Most of the inventions relating to medical device or an implant face the litmus test –"method of treatment" objection during prosecution by Indian Patent Office. More specifically, if the invention is claiming a method which directly or indirectly makes a reference to a medical condition, it becomes difficult to convince the Examiner. However, there are some successful strategies which can be adopted to avoid such situation or to handle the situation in a better way.
Section 3 defines what not inventions within the meaning of the act are and sub section (i) reads as follows:
Section 3(i): "any process for the medicinal surgical curative, prophylactic diagnostic, therapeutic or other treatment of human beings or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products."
Strategy to handle objection under section 3 (i):-
How to claim method in inventions relating to medical device:-
- In the method claims, the terms such as "diagnose an individual", "obtaining test sample from the individual" and " indication that the individual is susceptible to a disease" should be avoided.
- Rewording the claim language, for example, in patent application 870/MUM/2007 to receive favourable Controller's decision (Feb 28, 2017), the term "performing" was deleted, a "means for surveying" was replaced by "a surveying coherence optical tomography system for surveying", "means for monitoring and controlling" was replaced by "a surveying controller and an ablating controller acting in a feedback loop for monitoring and controlling". This case has been granted Indian Patent 280777.
- Specifying the process to be "in-vitro‟ in claim of the invention. To overcome objection under sections 3(i) in patent application 861/CHE/2007 which was involving isolation of MSCs by negative selection using specific antibody combination viz. Gly-A and CD31, claims have been amended to specify the process to be "in-vitro‟. Specification has been amended to indicate that no embryo or fetus was used or destroyed in the instant application" to overcome objection under section 3(b) - relating to "unethical" invention. Controller's favourable decision came on Feb 6, 2017. This case has been granted Indian Patent 279948.
- Method claims in a digital Medical imaging device - Indian Patent 280533 is relating to a system for providing interactive computer aided detection of abnormalities captured in medical images. When the Controller cannot be convinced by Agent's arguments to overcome objection under section 3 (i) on method claims, the agent has made method claim dependent on system claim as " a method of acquiring a medical image, carried out without medication aided by system of claim 1".
- Another good example is patent application 5458/DELNP/2006 which is granted as Indian Patent 279332 on January 27, 2017. The examiner has objected to system and method claim relating to sustain release of therapeutically effective amount of the steroid dispersed within biodegradable polymer matrix which is placed in an ocular site or region of an eye under section 3(i). However, the applicant argued that problem to be solved can be seen in the provision of a steroid intraocular implant, having a sustain release of a therapeutically effective amount of steroid from the implant for a time greater than two months. The method claim was presented as "method of making biodegradable intra-ocular implant, comprising the steps of extruding a mixture of steroid & biodegradable polymer to form a biodegradable material that releases drug at a rate effective to sustain release of therapeutically effective amount of the steroid dispersed within biodegradable polymer matrix which is placed in an ocular site or region of an eye".
- In the inventions relating to genetic material in a medical device and method, it is advisable that applicant amend claims to recite only the variant form of the known natural sequences, having new substitutions (less than 100 % identity with existing data). BLAST search result for the claimed sequences can be submitted to demonstrate that the claimed sequences are a variant form of the known natural sequences having new substitutions. Claimed specific fragments can be identified by their respective SEQ ID No. Also, source of each of the claimed sequences provided in specification. Accession number of the wild type sequence as well as claimed sequence SEQ ID can be provided. These steps help in convincing the examiner during prosecution of the application.
- Directing the invention and method purely for cosmetic purposes. It has been given in recent draft Manual of Patent Practice and Procedure that "application of substances to the body for purely cosmetic purposes is not therapy".
An interesting example is 3321/DELNP/2007 - relating to method for determining if an pancreas isolated from a member of species will be a source of therapeutically useful islets which has been objected under section 3 (i).
In this application, it has been argued that the claimed process does not involve isolation of pancreas and method is carried out on sample, which is isolated pancreas include ischemia time which is defined as the time between initiation of exsanguinations and placement of the pancreas in cold preservative. However, the Controller objected that claims fall within the scope of such clause of section 3(i) of the Patents Act, 1970 as the treatment given to animal during isolation of organ affect the quality of organ as potential donor of islets, such method of treatment of animal increasing the economic value of its organ as donor are not allowable. Further, the Controller has objected that claims fall within the scope of such clause of section 3(b) of the Patents Act, 1970 (relating to morality/ ethical) because pancreas organ has been collected from animal, which were stunned electrically and sample is collected in a manner that Cold ischemia times ranged from 15-20 minutes. Treatment of animal such as electrocution of animals cause very hardship to animal and cause serious prejudice to life to animal and further it is related to trade/commerce in the field of organ trade, and it is against morality. In addition, the Controller has objected that claims fall within the scope of such clause of section 3(k) of the Patents Act, 1970 (relating to Computer/ algorithm) as it is related to evaluation of pancreas biopsies for its suitability for islet isolation by assessing five variables and in each case a score of either +1 or -1 has been assigned to the variable. If more than 15 minutes transpire, a score of -1 was assessed. Thus, present invention is related to scoring method for determining the yield of islets in the isolated pancreas which is a mathematical method, a kind of algorithm for assessing five variables as numerical value has been given as score for phenotypic expression of characteristic of Pancreas biopsies, hence not allowable. This application was rejected under section 3(i), 3(b) and 3(k) of Indian Patents Act.
Most referred decision of the Board of Appeal of the European Patent Office
- G 1104 (OJ 2006 334}, has been mostly
referred by the agents during prosecution. In G 0001/04 it was
stated that an important contribution to diagnoses performed by
physicians in private practice and in hospitals was the
determination of medical laboratory parameters. Most of these
parameters were concentrations of molecules or cells in a body
liquid (e.g. blood or urine) and normally determined invitro. The
sample (e.g. body fluid) was mixed with the reagents in a reaction
vessel, and the detectable change was evaluated by the instrument
which belonged to the system. Inventions relating to such in-vitro
determination of medical laboratory parameters could in most cases
be protected by product claims. But where method claims were
appropriate, such methods should neither be excluded from
patentability under Article 52(4} EPC, since none of the method
steps was carried out on the body. Only if direct
interaction with the body made a real difference whether the object
of the invention was achieved, should a diagnostic method be
regarded as falling within the exclusion under Article 52(4)
EPC. Moreover, for the exclusion to operate, the
entirety of the diagnostic method had to be practiced on
the body. Thus, it is clearly established by the European Patent
Office that diagnostic treatment methods performed on the human
body are excluded from patentability, however in-vitro assay
methods or in-vitro diagnostic methods that is performed on tissue
or fluids permanently removed from the body are not excluded from
Comparing Article 52(4) EPC provision and Section 3(i) of Indian Patents Act.
In most of the cases, Indian examiners are allowing method claims where "in-vitro" is specified.
However, there is no clear distinction of in-vitro or in-vivo diagnostic method in the clause (i) of section 3 of Patents Act, 1970. It is very clearly expressed in the EPC provision on the method practiced on the body of human or animal are only not patentable whereas the provision of clause (i) of section 3 of Patents Act, 1970 states that "any process for the .....diagnostic of human beings...." is not patentable. Therefore, it is strongly advised that along with method claims, system or device claim should be present in patent application. In some cases, technical features of "deleted matter of method claims" have been incorporated as dependent claims on a system.
- Decision of Technical Board of Appeal
in T383/03 in Europe, in General Hospital Corporation also relied
upon by Virulite where the invention related to a method of hair
removal from skin region by applying short bursts of light of a
selected wavelength to the skin.
The Board at paragraph 4.1 has held the following:-
"While the underlying cause of excess hair may be malignancy or endocrinologic diseases, excess hair itself is not harmful and its removal does not treat the underlying cause of unwanted hair, nor is it relevant to the physical health of the treated person, the treatment merely results in an aesthetic improvement of the appearance of the person. The claims are directed to a "cosmetic method" in order to emphasise that the purpose of the claimed method is to improve the aesthetic appearance of the person treated rather than to cure the underlying malady."
In Virulite, the following two steps were laid down for determining whether a method is a method of treatment or not:-
- Whether there is non-insignificant intentional physical intervention
- Whether the treatment is suitable or potentially suitable for maintaining or restoring health, the physical integrity, or the physical well being of human beings or animals
Position at Indian Patent Office:
It has been given in recent draft Manual of Indian Patent Practice and Procedure that application of substances to the body for purely cosmetic purposes is not therapy. Therefore, such claims do not fall under section 3(i) of Indian Patents Act.
Conclusion: Inventions relating to medical device or an implant and claiming a method also can avoid objection under section 3 (i) –"method of treatment" during prosecution at Indian Patent Office. There are some successful strategies which can be adopted to avoid such situation or to handle the situation in a better way.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.