalityof healthy individuals or the use of cholineor derivatives thereof for accelerating 5Decision of the Technical Board of Appeal T 385/86; cf. O.J. EPO 1988; 308, in particularpoint 3.5.2 of the Reasons for Decision 6Decision of the Technical Board of Appeal T 11Decision of the Techncial Board of Appeal European Patent Office July 1999, C-IV, 4.3 12Decision of the Technical Board of Appeal 9Decision of the Technical Board of Appeal T 13Decision of the Technical Board of Appeal GRÜNECKER, KINKELDEY, STOCKMAIR & SCHWANHÄUSSER
arises whether the non-therapeutic effect obtainable after administration of the drug effect of the drug or whether the patientpopulations receiving the drug for non- Therefore, in light of Decision T 469/9416 need for the formulation as secondmedical use claims should be patentable therapeutic effect or (ii) the therapeutic derivative thereof for increasing the acetyl choline level in the brain and the tissue,thereby reducing the perception of fatigue Surgical Methods
in a person about to participate in majorexercise or in a person having performed (Guidelines), surgery defines the nature of the prior art. The Board considered that in said case the two effects of choline are not inseparably linked or correlated, but on the purposes or for embryo transfer as well as surgical treatment for therapeutic purpo- ses. Interesting to note, surgical methods therapeutic benefit from the treatment.
Moreover, the times necessary for Diagnostic Methods
obtaining the different effects (days for thetherapeutic effect and minutes or hours for According to Article 52(4) EPC, diagnostic the non-therapeutic effect) appeared to be should be noted that diagnostic testing of the Board held that a condition of fatigue human or animal body, e.g. blood, sputum, methods excluded from patent protection.
removable by simple rest. Pain or serious In Decision T 385/8618 the Board ruled that tations of fatigue, which therefore is not typical of a disease or an injury. Thus, theperception of fatigue is not comparable 14Decision of the Technical Board of Appeal T 469/94; not yet published in the O.J. EPO GRÜNECKER, KINKELDEY, STOCKMAIR & SCHWANHÄUSSER
the requirements of industrial applicability in accordance with Article 57 EPC. In the interim results (e.g. measurement of blood 52(4) EPC.21 Provided that the therapeutic 52(4), first sentence, even if they could be and non-therapeutic (e.g. cosmetic) effects are distinguishable, the applicant mayobtain acceptance of a claim by introducing the feature “cosmetic“ or “non- Board outlined the essential elements of a Methods of Contraception
palpating and ausculating various parts of decide whether a claim directed to the use of a contraceptive composition for applying tests (the examination and data gathering of conception is excluded frompatentability by Article 52(4) EPC. The Board noted that methods of contraception values, recording any significant deviation are not excluded per se from patentability as stipulated in Article 52(4), first sen-tence, EPC, since pregnancy is not an illness and therefore its prevention is not a general therapy according to Article 52(4) The Board pointed out that if only one of Methods of Testing
said essential elements was lacking, nodiagnostic method within the meaning of Article 52(4), first sentence, would have that the utilization of (healthy) test animals for test purposes in industry, e.g. fortesting industrial products, would be Cosmetic Methods
patentable provided that the test animalsare not prophylactically treated or cured considered to relate to non-therapeuticindications. It was found in Decision 21Decision of the Technical Board of AppealT 290/86; cf. O.J. EPO 1992, 414.
22Decision of the Technical Board of Appeal 19Brockhaus Enzyklopädie, volume 4, 1968, 24Decision of the Technical Board of Appeal GRÜNECKER, KINKELDEY, STOCKMAIR & SCHWANHÄUSSER
In Vitro Methods
priate protection for him was therefore inits broadest form a purpose-limited product claim, the only purpose being the treatment as excluded by Article 52(4)EPC is to insert “in vitro“ into the method claim provided (i) the specification pro- however, the following should be noted.
vides sufficient support and (ii) said claimsprovide acceptable protection. According to the authors’ experience, the drafting of the fact that the same specific therapeutic in vitro claims is in particular useful for other specific therapeutic medication using outside of the living body) e.g. a one step First and Second Medical Uses
of known Compounds
First Medical Use
Article 52(4), second sentence, rules that A particular first medical use claim is the the provision of Article 52(4) EPC, i.e.
patentability, shall not apply to products, in particular, substances or compositions for use in the medical field, Article 54(5) EPC preparation for simultaneous, separate or sequential use in cytostatic therapy,wherein the first compound was a known [T]he provisions of [Article 54] paragraphs 1 to 4 shall not exclude the patentability of any substance or composition, comprised in the state of the art, for use in a any method referred to in Article 52, paragraph 4, provided that its use for any method for a new joint effect and were unknown as referred to in the paragraph is not comprised in the state of the art (emphasisand [ ] added). Combined preparations the individual components of which represent known therapeutic agents may be protected in a medical indication“ could obtain purpose- formulation corresponding to Article 54(5) EPC even when claimed as a kit-of-parts, providing those components forming a functional unity (true combination) through a purpose directed application (headnote). specified therapeutic purpose. The appro- 26Decision of the Enlarged Board of Appeal 27Decision of the Technical Board of Appeal GRÜNECKER, KINKELDEY, STOCKMAIR & SCHWANHÄUSSER
It should be noted that in accordance withsaid Decision claims are considered to be As a kit-of-parts, however, it is not allowable which are directed to the use of necessarily a true combination in view of the physical separation of the individual components. Mere loose association of components does not in itself turn them into a functional unity in which a necessary and direct interaction between the components is a precondition for the purposive use. Although components inthe claimed combination do not enter into 3.3.2 Novelty of Second Medical Use
such a direct interaction with each other the indication of purpose for the combinedtherapy may re-establish the unity of the The following section provides options for product as a functional amalgamation of its two components, if it represents a genuine restriction to the specifiedapplication (point 6 of the Reasons). Therefore, a kit-of-parts claim should be considered when the core of the invention table, even in a case in which the process of manufacture as such did not differ fromknown processes using the same active Second (or further) Medical
ingredient. The novelty of the claim relied Indication
upon the new purpose (or medicalindication). Therefore, of course, a newly A second (or further) medical use claim for therapy but for a different indication.
3.3.1 Wording of Claims
decided that novelty of a second medicaluse claim could also be established by the In the pharmaceutical field, the “normal“ group of animals to be treated, the medical indication being known from the prior art.
compound X for treating disease Y“ isprohibited by Article 52(4), because such a therapeutic application was incomplete if admissible under Article 52(4).28 However, identified; only a disclosure of both the represented a complete technicalteaching. The principle that the identifi- Use of substance X for the manufacture of cation of a novel group of patients to be GRÜNECKER, KINKELDEY, STOCKMAIR & SCHWANHÄUSSER
use claim novel was later on confirmed in removing plaque to be novel and inventive and/or the treatment regimen in which the use of the same medicament for the treat- medicament is applied to a patient. In the ment of the same disease in sero-positive Decision T 570/9234 the Board inter alia said therapeutic applications was that thepopulations being treated differed in their Use of nifedipine crystals having a specific surface of 1 to 4 sqm/g for the preparationof solid pharmaceutical preparations for obtaining long-lasting blood levels for oral treatment of hypertension, to be adminis- tration into the claim. In Decision T 51/93it was acknowledged by the Board that the The Board noted that the wording used did mode of administration, i.e., subcutaneous administration versus known intramuscular frequency of administration actually inten- ded when treating an individual patient but merely to convey the teaching that thesuccess of the treatment was ensured if a claimed invention are both concerned with than twice a day. Although not explicitly a similar treatment of the human body for the same therapeutic purpose, the claimed twice a day is a critical feature which can prior document within the meaning of theDecision G 5/8333 if it is based upon a decision T 469/94 to a different conclusion whether the use of compositions including regarding novelty of a second medical use claim due to the indication of the treatment plaque from teeth, thereby inhibiting tooth decay was different from a prior art use of lanthanum salts in dental composition for medical use claim in view of the prior art, the purpose of depressing the solubility of the only novelty conferring element was a tooth enamel in organic acids developed in different treatment regimen in the claimed cerns in an obiter dictum only. 35 final therapeutic purpose is the same inboth cases, the Board held the useaccording to the opposed patent for 31Decision of the Technical Board of Appeal 32Decision of the Technical Board of Appeal GRÜNECKER, KINKELDEY, STOCKMAIR & SCHWANHÄUSSER
Scope of Protection of Patent
Claims in the Medical Field
known as a medicinal product. Anindication free claim wording, hence, however, was not chosen by the applicant.
Article 69 EPC, first paragraph whichreads as follows: Thus, to generally obtain the broadestscope of protection for a first medical use The extent of the protection conferred by a European patent or a European patent application shall be determined by the terms of the claims. Nevertheless, the claim that the product is useful only as a description and drawings shall be used to medical indications - such as antiviral -should be omitted.
Any infringement of a European patent isdealt with by national law (Article 64(3) Scope of Protection of Process
In the following the main emphasis will be A claim directed to e.g. cosmetic methods or ex vivo diagnostic methods is con- sidered to encompass the particularsequence of method steps which can also encompass the use of particular products.
patent is to be interpreted in the same way patent or is a national German patent.
resulting from the treatment. It should benoted that preparatory acts are also not Scope of Protection of First
Medical Use Claim
The first medical use claim is considered Scope of Protection of Second
to be a purpose-limited product claim
Medical Use Claims
wherein the purpose forms an essentialelement of the claimed teaching. The scope of protection will be limited to the indicated purpose. In the Decision of the specific use of a product. In the medicinal virusmittel“36 the Board had to decide on a treatment regimen with a known product is The single patent claim reads as follows: found. In accordance with the Decision“Hydropyridin“38 the German Federal “Anti-virus agent, characterized in that it packaging of the product with instructionsfor the claimed use. This means that by the medical indication (anti-virus) to be alimitation of the product claim, although 37BGH “Heliumeinspeisung“; cf. GRUR 1992, 36BGH “Antivirusmittel“ GRUR 1987, 794 38BGH “Hydropyridin“; cf. GRUR 1983, 729 GRÜNECKER, KINKELDEY, STOCKMAIR & SCHWANHÄUSSER
easily find and prove patent infringement of the use patent. It should be noted that applicable to use claims. The scope ofprotection might thus be extended to other 5.1.2 Both method claims considered to
been rejected by the EPO for violatingArticle 52(4) EPC.
Recent Developments and Out-
In the following the possibility of obtainingclaims relating to aspects of somatic ex Gene Therapy
vivo gene therapy will be considered.
Article 52(4) EPC precludes the patenta- According to definition, gene therapy is the bility of the complete gene therapy method cells (somatic gene therapy) or of cells of the germ line (germ line gene therapy).
Furthermore, gene therapy can be dividedinto ex vivo and in vivo gene therapy, Regarding the patentability of single steps wherein the former relates to removing of of the ex vivo somatic gene therapy body cells from a patient, treatment of said binant vector) and subsequent recycling of the treated cells to the patient, whereas the latter implies direct administration of excluded by Article 52(4). Of course, such the recombinant gene vector by, e.g.
performed already for e.g. a scientificpurpose, non-related to a gene therapy 5.1.1 US patent practice differs signifi-
regarding the grant of patents directed to manipulated cells. Claims directed to the use of transfected cells for the preparation very broad claims relating to ex vivo gene patient’s disease would be admissible as A process for providing a human with a 6. Summary
introducing human cells into a human, said the basic principles and recent trends in human cells having been treated in vitro to the assessment of patentability of methods insert therein a DNA segment encoding a therapeutic protein, said human cells expressing in vivo in said human atherapeutically effective amount of said 39US patent no. 5,399,346 (Anderson et al.) 40US patent no. 5,858,354 (Brinster) issued GRÜNECKER, KINKELDEY, STOCKMAIR & SCHWANHÄUSSER
inventions in the medical field. Thediscussed cases reflect the author’spersonal opinions of highly relevant caselaw which should be taken into accountwhen drafting a patent application in themedical field. As the discussion shows,although methods of treatment of the livinganimal and human body are excluded frompatent protection there is a fairly largerepertoire of options for getting usefulpatent protection in this important field.
GRÜNECKER, KINKELDEY, STOCKMAIR & SCHWANHÄUSSER

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