It’s Ranbaxy versus FDA……Again!!

The Ghost of FDA continues to haunt Ranbaxy. After blacklisting all of its Indian facilities, the FDA (US Federal Drug Administration) has now annulled its tentative approval to grant Ranbaxy a market exclusivity which latter had procured for manufacturing generic versions of two off-patent drugs. This missed opportunity is going to cost Ranbaxy more than $200 million as per the analysts. FDA has found that the source of these drugs would have been Panota Sahib and Devas facilities that have been blacklisted for manufacturing lapses and other regulatory non-compliances way back in year 2008. The other factories at Mohali in Punjab and Toansa in Himachal Pradesh were blacklisted in last and this year respectively. There were speculations that the acquisition of Ranbaxy by Sun Pharmaceuticals might allay Ranbaxy’s troubles, but this incident has shattered that hope also.

Ranbaxy was granted a market exclusivity of 180 days after its Abbreviated New Drug Application (ANDA) was accepted by the USFDA with respect to two drugs. An ANDA is basically a tool provided under the Drug Price Competition and Patent Term Restoration Act, 1984 (also called the Hatch-Waxman Act) to allow flow of generic medicines by granting approvals without conducting duplicative clinical trials. The drugs involved here are the generic versions of Roche’s antiviral drug Valcyte and AstraZeneca’s heartburn pill Nexium. Ranbaxy was supposed to launch Nexicum by the month of May and market it till November, but that never happened. This made other generic companies come out of their coffins and demand the revocation of the exclusivity rights granted to Ranbaxy.

It is obvious for us to assume that Ranbaxy ought to have delivered upon its promise to market the generic drug after it procured market exclusivity rights for 180 days. Other generic manufacturers and general public was ultimately bearing the cost of this leeway for they still had to pay high price for the drug which was already off-patent. Nevertheless, my concern lies on a different platform here. Indian generic companies have been the target of USFDA for quite a long time now. The blacklisting of Ranbaxy’s facilities, however has taken this issue to a whole new level now for the number of warnings have suddenly surged after the incident. Cadila Pharmaceuticals was warned by the USFDA for not complying with the quality standards at its manufacturing factory situated at Akhileshwar in Gujarat this year. The exact reason was cited as inaction towards consumer complaints between 2011 and 2012 for unpleasant odours and impurities in its drugs. Drugs are meant to be unpleasant and assuming that the deft ‘consumers’ identified impurities, why it took USFDA three long years to issue the warning? Similarly, in the month of July this year, an Ahemadabad based drug-maker Marck Biosciences was issued a warning because of ‘Unclean Toilets and Decaying Frogs’ found in the facilities.

The bigger picture here portrays India as a soft target for the US policymakers and they have left no stone unturned to insert slabs in the shoes of the Indian Generic spearheads. One of the complainants in the present Ranbaxy’s case was the Attorney General of Connecticut who urged FDA to cancel Ranbaxy’s ANDA application. As per the June 2014 issue of a report released by CRISIL, the spurge in the number of actions launched by FDA on Indian drug facilities has nothing to do with a country specific bias and is aimed at “Boosting the US supply chain”. It also states that the balance sheet of Indian drugmakers is quite strong and will continue to remain healthy in the near future also. But the story of Ranbaxy speaks otherwise. It got acquired by other companies after its facilities got blacklisted. This year only, a Bangalore based Pharmaceutical company known as Medreich Ltd. was acquired by Meiji Holdings Ltd., a Japanese company for $290 million. In 2010, US based drug manufacturer Cambrex Corporation purchased 51% stake in India’s Zenara Pharma. Big companies though don’t get acquired that easily, but they have to keep shedding their leaves by selling their shareholdings to offset the losses.

India’s reputation as a reliable drug supplier has been blotted very succinctly by the US authorities. It may remain the biggest drug supplier to the United States but will never be able to retain the credibility for its goods like it was some years ago. It’s true that to some extent the companies have also been negligent, but the direct interference of a country’s department into our local periphery and the indifferent attitude of the Indian Government towards the plight of the Generic Drugmakers is quite whimsical. It’s time that government must come to aid these companies or they will be left with no option but to exhibit a parade in front of the US and Indian premiers this Republic Day with their flags down to display their plight.

Drug Maker ‘Novartis’ to Face the Cold

The Bull is all set to lock its horns once again. We all know of the famous Novartis v. Union of India case which spread waves of debates across the country hovering around the themes like monopoly v. affordability, innovation v. public good, rich v. the poor, etc. Then solicitor general of India, Mr. Paras Kuhad left no stone unturned to highlight the consequences of allowing Novartis’s patent application for Gleevec in India which ultimately convinced Supreme Court to dismiss Novartis’ appeal. While Novartis is still recovering from that blow, a Generic Drug manufacturer, Cipla, is all set to ruffle Novartis’ feathers by launching an attack on five of its patent for a drug called Onbrez.

Cipla Ltd. India’s fifth largest drug manufacturer, has requested the Government to revoke five patents harbored by the Swiss based pharmaceutical company, Novartis AG. These five patents are with respect to a drug called Onbrez/Arcapta (INN-Indacaterol), which is used to treat a very specific kind of respiratory disorder called Chronic Obstructive Pulmonary Disease (COPD) which is a very severe respiratory disorder caused mainly due to excessive tobacco smoking and prolonged exposure to air pollution. As per the estimates released by the World health Organization, COPD is all set to account for nearly 5% of Human deaths across the world by 2030 and as far as India is concerned, the estimates don’t look healthy at all. Number of people suffering from COPD in India is quite huge with estimates suggesting a hovering 30 million patients (and counting) suffering from COPD. This is for the reason why Cipla has also recommended the government to declare a "public health crisis" in India.

Section 66 of the Indian Patents Act vests the Central Government with the power to revoke a patent in public interest if it is exercised in a mischievous mode or if it is generally prejudicial to the public. The contention put forth in the alleged representation asserts that despite after being granted Patent for the said drug in year 2008, Novartis never manufactured the drug in India and is using the import route, that also in small quantity from Switzerland, to supply the same. As reported by The Economic Times on 30th October, only 54,000 units of drugs have been imported which is just a drop in the ocean compared to the thousands that is required to meet the demand. Besides, Cipla has also accused Novartis for extending single headed monopoly by filing five patents for the "same or similar substance" or "ever-greening" by Novartis.

This is the first instance in the history of India’s patent regime that a generic company has exhorted the Government under section 66 of the Patent Act 1970 to revoke a patent on the grounds of Public Interest. However, what remains noteworthy is the route that Cipla has adopted to question the patents. We had reported earlier this month about the Bombay High Court’s order approving the grant of compulsory license issued to a generic drug-maker called Natco Pharma on the grounds of Public Interest. Cipla could have applied for grant of a compulsory license under section 84 of the Patents Act and given the kind of strong precedent on its side, (also being the only precedent in India for CL) it would have a strong case against Novartis. But interestingly it didn’t even waited for the revocation of these patents and has already launched the generic version, priced at one-fifth the drug’s price, straightaway.

This is not the first time that there has been a smack-down between a foreign drug innovator company and Indian generic pharmaceutical company. And like every other time, activists and public welfare driven enthusiasts might be projecting the success of Cipla to mean victory for India, because ultimately the patients and sufferers will benefit. But I am of the view that the issue is no longer confined to a battle between good versus bad or a Branded versus Generic Drug Manufacturer. While we all know about the strategies of branded drug manufacturers to extend their monopoly for a longer periods (also referred to as ever greening), the commercial interests of generic drug-makers also cannot be ignored. This is for the reason why US, for instance, has rigorous quality standards for Generic Manufacturers before it launches its products apart from those relating to Public Interest. The rationale behind such stringent measures taken by Government(s) overseas raises various questions. Why Cipla didn’t waited for the revocation of impugned patents before launching its products? Why to seek revocation when obtaining a compulsory license would suffice? Does the concept of Public Interest indeed has some morals or is it just a tool to justify the acts of deliberate violation of patent rights? While the Department of Industrial Policy and Promotion (DIPP) examines the reference placed before it, it will be interesting to see how the matter moves forward. Novartis is an ardent protector of its patents and irrespective of what the central Government decides, the loosing party is going to knock the doors of Court.

And for those who are still fancying Cipla as a savior of mankind, here is a hitch. Shares of Cipla are trading 3.14% higher on National Stock Exchange since last 3 days.

Can anyone guess me the reason why??

Mouse Trapped: Dead Mouse v. Mickey Mouse!!

Mickey Mouse may be sweet, fun and loving on screen, but off the screen, Mickey is the Big Daddy. When someone tried to use Mickey’s iconic ears, he didn’t like it at all. The alleged offender is DJ Joel Thomas Zimmerman, a Canadian DJ. And this time, Mickey has even geared up, uh, I mean lawyered-up. Let me unfold the story for you so far.

Joel Zimmerman, also known as Deadmau5 as his stage name, wears a costume while performing on stage that resembles the signature Mickey Mouse head and ears. Hold on, I am not saying this. That's what The Walt Disney Company is going around and claiming. All this story dates back to July when Deadmau5 was offered to remix the Star Wars theme for the upcoming Disney's flick, Star Wars Rebels. And this offer was extended by none other than The Walt Disney's music division. Unfortunately, the ending was different from those in the Disney cartoons! A wolf in sheep’s clothing, Disney was already investigating Deadmau5's use of the trademark since the onset of this year. Zimmerman has already acquired trademark rights for the on stage costume in over 30 countries. Now Disney is pinged with the fact that the trademark obtained by Zimmerman would encompass a wide range of merchandise which will be similar to the iconic ears of Mickey Mouse.

The issue grabbed public attention through an array of tweets posted by Joel which went viral on the net space. He not only mocked Disney’s allegations, but also challenged Disney to ‘Lawyer up’ in the near future. A normal trademark issue thus got transformed into a high profile battle between two players who are ready give whatever it takes to legally haunt each other.

The infamous DJ has been using a mouse head in almost all his live appearances for over a decade now. Now Disney is claiming that Deadmau5's costume resembles Mickey Mouse silhouette and hence it has filed a formal opposition against Deadmau5 from obtaining trademark rights over his onstage logo. Up until now, Walt Disney had no issues. But the things went fuzzy when rather than defending itself, Deadmau5 decided to give Disney a taste of its own medicine. It figured out that Disney has been using its famous "Ghosts 'n' "Stuff" song in a video, for which Disney never sought permission from him. It thus sent it a counter cease and desist.

On September 2, Disney submitted a 171 page trademark filing at the U.S. Patent and Trademark Office, claiming that if Deadmau5 was granted the logo, then it would degrade the reputation and business of the parent company worldwide. In response Mickey dragging the DJ to the court, Zimmerman, who is now staring at a mammoth trademark prosecution, said that he had never granted the permission to Walt Disney to expend his song. A representative from Disney said in reply that there was no merit in Zimmerman’s statement.

Trademark battles can destroy the career of many artists. Disney slams full authority on all its trademarks and vigorously protects them. The question arises that why wear a Halloween mouse head in your appearances. Is it to gain sheer public attention, which would be thumbs up for Disney in the legal case. Or is Zimmerman just an avid performer? Why did Disney wait for 10 long years to press legal charges? Are the two mice similar? Will you really be confused between the two? To be fair and honest, it’s a tricky situation. With so many questions, let us see who gets out of the maze first; Dead Mouse or Mickey Mouse. That being said, Disney is a multi-billion dollar company and Zimmerman stands nowhere in front of them. Meanwhile, it has also came in to our knowledge that the battle has already cost Deadmau5 dearly. I just hope that Deadmau5 can offset its financial losses through this “free publicity” it is accruing from the net-space. But for now, chances are that Deadmau5 might become a legit dead mouse!

Lex Protector: Start-Up of the Year-Congrats Auro!!

Lex Protector International Law Office has been selected as the Start-up of the year for Intellectual Property field by the Silicon India Magazine in its October 2014 issue. It’s a proud moment for our dear friend Mr. Aurobinda Panda who spearheaded the firm after its establishment in year 2012. It’s an equally proud moment for me and Bhaskar who are actively working with Auro to strengthen its work-base. Lex Protector was started with a vision to establish a global reputation in the field of Intellectual Property Rights and with the grace of almighty, we are glad that we are progressing towards our goal briskly after successfully completing two challenging years. Aurobinda is also the founder of Quick Lex, a virtual online workplace (of-course Global) for law professionals, students and Academicians which is all set to launch next year.

Silicon India is a Globally Acclaimed magazine that prints articles and reports related to technology and business fields. The magazine has cited excerpts from their conversation with Auro to communicate the exact idea behind the formation of Lex Protector. I would personally like to thank Silicon India for acknowledging our efforts and for sparing a few pages of their October issue for our start-up among others that have achieved similar accolade in their respective fields.

While it’s still a long way to go, I am sure that this news will provide a much needed stimulus to the firm to help us strive towards our goals in the long run. We are making all efforts possible to implement our “learning by doing” concept at our work place and will try to make sure that it remains so in the near future also. Meanwhile, through this blog I would like congratulate the whole team for this small feast we have achieved at the end of this year and would request Auro to skip his budget worries for this week…….we deserve a treat buddy!!

Lex Protector: Start-Up of the Year-Congrats Auro!!

Lex Protector International Law Office has been selected as the Start-up of the year for Intellectual Property field by the Silicon India Magazine in its October 2014 issue. It’s a proud moment for our dear friend Mr. Aurobinda Panda who spearheaded the firm after its establishment in year 2012. It’s an equally proud moment for me and Bhaskar who are actively working with Auro to strengthen its work-base. Lex Protector was started with a vision to establish a global reputation in the field of Intellectual Property Rights and with the grace of almighty, we are glad that we are progressing towards our goal briskly after successfully completing two challenging years. Aurobinda is also the founder of Quick Lex, a virtual online workplace (of-course Global) for law professionals, students and Academicians which is all set to launch next year.

Silicon India is a Globally Acclaimed magazine that prints articles and reports related to technology and business fields. The magazine has cited excerpts from their conversation with Auro to communicate the exact idea behind the formation of Lex Protector. I would personally like to thank Silicon India for acknowledging our efforts and for sparing a few pages of their October issue for our start-up among others that have achieved similar accolade in their respective fields.

While it’s still a long way to go, I am sure that this news will provide a much needed stimulus to the firm to help us strive towards our goals in the long run. We are making all efforts possible to implement our “learning by doing” concept at our work place and will try to make sure that it remains so in the near future also. Meanwhile, through this blog I would like congratulate the whole team for this small feast we have achieved at the end of this year and would request Auro to skip his budget worries for this week…….we deserve a treat buddy!!

Apple: Too Hot for Chinese Menu!

A Beijing court’s judgment against Apple Inc. with respect to the validity of a patent held by Zhizhen Internet Technology, a Chinese company, is making headlines. Apple challenged Zhizhen's contention alleging that the patent rights of Zhizhen Internet Technology to a speech recognition technology were invalid and thus dragged the Shanghai based company to Beijing's Number One Intermediate People's Court to procure a verdict in its favour on the matter. Since the Lower court found no merit in the contentions made by Apple Inc., the company is now planning to bring the case to Beijing Higher People's Court, with the hope to reverse the original verdict after its initial efforts have been thwarted.

On more than one occasions, Apple has been down and out in China over patent-infringement case(s). In 2013, Zhizhen sued Apple laying claim that the company's Siri, which is used on iPhones, violates intellectual property rights in its speech-recognition technology. Zhizhen also accused Apple the same year for the violation of its intellectual property rights after Apple declared that Mandarin and Cantonese were being appended to the list of Siri's supported languages. Zhizhen maintained that it had filed a Patent application to the rudimentary technology in 2004 and was granted a patent after two years. Apple also sought to impede the case by calling for China's State Intellectual Property Office to invalidate the patent, but was shown a red signal.

Siri is a voice recognition software that permits users to inquire a virtual personal assistant with doubts or questions after which the virtual personal assistant responds through its natural language user interface accordingly. For example, it allows users to find train and flight times, shopping malls, restaurants, stock prices etc. Zhizhen volunteers as an app over Xiao i Robot in Apple's iOS .The Chinese company had issues with the method in which a person's speech is distinguished, recognized and examined through Siri.

The bombardment of trademark infringement claims against Apple in China is setting out to build up the steam. Some time ago, a chemical company registered a complaint against Apple for the Snow Leopard trademark, and now Zhizhen has filed this complaint about the much talked about “Siri” trademark. The dust around Siri was far from being settled, when Apple has faced a fresh slaughter recently, with the Chinese state broadcaster charging Apple’s "Frequent Locations" function of flummoxing Chinese security by alleging it to be a potential ‘security risk’ to the country. Clearly it is tough times ahead for Apple Inc. in its second largest market, China. This is not the first time that Apple has had problems in taming the Dragon. Taiwanese company Proview Electronics sued Apple in 2006, claiming the company infringed its trademark for the word 'iPad'. Apple had to settle the Trademark Dispute with Proview for a hovering $60 Million. After the multimillion-dollar settlement with Proview Technology, Chinese company Jiangsu Xeubao also filed a lawsuit against Apple, claiming its OS 'Snow Leopard' contravene Jiangsu Xeebao's trademark of its name. The company's logo Xuebao (雪豹) is the Chinese tantamount of ‘Snow Leopard’.

What is my conclusion? A little bit of greed is health. Everyone wants a slice of Apple, but China wants the whole damn pie! It seems Chinese firms will continue excruciating Apple until they own the company; there is simply no denial to that. On a serious note, if such a scenario persists, it won’t be far-fetched to argue that Apple might bid farewell the nation. While I continue my quest for something more juicy on this topic, you folks can stay tuned for more!