pharma patent law and recent trends - india
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Pharma Patent Law and Recent Trends - India / A presentation by Dr. Kalyan C Kankanala and Mr. Vikram Pratap Singh ThakurTRANSCRIPT
Pharma Patent Law & Recent Trends - India
Dr. Kalyan C. Kankanala Vikram Pratap Singh Thakur
© 2011 BananaIP
Patent Law EvolutionPatent Act
First Patent legislation - Act VI of 1856 Patent Act, 1970 (brought into force w.e.f. 20th April, 1972)
Patents (Amendment) Act, 1999 Patents (Amendment) Act, 2002 Patents (Amendment) Act, 2005
Patent Rules Patents Rules, 1972 (brought into force w.e.f. 20th April, 1972)
Patents (Amendment) Rules, 2005 Patents (Amendment) Rules, 2006
Patent Manual Draft Patent Manual 2010
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A few important changes
From 1.1.1995 Mail-Box for pharmaceutical and agrochemicals
products Exclusive Marketing Rights
From 1.1.2000 Patent term increased to 20 years Definition of invention – inclusion of inventive
step Right of patentee (importation also included)
From 1.1.2005 Product patents for food, chemical and
pharmaceutical
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Patentability Requirements
Subject matter
Industrial applicability
Novelty
Inventive step
Specification
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Subject MatterPatentable Subject Matter
Product or process
Non Patentable subject matter 3 (d)
New form Efficacy
New property or new use Mere use of a known process
New product New reactant
Explanation- salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance. efficacy
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Novartis case 3(d)Imatinib Masylatebeta crystal form of Imatinib Masylate, which is non-needle shaped, having better flow properties, thus better processible, less hygroscopic and more thermodynamically stable, thus better storable than its needle shaped, alpha crystal form,
Pre grant opposition
Increased efficacy (therapeutic effect in healing a disease)
Challenged constitutional validity of sec. 3(d) Not vague, ambiguous and arbitrary Section along with explanation – clear and has inbuilt measures to
guide controller
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Non Patentable subject matter 3 (e) Mere admixture
Aggregation of properties Synergistic effect
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Industrial Applicabilitycapable of industrial application
Test Make Repeat Use
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NoveltyAnticipation:Public knowledge or public use
Exemption - Secret usePrior publication
Wrongful obtainment Govt. Learned society
Grace periodOn sale
Reasonable trialPublic display
Central govt. notified exhibition Grace period
Public working Reasonable trial
Grace period
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Inventive StepTechnical advance as compared to the existing knowledge ; or having economic significance; or both
not obvious to a person skilled in the art
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Hoffmann-La Roche v. Cipla
Human epidermal growth factor type 1 / epidermal growth factor receptor (Her/Egfr) inhibitor popularly known as Erlotinib
Clarified the concept of inventive step
Test of obviousness– whether in light of prior art, it was possible for a normal but unimaginative person skilled in the art to discern the inventive step of the invention on the basis of general common knowledge of the art at the priority date.Whether the differences between the prior art would, without knowledge of the alleged invention, constitute steps which could have been obvious to the skilled man or whether they required any degree of invention
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SpecificationWritten DescriptionEnablementBest modeClaims
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Controller DecisionNovartis patent IN212199 claiming single-pill combination of aliskiren and valsartan marketed as Valturna rejected
Post grant opposition by Sun pharma lack of inventive step, insufficient disclosure, not an
invention and non-patentable under the Act
Claims amendedNone of examples exemplified the compositions of amended claims.
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Filing
Publication
18 months
FER
Putting app in order for grant
6 months
12 months
Request for Examination
48 months
6 months
Patent Process
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OppositionPre grant
Post grant
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CaseBayer’s IN/PCT/2002/410/CHE claiming contraceptive formulation of drospirenone and ethinylestradiol (EE) marketed as Yasmin and Yaz/Yasminelle in Europe and the US refusedOpposed by cipla and natcoThe decision was more or less influenced by the District Court and the CAFC decisions in Bayer Schering Pharma AG v. Barr Laboratories, Inc. which held US6787531 obvious and invalid.Equivalent of ‘531 patent“obvious-to-try” test
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InfringementLiteral infringement
Infringement by equivalence Substantial equivalence test
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Infringement examplesLallubhai Cakubhai Jariwala v. Chimanlal Chunilal Process of treating dry fruits
Sulphuric acid – washing soda 3% bleaching solution – 4 and 2 % bleaching solution Acetic acid – Muriatic acid Sulphur dioxide fumes under presssure – sulphur
dioxide fumes without pressure
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DefensesPatent invalidGovt. useResearch exemptionParallel imports
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Compulsory LicensingSection 84Application for compulsory license
(a) that the reasonable requirements of the public not been satisfied, or
(b) that the patented invention is not available to the public at a
reasonably affordable price, or (c) that the patented invention is not worked in the
territory of India.
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Compulsory license for export Country having Insufficient or no manufacturing
capacity in pharma sector to address public health problem
Such Country Granted compulsory Allowed importation
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Recent Trends
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Prosecution HistoryTraditionally this communication was treated by the patent office as confidential
Complete Specifications of only granted patents were available
As per notification of April 15, 2010; patent office to supply upon request all correspondence between the applicant and patent office
Helpful for pre grant opposition
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Prosecution History Estoppel (PHE)Well accepted principle internationally
No case supporting the principle in India
Making available the entire prosecution history on request may lead towards PHE
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Speaking OrderPatent application for a molecule used in the treatment of diabetes
First Examination Report “…The molecule lacks novelty and inventive step
because it forms part of a publication in a text that discloses a herbal extract for diabetes treatment.”
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Applicant responds by giving a detailed explanation of differences between the extract disclosed in the text and the molecule. Applicant further states that a hearing must be given before making an adverse decision.Second Examination Report-
“…The molecule lacks novelty and inventive step because it forms part of a publication in a text that discloses a herbal extract for diabetes treatment.”
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First Examination Report “…The molecule lacks novelty and inventive step
because it forms part of a publication in a text that discloses a herbal extract for diabetes treatment.”
Second Examination Report- “…The molecule lacks novelty and inventive step
because it forms part of a publication in a text that discloses a herbal extract for diabetes treatment.”
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Not a speaking Order
Hearing must be given- adherence to principles of natural justiceMagical Sentence- “Kindly provide hearing in case of adverse decision on the application.”Valencia CTT v. Union of India (decided on 26th Feb 2010)
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Abandonment v. RefusalAbandonment
Application considered abandoned if all requirements not complied with
Cannot be appealedRefusal
General power of the Controller to Refuse Can be appealed
Patent Office Practice- Application abandoned whether reply to examination
report filed or not.
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Ericsson v. UOI (Decided on March 11, 2010)29th July 2005- Ericsson filed national phase patent application8th October 2007- First Examination report issued and defects pointed out which was replied on 10th Dec. 200725th July 2008- Another examination report sent by controller restating points already mentioned in first information report. Replied on 22nd Sept 200810th October 2008- Patent office wrote a letter to the petitioner stating that despite response of the petitioner on 22nd September 2008, the specification of the petitioner was still defective on various grounds and the application was deemed to be abandoned under section 21(1).
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Delhi High Court Held:Abandonment-
When reply to examination report is not filed at all.
Refusal-If reply is filed then the application cannot be
abandoned and has to be refused.
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Patent Law and LinkageBayer Corporation v. Union of India
Decided on 9th Feb 2010
CIPLA filed for a drug license for the generic drug ‘Soranib’.Bayer corporation sent a letter to the drug controller requesting him not to grant approval as Bayer holds a patent on ‘Sorafenib Tosylate’ and Soranib is a substitute of their patented drug.Drug Controller granted the drug license.
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Bayer filed a petition in the Delhi High Court against the approval granted by the Drug Controller.Bayer’s contention- If drug controller had previous knowledge of potential patent violation he should not grant approval.Decision- Drug Controller doesn’t have to travel beyond the scope of Drugs & Cosmetics Act and rules. Shouldn’t refuse license on the pretext of possible violation of a patent.
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2010 Patent draft manual released
Scientific advisors
Application status search available
TKDL involved in rejection and withdrawal of patent application
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Thank You
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