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An ISO 9001:2015 Certified Firm
Three Days Symposium On Pharmaceutical, Biotechnology & Chemical Patent Laws :12-15’th November 2018
PATENT OPPOSITIONS & PROSECUTION : INDIAN PERSPECTIVE - LIFE SCIENCES
Mita Sheikh
OUTLINE
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} Pre-grant Opposition Case Laws } Post-grant Opposition Case Laws} Key Decisions Relied Upon} Key Findings – Strategies for Prosecution &
Oppsitions
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S 25(1) PRE-GRANT OPPOSITION CASE LAWS
SUNESIS V/S IPA
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} SUNESIS PHARMACEUTICALS, INC. of U.S.A. - The Applicant
} INDIAN PHARMACEUTICAL ALLIANCE - The Opponent
} Application No.: 2862/CHENP/2010 dated 14/05/2010 (05/11/2010)
} Opposition Filed on: 02/04/2011
} Hearing Notice Issued: 21/11/2017, S.14, 25(1)
} Hearing Scheduled: 29/12/2017
} Opposition: Not Attended by any party, Applicant – not interested
} Order : Patent appn refused, 08/01/2018, S.25(1), 15
} Controller: DR. ARINDAM CHATTERJEE
} Product covered: Vosaroxin (SNS 595, voreloxin)
} A topoisomerase II inhibitor under phase III clinical trial for acute myelogenous leukemia (AML)
SUNESIS V/S IPA
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} SUMMARY} Claims as filed:1-35 method of treating cancer by administering
} Compd+Cisplatin, or Gemcitabin, or Carboplatin, } Opposition: Cited documents D1-D3 (of D1-D4 cited in ISR publ
30.04.2009, D1-D2-SUNESIS’s own patent applns), anticipation, obviousness
} FER Issued: 24/11/2016 Cited D1-D5} Claims (FER): 1-16, 23-08-2017
} A pharmaceutical composition for treating non-small cell lung cancer or pancreatic cancer in a patient comprising compd+Gemcitabin
} Representation (statement and evidence) 31-10-2017 by IPA} D1-D3, D4 (CS)+Exhibit 1 Decision of 1608/CHENP/2008 (priority
D1) } Additional contention-Section 57 and 59 (non-allowability due to
change in claim scope)+ Anticipation, obviousness, 3(d), 3(e), 3(i),
SUNESIS V/S IPA
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} SUMMARY
} Objections – Hearing:
} Non-Patentability u/s 3,
} Invention u/s 2(1)(j) – No industrial applicability, anticipation
} Unity of Invention u/s 10 (5), Sufficiency u/s 10 (4)
} Key Points:
} Non-Patentability u/s 3 / Formal Requirement(s)
} The scope of amended claims 1-16 (product claims) does not fall wholly within the scope of the original claims 1-35 (method of
treatment claims); and therefore, cannot be allowed under the
provisions of section 59(1) read with section 57 of The Patents
(Amendment) Act 2005. Hence, the claims on record as on date
stand are the original claims 1-35. The subject matter of claims 1-
35 fall within the scope of Section 3(i) of The Patents
(Amendment) Act, 2005.
GENERICS[UK] V/S IPA
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} GENERICS[UK] LIMITED - Applicant} INDIAN PHARMACEUTICAL ALLIANCE - The Opponent} Application No.: 2214/MUMNP/2009 dated 27/11/2009
(18/06/2010)} Opposition Filed on: 11-10-2010} Hearing Notice Issued: 16/05/2017, S.14, 25(1)} Hearing Scheduled: 27/06/2017 (14), 28/11/2017 (25(1))} Opposition: Not Attended by Applicant, withdrawn by Opponent} Order : Patent appn refused, 19/12/2017, 15 } Controller: N.Ramchander} Product covered: Tracleer (Bosentan)
} A dual endothelin receptor antagonist used in the treatment of pulmonary artery hypertension (PAH)
GENERICS[UK] V/S IPA
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} SUMMARY} Claims as filed:1-83 Crystalline form I-IV of bosentan
} Process for prep, composition, Amorphous form, method of treating
} Opposition: Cited documents D1-D13(D13-CS), lack of novelty, inventive step, utility, 3(d), 3(e), 25(1)(g),(h)
} FER Issued: 23/01/2014 Cited D1-D3} Statement U/R 55(4) by Applicant 23/04/2014
} Claim amendments - A process for preparing crystalline form 2 of bosentan,
} FER Response: 07-05-2014} Opponent withdrawn: 20-11-2017
GENERICS[UK] V/S IPA
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} Key Point:} Applicant: Evidence filed by Opponent without affidavit S. 79 hence
should be dismissed} Opponent: Besides novelty, inventive-step objection on industrial
applicability:} No disclosure about surprising/superior physical, chemical or
therapeutic properties or no details how the polymorphic forms/amorphous form and process of preparation as per the invention have industrial utility/applicability as far as yield, purity and cost effectiveness. No comparison with any prior art.
HELEN OF TROY V/S HINDUSTAN UNILEVER
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} HELEN OF TROY LIMITED- APPLICANT
} HINDUSTAN UNILEVER LIMITED-OPPONENT
} Application No.: 7278/DELNP/2007, dated 20/09/2007
} Order Date: 09/02/2018
} Key Poiints:
} Expert Evidence: Regarding expert evidence, (reference drawn from
Hon’ble IPAB decision ORA/1/2007/PT/MUM) that expert should not
be biased. Expert in this case was employee of the opponent.
} Expert’s opinion should not be merely repeating the grounds of
opposition given in the representation.
GRUNENTHAL V/S DR. SUBRAHMANYAM
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} GRUNENTHAL GMBH - Applicant
} DR.G.SUBRAHMANYAM - The Opponent
} Application No.: 7B/KOLNP /2OIO dated O6/O1/2O1O-Divisional of
3453/KOLNP/2006
} Hearing Notice Issued: 29/O5/2OI7, S.14, 25(1)
} Hearing Scheduled: 12/05/2017
} Opposition: Not Attended by Opponent
} Order : Patent appn refused, 07/09/2017,
} Controller: Bhaskar Ghosh
} Product covered: Tapentadol (Nucynta, Palexia and Tapal)
} A centrally acting opioid analgesic
GRUNENTHAL V/S DR. SUBRAHMANYAM
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} Objections –Opposition & Hearing:} 3(d), 3(e), S 16,
} Key Points:} No comparative experimental data for superior therapeutic
efficacy of the claimed crystalline Form A in comparison to other polyrmorphic Forms. Form A is actually mere new form of already known compound. Form A is more stable than Form B, but stability is a physical property of the claimed crystal Form A not the criteria to overcome section 3(d).
} 3(e): In absence of any surprising or synergistic effect of the claimed composition, it is tantamount to a mere admixture of a known compound and a know additive/auxiliary substance.
GRUNENTHAL V/S DR. SUBRAHMANYAM
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} Key Points:} Lacking in unity objection raised in process claims 11-13 of the
mother application, but the Applicant tried this instant divisional application (A2) with claims relate to Crystal Form A, and process for preparation of crystalline Form-A, instead of claims 11-13. No difference between granted claim 2 of mother application and claim 5 of this instant divisional application. From section 16 of the Act I am of the opinion that the said section of the Act has not been dealt in appropriate manner for A2 as it has been filed as a divisional application with the same set of claims as A1 for which no lacking unity objection has been raised.
} The claims 1-6 of the instant application lack novelty and inventive step in view of the prior art documents (not ground of opposition by Opponent).
ASTELLAS V/S THEMIS MEDICARE et al.
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} ASTELLAS PHARMA INC- Applicant
} THEMIS MEDICARE LIMITED - The Opponent 1
} INDIAN PHARMACEUTICALS ALLIANCE - The Opponent 2
} Application No.: 3071/KOLNP/2008 28/07/2008
} Hearing 1: Opponent 1 - 7/05/2017, Oppon 1 did not appear
} Hearing 2: Opponent 2 - 2I/07/20l7, attended by rep of Oppon 2, Applicant – not interested
} Order : Patent appn refused U/S 15 as Applicant did not attend, 29/08/2017,
} Controller: Bhaskar Ghosh considered grounds and submission of Opponerrt 2
} Product covered: Mirabegron (alpha form)
} A drug for the treatment of overactive bladder
ASTELLAS V/S THEMIS MEDICARE et al.
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} Key Points:
} 2(1)(j) Novelty – YES, 2(1)(ja) Inventive Step – NO,
} 3(d) – NO: less hygroscopicity, higher stability per se which is physical property of the claimed alpha-form crystal should not be the criteria for establishing the present section and capable to overcome section 3(d) for the impugned application over the prior art. Hence, the alpha -form crystal (polymorph) as claimed in the presently amended claims has been unable to pass the test of Section 3(d).
} 3(e) in view of the absence of any surprising or synergistic effect of the claimed composition, the present claimed composition is tantamount to a mere admixture of a known compound and a known additive/auxiliary substance. so claim falls within S 3(e).
} Patent application refused U/S 15 as patent agent of Applicant did not attend hearing
ROCHE V/S IPA
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} F.HOFFMANN- LA ROCHE AG, SWITZERLAND - Applicant} INDIAN PHARMACEUTICALS ALLIANCE - The Opponent} Application No.: 961/CHENP/2012 31/01/2012} Hearing : 05/01/2017} Order : Patent appn refused U/S 15 as Applicant did not attend,
29/08/2017, } Controller: Dr. SHARANA GOUDA} Product covered: Trastuzumab (Herceptin), Pertuzumab and T-DM1
} A monoclonal antibody directed against the human epidermal growth factor receptor 2 (HER2). Treatment of breast cancers
ROCHE V/S IPA
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} Key Points:} 2(1)(j) Novelty – YES, 2(1)(j) &2(1)(ja) Inventive Step – NO, } 3(d) – YES: Controller held the claimed formulation is not a new
form of the known substance and agreed to Applicant’s following submissions:} Sec. 3(d) does not apply to all pharmaceutical and chemical
inventions, and in particular does not apply to formulation. Sec. 3(d) was designed to make a higher bar of innovation for patentability of new salts, esters, and other derivatives (second generation compounds) of known substances unless they differ significantly in properties with regard to efficacy, to avoid alterations being made to the FORM of such substances and thus extending market exclusivity of known substances. It is not meant to create a higher bar for formulation by deeming it to fall within the purview of “combination” provided under this Section
ROCHE V/S IPA
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} Key Points:} 3(e) Controller held applicant failed to show the synergistic effect
of the claimed formulation (combination of anti-HER2 antibody and Enzyme i.e. Hyaluronidase) and the results demonstrated only prove the aggregation of the properties of the components thereof. Hence, I am in agreement with the opponent that the claims 1 to 12 are not patentable.
} Patent application refused U/S 15 in view of failure to meet requirements of S 2(1)(j)(ja) and 3(e).
APR et al.V/S AHLUWALIA et al.
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} LABTEC GMBH & -APR APPLIED PHARMA RESEARCH S.A -Applicants
} TARUN PAL SINGH AHLUWALIA-Opponent I & SHILPI MEDICARE LTD-Opponent 2
} Application No.: 625/MUMNP/2009 30/03/2009} Hearings : Separate Hearings 06/02/2017 & 07/02/2017 Applicant did
not attend both} Grounds: 25(1)(b)/(c),(e),(I),(g), } Order : Patent appn refused 19/07/2017} Controller: Dr. Ajay S. Thakur} Key Point: Claims though drawn to a non-mucoadhesive orally
disintegrating film, it is infact a method of treatment by administering such a film and it is for this reason, the pharmacokinetic parameters are stated and set out in the claims. Pharmacokinetic parameters are a natural consequence of the kind of film used in the dosage unit. Hence, claim to pharmacokinetic parameters is not maintainable
FRESENIUS KABI V/S RA CHEM
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} FRESENIUS KABI ONCOLOGY LIMITED - Applicants} RA CHEM PHARMA LTD - Opponent} Application No.: 1196/KOL/2005 29/12/2005} FER : 11/04/2013} Opposition: 18/11/2013} Hearing : 23/04/2016} Order : Patent appn refused 24/03/2017} Controller: Bhaskar Ghosh} Product covered: Skelaxin (Metaxalone)
} Muscle relaxant used to relax muscles and relieve pain
FRESENIUS KABI V/S RA CHEM
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} Kay Points:} So from the teachings of the cited documents and also from other
prior art documents it is well known that Metaxalone and its Polymorphic form I is already known in art. Process for preparation is also obvious with respect to the cited documents because dissolving known drug (Metaxalone) in an organic solvent (which are also known), cooling the solution over a period of time and collecting the crystals of metaxalone is very obvious to person skilled in the art.
} Now I go through last part of the submission of the Opponent submitted after hearing "Use of solvent like ethyl acetate, ethanol, toluene, chlorobenzerae are known in the prior art references and ethyl acetate is the most commonly used solvent for crystallization this product which is mentioned in prior art specifications, such as US3062827, U53446814, US656298O, hence there is an express need to narrow the scope of solvents to specific category.”
FRESENIUS KABI V/S RA CHEM
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} Kay Points:} The argumentation of Opponent regarding the inventive step is not
clear and also not sufficient to establish their view regarding lack of inventiveness of claims. I opine that since the submission of the opponent regarding inventive step of the present invention is not sufficient and also not clear, so according to me the opponents failed to establish this ground properly.
} To pass the test of Section 3(d), the new form of a known substance must demonstrate substantially enhanced therapeutic efficacy in comparison to the known compounds itself i.e. Metaxalone. There is no support in the specification regarding therapeutic efficacy, except data for Bioavailability studies and pharmacokinetic parameters of crystalline Forms (A and B) have been given. The present claimed crystalline Form B is actually new form of known substance (Metaxalone) and the said compound and other polymorphic forms of said compound are also taught by cited documents.
FRESENIUS KABI V/S RA CHEM
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} Kay Points:} I am in the opinion that bioavailability per se which is physical
property of the claimed crystal Form B should not be the criteria for establishing the present section and capable to overcome section
3(d) for the impugned application over the prior art. } Hence, in my opinion, the crystalline Form-B (polymorph) as claimed
in amended claims has been unable to pass the test of Section 3(d).I opine that the opponents have been able to establish this ground
properly.
} From the discussion it is clear that process for preparing
polymorphic Form B is clear and also sufficiently defined. I do not agree with the opponent that the subject matter of the alleged invention is lacking in sufficiency Hence, I opine that the opponents
failed to establish this ground properly.} I hereby accept the representation and refuse grant of a patent.} Controller refused appln based on agreement with 1 out of 3
FRESENIUS KABI V/S RA CHEM
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} Kay Points:} After completion of hearing of pre-grant opposition, application was
re-examined based on the submission and observations given by the applicant with respect to FER.
} From the cited documents of hearing notice it is clear that metaxalone and its crystalline powder form (polymorphic Form I) and its use is already known.
} It is well known in the art that a particular crystalline form of a compound possesses a particular physical property like bio-availability which does not address the inventive step issue and hence, I opine that there is no contribution of the applicant to impose the said property to the claimed substance rather than it is an inherent physical property for the same and applicant has gone through experimentation to assess the same only.
FRESENIUS KABI V/S RA CHEM
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} Kay Points:} Process of preparing crystalline Form B also same with the process
as disclosed in cited document D1. Besides this, dissolving Metaxalone in an organic solvent at a reflux temperature, then cool the said solution and collect the crystal is also obvious to skilled person.
} So amended claims are novel but surely lacking in inventive step.} Crystalline Form-B is nothing but new form of a known substance
(Metaxalone) and no therapeutic efficacy data has been given in the specification, so claims are not allowable under section 3(d) of the Act.
} Applicant filed Review Petition on 24/04/2017.} Main contention being Controller has not provided reasons for
obviousness.
REATA PHARMACEUTICALS V/S IPA
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} REATA PHARMACEUTICALS ,INC. - Applicants} Indian Pharmaceuticals Alliance - Opponent} 3131 /KOLNP/2011 dtd.25/07/2011FER : 11/04/2013} Opposition: 23/03/2013} Hearing : 19/01/2017} Order : Patent appn refused 24/03/2017} Controller: Dr. S. Chattopadhyay} Product covered: Bardoxolone Methyl
} An experimental and orally-bioavailable semi-synthetic triterpenoid, based on the scaffold of the natural product oleanolic acid for the treatment of diabetic chronic kidney disease (CKD).
REATA PHARMACEUTICALS V/S IPA
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} Key Points} Controller held that there is no data establishing the role of HPMC
in improving the bioavailability over the known amorphous form Bhas been provided in the specification and undersigned is unable to figure out any trial of the applicant to establish the technical advancement of the presently claimed formulation over the amorphous form rather it disclosed comparative data regarding crystalline A form of the prior art as furnished in the specification.
} Controller held that combined teachings of prior art to a skilled person are already in knowledge and thus makes the impugned application obvious with regard to prior arts in context to both the initial claims and proposed claims in amended stages.
} I opine that the applicant did not try to prove upon the issue of therapeutic efficacy of the composition as claimed other than bioavailability, in absence of in the form comparative clinical data the application failed to overcome the section 25(f) (section 3(d) and 3 (e)).
ALFA WASSERMANN V/S IPA
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} ALFA WASSERMANN S.P.A. - Applicants
} Indian Pharmaceuticals Alliance - Opponent
} 1865/DEL/2005 18/07/2005 FER 05/02/2014
} Opposition: 10/10/2013
} Hearing : 29/08/2016
} Order : Opposition disposed, appln allowed 01/03/2017
} Controller: N R Meena
} Product covered: Xifaxan (Rifaximin)
} An antibiotic used to treat traveler's diarrhea, irritable bowel syndrome, and hepatic encephalopathy
ALFA WASSERMANN V/S IPA
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} Key Points} The Applicant submitted that the differences in the systemic
absorptions of the α , β, γ , δ, and ε forms of rifaximin are significant, since also at sub-inhibitory conc. of rifaximin, viz.in the range of from 0.1 to 1 µg/ml, the selection of resistant mutants has been demonstrated to occur.
} It has been further stated by the Applicant that it is not a problem of increasing of bioavailability, but to have active ingredient able to provide different bioavailability and by the value of Cmax obtained ,d form is useful to provide a topical effect with an increased systemic effect , lower than the g form , associable to an amorphous form. The e form is a form which provides exclusively a topical effect.
} I considered that the Applicant has been able to convince that the new forms shown some enhanced result over the existing forms and hence I believe that the subject matter of the present invention is new and hence do not fall within the purview of Section 3(d).
RICHTER GEDEON V/S IPA
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} RICHTER GEDEON NYRT OF H-1103 BUDAPEST, GYÖMRÖI ÚT 19-21, HUNGARY. - The Applicant
} INDIAN PHARMACEUTICAL ALLIANCE - The Opponent
} Application No.: 4256/KOLNP/2009 dated 08/12/2009
} Opposition Filed on: 01/10/2010
} Hearing :, S.14, 25(1)
} Hearing Scheduled: 20/10/2016 & 16/05/2017
} Opposition: Attended by both the parties
} Order : Patent appn granted, 08/01/2018, S.25(1), 15
} Controller: Dr. Santosh Kumar Samantaray
} Product covered: Cariprazine} An atypical antipsychotic used in the treatment of schizophrenia
and manic or mixed episodes of bipolar disorder.
RICHTER GEDEON V/S IPA
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} SUMMARY} Claims as filed: 20
} 1-5 :trans compd, 6:process, 7: composition, 11-13: method of Treatment,15-20: crystalline form
} Opposition: Cited documents D1-D10 } FER Issued: 02/02/2015} Claims (FER):
} 1:Specific trans compd, 2-3:process, 4: composition, 5: Specific crystalline form
} Objections/ grounds} Anticipation, obviousness, 3(d), 3(e), 3(i), 8
RICHTER GEDEON V/S IPA
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} SUMMARY} Objections :
} Non-Patentability u/s 3(d) relating to the process claim (only claims retained in the appln)
} Key Points:} The process to prepare the mono hydrochloride salt of cariprazine
is not a mere use of a known process since it results in a new product and therefore is outside the scope of Section 3(d).
SERUM INSTITUTE OF INDIA V/S BHARAT BIOTECH
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} SERUM INSTITUTE OF INDIA APPLICANT
} BHARAT BIOTECH-OPPONENT
} Application No.: 2365/MUM/2008, dated 07/11/2008
} Order Date: 28/03/2018
} Product Covered: ROTASIIL®, the rotavirus vaccine for preventing Rotavirus gastroenteritis
} Claim 1] A lyophilized rotavirus vaccine formulation comprising prior to lyophilization:
a) at least one strain of rotavirus at a concentration from 1x105 pfu/mL to 1000 x 105 pfu/mL;
b) sucrose at a concentration of 5% (w/v); and
c) glycine at a concentration of 5% (w/v).
SERUM INSTITUTE OF INDIA V/S BHARAT BIOTECH
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} Expert’s evidences by:
} Rajiv Dhere et al : Speaks for the unexpected and surprising
discovery
} Ravi Menon: In the affidavit deals with Sub-Saharan Africa
stability issue
} Dr. Prasad Kulkarni: Vaccine is safe and efficacious
} Dr. Sameer Naik: Stable for 36 months at 2-8°C, 36 months at
25°C, 18 months at 37°C, 18 months at 40°C
} Dr. Ashok Hajare: Formulation additives & processing parameters
are critical issues
} Prof. John Carpenter: Achieving high level absolute stability
extremely challenging
} Key Points: Lack of Inventive Step in view of background
} In view of these citations D1-D5 of FER and disclosure in the
background on invention on pg 3 of the specification, it is held that,
a person skilled in the art with knowledge from prior art that
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S 25(2) POST-GRANT OPPOSITION CASE LAWS
NOVARTIS V/S CIPLA
36
} NOVARTIS AG - Patentee
} CIPLA LTD - Opponent
} Patent(Appln No.): 256182(4247/CHENP/2006) 17/11/2006(17/05/2013)
} Opposition Filed on: 19-05-2013
} Reply Statement: 21.07.2014
} Hearing Scheduled: 13/06/2017
} Opposition: Not Attended by Opponent not
} Order : Patent maintained, 29/11/2017 (novel, inventive 2(1)(j), CS – 10(4))
} Controller: Dr.Bindhu Jacob
} Product covered: Utibron Neohaler (Indacaterol and Glycopyrrolate)
} Treatment of COPD
NOVARTIS V/S CIPLA
37
} SUMMARY} Claims as filed:1-19 A medicament comprising
} Glycopyrrolate + compound of formula (I) or (II)} FER Issued: 18/04/2012, 04/10/2012 Cited D1-D6. Response
19/07/2012} Claims (amended thrice): 1-7 A medicament comprising
} Glycopyrrolate + (R)-5-[2-(5,6-diethyl-indan-2-ylamino)-1hydroxyethyl]-8-hydroxy-1H-quinolin-2- one maleate in 5:1 to10:1
} Hearing (14) 18/04/2013} D7 cited against 2(1)(j)} Experimental data not satisfactory, not as per S 79
NOVARTIS V/S CIPLA
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} SECTION 2(1)(j)
} As relied by the Controller differences presented in table seems to be better approach
NOVARTIS V/S CIPLA
39
} SECTION 3(d)} Patentee: There is absolutely no prior art that suggests that this
composition is "known" per se and hence a comparative data evidencing enhanced therapeutic efficacy is impractical, illogical and superfluous.
} Controller : cited the Intellectual Property Appellate Board (IPAB) in their decision 173/2013 “The combination mentioned in the Explanation can only mean a combination of two or more of the derivatives mentioned in the Explanation or combination of one or more of the derivatives with the known substance which may result in a significant difference with regard to the efficacy”(para 19-Pharma guidelines). Accordingly the term “combination” in Section 3(d) indeed does not statutorily prohibit the permissibility of claims directed to a composition per se comprising two active drugs.”
NOVARTIS V/S CIPLA
40
} SECTION 3(d) No due consideration for requirement of enhanced efficacy} Controller held: Glycopyrrolate and indacaterol maleate are
structurally different active ingredients which cannot be considered/treated as derivative to each other. Components present in a particular ratio, hence it cannot be treated as a mere combination. Section 3(d) indeed does not statutorily prohibit the permissibility of claims directed to a composition per se comprising two active drugs.
} SECTION 3(e) No statistical data for significant improvement} Controller considered 4 trials (only 1 mentions reduced frequency
of exacerbations by 15%) and held formulation exhibits surprising and unexpected property.
} SECTION 25 (2) (g)/10(4) No data in CS of any activity} Controller held sufficient disclosure in the granted specification
for performing the alleged invention (examples only of
NOVARTIS V/S CIPLA
41
} SECTION 25 (2) (h) / 8(2)} Controller held inadvertently omitted details do not prejudice and
are not material to, maintain the suit patent.} Key points} If there are no data, experimental study w.r.t. enhanced /synergistic
activity at all, but proved much later, what would be the date of invention for subject matter of 3(d) and 3(e) which must show such activities to be considered as patentable invention.
} In absence of such data/study at least preliminary/indicative, shouldn't CS be considered not compliant with S10(4).
} Cite case laws showing rejection in absence of data showing enhanced /synergistic efficacy.
KEY DECISIONS RELIED UPON
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} Section 3(d): Efficacy
} Novartis AG v. Union of India,
} Hon’ble High Court of Madras was confronted by the Appellant to declare section 3(d) unconstitutional as it was vague and arbitrary.
} However, the Madras High Court rejected the argument of the Appellant and stated that the term ‘efficacy’ as mentioned in section 3(d) “in the field of pharmacology [means] the ability of a drug to produce the desired therapeutic effect” and that “efficacy” is independent of potency of the drug which expresses the amount of the drug necessary to achieve the desired effect.
} The Supreme Court of India upheld the interpretation given by the Madras High Court..
KEY DECISIONS RELIED UPON
43
} Section 3(d): Crystalline Form} IPAB in Fresenius Kabi Oncology vs Glaxo Group dated 27th July,
2013, (In matter of IN221171, Order No. 161 of 2013) } It was argued by Respondent-patentee that the derivative substance
can “sorb much lower amounts of water when exposed to broad range of humidities and can be prepared in a stable crystal form” and that “due to the improved moisture sorption properties of these compounds and increase in stability they exhibit enhanced efficacy”.
} However, the Hon’ble IPAB rejected the argument of the Respondent-patentee and did not allow showing of enhanced efficacy by way of improvement in physical properties.
KEY DECISIONS RELIED UPON
44
} Section 3(d): Substance
} IPAB in Sucampo AG Vs. Torrent Pharmaceuticals Limited & Sun Pharmaceuticals Limited in respect of the Patent No. 224855
} It was held that “Though the word “SUBSTANCE” has a border meaning in common knowledge that include a single compound or a mixture of compounds whether chemically bound or physically bound but the meaning for the word “SUBSTANCE” under the Section 3(d) and 3(e) has to be understood as a single molecule and the word “SUBSTANCE” under the Section 3(e) has to be understood as a composition. With this understanding I conclude that the stabilized composition as granted to the patentee does not fit into the provisions of the Section 3(d) and therefore the granted claims”.
KEY DECISIONS RELIED UPON
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} Section 3(d): Combination} IPAB in Ajanta Vs Allegran} It was held that “the combination mentioned in the Explanation can
be only mean a combination of two or more of the derivatives mentioned in the Explanation or combination of one or more of the derivatives with the known substance which may result in a significant difference with regard to the efficacy. A combination of two active drugs like Brimonidine and Timolol cannot be considered derivatives of each other.”
KEY DECISIONS RELIED UPON
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} Section 2(1)(ja): Common general knowledge } Enercon India Ltd. Vs. AloyWobben., IPAB Order No. 226/2010} “Therefore, it means the information which at the date of the
patent in question is known and accepted without question by those who are engaged in the art or science to which the alleged invention relates. It would also appear that when it is a question of common general knowledge i.e., knowledge available in a country for a long time, which every skilled worker in that field is, expected to know. Then such knowledge would be sufficient to invalidate a patent. Again such knowledge need not even be found in a particular document. In other words a patent application has to be assessed on the basis of not only what will be available from prior documents but also from the common general knowledge on the subject, which may or may not be available in any such document..”
KEY FINDINGS
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} Rejection U/S 10(4) seems to be prevalent after 2(1)(j).} Lack of novelty – easy to prove 3(d)} No consistency in considering formulations and combinations under
scope of 3(d), mostly consider formulation/combination as not falling U/S 3(d)
} Stability considered as physical property and not enough to prove 3(d) efficacy and 3(e) synergism. } Argument in this line helpful
} Bioavailability too is considered as physical property or not capable to prove therapeutic efficacy and hence not considered to overcome 3(d) objection.} Strong arguments with supporting NLP
} Citation suggesting adverse / harmful effect to prove against inventive step
} Multiple challenges with same prior art dealt differently and emphasizing different theories of unpatentability
THANK YOU} Mita Sheikh
} Email: [email protected]: www.iiprd.com, www.khuranaandkhurana.com IIPRD | Khurana & Khurana, Advocates and IP Attorneys
Noida (Delhi) . Pune . Mumbai . Bangalore . Indore . Hyderabad} US . Myanmar . Vietnam . Bangladesh . Nepal
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