Category Archives: Patent Opposition

Post-grant opposition and revocation proceedings under Indian Patent Act: what is better?

Patent Act, 1970 provides opposition/ revocation mechanisms to make sure that undeserving Patents are not granted in contravention of the provisions of the Act and if they are granted, they can be opposed/ revoked. Grant of patent can be opposed before as well as after grant of patent. Relevant sections for different mechanisms, locus standi, jurisdictions where they can be entertained, timelines within which they can be opted, and the grounds on which they can be based have been summarized in the below table:

Point of Comparison Pre-grant opposition Post-grant opposition Revocation
Section 25 (1) 25 (2) 64
Locus Standi Any person Person  Interested Person  Interested, Central Government or alleged infringer in a counter-claim
Jurisdiction Patent Office Patent Office Intellectual Property Appellate Board (IPAB) and High Court
Timelines Any time after publication of the application till the grant of the patent At any time after the grant of patent but before the expiry of a period of one year from the date of publication of grant of a patent Any time after grant of the patent
Grounds Limited  to those provided by section 25 (1) Limited  to those provided by section 25 (2) Not limited to the grounds provided by  Section 64

When we carefully analyse the mechanisms, it is evident that post-grant opposition gets stricter than pre-grant. However, down the time after grant, story again changes wherein in revocation, locus standi is also provided to central government, timeline for revocation is not restricted to 1 year after publication of grant and also the words ‘but on no other ground’ which appear in 25 (1) and 25 (2), do not appear in section 64. Absence of these words can be construed to mean section 64 does not require person to stick to the grounds provided by section 64 like section 25 (1) and section 25 (2) do.

Further observation also indicates that standard of obviousness required to oppose the patent during post-grant opposition is higher than that required during revocation.

Section 25 (2) (e) and section 64 (f) has been reproduced below:

Section 25 (2) (e): that the invention so far as claimed in any claim of the complete specification is obvious and clearly does not involve any inventive step, having regard to the matter published as mentioned in clause (b) or having regard to what was used in India before the priority date of the claim;

section 64 (f)

that the invention so far as claimed in any claim of the complete specification is obvious or does not involve any inventive step, having regard to what was publicly known or publicly used in India or what was published in India or elsewhere before the priority date of the claim:

It can be seen that section 64(f) unlike section 25 (2) (e) does not require invention to be clearly not involving any inventive step. Interestingly section 64 not only allows other grounds than those provided by section 64 to be used in the revocation, it also provides more/ additional grounds than those provided by section 25 (2).

While it is clear that revocation at high court cannot be chosen unless patentee has asserted patent infringement, revocation at IPAB can be chosen any time after grant and even when patentee has not asserted infringement. Patent revocation cannot be sought once proceedings for patent opposition under section 25 (2) have been initiated and are pending. Therefore, one has to clearly think of the advantages revocation proceedings provide over post-grant proceedings.

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Revocation of Valganciclovir patent by Controller of Patents, Chennai

Recently in a matter remanded from IPAB to Controller of Patents, Chennai, a decision of revoking Roche’s patent IN207232 for Valganciclovir was delivered after hearing both the parties. The subject patent was granted on January, 2009 followed which post grant oppositions were separately filed by CIPLA, Matrix, Ranbaxy and Bakul Pharma along with two NGOs Delhi Network of Positive People and lndian Network for People living with HIV/AIDS & The Tamil Nadu Networking People with HIV/AIDS (hereinafter INP+ and TNNP+), wherein INP+ and TNNP+ were allowed by the Apex court to raise all contentions in the form of an intervention cum affidavit before the Assistant Controller and the parties agreed to be heard along with CIPLA, Matrix, Ranbaxy and Bakul Pharma. In the opposition proceedings, the patent was revoked limiting it to single process claim by the Controller of Patents on 30.04.2010 and being aggrieved by this decision, Roche filed an appeal at IPAB challenging the decision. IPAB on 30.01.2014 set aside the Patent Controller’s decision to revoke the patent on technical grounds and remanded it to the Controller for re-consideration.

Issues before the controller:

  • Determining whether the expert evidence was prior art publication or disclosure

Answering the issue, controller observes that the expert evidence is not a prior art document to be relied upon for deciding a case, but it may be considered for understanding the prior art documents, if the evidence covers such prior art documents. The opinion of the expert evidence, if it is based on further laboratory or animal study of a given subject matter, it cannot be considered for concluding such invention because it is later acquired knowledge, but it can be used for understanding the present invention. Therefore, expert evidences cannot be considered as prior publications/disclosures, but it can be taken as opinion on the prior arts.

  • Deciding upon the obviousness of the present invention

The next issue which the controller addressed was whether the present invention was obvious with respect to prior art references. The controller observes that the present invention is obvious against two prior arts US 4957924 and EP 0375329A2.

Claim 1 of the present invention recites,

  1. The compound 2-{2-amino-1, 6-dihydro-6-oxo-purin-9-yl} methoxy-3-hydroxy-1-propanyl-L-valinate or a pharmaceutically acceptable salt thereof, in the form of its (R) or (S)- diastereomers, on in the form of mixtures of the two diastereomers.

Regarding this , the controller states that the monovaline ester of ganciclovir is disclosed in the form of Markush formula in EP ‘329, which covers both monovaline and di-valine ester of ganciclovir where support for the both mono and di-valine ester of gancicloviris is provided in the specification. Thus the disclosure of EP ‘329 is clear and unmistakable direction to the mono valine ester of ganciclovir. Hence, a skilled person working in the synthetic chemistry field can easily arrive at the present invention without further experimentation. Therefore mono valine ester of present invention is anticipated by EP’329. Controller further emphasizes that claim 1 of EP ‘329 clearly and unambiguously discloses as at least one of the substituents is valine residue which indicate the presence of mono valine ester. Therefore, EP’329 undoubtedly disclosed mono valine ester of ganciclovir.

With respect to process claim, controller observes that the synthetic method for preparing mono valine ester of ganciclovir as claimed in independent claim 12 of present invention may not be explicitly disclosed in EP ‘329, but said method is just a general method for coupling acid group in the amino acid with hydroxyl group, which can be adopted for any type of alcohols. Therefore, using EP’329, a person working in the synthetic chemistry can easily prepare ester of ganciclovir with lysine without undue burden.

Further the controller observes that the object of the present invention is to provide a prodrug of ganciclovir with improved oral bioavailability. Controller notes that the solution for poor absorption in the gastrointestinal tract for acyclovir is disclosed in US ‘924 patent. Therefore a person skilled in the art can perceive to prepare mono valine ester of ganciclovir from the teachings of both EP’329 and US’924 references. Thus all the claims including process claim are obvious to a skilled person in the art.

  • Deciding upon the efficacy of substance under the subject patent under section 3 (d)

Deciding upon the efficacy of substance under the subject patent, the Controller observes that the new form L-monovaline ester of ganciclovir molecule has shown improvement in oral bioavailability than bis-valine ester of ganciclovir and ganciclovir, whereas there is no support in the specification pertaining to efficacy. Controller observes that the ester modification of the present invention was made to protect the substance from destruction in the gastrointestinal tract and make the molecule more bioavailable. Thus the controller has ruled that while bioavailability is one of the factors affecting efficacy, it cannot be directly equated to efficacy. Citing Hon’ble Supreme Court of India’s decision on Novartis case, the Controller rules that: “lmprovement in bioavailability of the new form cannot be considered directly related to efficacy. Even any unforeseen property observed in new form, unless such property directly relate to efficacy, it will be considered as inherent property of such substance. Since there is no direct relation shown for the improved bioavailability of new form of ganciclovir in the description with regard to significant difference in the efficacy, and therefore such a new form shall be considered as a same substance. Thus new form of the present case Monovaline ester of ganciclovir is considered as a same substance i.e. ganciclovir because,the difference in enhanced efficacy is not shown in the complete specification.” According to the controller, since there is no direct relation shown for the improved bioavailability of new form of ganciclovir in the description with regard to significant difference in the efficacy, therefore such a new form shall be considered as a same substance. Further regarding process used for preparing present invention, the controller held that the process used to prepare new form is a conventional process as it is already known process as disclosed in EP ‘329. Thus, the Controller rules that the present patent was a ‘mere use of a known process’ which was not patentable under S. 3(d), Patents Act.

  • Locus standi of the two NGOs as “person interested” under section 2(1)(t)

Deciding the locus standi of the two NGOs, as person interested under section 2 (1)(t) of patent act, Controller notes that NGOs would fall under the ambit of persons interested as the criteria of locus standi in post grant opposition is to be viewed in broader perspective to grant quality patent. According to the Controller, the two NGOs are the end users or directly affecting parties, if the patent is granted. Thus it is held by the controller that viewing in to the broader prospective, the two NGOs falls under the purview of under section 2 (1)(t) of the patent act and hence the parties have locus standi to oppose the patent.

Thus hearing all the parties and considering all facts and relevant arguments, the Controller revoked the patent granted for the drug Valganciclovir under section 25(4) of Indian Patent act.

About the Author: Mr. Sitanshu Singh, Patent Associate at Khurana & Khurana, Advocates and IP Attorneys and can be reached at: sitanshu@khuranaandkhurana.com.

Section 3(D) of Indian Patent Act Strikes Again

India revoked yet another drug patent granted to a German MNC, Boehringer Ingelheim, for its respiratory drug, Spiriva (crystalline tiotropium bromide monohydrate) at a time when the US is putting pressure on Indian government for not providing adequate patent protection to multinational drug companies. In its decision, the patent office held that Boehringer failed to establish any technical advancement or any economic significance for the compound, and the monohydrate crystal form also fails to demonstrate any new therapeutic efficacy and therefore cannot fulfill the requirement of a patentable invention under Section 3(d) of the Patents Act.

Facts and highlights of the case:

  • Boehringer Ingelheim filed a patent application (558/DELNP/2003) for crystalline tiotropium bromide monohydrate in Patent Office, Delhi on 16th April, 2003.
  • A pre-grant opposition was filed by Intermed Labs Pvt. Limited on 05th November, 2007 against the grant of this patent application. The said pre-grant opposition was heard by the then Learned Controller Mr. S.K.Roy. However, the application was recommended for Grant of the Patent on 21st December, 2012 and was allotted the Patent No. IN254813.
  • CIPLA filed a post-grant opposition to Boehringer’s patent, claiming the drug was ‘obvious’, and the crystalline tiotropium bromide monohydrate did not demonstrate any significant change in ‘therapeutic efficacy’.
  • Indian Patent office issued an order on March 2015 to revoke the Boehringer’s patent (IN 254813) covering crystalline tiotropium bromide monohydrate.

This is considered as a landmark case as the patent was revoked after it was granted, with much scrutiny and examination, and after the pre-grant opposition had been dismissed a few years back.

Tiotropium bromide, being a pre-1995 molecule, was not patented in India as the Indian patent law did not provide patent protection for “products” till 1995. However, Boehringer filed a patent application for the crystalline tiotropium bromide monohydrate on the grounds that the monohydrate form is stable under rigorous manufacturing condition and post manufacture, and this specific form exhibits stable particle size distribution make it effective as an inhalable drug.

Cipla had filed an post-grant opposition to Boehringer’s patent in 2013, claiming the drug was ‘obvious’, and the monohydrate crystal form of tiotropium bromide did not demonstrate any significant change in ‘therapeutic efficacy’ as required under Section 3(d) of the Patents Act.

In its decision, the Patent office ordered,

            “The physical stability of the compound during formulation cannot be considered as a sole factor for improvement of therapeutic efficacy of the drug under as required under section 3 (d) of the Indian Patent Act, adding the compound is “a product of mere trial and error” and does not “involve any inventive skill”.

            “The data as submitted by the applicant relating to stability test provided in the reply statement fails to prove clearly the superior properties of the Monohydrate form in comparison with the prior art form, as stability does not have any relation with the therapeutic efficacy”, Assistant controller Ajay Thakur said.

            “In the present case, I would say that the Patentee achieved lowering of crystal growth of the active during the micronization process and such reduced particle size is effective to penetrate the lungs. But this cannot be considered to translate or exhibit enhanced therapeutic activity over the known substance “, Assistant controller Ajay Thakur said.

The Assistant controller further added that,

            “Grant of a patent in other countries cannot be cited as a proof of inventiveness, the fact as clear from the Chinese prosecution, where the Supreme People’s Court of People’s Republic of China upheld the invalidity of Boehringer’s crystalline tiotropium bromide monohydrate patent application reasoning that it lacked ‘unexpected technical effects’ and hence was not ‘creative'”.

Cipla (an Indian Pharma major) has been marketing the generic version of tiotropium bromide monohydrate under the brand name “Tiova” since 2003. The revocation of the patent paves the way for the Indian firm to continue selling its generic version in the Indian market.

Boehringer Ingelheim has a three month window to appeal to the Intellectual Property Appellate Board to seek a review on the order issued by the patent office.

The Section 3(d) was incorporated in the amended Patent Act with the objective of blocking the pharmaceutical companies’ attempt to claim patent right for incremental innovation involving new forms of a known molecule with no significantly enhanced efficacy. MNCs have been constantly trying to circumvent this provision ever since the Patent Act was amended in 2005. In view of the Public interest, the Indian government does not want pharmaceutical companies to unjustifiably profiteer from pharmaceutical substances that involve only incremental innovation.

About the Author: Antony David, Senior Patent Associate at Khurana & Khurana, Advocates and IP Attorneys and can be reached at: antony@khuranaandkhurana.com

Revocation Application/ Proceeding Summary: Improved Diffuser for an Air Conditioning System

Applicant in this case is M/s Air Master Equipments India (P) Ltd and Respondents are:

  1. Mr. Ramesh Nana Mhatre, who is the inventor and Applicant of the granted patent application being discussed, and
  2. Controller of Patents who granted the patent post examination and prosecution. Title of the application is ‘An improved Centre Core, Intermediate Core and an outer frame for a diffuser for use in central air conditioning system and an improved diffuser incorporating them and the method of manufacturing the same’ and case number is TRA/1/2008/PT/CH. The order number of case being discussed is NO 75/2011

 To brief a bit on the understanding the subject matter, in a central air conditioning system, air that is conditioned to a desired temperature at one source is distributed to various places through a network of ducts, and a diffuser is required at every outlet of the duct. Generally, these ducts are of square or rectangular cross section, most probably due to their easy self-resting and properly adjusting nature in corners of the ceiling in the buildings and vehicles, and therefore the diffuser used at the outlet of an air distribution duct is also of square or rectangular shape. The diffuser fitted at the end of the air distribution duct projects/exposes out from the ceiling of a room or any other space required to be air conditioned, and therefore plays a part in interior decoration or overall look of the room/space. Respondent, through his invention, therefore wishes to solve following drawbacks in existing diffusers:

  1. Sometimes, the side sections of each core and outer frame are welded together at corners to avoid gaps, or corner sections, after fixing into the grooved channel sections on the back of two adjacent side sections, are crimped for assembly. The cores are inter-connected through connecting strips that are welded to the collars of each core. The welding and crimping operations require extra equipment as well as these operations are very time consuming thereby increasing the cost of production.
  2. Due to the grooved channel sections at the back side of each side section and corner sections used for the assembly or cores, the weight of the diffuser is increased which also increases the cost of production.
  3. To avoid gaps at the corners of the core(s), the side sections of the cores are produced with high precision, which increases the cost.
  4. On assembly some times there remains a gap between two side sections, at the corners of the core(s), due to which diffusers are rejected, resulting into a big loss of production i.e. material and labour and which further increases the cost of production.
  5. When a diffuser is attached to a duct and conditioned air is blown through the duct, it is noticed that the air is not diffused equally to all sides at the corner sections as the grooved channel sections or ridges at the back surfaces of the cores come in the path of air and disturb the equal and proper diffusion of air in all directions. The enclosed collars of the centre core and intermediate core(s) rebounds the air, thereby reducing the flow or air through corners of the diffuser.
  6. As the diffuser is manufactured in several pieces, which are assembled, manufacturing process is cumbersome, time consuming and labour oriented and increases the cost of production.
  7. Due to the grooved channel sections and corner sections or ridges and welding spots on the back surface of the core(s), dust is accumulated therein, which is difficult to clean.
  8. Dust is also accumulated in gaps at corners on the front surfaces of the cores, which gives a dirty look to the diffuser and tarnish interior decoration look of the room/space.

 A main object of this invention is therefore to obviate the above mentioned drawbacks of the existing diffusers and to provide an improved diffuser for central air conditioning system, wherein each of the central core and/or the intermediate core(s) and/or the outer frame are manufactured in a single piece and both the outer as well as inner surfaces of the cores and/or the outer frame are smooth without any extra section, projection or groove which dispenses with the requirement of extra material, and the time taken for assembly is also very much reduced and at the same time there is no obstacle in the flow path of air, which is diffused equally in all the directions. As the cores are manufactured in a single piece, there is no question of any gap at the corners thus no chance of rejection of the product and no need of any welding and crimping operations and hence the cost of production of the diffuser will obviously be very less.

 Respondent No. 2 (Controller of Patents) was satisfied that the invention was patentable and accordingly the patent was granted vide No. 181821 on 18th Jan, 1995. On 25th August 2006 the Respondent No. 1 sent a legal notice to the Applicant, wherein according to this notice, the Applicant was inter alia informed of the patent in favour of the Respondent and that the Applicant was not entitled to manufacture or sell air diffusers identical to the patented product or substantially similar to it. The Applicant sent a lawyer’s reply dated 13-9-2006 alleging that  the patented product was known in the market, it was neither new nor novel, and that there is concealment of material facts and that the patent was obtained by fraud. It was also alleged that the Respondent was nothing but a job-worker.

 After this exchange of correspondence, the Applicant filed O.P. 704 of 2006 before the Hon’ble Madras High Court for revocation of the patent. This was transferred to IPAB. Counter statement was filed and both sides also filed the evidence to support their case.  Applicant submitted that there was no novelty in the invention and it was obvious and also submitted that the main feature of the invention even according to the Respondent was that it was a single piece centre core to facilitate clean flow of air. He submitted that diffusers have been known for long and there was evidence to show that there was prior art where the single piece units were known. He referred to Series 5700 louvre face ceiling diffusers. From the paper book, he pointed out that there is specific reference to one piece stamped steel construction and that this prior art was also meant to provide an economic solution to air distribution problems requiring equal throw in all directions. According to him, this anticipated the patented product. Further, he submitted that if the only difference is the manner in which the inner assembly can be removed, that hardly qualifies for the grant of a patent.  He then referred to another prior art.  Series 5800 and 5800A louver face Directional Diffusers. He submitted that this too indicated provision of equal throw, quick release of inner assembly for immediate access and ease of installation. According to him, the fact that the prior art was used for ceiling air–conditioners while the patent product was for central air-conditioner will not make it non-obvious.  He also referred to Titus and Trox catalogues, without bearing any dates. On being asked to provide the dates of these documents, he was unable to give any acceptable evidence. Therefore, only two prior arts were provided by the applicant.

 Respondent (Patentee) on the other hand submitted that till 1995 there was no prior art that anticipated the claimed subject matter. All the single piece units were extruded aluminium, which meant that metal sheets were cut and joined. The patented product was, on the other hand, made as a single unit from a special die in a metal press.

 Respondent also produced, before the IPAB board, samples of the prior art and the patented product and submitted that it was wrong to call the Respondent a job worker and that he had won many awards and recognition of his expertise. He submitted that the patented product was supplied by the Respondent to persons in the same business not only in India but abroad too. He submitted that while the prior art shows joints, corners and gaps, the patented product is one smooth surface with no gaps or joints. Also, in the prior art, the assembly is detached by turning clockwise, whereas in the patent product, it is held by spring and is removed by applying pressure. He also submitted that in the prior art, there is a buttoned hole in the centre cone, while the patented product has an outwardly and downwardly directed slanting surface with neither a button nor hole. He submitted that the prior art has uneven surface and crimping and that the air is distributed by rebound, whereas in the patented product, there are no hindrances to the flow of air. The patented product has clear slots while the prior art does not. He further submitted that the prior art is limited to 2 or 3 cone inner assembly, whereas the patented product can have multiple cores depending on the requirement. The Respondent further pointed out to the tabular column in the Respondent’s counter statement where each and every distinguishing feature of the patented product is explained and submitted that the prior art does not teach the invention and that the patented produce is new and non-obvious.  He also submitted that, in addition to the counter statement, the Respondent has marked in evidence the affidavit of one Mr. Pankaj Dharker of impeccable credentials who has affirmed that the product is an invention. He submitted that there is no proof of wrongful use or suppression of information and therefore the Applicant can not raise these grounds without proof. As regards prior publication, the Respondent submitted that there should be material to show that it was published. Respondent further submitted that as regards the ETL report, no reliance can be placed on it without an affidavit to file it as evidence, and in any event, it only refers to diffusers constructed of extruded aluminium, which can not be prior art as far as this product is concerned.

 Submissions were heard and the matter was examined by Hon’ble Justice Prabha Sridevan, wherein it was concluded that the Respondent was most certainly not a job worker and that the evidence filed by the Respondent shows the number of awards and recognition of his merit that he has received from various people including the Government. It was further held that the Applicant also did not seriously urge that stand and that the applicant had not filed any evidence apart from the two prior arts to support its case. It was further stated that the Respondent, on the other hand, had filed a very important piece of evidence that was the affidavit of the expert in the field and spoke of the disadvantages that existed in the diffusers prior to 1995. Evidence of Pankaj Dharker showed that in the existing art, because of the corner sections and the grooved channels, flow of the air was obstructed and that there was a reduction of airflow because in the prior art air rebounded. It was also appreciated that the assembly of various parts was a costly process and that the prior art required joining of the various parts and if this was not done with a high degree of accuracy, there was likely to be higher rate of rejection. Furthermore, it was noted that the prior art designs were aesthetically inferior and that the accumulation of dust was high. His affidavit showed the prior art and the patented product in comparison, both with photographs and with explanatory notes. From the affidavit of the respondent and the supporting evidence, it was concluded that the prior art series 5700 and 5800 did not teach the patented product, and that the claimed subject matter was a new invention that served the object of the invention and also avoided the existing drawbacks of the prior art. 5700 and 5800 are the same except for the fact that 5700 has a 2 cone assembly, while 5800 has a 3 cone assembly. The TROX and the Titus catalogues were not considered since there was no date and It was not know if they are prior to the patented product, but the expert dealt with even those products and has given the opinion that they do not teach this invention. A test for obviousness was applied and it was concluded that the invention was non-obvious. In view of the reasons stated above, it was confirmed that the invention was novel and non-obvious and the revocation application was dismissed.

About the Author: Mr Ankur Sehgal, Patent Associate at Khurana and Khurana, Advocates and IP Attorneys and can be reached at: ankur@khuranaandkhurana.com