IP Strategy for Drug Patent Search
What should be the strategy for drug patent search?
As reported by WSJ, facing mounting criticism by President Trump about prices, drug companies have put some limits on their increases this year. As it is well known, prescription-drug makers traditionally raise list prices in January. This year, they didn’t raise prices for as many drugs as last year and imposed fewer boosts of 10% or greater, according to an analysis by the investment firm Raymond James & Associates.
New Drug Development – Patent Protection
As drugmakers pushed back against rising criticism over sky-high U.S. prescription drug prices, one pharmaceutical company went public with a pledge. Brent Saunders, CEO of Botox maker Allergan PLC, last September announced a new “social contract” under which the company would limit annual list price increases for its drugs to below 10 percent. Mr. Saunders stated that limiting price hikes forces companies to stay sharp and competitive in innovation and operational excellence. Specifically, pharmaceutical companies stay focused on their pipeline with (patent expirations) in mind, so if their big drug’s patent is ending, they need to formulate three to four R&D programs that, if successful, can cover such patent expiration and provide growth.
Strategy for Drug Patent Search
Traditionally, product and process patents in pharmaceutical sector are obtained with special emphasis on chemical structure patent search technique to determine the patentability of the pharmaceutical drug. Performing a structure based chemical search ensures broadest list of patent results. For example, review the patent search string below. The second drug patent search string provides more than sixteen thousand results for a drug molecule say “X”. Combining the CHEM (chemical structure based search) with other key string parameters can be helpful to perform the drug patent search.
Following example illustrates different parameters to consider while performing drug patent search (Molecule “Y”) for pharmaceutical medicine:
Pharmaceutical Patent Process
Once the patent search is conducted to determine the novelty of the drug process and product (medicine) before filing for patent, laboratory tests are performed to determine synergistic properties of the medical composition and collect scientific data for the same. This process is highly regulated and different countries follow distinctively comprehensive procedure for the same.
Thereafter, patent claims are written to cover both the process of manufacturing the drug and associated medicine products are claimed in separate patent applications. Subsequently, the scientific data description illustrating the synergistic properties of the medical composition in the patent application is provided to regulatory authorities and corresponding patent applications are filed along with request of examination, in accordance with the local patent laws.
Pharmaceutical Products’ Manufacturing – Indian Perspective
The end goal of research and patent grant is to provide affordable medicines to everyone in India. There is a compulsory licensing clause that has been used to allow manufacturing of patented products at affordable prices in public interest in India. Section 84 is applicable and an application for compulsory license on a patent can be made if reasonable requirements for the public with respect to the patented invention have not been satisfied, or if the patented invention is not available to the public at a reasonably affordable price.
Over the years, the Indian legal system has strictly followed the patent law and working requirements of patents in India. The approval of compulsory licensing for a drug is an exception rather than a rule. If a compulsory license of manufacturing a drug is granted by the Indian patent office, a royalty is paid to the patent holder (on agreeable terms between two parties). In recent years, the drug approval process in India has been expedited to keep up with the public demand and provide affordable healthcare to individuals. The Indian pharmaceutical law is now more clear and defined. To know more about drug patent expirations in 2017: click here.
About the Author
Prity Khastgir manages the Pharmaceutical and Biotechnology Patent Practice at Tech Corp Legal. Ms. Khastgir is a Patent attorney and intellectual property lawyer with 11+ years of experience in Biotechnology, Pharmaceuticals, Healthcare, Medical Devices, Drug Patent Search and Chemicals in international markets (US, Europe, Asia Pacific and MENA region).
Ms. Khastgir manages, Direct representation of parties before WIPO and IPO, Coordination and management of Global IP Prosecution and Litigation matters with patent lawyers worldwide, Global IP Strategy and development of Intellectual Assets, Drafting, reviewing and negotiating IP and Technology Agreements (Licensing, Technology Transfer and Collaboration Agreements), Strong patent claim drafting, preparation and prosecution skills for international applications filed before USPTO, EPO, WIPO, UKIPO, MyIPO, IP Australia, IPOS etc.
She has extensive experience in Pharmaceutical Patent Practice for patent searches, invalidation analysis, Freedom-to-Operate (FTO) and product clearance studies, patent infringement reports, claim charts, formulation development, analytical methodologies, regulations and new product development.
Step by step procedure to get medicine drug patent in India
- Step 1: Conduct Patent search to determine novelty of the drug process and product (medicine)
- Step 2: Perform lab test to determine synergistic properties of the medical composition.
- Step 3: Write patent claims to cover both the process of manufacturing the drug and claim the medicine product.
- Step 4: Provide the scientific data description the synergistic properties of the medical composition in the patent application.
|Patent Objection for Pharma & Drug Products||Indian Patent Law Explanation|
|Indian patent law section 3e explained||The mixture of drugs should exhibit some unexpected results or synergistic properties in their action. Once proved with scientific data in the patent description such composition can be considered as patentable subject matter and can overcome indian patent law section 3e.|
To read more click here
Your Patent Strategic Partner in India
Prity Khastgir is a Biotech and Pharmaceutical Indian Patent Attorney at Tech Corp Legal LLP, an Indian Intellectual Property law firm based in New Delhi. She advises clients regarding freedom to operate (FTO) studies for their new product or service and search for possible foreign IP rights that could be infringed. Patent clearance searches are rapidly becoming a necessity for any technology company to enter in India and in any other foreign country. Having multi-jurisdictional experience gives her clients insights in protecting and enforcing their intellectual property rights in several countries.
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Investing in creation of intellectual capital during initial stages results in valuable intellectual property (IP). Such IP can be monetised by way of B2B licensing and technology transfer, thereby creating additional revenue streams. IP portfolio usually comprises patents, trademarks, copyrights, designs and trade secrets, collectively contributing towards intellectual capital of the business.
Read more here.
Joshi Prabhakr Anant, Joshi Salil Prabhakar was Granted Patent For A Lock Assembly Published By Indian Patent Office On 14/11/2014 U/S 43(2) Of The Indian Patent Act, Indian Patent News, #Indiapatent
Patent Granted For A Lock Assembly Published By Indian Patent Office
Joshi Prabhakr Anant, Joshi Salil Prabhakar was Granted Patent For A Lock Assembly Published By Indian Patent Office On 14/11/2014 U/S 43(2) Of The Indian Patent Act, Indian Patent News, #Indiapatent
We at Tech Corp Legal LLP regularly POST such updates with details of International Patent Laws, and International Patent Procedures. Our team is proficient in services related to International Patents, PCT Filings, PCT National Phase in India, Patent Searches, Patent Drafting Services, Patent Claim Construction, Patent Drafting From Invention Disclosure Form, Patent Drafting to Indian Companies, Patent Draft for foreign inventors, Patent Oppositions, Pre-grant Patent Opposition in India, Post-grant Patent Opposition in India, Patent Infringement in India, Patent Drafting in India, USPTO Patent Drafting, EPO Patent Drafting, Patents, Trademarks, Copyrights, Designs, Domain Names, Geographical Indications, Layout Design of Semiconductor Integrated Circuits, Enforcement of Intellectual Property Rights etc.
Indian Patent Office publishes patent by way of official patent journal, which is published every week on Friday. We at Tech Corp Legal LLP, an International Law Firm headquartered in New Delhi, India, regularly post crucial details of published patents with details of Indian Patent Laws, Indian Patents Act and Indian Patent Procedure.
International Patent Filing in India FAQ
Does an International Patent Application filed under Patent Cooperation Treaty (PCT) designating India be treated as a patent application for grant of patent under the Indian Patent 1970 Act?
Yes, an international patent application filed under Patent Cooperation Treaty (PCT) designating India shall be treated as a patent application for patent under the Indian Patent Act if filed within 31 months from the earliest priority date of the patent application before the Indian Patent Office.
Will filing a patent application under PCT grant worldwide patent protection?
No, the Patent Cooperation Treaty (PCT) patent application doesn’t provide universal or worldwide protection for a claimed invention. The international patent application only provides interim way out to extend the time line for filing the patent application in other foreign countries. The time available under Paris Convention for securing priority of the patent application in other countries is 12 months from the date of initial filing. Under the Patent Cooperation Treaty (PCT), the time available could be as much as minimum 20 and maximum 31 months in case of India. Moreover, a patent inventor is also benefited by the international search report prepared under the PCT system to be sure that the claimed patent invention is novel and non-obvious to a person skilled in the art. The patent inventor can also select for preliminary examination before filing in other foreign countries to be very positive about the patentability of the claimed invention.
Required Details and Patent forms for filing of Patent Application in India | National Phase Patent Filing in India (PCT)
- Complete Patent Specification including patent claims (Patent Form 1, Patent Form 2, Patent Form 3 and Patent Form 5)
- Patent Drawings (if any)
- Patent Priority Documents
- Patent Abstract
- International Search Report (ISR)
- International Preliminary Examination Report
- WIPO Patent Publication
- Power of Attorney
To read more on Filling International Patent Application under National Phase in India before Indian Patent Office: Click Here
To read more on Prior Art Searching in India: Click Here
International Technology Business & Patent Law Firm in India: Patent Drafting, Patent Drafting Services, Patent Claim Construction, Patent Drafting From Invention Disclosure, Patent Drafting in India, Patent Draft, Patent Searching, Patent Filing in India, PCT National Phase Filings in India: http://www.techcorplegal.com/
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Tech Corp Legal LLP presents a summary of patent specifications with associated drawings for journalistic news purposes as each such patent application is disclosed by the Indian Patent Office in the official patent journal. Full text of any patent specification should be read in its entirety for full and accurate details by downloading the patent specification from the Indian Patent Office website. Tech Corp Legal LLP is no way associated with the above mentioned company/individual(s) in any manner whatsoever. About Comments: Tech Corp Legal LLP reserves the right to post, dismiss or edit comments.
US-based Intellectual Property Owners’ Association delegation will be meeting the Indian intellectual property office (IPO) officials
US-based Intellectual Property Owners’ Association (IPOA) delegation will be meeting the Indian intellectual property office (IPO) officials, Intellectual Property Appellate Board (IPAB) members, judiciary and judicial staff of high courts. It would be interesting to note the outcome of the meetings. However, it would be interesting to note whether the US pharma lobby will be able to influence the way India’s patent offices and judiciary interpret India’s patent law.
India amended its patent act in 2005 to comply with World Trade Organisation (WTO) agreement to introduce pharmaceutical patents protection for 20 years on medicines. However, in the interest of public health and providing affordable healthcare across the globe the Indian patent act included provisions like section 3(d) to prevent pharmaceutical companies from seeking patent extensions by modifying existing drugs and stop patent evergreening process. Over the years, numerous Intellectual Property Owners’ Association (IPOA) member entities have challenged section 3d.
In my view meeting with the patent officials will provide the Intellectual Property Owners’ Association (IPOA) members better overview on how to draft the pharmaceutical patent applications to be filed in India. The pharma and medicine based innovations should include data related to therapeutic efficacy to obviate section 3d of the Indian Patent Act. However, it is surprising to note that the Intellectual Property Owners’ Association (IPOA) members are being allowed to meet the judiciary. In a recent case the Supreme Court seriously viewed the allegation of 2G scam accused and coal scam accused meeting the CBI director Ranjit Sinha.
Intellectual Property Lawyers and Law Firms in India
Tech-Corp Legal LLP, is a leading technology-focused commercial law firm that practices in the dynamic field of Corporate and Technology law in India. Organized as a limited liability partnership (LLP) under Indian law, Tech-Corp Legal, is a LLP of patent attorneys (agents), trademark attorneys, and lawyers registered with State Bar Councils in India and qualified to practice law throughout India. Our practice is centered on a diverse range of areas encompassing various spheres of science engineering, and technology.
We at Tech Corp Legal LLP provide intellectual property services which includes a broad range of domain sectors including life sciences, medical devices, biotechnology, electronic devices, agriculture, diagnostics, polymer science, drugs and drug delivery, genetics, food science, pharmaceuticals, cosmetics, green technologies, chemistry, process engineering, physics, and communication.
Tech Corp Legal LLP is a full-service law firm in India uniquely positioned to provide strategic patent and intellectual property, corporate, contract reviewing and business advisory services. Located in the heart of capital of India, New Delhi and venture capital ecosystem, our techno-legal patent attorneys use their scientific, technical, business and legal expertise to help rising start-up companies, Entrepreneurs and Fortune 100 companies transform business model plans into industry leading enterprises.
Our team of intellectual property and patent attorneys are recognized industry experts in Patent Strategy & Technology Consulting. Our team of lawyers have assisted clients in formulating profitable and sustainable Patent & IP Strategy for international business.
Patent Filing Procedures in India | Patent Protection & Registration in India| How much does it cost to get a patent in India |Obtain Patent Protection and Registration in India | Patent Filing Process Information| Patent Law firm India from Prity Khastgir, Patent Attorney India Intellectual Property Law Firm IPR India
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Indian Patent Office recently rejected patent for anti-cancer drug Abraxane filed by US company Abraxis BioSciences. Main ground of rejection was Section 3(d) according to which new forms of known substances are not patentable unless it results in enhanced efficacy over the known substance. Other grounds of rejection included lack of inventive step and insufficient disclosure.
Supplementary Protection Certificate and Patent Term Extensions for Pharma Patents
Owing to specific life term of patents, patent expirations have significant commercial impact. In case of pharmaceutical patents, due to expiry of patents pertaining to famous drugs, sales worth billions of dollar are endangered every year.
As fist published on LinkedIn
Patent protection and patents extension strategies are equally important for pharmaceutical companies. Major goal of pharmaceutical companies is to build strong patent portfolios and subsequently monetize the same.
Pharmaceutical companies employ patent extension strategies to compensate for their R&D investments and regulatory approval costs of new drugs.
Broadly, three major extensions and protections exist, namely, Supplementary Protection Certificates (SPCs), Patent Term Extensions (PTEs), and Regulatory Data Protection (RDP).
One of the main reasons why companies intend for both market exclusivity and regulatory exclusivity is that there exist significant delays between the filing of pharmaceutical patent and approval of marketing authorization. Accordingly, pharmaceutical companies aim to safeguard their innovation efforts by securing balance with generic competitors.
Usually, various jurisdictions have different legal provisions to extend patent rights. Among the three major extensions and protections, Supplementary Protection Certificates (SPCs) are applicable for Europe (EP), Patent Term Extensions (PTEs) are applicable for jurisdictions including United States (US), Japan (JP), Taiwan (TW) etc.
A broad difference between Regulatory Data Protection (RDP) and patent protection is that while RDP protects the compound (active ingredient) that receives market authorization, patent protection is intended for compounds that are defined within the scope of corresponding claims, which may include derivatives, uses, formulations, synthetic processes etc.
Patent protection is generally aimed at stopping infringers from manufacturing, selling, using or importing claimed invention, whereas RDP protects direct or indirect use of clinical data filed in support of market authorization.
Latest legal developments and decisions effect companies strategies to enhance their patent portfolios. For example, companies in European region need to carefully study the impact of major SPC decisions in cases pertaining to Georgetown University, Actavis, Eli Lilly, and the like. Similarly, developments relating to Unitary Patent, Unified Patent Court and latest US patent reforms could also affect such strategies.
Companies should therefore carry out cross-jurisdictional analysis of various legal provisions and latest regulatory developments to plan advantageous extensions of pharmaceutical patents.
Author is a biotech and pharmaceutical patent attorney. Comments and feedback will be highly appreciated.
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