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Indian Patent Office Categorized Examiners and Controllers into Technology Groups

Following earlier circular dated April 29, 2009, the Controller General of Patents P.H. Kurian in its latest circular dated May 13, 2009 has categorized Examiners and Controllers in all four patent offices into Technology Groups. The move is to uniform allotment of patent applications for examination at the Patent Offices as per field of expertise to the controllers/examiners and to further improve quality of patent examination. Each group is having a Group Leader. On the first Monday of every month, the Group Leader is likely to receive required number of files from the Record Section based on the serial order of the Request of Examination pending under the Group Subject. Files will be allotted to the group members after group discussion. Group 1 is for Chemistry and Allied Subjects covering chemistry, biochemistry, pharmaceuticals, agrochemicals and food. Group 2 is for Biotechnology, Microbiology and Allied Subjects. Group 3 is for Electrical, Electronics and Related Subjects covering electrical, electronics, computer, communication and biomedical engineering and physics. Group 4 is for Mechanical Engineering and Other Subjects covering mechanical, civil, textile engineering and other subjects not specified in other groups. As a patent pracititioner, this move is highly appreciable as this will not only able to improve quality of examination but also help patent agents to effectively prosecute patent applications and put across their technical opinions.

More Problems for Tarceva

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 India is not covered by granted ‘774 patent claiming Erlotinib hydrochloride but is a polymorphic Form B for which Roche do not hold a patent. Knowing that the Indian Courts are unfamiliar with even basic understanding of pharmaceutical patents and technical know-how of pharmaceutical science, Cipla opportunistically deceived the divisional bench by arguing that the ‘774 patent covering Erlotinib hydrochloride per se is a mere admixture of polymorph A and B of Erlotinib hydrochloride. Cipla further argued that since the ‘774 patent is admixture of polymorph A and B of Erlotinib hydrochloride and marketed Tarceva tablet is polymorphic Form B, Roche cannot sue them for the ‘774 patent. Further capitalizing on admixture of polymorph A and B story, Cipla also challenged the validity of the ‘774 patent arguing that polymorph are not patentable under section 3(d). Unfortunately, the divisional bench was so inclined by Cipla’s arguments that the Court penalized Roche to pay Cipla Rs. 5 Lakhs (approx. USD 10000) for making false case against Cipla for the drug Tarceva for which Roche did not yet hold a patent. Surprisingly, the divisional bench never even bothered to look into independent claim of the ‘774 patent which reads as –

“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 India that may worth nothing after issuance. At least such decisions will be enough to shatter confidence of small companies and inventors who spent a decent amount of money to file and procure patents in India. How such small companies and inventors will be able to enforce their patents (most of them even do not have enough money to fight litigations). Companies like Cipla will always take advantage of system shortcomings, sometimes playing trump card of public health for their business interests whereas research/innovation will continue to die the way it is dying in India for so many years, decades.

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.

Wyeth-Lupin Settles Effexor ER Patent Dispute

Business Standard reports on patent infringement settlement between Wyeth and Lupin over USD 3 billion antidepressant drug Effexor ER, generically known as Venlafaxine extended release capsule. As per the term of settlement, Lupin will be licensed to launch a generic version of the drug in the US after June 01, 2011, or earlier under certain circumstances (not disclosed) but not before January 01, 2011. Lupin earlier filed a paragraph IV certification challenging the validity or non-infringement to to Orange Book listed US Patent Nos. 6,274,171, 6,403,120 and 6,419,958. This settlement will give Lupin a definite launch date as OB listed patents for Effexor ER will run expiration till late September 2017, however, what would be really interesting is the profit margin that Lupin will possibly be making from this settlement considering that Wyeth had already made multiple settlements for the same drug with other generic drug manufacturers. Lupin settlement agreement is quite similar to Wyeth’s earlier settlement agreements with Impax Labs and Anchen Pharmaceuticals for the same drug. In July 2008 and November 2008, Wyeth under the terms of settlement licensed Impax and Anchen to launch their generic versions of the drug on or after June 01, 2011, or earlier under certain circumstances, but not before January 01, 2011 in return of certain percentage of profits from the generic sale. In October 2005, Wyeth settled patent lawsuit for the same drug with Teva and as per agreement licensed Teva to launch a generic version in July 01, 2010 in return of certain percentage of profits from the generic sale. In October 2007, in a significant development Wyeth issued a “Covenant Not to Sue” Sun Pharmaceuticals for generic tablet formulation of Effexor ER. Sun too filed a paragraph IV certification for the same drug. Wyeth seems to be moving good business strategy by avoiding any further legal cost in patent disputes and at the same time receiving certain percentage of profits from the generic competition.

Chantix Patent in Post Grant Proceeding

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 India under the brand name Champix. However, in past there had been an alarming and strong adverse reports related with the use of Varenicline causing a wide spectrum of injuries, including serious accidents and falls, potentially lethal cardiac rhythm disturbances, severe skin reactions, acute myocardial infarction, seizures, diabetes, psychosis, aggression and suicide (read here). In November 2007, the United States FDA issued a safety alert for Varenicline reporting cases of suicidal thoughts and aggressive and erratic behavior in patients taking Chantix. Report also described Chantix affecting patients’ ability to drive or operate machinery. Later in May 2008, the United States FDA issued another alert highlighting important revisions made to the prescribing information for Chantix. Earlier this year in February, CBC News reported that Health Canada received 818 complaints for Canadian patients, many of them reporting mood swings, depression or suicidal thoughts.

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 India. Particularly considering that in India, it is not unusual to buy prescription drugs without doctor’s prescription – Varenicline may seriously pose high risk to Indian patients. And what if Varenicline generic versions also steps in?

Cipla Took the Delhi High Court for a Ride

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 24^th April, the divisional bench at the Delhi HC dismissed an appeal made by Roche against a last year single judge decision (dated 19^th 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 India. We do not know what sort of precedent will be set by this judgment but feel that it will considerably question and distort image of Indian patent law. Let us move to our analysis on the judgment. Please note statements included in bracket in bold are our remarks.

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 India, further adding no sales figures for the product for India provided in the plaint.

(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 18^th 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?