Calcutta High Court

Biotron Limited vs The Controller General Of Patents ... on 17 November, 2023

                           IN THE HIGH COURT AT CALCUTTA
                               ORIGINAL JURISDICTION
                                    ORIGINAL SIDE
                               [COMMERCIAL DIVISION]

BEFORE:
The Hon'ble Justice Ravi Krishan Kapur


                                  IPDPTA 61 OF 2023


                           BIOTRON LIMITED
                               VS
        THE CONTROLLER GENERAL OF PATENTS & DESIGNS & ANR



For the Appellant               : Mr. S. Majumdar, Advocate
                                  Mr. Paritosh Sinha, Advocate
                                  Mr. K.K. Pandey, Advocate
                                  Mrs. Mitul Dasgupta, Advocate
                                  Ms. A. Majumdar, Advocate
                                  Ms. Enakshi Saha, Advocate

For the Controller of Patents   : Mr. Swatarup Banerjee, Advocate
                                  Mr. T. Bhanja, Advocate

Reserved on                     : 17.07.2023

Judgment on                     : 17.11.2023

Ravi Krishan Kapur, J.:


   1. This is an appeal under section 117A of The Patents Act, 1970 against an

      order passed by the Assistant Controller of Patents and Designs dated 17

      September     2015    rejecting   the   appellant's   Patent   Application   No.

      290/KOLNP/2008.

   2. The subject invention pertains to novel compositions of compounds

      claimed to be effective against treating and preventing viral infections. It is

      alleged that the subject invention is potent against HIV, HCV and Dengue

      virus. It is also contended that compounds with cyclic substitutions are
                                       2

   better than compounds with non-cyclic substituents. Thus, the subject

   invention   is   technically   advanced   as   compared   to   other   known

   compounds.

3. The application was filed on 21 January 2008. Upon request for

   examination on 18 June 2009, the First Examination Report (FER) was

   issued on 29 May 2012 raising an objection on the ground of lack of

   inventive steps with reference to prior arts D1-D5. Thereafter, a response

   was submitted by the appellant with amendments. Being dissatisfied with

   the response, the respondent authorities provided the appellant with an

opportunity of hearing on 28 August 2015. Ultimately, the impugned

order was passed rejecting the patent application on the ground of lack of

inventive steps under sections 2(1)(j) and 2(1)(ja) of the Act, insufficient

disclosure under section 10(4) of the Act and non-patentable subject

matter under section 3(d) of the Act.

4. It is contended that the impugned order is erroneous insofar as it is based

on a selective reading of the specifications of the subject invention. The

prior arts cited in the FER and at the hearing were prior arts which the

appellant had themselves relied on. The prior arts were made available

after search and preliminary examination carried out by the International

Searching Authority (ISA). Any reliance on the views of the ISA and IPER

are also misplaced. It is contended that all the prior arts were common in

all other countries where the respective Patent Offices had granted patent

to the appellant. Nevertheless, it is only the respondent authorities which

have rejected the appellant's claim despite considering the same prior

arts. It is also contended that the amended claims were restricted to

acylguanidines with a naphthoyl substitution having cyclic group

substitutions and that there was comparative scientific data relied on by

the appellant to demonstrate that the compounds with cyclic

substitutions have better activity than compounds with acyclic

substitutions.

5. In respect of the objections raised under section 3(d) of the Act, the

appellant contends that the compounds in the subject invention are not

derivatives of the compounds of the prior art as has been recorded in the

impugned order. The impugned order does not indicate as to how a new

form of a known substance can be derived from a known substance and

also how the known substance does not differ significantly in properties

with regard to efficacy. It is also claimed that the compounds in the

subject invention are novel and are not derivatives of a known substance.

In support of their contentions, the appellant relies on the decision in

Novartis AG vs UOI & Ors, AIR 2013 SC 1311.

6. It is further contended that in view of section 10(4) of the Act, the

appellant has disclosed the best methods for working of the subject

invention. The specifications provided by the appellant enable the

preparation of the compounds and also provide for vitro data as regard to

the activity of the claimed compounds as well as compounds with non-

claimed acyclic substituents which amount to comparative data. It is

further contended that the proposal to delete compounds by the appellant

with non-cyclic substitutions does not amount to self-admission of lack of

inventive steps. Such amendments are permissible under section 59(1) of

the Act by way of disclaimer, correction or explanation. However, the

finding that the appellant failed in amending the description has only

been raised in the impugned order. The amendments carried out by the

appellant were declined by the respondent without providing any reasons.

In support of their contentions, the appellant relies on May & Baker

Limited Vs Boots Pure Drug Co Ltd, (1950) 67 RPC 23 to contend that

amendments may be carried out to an application and such amendments

cannot be considered as admissions. It is also contended that the

respondent authorities have failed to consider the fact that similar patent

applications had been granted in other countries despite having been

compared with the same prior arts.

7. On behalf of the respondent it is contended that the appellant has failed

to demonstrate that the subject invention involves any inventive step or

technical advancement. The compounds in the subject invention are the

same as that of the prior art except for the fact that the position of

bonding of the substituents are different. The amendments carried out by

the appellant also do not demonstrate any enhanced efficacy as

contemplated under section 3(d) of the Act. It is contended that no clinical

comparative study with the prior art compounds were disclosed to the

respondents. The appellant has also failed to demonstrate any change in

the nature of the compound which would have shown "hydrophbicity of

the ring system" and that the appropriate length of the substituents were

changed or were significantly different from compounds in the subject

application in comparison with the prior arts D1 and D2. It is further

contended by respondent that in terms of section 10(4) of the Act the

appellant ought to have disclosed the best method for performing the

invention which is only known to the appellant for which the appellant

claims protection. It was also the duty of the appellant to provide clinical

comparative data which would demonstrate that the said application

compound was more efficacious and inventive than the prior arts. The

respondent also contends that repeated amendments were carried out

resulting in change of the original product. In support of their

contentions, the respondent relies on Nippon A and L Inc vs. Controller of

Patents, 2022 SCC Online Delhi 1909 and Novartis AG vs. UOI & Ors, AIR

2013 SC 1311.

8. Drug development is a lengthy and complex process. Once new classes of

compounds have been found and shown to have some degree of activity a

patent application is filed to secure the priority date following which

further screening is required before a compound ultimately makes its way

to clinical trials. The extent of activity of the said compound being one of

the many factors in this trial process, drug availability profiles, in vitro

toxicity, modelling, acute toxicology studies and in vivo activity are some

of the other major factors taken into consideration. Only upon achieving

satisfactory levels are such compounds marketed after fulfilling the

market regulatory norms. Thus, the proposal to make additions,

alterations or deletions after filing of the subject patent does not amount

to self-admission or acceptance of lack of novelty or inventive steps. Such

amendments are permissible under section 59(1) of the Act whether by

way of disclaimer, correction or explanation. Additionally, disclaimers are

also provided with an object to limit the scope of the invention claimed or

to remove doubts as to the meaning of the specification. This further

reduces the ambit of monopoly renouncing the previous claim in its fullest

scope and limit. Hence, the finding in the impugned order that

amendments carried out by the appellant is proof or admission of lack of

novelty is erroneous.

9. Moreover, the finding that amongst the five prior arts cited, prior art D1 &

D2 are identical and similar to the subject invention is also without basis

and untenable. The unique activities of the subject compound were

demonstrated in Table 1 and 2 wherein a comparative study had been

provided showing that the cyclic substitutions have a better activity than

the compounds with acyclic substitutions. On the basis of the

comparative study, it was alleged that the cyclic substituents demonstrate

an average bacterial score of the compounds against 3 viral antigens Vpu,

HCV p7 and Den M as compared to the non-cyclic substitutions which do

not have any activity against the said antigens. Thus, there was

comparative scientific data relied on by the appellant to show that

compounds with cyclic substitutions have a better activity than

compounds with acyclic substitutions. The impugned order fails to

consider and deal with the comparative studies disclosed and relied on by

the appellant. On the contrary, the Controller has in passing the

impugned order arrived at a finding only on a selective reading of the

subject specification.

10. It has been held in the impugned order that the disclosure made in terms

of section 10(4) of the Act was insufficient. Specifications enable a skilled

person to have access to the knowledge of the best ways for preparation of

the claimed compounds and also provide in vitro data as regards to the

activity of the claimed compound along with its comparative data. Despite

all necessary descriptions having been sufficiently furnished by the

appellant and subsequent amendments being carried out, the impugned

order fails to deal with this aspect of the matter. In order to appreciate the

enhanced efficacy of a claimed compound, the Controller was bound to

take all such amendments into consideration and provide reasons for

rejecting the same. The guidelines to analyse the enhanced efficacy of

chemical and pharmaceutical compounds have been laid down in Novartis

AG vs. UOI & Ors AIR 2013 SC 1311:

87. The amended portion of Section 3(d) clearly sets up a second tier of qualifying standards for chemical substances/pharmaceutical products in order to leave the door open for true and genuine inventions but, at the same time, to check any attempt at repetitive patenting or extension of the patent term on spurious grounds.

168.We have held that the subject product, the beta crystalline form of Imatinib Mesylate, does not qualify the test of Section 3(d) of the Act but that is not to say that Section 3(d) bars patent protection for all incremental inventions of chemical and pharmaceutical substances. It will be a grave mistake to read this judgment to mean that section 3(d) was amended with the intent to undo the fundamental change brought in the patent regime by deletion of section 5 from the Parent Act. That is not said in this judgment.

Accordingly, section 3(d) of the Act does not bar patent protection for all

incremental inventions of chemical and pharmaceutical substances. This

aspect of the matter has also not been dealt with in the impugned order.

11. Moreover, although the appellant's claim has been rejected on the ground

of non patentability under section 3(d) of the Act, the impugned order

does not indicate the known substance or its known efficacy or the new

form of the known substance in arriving at such a conclusion. Section

3(d) of the Act requires the existence of a "known compound" and not

"known compounds". The impugned order does not deal with this aspect

of the matter.

12. Section 8 of the Act mandates that an applicant is to file all necessary

details and undertakings in respect of the same or substantially same

invention pending prosecution in other Patent Office in any other country

outside India. In this context, the Ayyangar Report had recommended as

follows:

"It would be of advantage therefore if the applicant is required to state whether he has made any application for a patent for the same or substantially the same invention as in India in any foreign country or countries, the objections, if any, raised by the Patent Offices of such countries on the ground of want of novelty or unpatentability or otherwise and the amendments directed to be made or actually made to the specification or claims in the foreign country or countries upto the date of acceptance of the application."

13. Thus, every applicant is bound to furnish information relating to

objections raised in such prosecution, both in respect of novelty and

patentability of the subject invention and all other information as and

particulars which may be required by the Controller to adjudicate the said

application. Admittedly, the appellant had complied with the mandate of

the above section and provided all details of all such patent applications

applied for and granted in other jurisdictions. In such circumstances,

although not binding, this aspect of the matter ought to have been

considered before passing of the impugned order (Stempeutics Research

Pvt Ltd vs. Assistant Controller of Patents (OA/3/2017/PT/CHN).

14. For the foregoing reasons, the impugned order dated 17 September 2015

is unsustainable and set aside. The matter is remanded to the respondent