Friday, October 02, 2009
Saturday, July 25, 2009
Prior to the third amendment, the Indian patent law categorically barred patent protection not only to chemical and drug compounds and intermediates but also to pharmaceutical compositions, drug combinations, drug deliveries and any physical/chemical modification to chemical/drug compounds (such as polymorph, co-crystals, complexes, enantiomers and so on). However, ten-year transitional period provided by TRIPS agreement mandated
What differentiate patent law from other disciplines of law is that this is the only subject of law that specifically and particularly deals with advance science and latest technology. Obviously with the advancement of scientific research and technology, certain practices that may have well thought-out inventive almost a decade back has now become more or less a customary practice to a person skilled in the art. For example, almost 10-15 years back resolution of racemic mixture into isomers/enantiomers was novel and inventive practice considering the state of technology and scientific practice prevailing at that particular point of time but now it has become known and customary to an ordinary person skilled in the art. Similarly, concepts such as bilayer tablet or controlled release formulation using HPMC that may obviously thought inventive almost a decade (or two) back is now a common formulation practice. However, despite such practices becoming customary and obvious in state-of-the-art, patents are regularly been issued for inventions using /based on such practices. Unfortunately, the patent law is not able to keep in race with the changing technology and scientific practices and in many cases still scrutinizing inventions keeping in account decade old scientific practice. Such patents are now a major point of concern in healthcare industry, which not only hamper healthy competition but also create litigious market, and is often used as a part of business strategy positively referred as Product LifeCycle Management and negatively referred as Ever-greening.
History is witness that many countries in past, from time to time, amended their patent law to support their social and economic development and
In our continuing post, we will particularly discuss section 3(d) in detail and will also try to rationalize the spirit and scope of section 3(d). However, we will be happy to welcome comments from our readers on this post and their opinion on section 3(d). Hope we can bring some value and clarity to section 3(d).
Friday, July 24, 2009
This is further to my blog post on “Patent Prosecution Made Easy” which reflects the initiatives taken by DIPP in making the patent prosecution easier for the applicants upon recommendations given by FICCI’s IPR Division. We would like to inform our readers that a lot more has been achieved as a result of FICCI-DIPP Consultative Working Group on Patents, Designs and Trade Marks System in India (read here).
The IPO has issued a detailed Patent Office Procedures (POP) in an attempt to streamline the procedures of the Patent Office and the POP became effective on July 1st, 2009. Under the POP, all the functions of the Patent Office, except the administrative functions, are divided under different sections, fixing responsibilities on each individual functionary. There will be separate sections for initial receipt and screening of the patent applications, record management and information dissemination, general patent matters, examination and grant, and patent office journal.
The POP provides for quick digitization of the patent applications, including the amendments filed, in Optical Character Recognition (OCR) format and making it available online for public access. This is a welcome step as this will ease the prior art search of the filed documents which was otherwise not possible with the scanned digitized documents. Also, there are directions in the POP that ensures data verification at various levels before the application is made available to the public, so that the public is able to access the correct information. Now, by the implementation of the POP, the applicants and the patent agents will be able to easily identify the status of their applications and can easily track the movement of the applications. The applicant will easily come to know before which examiner the file is pending, for how long it is pending, etc.
Another major highlight of the POP is that now the information regarding the ‘Working of Patent’, i.e., the extent to which the patented invention has been worked in
Friday, July 17, 2009
Wednesday, July 15, 2009
Continuing from our last post where we briefly discussed about the background of rejection of patent application for beta-crystalline variant of imatinib mesylate, Novartis writ petition to challenge the Chennai Patent Office decision and finally the Appellate Board denying the patent application for beta-crystalline variant. Now we will discuss and analyze the findings of the Appellate Board. The main issues raised and discussed were – (1) priority date, (2) novelty/anticipation, (3) inventive step/non-obviousness, (4) selection patent, and (5) section 3(d).
Issue regarding the priority date was decided in the favor of Novartis citing judgment made by Calcutta High Court in Agouron Pharmaceuticals Inc. v. Controller of Patents (AID No. 2 of 2001). The Appellate Board specifically reasoned that issue of priority date for mail-box application need to be considered as per situation on the date of examination not from the date of filing of application.
Novelty/anticipation issue was also decided in favor of Novartis. The Appellate Board specifically reasoned that none of prior art references produced by the Opposing parties disclose or anticipated beta crystalline variant of imatinib mesylate. Discussing anticipation, the Appellate Board also acknowledged the doctrine of enablement and concluded that a person skilled in the art just cannot predict the polymorphism and prepare beta-crystalline imatinib mesylate from EP 0564409 (disclosing imatinib free base and salts thereof) disclosure.
Inventive-step/non-obviousness issue too was decided in favor of Novartis. The Appellate Board specifically reasoned that the Opposing parties has not submitted any evidence that any person has prepared imatinib mesylate and found it to be present only in beta-crystal form prior to the application for beta-crystalline imatinib mesylate. Apart from this, the Appellate Board combined the selection patent argument made by Novartis counsel to strengthen inventive-step of the beta-crystalline form.
Selection patent issue as we already mentioned in our last post, helped Novartis to constitute inventive step for its beta-crystalline imatinib mesylate. The Appellate Board reasoned following minimum guidelines for a patent to be a selection patent.
(1) Whether there is any statement in the specification where the nature of the invention concerns with some kind of selection.
(2) Whether the selection is from a class of substances which is already generally known.
(3) Whether the selected substance in new.
(4) Whether the selection is a result of any research by human intervention and ingenuity opposed to mere verifications.
(5) Whether the selection is unexpected or unpredictable.
(6) Whether the selected substance possesses any unexpected and advantageous property.
The Appellate Board found that patent application for beta-crystalline variant of imatinib mesylate satisfied all the minimum requirements of above guidelines (though we leave it for our readers to decide the merit of the Appellate Board reasoning to reach such satisfaction).
Saturday, July 11, 2009
The Intellectual Property Appellate Board (IPAB), so called specialized and apex body for patent and trademark disputes, has finally put the last nail in the three year old, high-profile dispute concerning the patentability of Novartis’s anticancer drug Glivec, specifically beta-crystalline variant of Imatinib Mesylate which earlier got rejected by the Indian Patent Office. Well we personally believe this was one of the important cases that possibly will be deciding factor for incremental patents in
The application for beta-crystalline Imatinib Mesylate (1062/MAS/1998) was filed by Novartis on July 17, 1998 claiming priority from corresponding Swiss application. Importantly, when Novartis filed the application in
On June 26, 2009, the Appellate Board finally denied to allow beta-crystalline imatinib mesylate application for grant of a patent. In its 192-pages decision (a copy of judgment can be found on the website of SpicyIP and we sincerely appreciate Shamnad for the same), the Appellate Board detailed the lengthy arguments and counter arguments made by the parties during the hearing focusing on issues of priority date, anticipation, inventive step, selection invention and section 3(d). Odd 133 pages discussed the arguments made by the parties, however, one of the arguments that we would like to make special mention is argument made by Novartis Counsel in support of patentability of beta-crystalline imatinib mesylate. Novartis counsel interestingly brought concept of selection invention in context of polymorph which was quite unlikely. This argument was strongly opposed by the defendants. The concept of selection invention is often discussed when a particularly compound/group of compounds is claimed from earlier known markush structure, even selection of specific salt of drug compound is considered to be selection invention. During the hearing, Novartis Counsel puzzled the Appellate Board by combining two different phenomenons to make case of selection patent, first selection of mesylate salt from large number of known salts of imatinib and second selection of beta-crystal. Interestingly, Novartis Counsel was successful in making the Appellate Board accept the argument for selection invention in context of polymorph application and also to consider that such selection constitute inventive step.
Friday, July 10, 2009
One of our great friend and well wisher,
The new mechanism of sending electronic communication will alleviate the burden of both the Patent Office and the applicants. The significance of electronic communications in the digital era has been reiterated time and again as the easiest mode of communication, with provisions for easy access and storage. Further, the applicants need not be physically present at the mailing address. Another major problem with paper communication was the delay in receiving the communication, which can even result in abandonment of the patent application. This issue also is resolved by resorting to the electronic mode of communication. Introduction of electronic correspondence is a boon for stakeholders as it will ease the task of patent prosecution in
Patent Circle would also like to thanks and appreciate the contribution and painstaking efforts made by Sheetal and FICCI in recommending and bringing constructive changes in the working of the Indian Patent Office. We hope their efforts and hardwork will continue to bring positive changes and transparency in the Indian patent system.
Wednesday, July 08, 2009
Friday, May 29, 2009
IPWatchdog is conducting voting for the top patent law blogs and has listed around 50 blogs to select from. Incidentally
Thursday, May 14, 2009
Wednesday, May 13, 2009
Revolutionary anticancer drug Tarceva seems to be moving more into problems now. Last month, the Delhi High Court in highly unexpected findings that may create setback for drug research companies in India concluded that if an active ingredient (Erlotinib hydrochloride) of the drug (Tarceva) is sold in a polymorphic Form then that active ingredient in not covered/protected by the compound (drug substance) patent. To cut short, Pfizer received Indian Patent No. 196774 (the ‘774 patent) for Erlotinib hydrochloride (corresponding of US 5,747,498) and had a pending application for polymorphic Form B of Erlotinib hydrochloride (corresponding of US 6,900,221) which eventually got rejected in pre-grant opposition filed by Cipla. Both corresponding US patents are listed with Orange Book as Tarceva marketed tablet formulation contain polymorphic Form B. Roche brought infringement suit against Cipla with respect to granted patent in India (the ‘774 patent) but in counter-claim Cipla argued (rather framed argument) that Tarceva sold in India is polymorphic Form B of Erlotinib hydrochloride and not Erlotinib hydrochloride per se covered by granted the ‘774 patent. The Court unhesitantly agreed with Cipla’s arguments that Tarceva sold in
“A novel [6,7-bis(2-methoxyethoxy)quinazolin-4-yl]-(3-ethynylphenyl) amine hydrochloride compound of the formula A.”
Clearly the independent claim is no where restricted to any polymorph form or admixture polymorph A and B of Erlotinib hydrochloride (as argued by Cipla). The independent claim is covering compound Erlotinib hydrochloride per se and technically such claim cannot be circumvented and designed around by any polymorphic Form of Erlotinib hydrochloride (even a fresher working in pharmaceutical patents reasonably knows that). Why the divisional bench do not refer to the claims of the ‘774 patent? Though after reading the case we feel even the divisional bench would have referred the claims of the ‘774 patent they would not have understood anything (we are least confident about the divisional bench familiarity with basic pharmaceutical science and claim construction). But what is really interesting is the tactic used by Cipla’s lawyers (though completely and technically fallacious) that worked in favor of Cipla. What Roche lawyers can do in a case where unexpected arguments were raised by Cipla’s lawyers (which they possibly never thought in wildest dream) and the divisional bench was not familiar with nuances of basic pharmaceutical science and patent? Just imagining what Roche counsels back in Swiss Headquarters thinking about the judgment?
At least this case gives a cautionary picture that patentees should not be surprised to hear any unexpected reasoning from the judiciary and may think twice before spending money in procuring patents in
Coming back to Tarceva, lately the United States Food and Drug Administration (FDA) announced a black box warning for Tarceva (read here). In a letter dated April 2009, Genentech and OSI said that there had been reports of patients suffering gastrointestinal perforations while undergoing Tarceva therapy. This risk is greatest for patients receiving concomitant anti-angiogenic agents, corticosteroids, NSAIDs, and/or taxane-based chemotherapy, or who have prior history of peptic ulceration or diverticular disease. According to the letter, some instances of perforation had been fatal. The letter also said that some Tarceva patients had developed bullous, blistering and exfoliative skin conditions, which in some cases were suggestive of Stevens-Johnson syndrome or toxic epidermal necrolysis. Finally, the letter warned that patients treated with Tarceva had experienced corneal perforation or ulceration. Other eye disorders including abnormal eyelash growth, keratoconjunctivitis sicca and keratitis, have also been observed with Tarceva treatment. Last year in October, we reported Tarceva post-approval study reported a death. Such studies and report are often done by Innovator to avoid any post-launch tragedy.
Monday, May 11, 2009
Wednesday, May 06, 2009
Pfizer is involved in a post-grant opposition proceeding for its patent covering hugely popular antismoking drug Chantix. The post-grant opposition is filed by Dr. Reddy’s Laboratories against the Indian Patent No. 204091 (the ‘091 patent) covering tartrate salt of Varenicline, the active ingredient of Chantix. The ‘091 patent is issued against the Application No. 863/MUMNP/2003 and corresponding of Orange Book listed US Patent Nos. 6,890,927 and 7,265,119. Last year in February, Pfizer launched the Varenicline prescription drug in
We really wonder and concern whether the Indian Drug Regulatory had taken the Varenicline adverse reports seriously enough (read Mint story) and into consideration before giving marketing approval in
Friday, May 01, 2009
Finally after quite a hectic work schedule, we got some time to bring analysis on recent judgment by the Delhi HC in a high-profile patent litigation case between Roche and Cipla. On 24th April, the divisional bench at the Delhi HC dismissed an appeal made by Roche against a last year single judge decision (dated 19th March 2008) that rejected their appeal for grant of temporary injunction to restrain Cipla from manufacturing, offering for sale, selling and exporting the drug Erlotinib. Almost every leading Indian newspaper covered judgment story, some even provided sort of expert analysis on the judgment. In fact, daily English newspaper Mint quoted “judgment certainly go down as a landmark ruling.” We made this judgment publicly available and downloadable on our blog for our readers on April 27. Hope many of our readers have already gone through the judgment and may also reviewed the decision for its merit both on legal and technical grounds. However, before we proceed with our (as usual) critical analysis on this judgment we would like to know from our readers – how many of our readers think the decision is a landmark judgment? And how many consider the judgment not only lacked to take into account basic technical knowledge but also lacked basic ABC of pharmaceutical patent, reflecting sheer inability of judiciary to handle even not so complex patent issues? Will this judgment possibly go down as a low of Indian patent law? We would surely love to know our readers’ comments on this. This judgment is not a mere judgment but an eye opener to many believing in intellectual property to rethink before investing in research and innovation in
After the single judge rejected Roche’s appeal for temporary injunction against Cipla, Roche appealed the single judge decision. However, before deciding the case, the divisional bench reviewed the proceedings and conclusion of the single judge. The divisional bench particularly noted two points in Roche’s plaint made before single judge – (1) Patent No. 196774 (the ‘774 patent) is granted for Erlotinib hydrochloride marketed as Tarceva, and (2) no details of the specification of the ‘774 patent or the x-ray diffraction of Tarceva or Cipla’s generic product (Erlocip) was indicated [wonder why XRD data is asked by the single judge/divisional bench, particularly when Roche filed for infringement of Erlotinib drug compound patent not a particular polymorph patent?]. The divisional bench also noted arguments made by Cipla before single judge against the injunction application which include the following notable points.
(1) questioned the date of grant of patent, and also argued patent could not be presumed to be valid unless it was more than six years old,
(2) argued invalidity of patent under section 3(d) and obvious to a person skilled in the art, particularly argued the alleged patented product (Erlotinib) is nothing but a derivative from Gefitinib,
(3) argued patent is not worked fully and commercially in
(4) argued public interest issue that the drug should be made available at cheap and affordable prices.
(5) placed US Pat. No. 6,900,221 (the ‘221 patent) on records filed by OSI for polymorphic Form B of Erlotinib hydrochloride. [this was interestingly deceptive move by Cipla]
The divisional bench also noted counter-claim arguments made by Cipla before single judge, most importantly the argument stating that the ‘221 patent clearly stated that the compound Erlotinib hydrochloride was a mixture of two polymorphs A&B and that one needed to separate and purify that polymorphic Form B so as to get to the claimed compound (Erlotinib) for acceptable efficacy. Further adding that the ‘221 patent clearly defeated the inventive step of alleged invention (the ‘774 patent). [Does this mean that later dated patent is a prior art for earlier dated patent? Quite a new concept framed by Cipla and that too for “compound per se patent”] Cipla further argued [now this is the trick that made real impact on deceiving and confusing both single judge as well as the divisional bench] the ‘774 patent had been obtained by the plaintiffs by suppression of material information stating that the patentee knowingly suppressed the fact that the claimed product is in the form of polymorph.
Cipla further filed an application to dismiss injunction suit before the single judge [this move put the final nail in the coffin]. Cipla argued that plaintiffs filed two separate applications for grant of patent in respect of the same chemical compound for polymorphic Form B. Further arguing the ‘774 patent is mixture of polymorphs A and B which was known to plaintiffs but never stated in the application made before the Patent Controller. Cipla also provided x-ray diffraction data of Tarceva before the single judge to show Tarceva tablets are polymorphic Form B, not mixture of A and B polymorph and based on x-ray data argued that Tarceva sold by Roche in India is covered by pending patent applications and not by granted ‘774 patent. [what a statement made against compound per se patent? Does this mean if an active ingredient of a drug is sold in a polymorphic form then active ingredient is not covered by compound per se patent?] Cipla further argued that case made by plaintiff is completely false and incorrect and also suppressed the fact that it has made two further patent applications for the same compound in polymorphic Form B.
During proceedings, the divisional bench particularly referred to polymorphic Form B story raised by Cipla and was of opinion that the ‘774 patent is for erlotinib hydrochloride polymorph A&B mixture and Tarceva is polymorphic Form B for which the plaintiffs did not yet hold a patent and therefore no prima facie case was made out by the plaintiffs as they were seeking an injunction against Cipla in respect of a drug for which they did not yet hold a patent. [Now this sounds something out of the world analysis that compound per se patent is circumvented by polymorph patent] The divisional bench also was of opinion that the story framed by Cipla had been suppressed by the plaintiffs both before the Controller of Patents as well as in the suit and on this sole ground injunction ought to have been refused. [Now what to expect further when the divisional bench already got preconceived by Cipla’s arguments, better Roche to forget thinking about fair judgment]
The divisional bench further was of opinion that the plaintiff were trying to mislead both the Court as well as Controller of Patents to the effect that polymorph B was subsumed in Polymorphs A and B after the divisional bench found patentee (plaintiff) argument made before the Controller of Patents that the closest prior art i.e. US ‘498 did not teach a compound of polymorph B free of polymorph A contradictory to later statement dated 18th August 2008 by plaintiff that the earlier compound (disclosed in the ‘498 patent) included all known and unknown polymorphs. [A statement technically and patently correct and widely known to any patent practitioner in pharmaceutical area] But the divisional court opined that if Tarceva correspond to polymorphs A and B then there was no need for the plaintiffs to have applied for a separate patent in respect of polymorph B. [Obviously the divisional bench seems not able to understand basic ABC of pharma patenting]. The divisional bench also pointed that polymorphic Form B of Erlotinib hydrochloride was not known to the plaintiffs at the time they applied for a patent for Erlotinib hydrochloride as a combination of polymorphs A and B and therefore polymorphic Form B could not be said to be subsumed in the compound of combination of polymorphs A and B.
The divisional bench further discusses more issues pertaining to polymorphic Form B, polymorphs A and B mixture which was unfortunately crude, irrational and technically absurd and bizarre to read and understand. We do not even know how to pen down into words, observations made by the divisional bench is not only laughable but also annoying to read. Interestingly the divisional bench was of opinion that an applicant for a patent of a pharmaceutical product be bound to disclose the details of all other applications made by the applicant for grant of patent of derivatives or forms of such product. Also, there are some statements made by the division bench which we have no clue such as this one – “the Controller of Patents has confused the tests of inventiveness with obviousness (page 42).” Interestingly, the divisional bench also was of opinion that the Controller finding about obviousness of Erlotinib hydrochloride during pre-grant opposition is not obviousness but was about anticipation. [Does the divisional bench really understand what anticipation means in patent law?] We would request our readers to please go through the text of judgment, line by line to feel depth of absurdity.
While considering arguments framed by Cipla and observations made by the divisional bench, the Court concluded that Cipla has been able to demonstrate prima facie case that Roche do not hold a patent yet for the drug Tarceva, which is the polymorphic Form B of the substance for which they hold a patent. [Landmark ruling that active ingredient sold in polymorphic form is not covered by drug compound patent!!!] The court also concluded that Roche failure to bring the fact about filing of patent application for polymorphic Form B to the notice of the Controller of Patents was not consistent with the requirement of a full disclosure. Finally the divisional bench fined Roche to pay Rs. 5 lakhs to Cipla. [God knows why?] Is Roche penalized because the story framed by Cipla was suppressed by them?
Tuesday, April 28, 2009
Monday, April 27, 2009
Sunday, April 26, 2009
Monday, April 20, 2009
Friday, April 17, 2009
Thursday, April 16, 2009
Wednesday, April 15, 2009
Friday, April 03, 2009
Thursday, April 02, 2009
Some time back we ran couple of thought provoking posts touching issues pertinent to the Delhi HC Dasatinib order. In our first post we particularly analyzed that both Bristol-Myer Squibb (BMS) and the Delhi High Court acted within the periphery of the law and the Delhi HC order nowhere created any sort of “patent-drug regulatory” linkage, an argument unnecessarily sensationalized and propagandized by newspaper media. In second post we tried to clear distorted arguments that the Delhi HC Dasatinib order contravenes Bolar-provision aka section 107A (1) but at the same time emphasized that exemption under sec. 107A (1) is not a statutory go-ahead for willful infringement. Now continuing from our earlier two posts, we will analyze two important aspects – (1) Enforcement of drug patents, and (2) Patent-drug regulatory linkage.
Enforcement is the heart of drug patents and in absence of proper enforcement policies a patent is not even worth a penny. Proper enforcement is not possible without regulated monitoring mechanism particularly in a country such as
Many countries both developed and developing made enforcement and monitoring of drug patents possible at drug regulatory level. Drug regulatory agencies in countries like
However, there is a strong section of people arguing that a mere marketing approval to a generic manufacturer (for the generic version of a patented drug) by the DCGI is not a violation of patent right under sec. 48 of the Patents Act, 1970 – the infringement is only possible when the generic manufacturer launches its product in market. Though we do have difference of opinion on this but still let us assume that in India the DCGI is not allowed to reject application for generic dossier of patented drug before the expiration of patent and generic manufacturers can obtain marketing approval for generic versions of patented drugs. In other words, obtaining marketing approval for generic version of patented drug is not an infringement of patent right which mean that a patentee has no legal stand for filing patent infringement suit based on presumption that the marketing approval will lead to product launch until and unless the generic manufacturer(s) launches its generic product in market. Now let’s put this situation into hypothetical case studies.