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CHENNAI3rd Floor, ‘Creative Enclave’,
148-150, Luz Church Road,Mylapore,
Chennai - 600 004.Tel: +91 - 44 - 2498 4821
BANGALORE Suite 920, Level 9,
Raheja Towers,26-27, M G Road,
Bangalore - 560 001.Tel: +91 - 80 - 6546 2400
COIMBATOREBB1, Park Avenue,
# 48, Race Course Road,Coimbatore - 641018.
Tel: +91 - 422 – 6552921
WEBSITE
www.altacit.com
POLYMORPH PATENTS
P.ILANANGAIIP CONSULTANT
PATENT DEPARTMENT
CHENNAI3rd Floor, ‘Creative Enclave’,
148-150, Luz Church Road,Mylapore,
Chennai - 600 004.Tel: +91 - 44 - 2498 4821
BANGALORE Suite 920, Level 9,
Raheja Towers,26-27, M G Road,
Bangalore - 560 001.Tel: +91 - 80 - 6546 2400
COIMBATOREBB1, Park Avenue,
# 48, Race Course Road,Coimbatore - 641018.
Tel: +91 - 422 – 6552921
WEBSITE
www.altacit.com
POLYMORPH
• Polymorph is the ability of a solid material to exist in more than one form or crystal structure. When a drug substance exists in polymorphic forms, it is said to exhibit polymorphism.
• Polymorphism can potentially be found in any crystalline material including polymers, minerals, and metals.
• Polymorph is a natural property: polymorphs are not ‘created’ or ‘invented’; they are discovered normally as part of routine experimentation related to drug formulation.
CHENNAI3rd Floor, ‘Creative Enclave’,
148-150, Luz Church Road,Mylapore,
Chennai - 600 004.Tel: +91 - 44 - 2498 4821
BANGALORE Suite 920, Level 9,
Raheja Towers,26-27, M G Road,
Bangalore - 560 001.Tel: +91 - 80 - 6546 2400
COIMBATOREBB1, Park Avenue,
# 48, Race Course Road,Coimbatore - 641018.
Tel: +91 - 422 – 6552921
WEBSITE
www.altacit.com
• The pharmaceutical sector is a major user of the Patent system. While only a small number of new chemical entities are approved annually, thousands of patents are applied for to protect variants of existing products, processes of manufacture or, where admitted, second indications of known pharmaceutical products.
• With rapid improvements in technology and drug development, keeping up to date with the latest pharmaceutical research and best practice approaches is an essential part of improving drug efficacy, safety and quality.
CHENNAI3rd Floor, ‘Creative Enclave’,
148-150, Luz Church Road,Mylapore,
Chennai - 600 004.Tel: +91 - 44 - 2498 4821
BANGALORE Suite 920, Level 9,
Raheja Towers,26-27, M G Road,
Bangalore - 560 001.Tel: +91 - 80 - 6546 2400
COIMBATOREBB1, Park Avenue,
# 48, Race Course Road,Coimbatore - 641018.
Tel: +91 - 422 – 6552921
WEBSITE
www.altacit.com
ABOUT PATENTS
• Must be a product of human ingenuity; • Must have novelty-not part of the “state of
the art”;• Must not be obvious; • Must have utility-must serve some
worthwhile practical use;• Must contain an enabling description;• Inventor gains exclusive rights.
CHENNAI3rd Floor, ‘Creative Enclave’,
148-150, Luz Church Road,Mylapore,
Chennai - 600 004.Tel: +91 - 44 - 2498 4821
BANGALORE Suite 920, Level 9,
Raheja Towers,26-27, M G Road,
Bangalore - 560 001.Tel: +91 - 80 - 6546 2400
COIMBATOREBB1, Park Avenue,
# 48, Race Course Road,Coimbatore - 641018.
Tel: +91 - 422 – 6552921
WEBSITE
www.altacit.com
SECOND GENERATION PATENTS
• Originators are burdened with increasing cost for developing drugs.
• The cost of novel drugs are perceived as too high even for developed economies.
• There is a real pressure for the originators to increase the duration of their monopoly beyond the term of patent.
• Generics to break that monopoly.• Second Generation Patents• These patents seek to protect a drug after
the original patent on the drug has expired.• They protect some form of variation or
improvement.
CHENNAI3rd Floor, ‘Creative Enclave’,
148-150, Luz Church Road,Mylapore,
Chennai - 600 004.Tel: +91 - 44 - 2498 4821
BANGALORE Suite 920, Level 9,
Raheja Towers,26-27, M G Road,
Bangalore - 560 001.Tel: +91 - 80 - 6546 2400
COIMBATOREBB1, Park Avenue,
# 48, Race Course Road,Coimbatore - 641018.
Tel: +91 - 422 – 6552921
WEBSITE
www.altacit.com
SECOND GENERATION PATENTS-EXAMPLES
• Crystalline polymorphs• Single enantiomers• Second therapeutic use• Crystalline polymorphs• Complex molecules can crystallize in many ways:• Diamond, coal and carbon nanotubes are
different crystal structure of the same compounds.
• New polymorphs can have enhanced:• Stability and Shelf life• Improved production process and handling• Biovailability • Examples include: Ranitidine (Zantac®),
Paroxetine (Deroxat®), Cefnidir (Omnicef ®)
CHENNAI3rd Floor, ‘Creative Enclave’,
148-150, Luz Church Road,Mylapore,
Chennai - 600 004.Tel: +91 - 44 - 2498 4821
BANGALORE Suite 920, Level 9,
Raheja Towers,26-27, M G Road,
Bangalore - 560 001.Tel: +91 - 80 - 6546 2400
COIMBATOREBB1, Park Avenue,
# 48, Race Course Road,Coimbatore - 641018.
Tel: +91 - 422 – 6552921
WEBSITE
www.altacit.com
POLYMORPH PATENTS
• Polymorphism is playing an increasingly important role in establishing and protecting IPR in the pharma industry. Many drugs receive regulatory approval for only a single crystal form or polymorph.
• Independent patent applications on polymorphs have become increasingly frequent and controversial, as patents thereon can be used to obstruct or delay the entry of generic competition.
contd..
CHENNAI3rd Floor, ‘Creative Enclave’,
148-150, Luz Church Road,Mylapore,
Chennai - 600 004.Tel: +91 - 44 - 2498 4821
BANGALORE Suite 920, Level 9,
Raheja Towers,26-27, M G Road,
Bangalore - 560 001.Tel: +91 - 80 - 6546 2400
COIMBATOREBB1, Park Avenue,
# 48, Race Course Road,Coimbatore - 641018.
Tel: +91 - 422 – 6552921
WEBSITE
www.altacit.com
• The preparation, prosecution and protection of patent involving polymorph are quite challenging.
• Some compounds present in polymorphic forms, i.e., they crystallize in diverse forms. Such forms can be deemed within the prior art and therefore not patentable. However, process patent may be allowed for the new polymorph, if the polymorph is prepared by a novel process involving inventive step.
• contd…
CHENNAI3rd Floor, ‘Creative Enclave’,
148-150, Luz Church Road,Mylapore,
Chennai - 600 004.Tel: +91 - 44 - 2498 4821
BANGALORE Suite 920, Level 9,
Raheja Towers,26-27, M G Road,
Bangalore - 560 001.Tel: +91 - 80 - 6546 2400
COIMBATOREBB1, Park Avenue,
# 48, Race Course Road,Coimbatore - 641018.
Tel: +91 - 422 – 6552921
WEBSITE
www.altacit.com
• Polymorphic forms of a drug substance can have different chemical and physical properties, including melting point, chemical reactivity, apparent solubility, dissolution rate, optical and mechanical properties, vapor pressure, and density.
• These properties can have a direct effect on the ability to process and/or manufacture the drug substance and the drug product, as well as on drug product stability, dissolution, and bioavailability. Thus, polymorphism can affect the quality, safety, and efficacy of the drug product.
• The significance of different polymorphs is almost entirely in their relative rate of dissolution.
CHENNAI3rd Floor, ‘Creative Enclave’,
148-150, Luz Church Road,Mylapore,
Chennai - 600 004.Tel: +91 - 44 - 2498 4821
BANGALORE Suite 920, Level 9,
Raheja Towers,26-27, M G Road,
Bangalore - 560 001.Tel: +91 - 80 - 6546 2400
COIMBATOREBB1, Park Avenue,
# 48, Race Course Road,Coimbatore - 641018.
Tel: +91 - 422 – 6552921
WEBSITE
www.altacit.com
POLYMORPHS AND PATENTABILITY
• Main patentability criteria for polymorphs
-Clarity -Disclosure of the invention -Novelty -Inventive step -Unity of the invention
CHENNAI3rd Floor, ‘Creative Enclave’,
148-150, Luz Church Road,Mylapore,
Chennai - 600 004.Tel: +91 - 44 - 2498 4821
BANGALORE Suite 920, Level 9,
Raheja Towers,26-27, M G Road,
Bangalore - 560 001.Tel: +91 - 80 - 6546 2400
COIMBATOREBB1, Park Avenue,
# 48, Race Course Road,Coimbatore - 641018.
Tel: +91 - 422 – 6552921
WEBSITE
www.altacit.com
PATENTABILITY CRITERIA
• Clarity• A claim in the form of… crystalline form II of compound X
does therefore not comply with the requirement of clarity.• Polymorphs are defined in a claim by parameter values
which relate to the physical data used for defining their crystal structure.
• A polymorph is defined in a claim by its physiochemical parameters
• Ex: Single crystal X-ray diffraction, X-ray powder diffraction, IR spectroscopy
• Ex:• A crystalline tolterodine tartrate form I, characterized by
an x-ray powder diffraction spectrum having peaks expressed as 2.theta. at about 11.9, 13.6, 14.2, 15.9, 16.9, 18.4, 18.8, 20.4, 22.0, 23.9, 25.4, 26.3 and 29.8 degrees.
CHENNAI3rd Floor, ‘Creative Enclave’,
148-150, Luz Church Road,Mylapore,
Chennai - 600 004.Tel: +91 - 44 - 2498 4821
BANGALORE Suite 920, Level 9,
Raheja Towers,26-27, M G Road,
Bangalore - 560 001.Tel: +91 - 80 - 6546 2400
COIMBATOREBB1, Park Avenue,
# 48, Race Course Road,Coimbatore - 641018.
Tel: +91 - 422 – 6552921
WEBSITE
www.altacit.com
PATENTABILITY CRITERIA
• Disclosure of the invention The application must disclose the invention in a manner
sufficiently clear and complete for it to be carried out by a person skilled in the art.
• Novelty The invention shall be considered new if it does not form
part of the state of the art. • A chemical substance is held to be new if it differs from a
known substance in a reliable parameter.• Inventive step An invention shall be considered as involving an inventive
step if, it is not obvious to a person skilled in the art.• Unity of the invention The application shall relate to one invention only or to
group of invention so linked as to form a single general inventive concept.
CHENNAI3rd Floor, ‘Creative Enclave’,
148-150, Luz Church Road,Mylapore,
Chennai - 600 004.Tel: +91 - 44 - 2498 4821
BANGALORE Suite 920, Level 9,
Raheja Towers,26-27, M G Road,
Bangalore - 560 001.Tel: +91 - 80 - 6546 2400
COIMBATOREBB1, Park Avenue,
# 48, Race Course Road,Coimbatore - 641018.
Tel: +91 - 422 – 6552921
WEBSITE
www.altacit.com
PATENT CASE
• RANITIDINE HYDROCHLORIDE (Zantac®)
• The pharmaceutical company GlaxoSmithKline defended its patent for the polymorph type II of the active ingredient in Zantac against competitors while that of the polymorph type I had already
expired.
CHENNAI3rd Floor, ‘Creative Enclave’,
148-150, Luz Church Road,Mylapore,
Chennai - 600 004.Tel: +91 - 44 - 2498 4821
BANGALORE Suite 920, Level 9,
Raheja Towers,26-27, M G Road,
Bangalore - 560 001.Tel: +91 - 80 - 6546 2400
COIMBATOREBB1, Park Avenue,
# 48, Race Course Road,Coimbatore - 641018.
Tel: +91 - 422 – 6552921
WEBSITE
www.altacit.com
• Roche and Wockhardt• Roche got its first first pharma product
patent for Hepatitis Drug Pegasys in India in 2006. Its struggle over its patents started in 2007, when India’s first post grant opposition was filed by Wockhardt and a Mumbai based NGO for “IN198952” on Pegasys attacking its validity claiming it to be non-inventive and not satisfying Section 3d. Roche could taste success with its patent by defending it successfully by clearing the “enhanced efficacy” test in the Section 3d of the Indian Patent Act.
CHENNAI3rd Floor, ‘Creative Enclave’,
148-150, Luz Church Road,Mylapore,
Chennai - 600 004.Tel: +91 - 44 - 2498 4821
BANGALORE Suite 920, Level 9,
Raheja Towers,26-27, M G Road,
Bangalore - 560 001.Tel: +91 - 80 - 6546 2400
COIMBATOREBB1, Park Avenue,
# 48, Race Course Road,Coimbatore - 641018.
Tel: +91 - 422 – 6552921
WEBSITE
www.altacit.com
• The Glivec battle in India• It concerns the patentability of
the Beta crystalline form of Imatinib, the active pharmaceutical ingredient in the blockbuster drug Glivec (Gleevec).
CHENNAI3rd Floor, ‘Creative Enclave’,
148-150, Luz Church Road,Mylapore,
Chennai - 600 004.Tel: +91 - 44 - 2498 4821
BANGALORE Suite 920, Level 9,
Raheja Towers,26-27, M G Road,
Bangalore - 560 001.Tel: +91 - 80 - 6546 2400
COIMBATOREBB1, Park Avenue,
# 48, Race Course Road,Coimbatore - 641018.
Tel: +91 - 422 – 6552921
WEBSITE
www.altacit.com
• Kolkata Patent Office issued an Indian Patent No. 225209 to Eli Lilly & Co. for crystalline non-solvated anhydrous Arzoxifene. Lilly had been fairly successful in prosecuting and convincing Indian Patent Office (IPO) for polymorph and salt patent applications.
CHENNAI3rd Floor, ‘Creative Enclave’,
148-150, Luz Church Road,Mylapore,
Chennai - 600 004.Tel: +91 - 44 - 2498 4821
BANGALORE Suite 920, Level 9,
Raheja Towers,26-27, M G Road,
Bangalore - 560 001.Tel: +91 - 80 - 6546 2400
COIMBATOREBB1, Park Avenue,
# 48, Race Course Road,Coimbatore - 641018.
Tel: +91 - 422 – 6552921
WEBSITE
www.altacit.com
CONCLUSION
To ensure availability of quality medicine at affordable price, patent system should be used judiciously. Indian Patent Act 1970 that was amended in 2005 has ensured that pharmaceutical companies do not misuse the patent system. Provision of effective safeguards and its appropriate implementation would ensure balance between incentive for innovation and access to affordable medicines.
CHENNAI3rd Floor, ‘Creative Enclave’,
148-150, Luz Church Road,Mylapore,
Chennai - 600 004.Tel: +91 - 44 - 2498 4821
BANGALORE Suite 920, Level 9,
Raheja Towers,26-27, M G Road,
Bangalore - 560 001.Tel: +91 - 80 - 6546 2400
COIMBATOREBB1, Park Avenue,
# 48, Race Course Road,Coimbatore - 641018.
Tel: +91 - 422 – 6552921
WEBSITE
www.altacit.com
THANK YOU
