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C.A.(COMM.IPD-PAT) 479/2022 ELANCO TIERGESUNDHEIT AG .....Appellant
Through: Mr. Shatadal Ghosh, Mr. Abhishek Jan, Mr. Kapil Kumar, Advocates
(M:7042079908)
Through: Ms. Nidhi Raman, CGSC
Nanda, Advocates for UOI (M:9958614305, email:nidhiraman.office@gmail.com)
JUDGMENT
1. The present appeal has been filed under Section 117-A of the Patents Act, 1970 (“the Act”) read with Section 151 of the Code of Civil Procedure, 1908 (“CPC”), against order dated 24th March, 2022 passed by the Assistant Controller of Patents and Designs under Section 15 of the Act, in the Patent Application No. 3679/DELNP/2015 (“Patent Application”). By way of the impugned order, the claimed invention of the appellant has been rejected on the grounds of lack of novelty and inventive step under Sections 2(1)(j) and 2(1)(ja) of the Act. The claim has further been rejected on the ground of lack of sufficiency of disclosure, as provided under Section 10 of the Act.
2. Brief facts of the case are as follows: 2.[1] The appellant had filed the patent application on 30th April, 2015 for the invention titled “Preparation of Live Vaccines”. The patent application claimed a method for generation of live vaccine containing stable bacteria carrying at least three attenuating mutations and a vaccine containing bacteria obtained by said method. The original applicant listed on the patent application was „Lohmann Animal Health Gmbh‟. Subsequently, on 18th September, 2018, rights in the patent application were assigned to the appellant herein. 2.[2] The patent application was examined, and the First Examination Report (“FER”) was issued on 5th December, 2018, in which various objections were raised on behalf of the Patent Office. 2.[3] The appellant filed a detailed response to the FER on 3rd June, 2019, along with amended claims. 2.[4] The Patent Office issued a hearing notice dated 28th February, 2020, scheduling the hearing for 12th March, 2020, wherein, certain objections in the FER as regards lack of inventive step under Section 2(1)(j) and (ja) and sufficiency of disclosure under Section 10 of the Act were maintained. 2.[5] Upon request of the appellant, the hearing was adjourned to 10th April, 2020 by notice dated 12th March, 2020. Due to lockdown caused by Covid-19, the hearing was further adjourned to 21st September, 2020, by notice dated 19th August, 2020. The appellant again requested for adjournment owing to Covid-19. Thereafter, the respondent adjourned the hearing to 16th August, 2021 by notice dated 30th July, 2021. 2.[6] The appellant made extensive oral arguments at the time of hearing. Detailed written submissions, along with amended set of claims, were filed by the agent for the appellant on 30th August, 2021. 2.[7] The respondent, vide the impugned decision, refused to grant the patent in respect of the patent application. Hence, the present appeal has been filed.
3. Learned counsel for the appellant, in the first instance, without going into technical aspect of the matter, submitted that the matter be remanded back, as the impugned order has been passed mechanically, without any application of mind. Attention of this Court was drawn to the impugned order of the respondent dated 24th March, 2022 and the final hearing notice dated 30th July, 2021, to submit that the impugned order is a verbatim reproduction of the hearing notice.
4. It is submitted that the respondent has copied and pasted the objections without applying his mind to the submissions made by the appellant at the time of hearing, as well as in the post hearing written submissions. The respondent has not given any reasons and has not passed a speaking order for rejecting the patent application, which has been dismissed, by a single sentence claiming that the said submissions could not justify the objections. Thus, it is submitted that the matter be remanded back for fresh consideration.
5. Per contra, learned counsel appearing for the respondent justified the impugned order. It is submitted that the patent application has rightly been refused by the respondent office, citing lack of novelty and inventive step along with lack of sufficiency of disclosure.
6. I have heard learned counsels for the parties and have perused the record.
7. Considering the documents on record, it is manifest that the impugned order has been passed without any independent reasoning, by merely reproducing the contents of the hearing notice dated 30th July, 2021 issued to the appellant. In this regard, it is apposite to refer to the contents of the impugned order and the hearing notice. On the issue of lack of novelty and inventive step, the impugned order dated 24th March, 2022 passed by the respondent, reads as under: “xxx xxx xxx Invention u/s 2 (1) (j) read with 2 (1) (ja)
1. Applicant's reply carefully considered, but the explanation given by the agent is not persuasive. The agent just mentioned that D1-D[3] is the previous work of the one of the inventor. The D[1] discloses a method of obtaining live vaccine by passaging of wildtype bacterial strains and isolation of spontaneous attenuated clones that carry metabolic drift mutations. Selection is done on plates by selecting smaller colonies, i.e. 75% or 50% of the size of wild-type, in a dying-off culture, i.e. cultures incubated at 37 degrees Celsius for 3 weeks. Said metabolic mutations are antibiotic-dependent mutations, and the strain may carry two or three mutations. D[2] 2 discloses the use of at least one living attenuated immunogenic Salmonella-vaccine strain, with an envelope marker making it sensitive to macrolide antibiotics, in the production of a living vaccine intended for a specific host. In the event of the vaccine causing an infection in another host, effective therapeutic treatment of the infected host is possible using macrolides. D[3] teaches that optimally attenuated mutants for highly susceptible hosts and protecting after a single oral vaccination are often over attenuated for host species being less susceptible. Therefore, to select vaccine strains optimally attenuated for the particular host species it is essential that a range of mutants with graded levels of attenuation be provided so as to permit lesser susceptibility to being compensated for by a correspondingly lower level of attenuation. This, while guaranteeing the stability through two markers or multi-marker attenuation, can be suitably accomplished by slightly to moderately virulence-reducing mutations. Aspartic acid auxotrophy and, in particular, 'metabolic drift' mutations, possibly by additionally incorporating antiepidemic markers, are adopted for the mouse model to demonstrate stepwise production of S. typhimurium and S. typhi vaccine candidate strains with graded attenuation or any level of attenuation desirable. Hence, the amended claims lacks novelty and inventive steps u/s 2(1)(j) and 2(1)(ja) of the Indian patent act respectively. xxx xxx xxx”
8. For comparison, the hearing notice dated 30th July, 2021 on the issue of lack of novelty and inventive step, reads as under: Invention u/s 2(1)(j)
1. Applicant's reply carefully considered, but the explanation given by the agent is not persuasive. The agent just mentioned that D1-D[3] are the previous work of the one of the inventor. The D[1] discloses a method of obtaining live vaccine by passaging of wild type bacterial strains and isolation of spontaneous attenuated clones that carry metabolic drift mutations. Selection is done on plates by selecting smaller colonies, i.e. 75% or 50% of the size of wild-type, in a dying-off culture, i.e. cultures incubated at 37 degrees Celsius for 3 weeks. Said metabolic mutations are antibiotic-dependent mutations, and the strain may carry two or three mutations. D[2] 2 discloses the use of at least one living attenuated immunogenic Salmonella-vaccine strain, with an envelope marker making it sensitive to macrolide antibiotics, in the production of a living vaccine intended for a specific host. In the event of the vaccine causing an infection in another host, effective therapeutic treatment of the infected host is possible using macrolides. D[3] teaches that optimally attenuated mutants for highly susceptible hosts and protecting after a single oral vaccination are often over attenuated for host species being less susceptible. Therefore, to select vaccine strains optimally attenuated for the particular host species it is essential that a range of mutants with graded levels of attenuation be provided so as to permit lesser susceptibility to being compensated for by a correspondingly lower level of attenuation. This, while guaranteeing the stability through two markers or multi-marker attenuation, can be suitably accomplished by slightly to moderately virulence-reducing mutations. Aspartic acid auxotrophy and, in particular, 'metabolic drift' mutations, possibly by additionally incorporating antiepidemic markers, are adopted for the mouse model to demonstrate stepwise production of S. typhimurium and S. typhi vaccine candidate strains with graded attenuation or any level of attenuation desirable. Hence, the amended claims 1-5 and 7-11 lacks novelty and inventive steps u/s 2(1)(j) and 2(1)(ja) of the Indian patent act respectively
9. Then again, on the issue of sufficiency of disclosure, the impugned order dated 24th March, 2022, reads as under:
2. Sufficiency of Disclosure u/s 10 (4) a) Deposition number needs to be mentioned in the description and claims b) Firstly, the instructions for identifying the desired mutant strains through growing and selection of metabolically drifted strains cannot be considered as being a routine method, because they are nothing else than carrying out the method of the invention as present in claim 1, which can hardly be considered as routine. Secondly, it would require undue experimentation to mutated strains through growing and selection. The reason therefore is that there is no limitation to the number of strains and antibiotics that can be used for selection, thus performing the method is very cumbersome and has no guaranty of success. Thus, having no guidance in claim 1 for selecting a sui table starting point (a combination of bacterial strain and antibiotics), the skilled person after having screened a multiplicity of strains still might not have identified any strain with the desired properties and mutations. Consequently, the definition of the bacterial strain in terms of a result to be achieved renders the scope of the subject-matter of claims 8-11 unclear. Moreover, it might be said that claims 8-11 try to define strains in terms of their function. Their function being "mini" and MD"res" or that they are identified as such by one of the methods of claims 1-7. Functional features may be used to define the scope of the claims, even in the extreme case that only a single example of such a functional feature has been given. Presently however not a single example of MD"res" strains has been given and neither is the skilled person aware of such strains. The strains mentioned on page 13 seem to merely be intermediate strains (compare example 6). Moreover, in the present case the functional feature could not even be allowed if said single example would be present, since the description doesn't reasonably make it clear which mutations the desired strains actually carry. Consequently, the subject-matter of claims 8-11 in not supported by the description because it is defined by an unallowable functional definition of the strains alluded to in said claims Thus, having no guidance in claim 1 in selecting a sui table starting point, the skilled person, after having screened many combinations of strains and antibiotics, might still not have identified any desired strain. This leaves the successful performance of the invention entirely up to the chance of accidentally having chosen a bacterial strain that can grow "mini" colonies in the presence of a certain antibiotic. Also, the invention might be found unrepeatable as the attenuated bacteria strains can only be found in a totally unreliable way, that is, either the desired mutation occurs, or it doesn‟t. Therefore, the subject-matter of claims 8-11 is not sufficiently disclosed.
10. Again, in comparison to the aforesaid, relevant portion of the hearing notice dated 30th July, 2021, pertaining to sufficiency of disclosure, reads as under: Sufficiency of Disclosure u/s 10 (4)
1. Deposition number needs to be mentioned in the description and claims.
2. Firstly, the instructions for identifying the desired mutant strains through growing and selection of metabolically drifted strains cannot be considered as being a routine method, because they are nothing else than carrying out the method of the invention as present in claim 1, which can hardly be considered as routine. Secondly, it would require undue experimentation to identify the mutated strains through growing and selection. The reason therefor is that there is no limitation to the number of strains and antibiotics that can be used for selection, thus performing the method is very cumbersome and has no guaranty of success. Thus, having no guidance in claim 1 for selecting a suitable starting point (a combination of bacterial strain and antibiotics), the skilled person after having screened a multiplicity of strains still might not have identified any strain with the desired properties and mutations. Consequently, the definition of the bacterial strain in terms of a result to be achieved renders the scope of the subject-matter of claims 8-11 unclear. Moreover, it might be said that claims 8-11 try to define strains in terms of their function. Their function being "mini" and MD"res" or that they are identified as such by one of the methods of claims 1-7. Functional features may be used to define the scope of the claims, even in the extreme case that only a single example of such a functional feature has been given. Presently however not a single example of MD"res" strains has been given and neither is the skilled person aware of such strains. The strains mentioned on page 13 seem to merely be intermediate strains (compare example 6). Moreover, in the present case the functional feature could not even be allowed if said single example would be present, since the description doesn't reasonably make it clear which mutations the desired strains actually carry. Consequently, the subject-matter of claims 8-11 in not supported by the description because it is defined by an unallowable functional definition of the strains alluded to in said claims. Thus, having no guidance in claim 1 in selecting a suitable starting point, the skilled person, after having screened many combinations of strains and antibiotics, might still not have identified any desired strain. This leaves the successful performance of the invention entirely up to the chance of accidentally having chosen a bacterial strain that can grow "mini" colonies in the presence of a certain antibiotic. Also, the invention might be found unrepealable as the attenuated bacterial strains can only be found in a totally unreliable way, that is, either the desired mutation occurs, or it doesn't. Therefore, the subject-matter of claims 8-11 is not sufficiently disclosed.
11. On the issue of clarity and conciseness, the impugned order dated 24th March, 2022, reads as under:
3. Clarity and Conciseness a) Applicant's reply carefully considered, but it is not persuasive. Step (b) of claim 1 is unclear. The term "mini colonies which correspond to clones which are dependent on the first antibiotic" is quite vague. Mini is a relative term and it is unclear how small a colony is supposed to be to be considered as mini. It is noted that simply growing for a longer or shorter time will influence the size of the colony considerably. It is also not clear if the term mini is supposed to indicate growing for a short time or perhaps mini is in relation to other colonies. The step of identifying "colonies which correspond to clones which are dependent on the first antibiotic" is also not clear. Some strains are not resistant and again to antibiotics, other strains other are strains are dependent resistant, on certain antibiotics. It is noted that in carrying out the method of claim 1 the skilled person is not limited in the type of strain to use. It is not clear how to identify whether a mini colony has gained a little resistance to antibiotics, has lost a little resistance to antibiotics, or has lost some dependency on the antibiotics. Thus steps a) and b) might result in strains that are more virulent instead of attenuated, leading to a discrepancy between the purpose of the claimed method and the steps provided to achieve that purpose. Step (c) appears to select for revertants in the absence of antibiotics. These revertants are to be attenuated. However, the criterion for selecting the colony is that the size is more than or equal to 50% of the "wild strain" this includes colonies that are 100% equal in size as the wild strain and are thus not attenuated and perhaps do not have the desired mutations as a loss of the mutation gained in steps a) and b) might have occurred. Step c) also lacks clarity in that the way of measuring the size is not specified. Size can be measured in diameter, or a surface or perhaps even otherwise. Depending on the type of measurement one will get different results. A colony could be selected if the diameter (mm) is reduced by 50%. However, the same colony could also be excluded when its surface (mm[2]) is used to measure its size. It is also not clear to what "wild strain" refers. The term is not mentioned earlier in claim 1. However it could simply refer to the strain provided in step a), although the strain used in step a) doesn‟t need to be a wild-type strain in the sense that it is a strain that is exactly as it occurs in nature. The strain provided in step a) could already contain certain mutations. Step d) refers to a "sui table concentration" but doesn‟t state to which end the concentration needs to be suitable. It is unclear whether in step e) "reduced size" is in relation to the wild strain in that after every passage the colonies stay smaller than the wild strain or that it is intended that after every passage the smallest colonies are picked from the plate for the next passage. The various unclarities and internal discrepancies between method and the results achieved the purpose of the by the method when considering its whole scope, render the claimed subject matter unclear, unsupported and insufficiently disclosed.
12. Comparing the same, on the aforesaid issue of clarity and conciseness, the hearing notice dated 30th July, 2021, reads as under: Clarity and Conciseness
1. Applicant's reply carefully considered, but it is not persuasive. Step (b) of claim 1 is unclear. The term "mini colonies which correspond to clones which are dependent on the first antibiotic" is quite vague. Mini is a relative term and it is unclear how small a colony is supposed to be to be considered as mini. It is noted that simply growing for a longer or shorter time will influence the size of the colony considerably. It is also not clear if the term mini is supposed to indicate growing for a short time or perhaps mini is in relation to other colonies. The step of identifying "colonies which correspond to clones which are dependent on the first antibiotic" is also not clear. Some strain are not resistant to antibiotics, other strains are resistant, and again other strains are dependent on certain antibiotics. It is noted that in carrying out the method of claim 1 the skilled person is not limited in the type of strain to use. It is not clear how to identify whether a mini colony has gained a little resistance to antibiotics, has lost a little resistance to antibiotics, or has lost some dependency on the antibiotics. Thus steps a) and b) might result in strains that are more virulent instead of attenuated, leading to a discrepancy between the purpose of the claimed method and the steps provided to achieve that purpose. Step (c) appears to select for revertants in the absence of antibiotics. These revertants are to be attenuated. However, the criterion for selecting the colony is that the size is more than or equal to 50% of the "wild strain" this includes colonies that are 100% equal in size as the wild strain and are thus not attenuated and perhaps do not have the desired mutations as a loss of the mutation gained in steps a) and b) might have occurred. Step c) also lacks clarity in that the way of measuring the size is not specified. Size can be measured in diameter, or a surface or perhaps even otherwise. Depending on the type of measurement one wi II get different results. A colony could be selected if the diameter(mm) is reduced by 50%. However, the same colony could also be excluded when its surface(mm[2]) is used to measure its size. It is also not clear to what "wild strain" refers. The term is not mentioned earlier in claim 1. However it could simply refer to the strain provided in step a), although the strain used in step a) doesn't need to be a wild-type strain in the sense that it is a strain that is exactly as it occurs in nature. The strain provided in step a) could already contain certain mutations. Step d) refers to a "suitable concentration" but doesn't state to which end the concentration needs to be suitable. It is unclear whether in step e) "reduced size" is in relation to the wild strain in that after every passage the colonies stay smaller than the wild strain or that it is intended that after every passage the smallest colonies are picked from the plate for the next passage. The various unclarities and internal discrepancies between the purpose of the method and the results achieved by the method when considering its whole scope, render the claimed subject-matter unclear, unsupported and insufficiently disclosed.
13. Reading of the two documents, as aforesaid, i.e., hearing notice dated 30th July, 2021 and the impugned order dated 24th March, 2022, makes it apparent that the respondent has not applied its independent mind. The patent application has been dismissed, by holding as follows: After carefully reading through the FER response, while hearing oral and post-hearing written submissions and in light of the specification and amended claims, it is understood that the requirements of formal and clarity stand complied/waived off. The oral & written submission placed before me could not justify the objections for the above discussed reasons u/s 2 (1) (j) read with section 2 (1 (ja) and section 10 (4). Therefore, in view of the above discussion, this application is refused patent u/s 15 of "The Patent Act 1970" for want of compliance u/s 2(1) (j) read with section 2(1(ja)& section 10(4) of "the Patent Act 1970". The application stands disposed off.” (Emphasis Supplied)
14. Perusal of the impugned order clearly shows that the respondent has completely failed to provide any detailed justification and has rejected the patent application merely by holding that the submissions of the appellant herein, could not justify the objections. The respondent has merely stated that the detailed oral submissions at the hearing, and post hearing written submissions by the appellant, were insufficient to meet the objections. In effect, the respondent has copied and pasted the objections without applying his mind to the submissions made by the appellant at the hearing, as well as in the post hearing written submissions.
15. Holding that recording of reasons while passing a decision, is a basic tenet of the Principles of Natural Justice, Supreme Court in the case of Manohar S/o Manikrao Anchule versus State of Maharashtra and Another[1], has held as follows:
19. In Kranti Associates (P) Ltd. v. Masood Ahmed Khan [(2010) 9 SCC 496: (2010) 3 SCC (Civ) 852] the Court dealt with the question of demarcation between the administrative orders and quasi-judicial orders and the requirement of adherence to natural justice. The Court held as under: (SCC pp. 510-12, para 47) “47. Summarising the above discussion, this Court holds: (a) In India the judicial trend has always been to record reasons, even in administrative decisions, if such decisions affect anyone prejudicially. (b) A quasi-judicial authority must record reasons in support of its conclusions.
(c) Insistence on recording of reasons is meant to serve the wider principle of justice that justice must not only be done it must also appear to be done as well.
(d) Recording of reasons also operates as a valid restraint on any possible arbitrary exercise of judicial and quasi-judicial or even administrative power. (e) Reasons reassure that discretion has been exercised by the decision-maker on relevant grounds and by disregarding extraneous considerations. (f) Reasons have virtually become as indispensable a component of a decision-making process as observing principles of natural justice by judicial, quasi-judicial and even by administrative bodies.
(g) Reasons facilitate the process of judicial review by superior courts. (h) The ongoing judicial trend in all countries committed to rule of law and constitutional governance is in favour of reasoned decisions based on relevant facts. This is virtually the lifeblood of judicial decision-making justifying the principle that reason is the soul of justice.
(i) Judicial or even quasi-judicial opinions these days can be as different as the Judges and authorities who deliver them. All these decisions serve one common purpose which is to demonstrate by reason that the relevant factors have been objectively considered. This is important for sustaining the litigants' faith in the justice delivery system. (j) Insistence on reason is a requirement for both judicial accountability and transparency. (k) If a Judge or a quasi-judicial authority is not candid enough about his/her decision-making process then it is impossible to know whether the person deciding is faithful to the doctrine of precedent or to principles of incrementalism.
(l) Reasons in support of decisions must be cogent, clear and succinct. A pretence of reasons or ‘rubber-stamp reasons’ is not to be equated with a valid decision-making process.
(m) It cannot be doubted that transparency is the sine qua non of restraint on abuse of judicial powers. Transparency in decision-making not only makes the Judges and decision-makers less prone to errors but also makes them subject to broader scrutiny. (See David Shapiro, “In Defence of Judicial Candor” [(1987) 100 Harv L Rev 731-37]. (n) Since the requirement to record reasons emanates from the broad doctrine of fairness in decision-making, the said requirement is now virtually a component of human rights and was considered part of Strasbourg Jurisprudence. See Ruiz Torija v. Spain [(1994) 19 EHRR 553], wherein the Court referred to Article 6 of the European Convention of Human Rights which requires, „adequate and intelligent reasons must be given for judicial decisions‟. (o) In all common law jurisdictions judgments play a vital role in setting up precedents for the future. Therefore, for development of law, requirement of giving reasons for the decision is of the essence and is virtually a part of „due process‟.” xxx xxx xxx
21. Referring to the requirement of adherence to principles of natural justice in adjudicatory process, this Court in Namit Sharma v. Union of India [(2013) 1 SCC 745] held as under: (SCC p. 799, para 99)
16. Thus, it is evident that the respondent has not applied its mind to the appellant‟s submissions at the hearing, as well as at the post-hearing submission. The respondent has disposed of the patent application, without application of mind and without giving a reasoned order. The respondent has merely extracted the objections from the notice of hearing in the impugned order.
17. In view of the above, the impugned order dated 24th March, 2022 rejecting the patent application of the appellant, is set aside. The Patent Application No. 3679/DELNP/2015 is restored to its original position. The matter is remanded back to the respondent for fresh consideration.
18. An opportunity of hearing shall be granted to the appellant and a reasoned order shall be passed, within four months from today.
19. In the facts and circumstances of the present case, it is directed that the matter be placed before an Officer, other than the Officer who has passed the impugned order.
20. It is clarified that the Court has not examined the merits of the matter, and all rights and contentions of the parties are left open.
21. The Registry is directed to supply a copy of the present order to the Office of the Controller General of Patents, Designs and Trade Marks of India, on E-mail Id: llc-ipo@gov.in for compliance.
22. The present appeal is disposed of, in terms of the aforesaid directions.
JUDGE JULY 30, 2024