From the Desk of Patent Circle: Delhi HC Dasatinib Order

From the Desk of Patent Circle: Delhi HC Dasatinib Order

A patent has no value if it cannot be monitored and enforced under the law and Indian patent is no exception to it. Though the Indian Patent Office (IPO) has started granting patents for drug compounds but industry runs serious concerns about their enforceability. Enforcement is not possible without proper and regulated monitoring which is already a major problem in fragmented Indian drug industry and the gravity of which can be gauged by the fact that about 20 percent drugs marketed in India are spurious drugs despite having both Central and State drug regulatory agencies. Both domestic and foreign companies are constantly struggling to tackle and raid counterfeit and spurious drugs in India. Even the government has shown serious concern over spurious drugs and has brought the Drugs and Cosmetic (Amendment) Bill, 2008 which is already been passed by both the Houses of Parliament and lately got approval of the President. However, the issue of spurious drug is not our main concern of discussion here it is just to give an idea about what extreme damage lack of proper monitoring policies can bring to Indian drug industry and consumer. Our focus of discussion is a recent order of the Delhi High Court (HC) restraining generic Dasatinib. Albeit we are bit late in reporting on this but still personally believe that the Delhi HC order got invariably distorted in the news media. So we thought running a post on the Delhi HC Dasatinib Order.
Dasatinib is an anti-cancer drug belonging to the class of tyrosine kinase inhibitors first approved in the United States on June 28, 2006 and marketed by Bristol-Myer Squibb (BMS) under the brand name Sprycel. BMS has a granted Indian patent (IN203937) for drug compound dasatinib conferring BMS the exclusive right under Sec. 48 of the Patents Act, 1970 to prevent third parties, who do not have his consent, from the act of making, using, offering for sale, selling or importing dasatinib in India. Regardless of patent protection, Hyderabad-based generic manufacturer Hetero Drugs submitted an application with the Drug Controller General of India (DCGI) for a grant of license to manufacture and distribute generic dasatinib tablets in India. Although BMS said to inform Hetero about the dasatinib patent but Hetero kept unanswered to BMS and continued to pursue its application before the DCGI. Clearly, the DCGI approval of license for generic dasatinib would have been a blatant violation of BMS right under Sec. 48 of the Patents Act, 1970. What is important to note that patent is a statutory right created by the legislature and it is duty of the executive (government) to enforce the right of the patentee. Also, it would be a complete mockery of jurisprudential aspect of ‘right’ if one government body (Indian Patent Office) confers BMS the exclusive right to prevent third parties from the act of making, using or selling dasatinib in India and the other government body (DCGI) dilutes, in fact, ignores the same right by issuing license to third party for making and selling dasatinib in India.
In law, there is a well-established legal maxim that says “ubi jus ibi remedium”: where there is a right, there is a remedy. Now in absence of any legal provision which would have prevented Hetero from pursuing application before the DCGI or would have authorized the DCGI to stop regulatory approval for generic version of patented drug, BMS had valid grounds and reason for approaching the judiciary for remedy against its right under Sec. 48 of the Patents Act, 1970. To make an appropriate case, BMS sought a legal recourse under Sec. 151 of the Code of Civil Procedure (CPC) from the Court to pass an ex parte ad interim order to restrain Hetero from manufacturing, selling, distributing, advertising, exporting or offering for sale generic dasatinib, and also an ex parte relief to restrain Hetero from pursuing their application before the DCGI. Sec. 151 of CPC triggers inherent powers of Court particularly in cases where there is no specific provision provided under the law. The Court is open to pass an appropriate consequential order under Sec. 151 of CPC as may as necessary for ends of justice.
After hearing BMS counsel and considering a prima facie case for grant of ex parte ad interim order, the Court restrained Hetero from manufacturing, selling, distributing, advertising, exporting or offering for sale generic Dasatinib. While referring BMS ex parte relief of restraining Hetero from pursuing their application before the DCGI, the Court added that it is expected that the DCGI while performing statutory functions will not allow any party to infringe any laws and if the drug for which approval has been sought by defendants (Hetero) is in breach of the patents of plaintiffs (BMS), the approval ought not to be granted to the defendants (Hetero). The Court further instructed BMS to make a representation to the DCGI within one week making out a case that Hetero generic drug for which approval has been sought being in breach of the patent granted to BMS.
Important to note that the learned Judge knowing that there is no legal provision to restrain the DCGI from approving the application for generic Dasatinib, has diligently and aptly used the word ‘ought’ while referring BMS ex parte relief of restraining Hetero from pursuing application before the DCGI. In fact, the Delhi HC order finds reasonable support in Sec. 2 of the Drugs & Cosmetic Act, 1940 (DCA) which states that the provisions under DCA shall be in addition to and not in derogation of any other law for the time being in force. Further it is important to note that this is just a temporary order which is passed to stop Hetero generic dasatinib during the pendency of the trial and also the order is restrictively limited to Hetero case. Till here, both the Delhi HC and BMS acted within the periphery of the law. The order nowhere creates any ‘patent-drug regulatory’ linkage or authorizes the DCGI to monitor drug patents and framing such an opinion at this moment when the Delhi HC has not even started hearing on the issue (just made a temporary order) and judgment still awaited is completely irrational. The issue is been unnecessarily sensationalized by the newspaper media, further creating more confusion and chaos among the domestic pharma companies and patent practitioners, however, the whole dasatinib episode has surely left us with few questions that now need utmost attention.
(1) Whether approval of generic version of a patented drug violates the exclusive right of the patentee under Sec. 48 of the Patents Act, 1970?
(2) Is there a need to formulate substantive and procedural laws under Drugs & Cosmetic Act, 1940 regarding approval of generic version of a patented drug?
(3) How enforcement of drug patents feasible in India?
(4) Is ‘patent-drug regulatory’ linkage a necessity?
(5) Importantly is India really serious about drug patents or possibly we are moving toward creating more chaos?
The Delhi HC order has surely opened a wide platform for policy discussions, particularly related to ‘patent-drug regulatory’ linkage and enforcement of patent right.

From the Desk of Patent Circle: Is Dasatinib Order Contravenes Bolar-Provision?

From the Desk of Patent Circle: Is Dasatinib Order Contravenes Bolar-Provision?

Continuing from our earlier post, we will now focus on another issue whether the Delhi HC Dasatinib order contravenes bolar-provision? However, before going further into details of this let us briefly discuss what is bolar-provision?
Bolar-provision, also referred as Regulatory-use exemption is a statutorily created exemption from the patent infringement under Sec. 107A (1) of the Patents Act, 1970 which states –
(a) any act of making, constructing, using, selling or importing a patented invention solely for uses reasonably related to the development and submission of information required under any law for the time being in force, in India, or in a country other than India, that regulates the manufacture, construction, use, sale or import of any product;
In simple words, the exclusive right conferred under Sec. 48 does not extend to prevent third party from any act specifically and reasonably necessary in the development and submission of information required under regulatory laws in India or any other country. The bolar-provision is of high importance to generic manufacturers to conduct certain trials on patented drug needed to generate data to demonstrate bioequivalence prior to the expiry of the patent. The purpose of bolar-provision is to ensure that the generic drugs are on the market immediately after the patent expiry – we again emphasize immediately after the patent expiry, not during the lifetime of the patent. In other words, the bolar-provision allows generic manufacturer to use and make patented drug for conducting necessary trials to generate data to demonstrate bioequivalence and to prove the drug is similar to the reference product (as needed by the Drug Regulatory agencies) without the consent of the patentee. However, exemption under Sec. 107A (1) does not extend to use of patented drug to obtain the license to manufacture and distribute the generic drug before the patent expiry.
We would like to add a word of caution that the bolar-provision exempts use of patented product (drug) to generate necessary regulatory data, not use of patented product to obtain license to manufacture and distribute the drug before the patent expiry and not even to induce willful patent infringement. Usually applicability of the bolar-provision comes in use just couple of years before the patent expiry not at least 10-12 years before the expiration.
Now coming back to our main issue – whether the Delhi HC Dasatinib order contravenes Bolar-provision? Considering (1) the scope of Sec. 107A (1) allows “the use” of patented product to generate bioequivalence data and (2) Hetero while seeking generic drug approval would have generated and submitted the same to the DCGI, it seems there is no contravention of “bolar-provision” by the Delhi HC Dasatinib order. In fact, if the DCGI gives Hetero the approval for marketing and Hetero possibly launches the drug before patent expiry then in such case none of Hetero’s action will be exempted under Sec. 107A (1) and will definitely lead to a case of blatant willful infringement. It is quite unfortunate that exemption under Sec. 107A (1) is distortedly portrayed as statutory go-ahead for willful infringement.
On the lighter note, if Hetero has already conducted bioequivalence studies without having a bona fide intention to launch the generic drug after the patent expiry then Hetero cannot seek immunity under Sec. 107A (1) and has already made a case of patent infringement, possibly willful …

New Book Release: Patent Agent Examination

New Book Release: Patent Agent Examination

One of my close friend and indeed a dedicated and knowledgeable patent professional, Sheetal Chopra has recently wrote an interesting reference book on patents particularly for readers preparing and appearing for patent agent qualifying examination. This is a commendable effort by her to provide students as well as professionals who are aspiring to become patent agent with relevant study material useful for preparing and qualifying patent agent examination. Sheetal is a qualified organic chemist and registered patent agent with rich experience in handling complex patent issues while working with India’s largest global generic company Ranbaxy before joining FICCI. At FICCI, she has been very instrumental in raising industry’s concerns regarding intellectual property laws and policies, and also bridging much-needed gap between industry and policy-makers. Notably, she is been actively involved in conducting and promoting various IP awareness seminars and workshops across the country.

Her book surely will be of great resource for readers which not only explain the substantive and procedural patent laws in detail but also provide model answers to previous years’ question papers and useful tips on the viva voce. I am grateful to Sheetal for considering and giving me an opportunity to review her book before going into publication. And it is must recommended for those who are keen to understand Indian patent laws and looking to appear for patent agent qualifying examination. The book is published by LexisNexis the details of which can be found

Patent Office Rejects Valganciclovir PreGrant Opposition

Patent Office Rejects Valganciclovir PreGrant Opposition
The Chennai Patent Office has dismissed the pre-grant opposition (download pre-grant opposition decision) made by the Tamil Nadu Networking People with HIV/AIDS and the Indian Network for People living with HIV/AIDS (collectively hereinafter referred as the ‘the NGOs’) against the Application No. 959/MAS/1995 claiming antiviral drug compound Valganciclovir. The Chennai Patent Office was hearing the Valganciclovir pre-grant opposition after been directed by the Chennai High Court (download Chennai HC Order) to consider and hear the pre-grant opposition made by the NGOs who earlier filed a petition against the Chennai Patent Office decision for denying opportunity for hearing under the Section 25 (1) of the Patents Act, 1970 before the issuance of Patent No. 207232 for Valganciclovir. However, Roche later challenged the Chennai High Court order in the Supreme Court of India. The Supreme Court modified the order to add that “while deciding the above application (959/MAS/1995), the Assistant Controller shall take into account the pre-grant opposition filed in this case (which is on record) by respondent nos. 1 and 2 (NGOs) herein.” Also adding “The third respondent (Assistant Controller of Patent & Designs) need not consider any other pre-grant objection pursuant to this judgment.”

Valganciclovir PreGrant Opposition: A Case of Frivolous Objection I

Valganciclovir PreGrant Opposition: A Case of Frivolous Objection I

It seems to be that the Chennai Patent Office was quite correct in its approach not to consider giving opportunity of hearing for Valganciclovir pre-grant opposition filed by the Tamil Nadu Networking People with HIV/AIDS and the Indian Network for People living with HIV/AIDS (collectively hereinafter referred as ‘the NGOs’) which not only lacked substance to challenge the issuance of patent but also irrationally burdening the Indian Patent Office with legally absurd and unsupported objections. No doubt it takes no special efforts to make public statement quoting Valganciclovir a pre-1995 molecule not qualifying for patent protection but when it comes to patent law one do require pre-dated publications to corroborate the statement. This is what Valganciclovir pre-grant opposition seems to reflect that the NGOs just went on stating pre-1995 objection without any proper understanding and records to prove it. In their application for pre-grant opposition, the NGOs made objections on the following grounds namely:
(1) That the subject of any claim of the complete specification is not an invention within the meaning of this Act, or is not patentable under this Act under section 25(1)(f); and
(2) That the applicant has failed to disclose to the Controller of Patents the information required by section 8 or has furnished the information which in any material was false to his knowledge under section 25(1)(h).
The objections was raised relying on four supporting evidences submitted by the NGOs which include a copy of press release from Hoffman-La-Roche dated 2nd April 2001, a copy of European Patent No. EP 0694547A2, a copy of online European Patent Register, and a copy of US Patent No. 6083953. What is notably important to note that none of the supporting evidences was published before the priority date (and even the filing date) of Valganciclovir Application 959/MAS/1995 which is sufficiently enough for someone of Assistant Controller rank in the Indian Patent Office to acknowledge the fact that none of the evidences even adequate to uphold the pre-1995 objection. Now before going further into objections raised by the NGOs let us discuss what exactly pre-1995 argument mean? After India amended its patent law to allow patent applications for drug compounds under mail-box provision, it was well considered that drug compounds known prior to 1995 are not eligible for patent protection. In other words, it is consider that any drug compound known or published prior to 1995 (in short pre-1995 public disclosure) is not to be granted patent in India (the argument reasonably acceptable in patent law that any invention publicly known or published in literature cannot be patented). Based on such theory, the NGOs objected Valganciclovir patent application, however, while submitting the pre-grant opposition the NGOs went a step ahead on pre-1995 argument to conclude that any compound even though not published or reported prior to 1995 but was invented before 1995 is a pre-1995 public disclosure and not eligible for patent protection in India. Quoting section 25(1)(f), the NGOs argued that the Valganciclovir patent application ought to be rejected as it claims priority from a pre-1995 convention country application (precisely referring to Valganciclovir priority document i.e. US Serial No. 08/281,893 dated July 28, 1994). Again it is a well-known fact that a patent application is not considered to be in public domain till it is published which is usually made on completion of 18 months from the date of filing of application. Now considering that Valganciclovir priority document was filed on July 28, 1994 then the possible earliest date for its publication would have been January 27, 1996 (reasonably beyond 1995). Further to prove their pre-1995 argument, the NGOs submitted documents which are published on much later date of filing of Valganciclovir Indian Application. Obviously after reviewing the NGOs pre-1995 argument (i.e. an invention not published but invented before 1995 is a pre-1995 public disclosure) and inappropriate documents submitted to corroborate the objection, the Assistant Controller would have been in no better position to dismiss the pre-grant opposition. But what is even more interesting that the NGOs were so damn confident about their arguments that they in fact approached the Chennai High Court to order the Chennai Patent Office to consider their frivolous objections

U.S. patent statistics

When researching industries, companies and technology, have you ever stopped to consider what insight patent activity might provide?Patent activity is an indicator of technological activity, both foreign and domestic and therefore provides a unique perspective particularly for the economic activities of competitors and industries. By looking at the “who, where, what and when“ of patent activity, one can derive interesting information about technology and industry. Patent documents contain technical information not published elsewhere and as a result, can be a powerful tool for many uses other than the obvious ones.Since browsing through patent documents is not ideal when researching general trends within industries and geographic areas, this tutorial will guide you through the United States Patent and Trademark Office's website in order to locate pre-existing patent reports as well as show you how to create your own reports.What if you are are curious about technological development in the state of Connecticut? What if you are curious about the current technological trends in biotechnology?For this, consider discovering the wealth of information provided by patent statistics!

What is Patent Classification?

What is Patent Classification?A Patent Classification is a code used to categorize an invention. Classification are typically expressed as "482/1". The first number, 482, represents the class of invention. The number following the slash is the subclass of invention within the class. There are about 450 Classes
of invention and about 150,000 subclasses of invention in the USPC.Classes and subclasses have titles which provide a short description of the class or subclass. Classes and subclasses also have definitions which provide a more detailed explanation. Many Classes and subclasses have explicitly defined relationships to one another. Subclasses contain patents. In a sense, classes also contain patents but for classification purposes patents are always classified at the subclass level. That is one or more classifications (i.e., class/subclass designations) are assigned to each granted patent and each published application.Why is classification so important?While it is possible to search patents using keywords, the best way to conduct a comprehensive patent search is by Classification. By determining the Classification of an invention you eliminate any ambiguity that terminology may create.Please consider if something is truly new a common term (or name) does not yet exist. For example, before personal computers a mouse was nothing more than a rodent. Thus, having invented the first "Computer Input and Display Control" one would not be able to search for keyword "mouse."By determining classification you are able to search a group of patents that are similar to the one you are research. This makes it easier to determine patent infringement.A classification is used both as a tool for finding patents (patentability searches), and for assisting in the assignment of patent applications to examiners for examination purposes.Classifications have definitions.Classifications have hierarchical relationships to one another.

Electronic Filing System

Electronic Filing System
"The Department of Commerce is using the web to entirely change the way we interact with our customers. What eBay has done for auctions, we are trying to do for government. The EFS Pilot moves Commerce another step closer to going from a paper-based bureaucracy to an all-digital Department by the year 2002."
U.S. Commerce Secretary William M. Daley
The US Patent and Trademark Office is developing the Electronic Filing System (EFS) to allow the submission of patent applications electronically via the Internet. The USPTO has established as crucial to its Strategic Business Plan, the eventual goal of complete electronic filing of patent application submissions and the creation of an electronic workplace. The Electronic Filing System is one of several electronic commerce automated services to be provided to patent business customers

US Design Patents - Classification and Popularity

US Design Patents - Classification and Popularity
In the United States a design patent can be granted for a "new, original, and ornamental design for an article of manufacture". It may only have a single claim. A design patent lasts for 14 years from the date granted. Design patents MUST be for the design and not the function or utility of an invention. Where a design contains both functional and non-functional elements, the scope of the claim will be construed in order to identify the non-functional aspects of the design as shown in the patent. Furthermore, the scope is limited to the "overall ornamental visual impression". Designs that are hidden in their end use, or are necessary for the proper functioning of the device are not ornamental and therefore not patentable as a design patent. Below are a few examples, as well as an index of the 33 design classes. The column labeled "popularity" shows the relative number of patents in each class with an orange graph:
D04 Brushware (Pictured: Electric Toothbrush)(Assignee: Braun)
D06 Furnishings (Pictured: Task Chair)(Assignee: Herman Miller)
D09 Containers for Goods (Pictured: Chewing Gum Tin)(Assignee: Starbucks)
D10 Measuring Instruments (Pictured: Watch Dial)(Assignee: Seiko Watch Co.)
D12 Transportation (Pictured: Automobile body molding kit)(Assignee: Veilside)
D19 Office Supplies (Pictured: Duck Financial Transaction Card)(Assignee: Target)
D32 Cleaning Machines (Pictured: Vacuum Cleaner)(Assignee: Dyson)
D99 Miscellaneous (Pictured: Automated Teller Machine)(Assignee: Diebold)

Patent Searching

Patent Searching
The FreePatentsOnline search engine is one of the most powerful, fastest and easiest patent search engines on the web. Our search allows advanced search techniques such as word stemming, proximity searching, relevancy ranking and search term weighting to help you find exactly what you are looking for. And, our account features let you organize, annotate and share documents, and Alerts let you instantly be notified when new documents of interest are published.