Patent Notice

Patent Caution Notice that appeared in TOI, Mumbai. I am reserving an entire post on the same.

Paradigm shift in mindset of off-patent drug manufacturers paying rich dividends

The change in the mindset of off-patent drug manufacturers, or generic manufacturers, is paying rich dividends. Recent reports suggest that an Venus Remedies Ltd, a Chandigarh based company, has received a patent from the Indian patent office on a Novel Injectable Aceclofenac Formulation. The company has also received a patent from the European Patent Organization (EPO) for its anti-infective product, ''Sulbactomax''. The firm is now negotiating licensing deals with multinational pharma giants for the anti-infection product.

On the other hand, Bangalore based drug maker Avesthagen Ltd has received a 'process' patent for an arthritis drug. The arthritis drug is a bioequivalent of Amgen’s blockbuster medicine Enbrel that is used to treat rheumatoid arthritis. The company is planning to launch the drug by June 2012. However, the company says that it has no plans to manufacture drugs, and would outsource it while focusing on developing drugs.

The most important patent success story comes from Ahmedabad based pharma company, Troikaa Pharmaceuticals Ltd. The company has recently received a patent for ‘Dynapar AQ’, a diclofenac or painkiller injection, from the CIS countries CIS countries include Ukraine, Kazakhastan, Belarus, Uzbekistan, Turkmenistan, Kyrgyzstan, Russia among others. This is after the drug has gotten patent approval in Australia, and is awaiting patent approvals in US and Europe. Reportedly, the company has spent `3 crore on the patent protection endeavor.

All this comes after the latest media report estimates that in 2008-09, Indian companies such as Dr Reddys, Ranbaxy and Cadila Healthcare had filed over 500 applications with the Indian Patent Office. Others such as Natco, Sun Pharma, Wockhardt and Cipla have also sought patent for key drugs.

Inohelp Consulting Solutions Pvt. Ltd.

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Are the policies restricting access to quality legal education for professionals?

Gone are the days, when the term lawyer imaged a black robed guy sitting in a court chamber, or sometimes outside with an umbrella atop. Lawyers have moved from court chambers to carpeted bays of corporate offices. The practice has moved from saving shady criminals to merging two multi-national companies. From contending a family feud over a piece of land to getting injunctions over intellectual property infringement. Certainly, the legal profession is rapidly evolving, and so is the legal services industry. Cross-domain expertise is now highly sought. Company Secretaries well aware of business and compliance laws, Charted accountants that are versed with tax laws and PHDs that are well versed with patent laws are accepted with open arms, and of course remunerated very well. There is an optimistic demand in the industry for such professionals. The concerns remain regarding the supply. Is our legal education system able to quality train such professionals? I certainly do not think so.

The Bar Council of India, the body responsible for accreditation of courses at law schools, prescribes two streams of law courses required to be enrolled as an advocate viz. a 5 year integrated LLB degree open for students after 10+2 or 11+1, and a 3 year law course for graduates. The onus of choosing what to offer is on the law schools, and all of the top law schools including NLSIU, NLUI, NALSAR and NUJS, have opted to offer the 5 year integrated LLB degree (although initially few of the top law schools did offer 3 year LLB, but, then they gradually moved to the 5 year year program). This leaves graduates and professionals with very few options to pursue quality 3 year LLB education. The reasons for lack of 3 year LLB programs are best known to these law schools. Some suggest that by offering 5 year programs, students save an year in completing their education. However, most often than not saving an year lack of interest in students is quoted as an excuse. Is lack of interest really a justified reason? Again, I beg to disagree.

Recently, IIT Kharagpur started a 3 year LLB program restricted to engineers, doctors and post graduate in sciences, and it has been a huge success. The 3 year LLB program at University of Delhi (the only program for graduates that has some credibility and quality) has always been well attended by professionals from civil administration, police, corporate, and science and technology. Lately, the number of applications received by the university has increased by about 30 % in last 2 years. All this surely suggests an increase in awareness among professionals in pursuing legal education as a means for obtaining cross-domain expertise, and specifically meeting the demand of the industry, especially the legal industry.

Another reason given by administrators is that professionals do not consider study of law seriously, and only see it as a part time vocation. Law is serious business, and market forces cannot be allowed to govern studies in law. This argument though partly true, is not true in its entirety. Lackadaisical attitude has been prevalent in many quarters regarding legal education, wherein working professionals opt for LLB programs with a typical “ho jayega” (we will manage it somehow) attitude, and wherein graduates opt for LLB programs with a typical “kuch nahin se kuch to sahi” (better study law then do nothing).

However, this does not mandate closing the doors of quality education for professionals who are serious about studying law. I am sure, if given an opportunity of studying at top law schools of the country, a student will definitely think of means to balance his professional occupation with studies, and even might think of taking a sabbatical. If the policy makers believe that a professional is incapable of such balancing act, then I would like to politely mention that these indecisions are better than apprehensions of a typical teenager, who enters these top law schools. Moreover, maintaining minimum standards, such as minimum level of attendance, minimum passing marks, and who should pass and who shouldn’t is always in the hands of the administrators of universities.         

The old BCI rules (rule 5, 7 and 8 of section A) mandated all law schools to provide an option of lateral entry in their 5 year LLB courses, wherein graduate and post graduate students can enter the 3rd year of such programs. Notwithstanding, the concept of lateral entry might not be an attractive proposition anyway for professionals as this would mean studying with fellows, who are easily 5-6 years junior to them. This at least provided flexibility to graduates and post graduates to enter laterally into the 5 year LLB programs. However, these rules seem to have been scrapped and the latest set of BCI rules (rule 13 of Section A), prohibits such lateral entry and exit. 

Therefore, a review of 3 year LLB policy at top law schools is highly desirable, since the onus is completely on these schools to provide access to quality legal education to a sizable mass of students. Also, a review of lateral entry to 5 year LLB by the BCI might also provide means for professionals and graduates to pursue quality education. Until then it will be fair to say that our legal education system, which is supposed to teach justice, might be ignorantly or intentionally imparting injustice to lakhs and lakhs of law aspirants.

Inohelp Consulting Solutions Pvt. Ltd.

www.inohelp.com 

Pharma Cos against patent linkage - Government considering easing the linkage requirement

The pharmaceutical industry in India for long time has been opposing all efforts of Bayer Corporation to connect patent status of a drug to regulatory approvals. Their efforts to oppose have gotten more stronger.

In 2009, honorary High Court of Delhi in Cipla V. Bayer had smeared the efforts of Bayer to connect patent status of a drug with regulatory approvals. The High Court had ruled that grant of a patent on a drug and regulatory approvals for producing generic version of the same are two separate issues. Further, the court concluded that the drug approval authorities are under no obligation to look into the patent status of the drug and consequently deny regulatory approvals to generic manufacturers who want to manufacture the drug. The court also opined that regulatory approvals are only to ensure safety of the proposed generic version of a drug. However, later Bayer challenged the decision of the High Court in the Supreme Court. The hearing of the matter in the Supreme Court is scheduled to commence shortly.

Now, in a recent statement the pharmaceutical industry has appealed to the government to completely lay to rest the patent linkage issue. The industry has appealed to the government to remove the clause on 'Patent status' in Form-44 of D&C rules. 

Recently, reports have emerged that the Indian drug makers met health minister Ghulam Nabi Azad in Mumbai to strengthen their appeal. “The minister saw some sense in our recommendation and agreed to it. Why should the drug regulator have any linkage with the patent status of a drug?” said Daraa B. Patel, secretary general of the Indian Drug Manufacturers’ Association. This clearly shows that the proposal has been considered by the government, and the health ministry may move soon to remove a question on the patent status of a drug from the form that medicine companies. This is a big blow to Bayer’s efforts of connecting drug approval with patent status of a drug. 

Inohelp Consulting Solutions Pvt. Ltd.

www.inohelp.com

Ahmedabad and Tech Transfer 2010

Ahmedabad is just like any other city. Starts from a railway station situated in a noisy old area, moves into a clean and organized new area, and extends into the glitterati of malls. I have no doubts Ahmedabad can be easily counted in the league of Tier A cities, which includes our four metros, Banglore and Hyderabad. The people are helpful, cultured, and when it comes to doing business: "Guju ne khabar che ke dhando kem karo" [A guju knows how to go about doing business].    

The people of Ahmedabad have yet again displayed their ingenuity by hosting a first of the kind event in the country, The Tech transfer 2010. As I have already blogged, this event focused at auctioning patented/patent pending technologies. In fact, the event auctioned 48 technologies covered by 50 patents. I was fortunate to be the part of the event, and had a chance of meeting people academics and industry, who were serious about technology and highly aware about protecting technologies using the instrument of patents.

The event started with welcome addresses by Dr. Subodh Adeshara, Ex-commissioner food and Drugs Control  Administration, followed by introductory speeches from organizers. The event then moved into presentations on the 48 technologies from domains, such as API, Medical Devices, Herbal Drugs, and Biotechnology. A major attraction at the auction was a novel process for producing Gefitinib (Iressa), a drug which is used in treatment of non-small cell lung cancer. The novel process already has a granted patent in India. Other interesting technologies at the auction included a herbal drink that tastes like beer, a bio-insecticide product that attracts and kills mosquitoes using bird feather, an informational device for the blind, a transdermal patch for contraceptives drug delivery and a technology that can make a snake venom into analgesic that can help cure neuropathic pain. 

Before attending the event, I had an impression of a road show, wherein innovators will put up dedicated stalls displaying their inventions. Therefore, being presented technologies on power point slides by organizers came as a surprise. In my experience, no one can explain an invention better than the inventor. Hence, the event would have been better served if the innovators themselves explained their inventions to the buyers.

However, overall I would rate the event as a success. Wishing the organizers all the best for their future plans of holding such event at even grander stage. 

Ups:

1. Novel concept neatly put together

2. Great stage for innovators to showcase their technologies

3. Increased awareness in industry regarding patents. It was a pleasant surprise to meet people from other industries, such as software, and telecom attending the event.

Down

1. Lack of publicity

2. Small scale of the event

3. Unwelcoming and apprehensive organizers. Registrations were highly restrictive. Further, the organizers refrained from sharing details about innovators, and even patent numbers of the technologies. I think the organizers should appreciate that finding out these details from what all details they provided is not a very difficult task.

Inohelp Consulting Solutions Pvt. Ltd.

www.inohelp.com

Off to Ahmedabad for TECH TRANSFER 2010

Yes, finally decided to attend this first of this kind exhibition. I am off to Ahmedabad for the weekend. Thanks to Abhishek Pandurangi, Founder of Closer2patents.com for all the help.

Will reserve an entire post describing the event.

Take Care

Inohelp Consulting Solutions Pvt. Ltd.

www.inohelp.com

Exhibition showcasing patented inventions

While reading today's news bits, I was in for a surprise. The first ever exhibition on patented inventions is being held in the city of Ahmedabad. The exhibition named as “Promoting Innovative Cluster – TECH TRANSFER 2010" is organized by Skyquest Tech Group, a Global Technology Aggregator & Accelerator working in the areas of Life Sciences and Green Technologies.

Interestingly, the exhibition is a first of its kind patent showcase that has been organised in the country, where patent holders (sellers) and companies (potential buyers) will come face-to-face on the same platform to discuss, negotiate and strike a deal.

I could have attended the exhibition if my google alerts could have captured this event on time, too late to get the reservations in place it seems. I need to revise my google alert strategy to include keywords for capturing events like these.

Inohelp Consulting Solutions

www.inohelp.com

Cipla on a patent knock down spree - Successfully opposes Novartis’ Dulera patent

Cipla has continued its knocking down spree by successfully opposing Novartis’ Dulera patent. Dulera is an anti-asthma drug, which includes a combination Formoterol, and Mometasone furoate in a weight ratio of 1:1 to 1:1000. The drug was granted an Indian patent numbered 202350 in 2007. The grant of patent was opposed by Cipla by way of a post grant opposition filed in February 2008 on grounds including: Lack of inventive step and Insufficiency of Description. It is interesting to note that the drug has valid patents in jurisdictions including Europe, United States, Korea and Israel.

            Lack of Inventive Step or Obviousness

The drug was challenged on count of obviousness on basis of US patent nos. 5874063 (D1), 5674860 (D5) and WIPO publication no. WO9520393 (D2). The patent office acknowledged the following:

1. The prior art D1 teaches already an anti-asthmatic drug having Formoterol, and Mometasone furoate.
2. The weight ratio of 1:1 to 1:1000 as suggested in the impugned patent is obvious in light of D5, which teaches a combination therapy comprising Formoterol and Budenoside (steroid similar to Mometasone furoate) combined in a weight ratio of 1:60.
3. The prior art D2 teaches administration of Mometasone furoate along with other drugs including bronchodilator, such as albuterol. Accordingly, any skilled person will be motivated to combine the teachings of D1 with teachings of D2 to achieve the therapeutic results as taught by the impugned patent.

The ground of obviousness as contended by the patent office though seem easily deducible, might not be reasonable. However, I would like to reserve an entire post on an analysis of the same.

            Insufficient Description

Interestingly, the opponent submitted that the impugned patent though mentions about unexpected therapeutic benefits of the combination as claimed, there is no disclosure or data in the specification to substantiate the same. Accordingly, the claims of the impugned patent are not sufficiently described and ought to be revoked on this ground alone. The patent office seems to have agreed to the contention of the opponent.

           

This ground of Insufficient Description further highlights the importance of amending or altering a patent application based on requirements of Indian patent laws. In the present case, inclusion of data showing synergistic effects of the combination of Formoterol, and Mometasone furoate in a weight ratio of 1:1 to 1:1000 was absolute necessary not only to prevent insufficiency requirements, but also, to circumvent all doubts that may arise under section 3 (e) of the Indian patent act. However, seldom do patent law firms follow such practices. A mere forwarding of an application written by a foreign patent attorney to the Indian patent office may result in problems such as the one illustrated above. Although, the patent attorney handling this case may be let off the hook as the application was filed way back in 2001, before the introduction of the critical 2005 amendments.

We at Inohelp, follow a strict practice of reviewing all national phase or convention patent applications, and suggesting our client possible amendments in the complete specification before filing the application at the IPO. The acceptance of these amendments is on the discretion of the client, who we find seldom disagrees with the suggestions. 

Inohelp Consulting Solutions Pvt. Ltd.

www.inohelp.com

India’s efforts to protect traditional knowledge - Foils Danish and Chinese attempts of bio-piracy

India's effort to digitize its traditional knowledge in form of Traditional Knowledge Digital Library (TKDL) is paying rich dividends. Recently, Council of Scientific and Industrial Research (CSIR), the proprietor of the database, foiled the attempts of a Danish firm, Claras ApS, and a Chinese Firm, Livzon, of bio-piracy. The Danish firm tried to patent in Europe an invention relating to turmeric, cumin, ginger and onion as slimming agents. On the other hand, the Chinese firm tried to patent in Europe an invention relating to use of medicinal plants 'pudina' (mint) and 'kalamegha' (andrographis) for the treatment of H5N1 avian influenza or bird flu.  These efforts come after CSIR uploaded 900 yoga postures in the library in June to prevent attempts of patenting these postures anywhere in the world.

When in India, do what Indian Patent Offices (IPOs) do - Inohelp explores the necessity of amending PCT national phase or convention applications according to practices at IPO

Last year, close to 25,000 patent applications were filed in the Indian Patent Office by foreign applicants. Most of these applications either came through the Patent Cooperation Treaty (PCT) route, or came through the Paris convention route.

These PCT national phase or convention applications are usually forwarded by foreign patent attorneys to their Indian associate, which may be a patent filing and prosecuting firm, a law firm or an individual patent agent. The Indian associate prepares prescribed forms, and files the application along with prescribed fees at the Indian Patent Office (IPO).

A key aspect that may be involved in filing a PCT national phase or a convention application is modification or amendment of the parent application according to the best practices followed at the IPO. The parent application is usually drafted by a foreign attorney, who drafts the parent application according to the requirements and best practices accepted at the receiving patent office.

Accordingly, it becomes a strict duty of the Indian associate to amend the parent application according to the best practices of the IPO, which significantly differ from say practices at United States Patent and Trademark Office (USPTO).

At Inohelp, we conducted a study to determine a set of best practices followed at the IPO. For this, we analyzed the prosecution history of close to 50 granted patents to identify the set of best practices, and tried to determine examiner objections, which could have been easily avoided by making minor or appropriate amendments at the time of filing the PCT national phase or convention patent application.  Table 1 classifies practices in 3 categories related to sections of a complete patent specification: Description, Claims, Figures, and a category: Filing Formalities.

 The study concluded that if these minor and appropriate amendments are made to the PCT national phase or convention patent applications at the filing stage itself, a lot of examination time could be saved, leading to better and timely grants of the patents.

Unfortunately, the practice of modifying or amending the patent application according to the best practices is not religiously adopted by attorneys in India. The attorneys only amend sections, such as figures, or abstract, and refrain from amending claims and description section. The main reasons for such non-amendment may be inhibition on the part of an attorney to approach clients and suggest voluntary amendments. Moreover, such amendments may additionally involve efforts and separate formalities in terms of preparing additional forms, which attorneys may try to avoid. Therefore, attorneys may resort to a well accepted practice of filing the application as it is, allowing the patent office to raise the objections in the FER, and traversing the objections later. This wasteful effort may be avoided by adopting the patent application according to the best practices, some of which are as cited above, leading to speedy grant of a patent.

We at Inohelp, follow a strict practice of reviewing all national phase or convention patent applications, and suggesting our clients possible amendments in the complete specification before filing the application at the IPO. The acceptance of these amendments is on the discretion of the client, who we find seldom disagrees with the suggestions.

Inohelp Consulting Solutions Pvt. Ltd.

www.inohelp.com

High Court cracks down on frivolous pre-grant opposition practice - Orders patent office to publish grant of patents on its website

The High Court of Delhi cracked down heavily on the practice of filing frivolous pre-grant oppositions in the Indian patent system.

Section 25 (1) of the Indian Patent Act allows any interested party to oppose grant of a patent to an applicant, provided the opposition is instituted anytime before the grant of the patent. The pre-grant opposition could be on any of the 11 grounds mentioned in the act including lack of novelty, obviousness, and wrongful obtaining of an invention.

The court observed in (Snehlata V. UOI) that there has been a rampant exploitation of the mechanism of pre-grant oppositions to the detriment of a patent applicant. The court noticed that opponents use additional time (arising due to bureaucratic delays in issue of ‘certificate of grant’ to the applicant) to institute pre-grant opposition proceedings. The Indian patent laws mandate the patent office to dispose all pre-grant opposition proceedings before granting the patent. Consequently, institution of pre-grant oppositions in this additional time puts the patent applicant in disadvantage by further delaying the issue of certificate of grant.

The High Court order clarified that a patent is deemed to be granted on the date, when an order of grant is signed by controller of the patent office. Further, the court ordered the patent office to immediately place the order of grant on the patent office website so as to eliminate any such detrimental time gap. However, its been 2 weeks, still there seems to be no signs of any such orders uploaded on the Indian patent office website.

The decision is considered to be a landmark judgment in the Indian patent prosecution practice. For the first time, any court has interpreted what the date of grant is? This interpretation also clarifies that the patentees could enforce their patent rights from the date the order is passed by the patent office, rather than after the issue of certificate of grant.

Inohelp Consulting Solutions Pvt. Ltd.

www.inohelp.com

Blog Created on Sunday 8th August 2010

Blog created on Sunday, 8th August 2010.