Patent Business Lawyer in Asia
Patent Attorney practicing Patents, Corporate Law, Mergers and Acquisitions, Venture Financing, Startup Technology Law
Patent Attorney practicing Patents, Corporate Law, Mergers and Acquisitions, Venture Financing, Startup Technology Law
Pharmaceutical patents for inventions resulting from combination of previously known active ingredients face higher level of scrutiny from the patent examiner as patent office does not generally allow the patent owners to extend the life of existing patents by filing new patents for substantially same or similar inventions, without any novelty or inventive step (non-obviousness).
Q. What is evergreening of patents?
Such strategies are commonly followed in pharmaceutical sector for drug patents and hence, patent offices rely on the determination of a new or a non-obvious synergy or a distinct effect. In use, such a novel and non-obvious synergy or the distinct effect has to be covered comprehensively by drafting a strong and focused set of patent claims, which can be further supported by way of accompanying detailed description of the invention including results of clinical (laboratory) and biology test results.
Therefore, while drafting patent applications covering drug patents and pharmaceutical inventions, pharma patent attorneys follow the best practice of writing patent specifications with the required detailed description of the inventions to satisfy the patent eligibility criteria.
Q. What is a patent thicket?
Another term related to evergreening of patents is patent thicket, which implies a dense web of overlapping intellectual property rights that a company must hack its way through in order to actually commercialize new technology, in other words, “an overlapping set of patent rights” which requires innovators to reach licensing deals for multiple patents from multiple sources.
Q. What is product hopping in pharmaceutical sector?
As it is well known, pharmaceutical sector often experiences battle between generic drug makers and multinational pharmaceutical companies, which results in “product-switching” or “product hopping”, whereby brand name pharmaceutical companies make an effort to block generic drug manufacturers, which are their competitors, on a patented drug by making slightly different reformulations that offer little or no therapeutic advantages.
Advocate Rahul Dev is a Patent Attorney & International Business Lawyer practicing Technology, Intellectual Property & Corporate Laws. He is reachable at rd (at) patentbusinesslawyer (dot) com & @rdpatentlawyer on Twitter
Quoted in and contributed to 50+ national & international publications (Bloomberg, FirstPost, SwissInfo, Outlook Money, Yahoo News, Times of India, Economic Times, Business Standard, Quartz, Global Legal Post, International Bar Association, LawAsia, BioSpectrum Asia, Digital News Asia, e27, Leaders Speak, Entrepreneur India, VCCircle, AutoTech)
Regularly invited to speak at international & national platforms (conferences, TV channels, seminars, corporate trainings, government workshops) on technology, patents, business strategy, legal developments, leadership & management
Working closely with patent attorneys along with international law firms with significant experience with lawyers in Asia Pacific providing services to clients in US and Europe. Flagship services include international patent and trademark filings, patent services in India and global patent consulting services.
Law office of Rahul Dev is a niche technology and research based law firm focusing on next generation business and legal issues faced in India and outside India during international business and cross-border technology transactions. We assist our clients in close collaboration with our associates and counsels within India and outside by providing custom engagement models to address our client’s needs.
Practice areas include drafting and filing pharmaceutical and drug patent applications, pharmaceutical and drug patent prior art searches, pharmaceutical and drug patent prosecution, pharmaceutical and drug patent filing in India, pharmaceutical and drug PCT national phase entry in India, pharmaceutical and drug PCT international applications with WIPO, freedom to operate searches for pharmaceutical products and drugs, patentability analysis of pharmaceuticals and drugs and patent strategy to create a valuable patent portfolio comprising of new pharmaceutical and drug.
Pharmaceutical Patent attorney Rahul Dev works with clients providing expert legal services in the field of innovative pharmaceutical products, branded drugs, generic drugs, molecular biology, immunology, cell biology, regenerative medicine including ESCs, iPSCs, pSCs, diagnostics, therapeutics, theranostics, drug delivery systems, host-vector systems, high throughput screening, bioinformatics, diagnostic imaging, ancillary services (PET, CT, MRI, ultrasound, greenlight, lithotripsy, radiation therapy, cyber-knife, nuclear camera, clinical lab, pathology, physical therapy and dispensing prescriptions).
Patent attorney and technology lawyer Rahul Dev works closely with USPTO licensed patent attorneys to assist clients with patent reexaminations, patent prosecution, drafting USPTO office action responses, patent infringement litigation, patent claim mapping and patent licensing. For international patent filings, we have an established network of global patent attorneys to provide reliable and cost effective services to our clients.
India is facing tremendous pressure from US for enforcement of Intellectual Property Rights (IPR) since last few months, specifically with regards to concerns over violations of pharmaceutical patents in India.
Originally published here.
Recent Issue – Dasatinib [Bristol-Myers Squibb (BMS)’s Cancer drug]
Dasatinib, an anti-cancer drug produced by pharma major Bristol-Myers Squibb (BMS), is used to treat chronic myeloid leukemia. Recently, the health ministry of India is exploring various options to revoke the patentee’s rights for Dasatinib, arguing that such move is required to deal with an “emergency”.
Although the health ministry is confident about revocation of Dasatinib’s patent, it is bound to attract stringent criticism from global pharmaceutical companies. However, such step by the health ministry of India can be attributed to the strong pressure exerted by public health groups, who usually reprimand the public authorities of being non-responsive to their concerns regarding affordability and availability of medicines for life-threatening diseases.
As per news reports, the health ministry is in communication with the department of industrial policy and promotion (DIPP), wherein it is being discussed that the cost of the drug produced by Bristol-Myers Squibb (BMS) will be met through government schemes.
Revocation of Patent by Government – Indian Patent Laws
In accordance with various provisions of the Indian Patents Act, the government can revoke a granted patent under following circumstances:
(i) Revocation of Patents by Controller for Non-working, Non-availability at Reasonable Price
As per Section 85, any person interested, or the Central Government can approach the Controller to pass an order revoking the patent on the ground that the patented invention has not been worked in the territory of India or that reasonable requirements of the public with respect to the patented invention has not been satisfied or that the patented invention is not available to the public at a reasonably affordable price.
However, as mentioned in section 85 of the patents act, this is only applicable if a compulsory license has been granted in respect of a patent, and such application can only be made to the Controller after the expiration of two years from the date of the order granting the first compulsory license.
In addition, if such an application is made by an individual or a legal entity, other than by the Central Government, the applicant is required to set out the nature of the applicant’s interest, along with the facts upon which the application is based.
Alternatively, if the Controller is satisfied:
that the reasonable requirements of the public with respect to the patented invention have not been satisfied, or
that patented invention has not been worked in the territory of India, or
that the patented invention is not available to the public at a reasonably affordable price,
an order revoking the patent can be passed.
(ii) Revocation of Patent in Public Interest
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In accordance with Section 66 of the Indian Patents Act, where the Central Government is of opinion that a patent or the mode in which it is exercised is mischievous to the State or generally prejudicial to the public, it may, after giving the patentee an opportunity to be heard, make a declaration to that effect in the Official Gazette and thereupon the patent shall be deemed to be revoked.
(iii) Revocation by High Court on Petition of Central Government
According to Section 64(4), a patent may be revoked by the High Court on the petition of the Central Government, if the High Court is satisfied that the patentee has without reasonable cause failed to comply with the request of the Central Government to make, use or exercise the patented invention for the purposes of Government within the meaning of section 99 upon reasonable terms.
Going by the limited information available in the public domain with regards to communication between the ministry of health and DIPP (public body governing IPR), it is yet to be seen under which provision the government intends to revokes Dasatinib’s patent granted to BMS.
As the government has already turned down health ministry’s request to issue a Compulsory License under Section 84, the ministry is expected to file an application with the Patents Office under Section 85, which will provide an opportunity to BMS to put forward its objections as its right to be heard under principles of natural justice.
Compulsory Licensing in India – Controversial for Pharmaceutical Patents
Rejection of Compulsory License for Dasatinib
Compulsory licensing is one of the most debatable provisions of the Indian Patents Act. In October 2013, the Patents Office rejected an application from BDR Pharma to make a generic version of BMS’s Dasatinib. The proposal was rejected on the grounds that the Indian company did not make enough efforts to obtain a voluntary license for the anti-cancer drug.
As per the application made by BDR Pharma, BMS responded with number of queries asking BDR to answer, when BDR applicant requested BMS for issuance of a voluntary license. It shall be noted that making such request for voluntary license is mandatory under patents act, before an application for compulsory license is made to the Controller. BDR alleged that BMS used these queries as delaying tactics, while the Controller General of Patents held that prior to deciding on the merits of the case, the threshold requirement of establishing a prima facie case must be satisfied.
The CG of Patents held that BDR had not really made any credible attempt to procure a license and therefore could not be said to have satisfied the statutory requirement that the applicant must have negotiated in good faith for 6 months at least.
Compulsory License Granted for Bayer’s Nexavar in 2012
In March 2012, the Indian Patent office granted first compulsory license to NATCO pharma to make anti-cancer drug sorafenib for the India market. However, the compulsory license is subject to certain conditions, such as maintaining account of sales, and payment of royalty at six percent of the net sales on a quarterly basis to Bayer. The order also makes it obligatory for NATCO to supply the drug free-of-cost to at least 600 needy and deserving patients per year.
More details can be seen here.
“Pharmaceutical Patents in India – Compulsory Licensing, Health Emergency & Affordable Healthcare – Patent Laws in India”
Author: Advocate Rahul Dev
A brief analysis of pharmaceutical patent laws in India in light of recent developments including compulsory licensing provisions.
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