Semiconductor Integrated Circuit Layout Design (SICLD)…… Unused Potential IP

When we indulge in conversations related to Intellectual Property, what typically comes to our mind are Patents or Trade Marks or Copyrights or maybe Geographical Indication (GI). Other Intellectual Property Protection Acts such as Industrial Designs and Semiconductor Integrated Circuits Layout Design Act (“SICLD” hereinafter) rarely attract our attention, hardly discussed and to utter surprise of all, being zero practiced so far.

Integrated circuits (ICs) form an integral part of every electronics device. To generate a desired output from a given input, electric signal has to pass through hundreds or even thousands of electrical/electronic components. A lay out is created to arrange these components in smallest possible area meeting the circuit requirement to gain some specific electrical output. With introduction of technologies such as very large scale integration (VLSI), and ultra large scale integration (ULSI), these circuits are getting further miniaturized day by day. To reduce power consumption and to enhance processing speed, new layouts designs are rolled out frequently, thanks to continuous research in the field.

An integrated circuit is an arrangement/pattern of transistors and other circuit elements on a semiconductor chip in accordance with a circuit that provides a logical electrical output. SICLD was introduced to protect layout of said unique arrangements of electrical components. Under this act “Layout-Design”, which essentially is the mask layout or floor planning of the integrated circuits, can be registered and protected.Information such as a procedure, process, system, program,and method of operation among others are exempted from protection.

India heavily depends on semiconductors imports to meet industry needs. Until last decade, 80-90% of semiconductors were imported from countries such as China, Japan, Korea among others. With initiatives like “Make in India”, “Digital India” and other efforts by newly formed government, promotion of local semiconductor manufacturing is logical. If statistics are to be believed, it is quite interesting to note that semiconductor import has come down to 65-70% during fiscal year 2014-15. According to Mr. Ashok Chandak, chairman of Indian electronics and semiconductor association (IESA), import may further come down to 50% during current fiscal year itself.

Prime Minister’s recent business tours, to countries such as China, Korea, Japan among others that are world’s leading semiconductor producers has attracted investment worth billions to India. With increase in number of companies that are willing to invest and setup their manufacturing units in India, semiconductor industry is going to see “Acche Din”.

Despite ever increasing research in electronics and semiconductors industry, it is hard to swallow the truth that there is little or zero awareness of SICLD. The fact is that the Indian SICLD Registry is still looking for first applicant to file an application. It is indeed depressing to see that the official gazette published by SICLD registry says “No Application Received” month after month, ever since it was first introduced.

With revival of semiconductor manufacturing in India, it is high time the SICLD registry also gets revived and makes way for “Acche Din” for itself. The registry with support of renowned law houses, can ensure something fabulous to attract layout design applications. Creating awareness through conferences, workshops, seminars and webinars can simply do wonders. Layout designs hold some unused and unturned potential.Who knows it may turn out to be best bet among all the intellectual properties during years to come.

About the Author: Lalit Suryavansi, Patent Associate at Khurana & Khurana, Advocates and IP Attorneys and can be reached at: lalit@khuranaandkhurana.com

Advocates as Patent Agents

In a landmark (and in a way divisive) judgment, Justice S. Tamilvanan of the Madras High Court, on 15th March 2013, allowed the writ petition filed by Mr. S.P. Chockalingam (W.P.No.8472 of 2006) and declared the amendments introduced to Section 126 of the Patents Act 1970, by Section 67 (a) of the Patents (Amendment) Act, 2005 (Act 15 of 2005) as illegal, unconstitutional, ultra vires, void and unenforceable. Thereby restoring the status quo on the patent agent qualification under the Indian Patent Act, 1970 as was in existence before the Patents (Amendment) Act of 2005.

Now in order to comprehend the impact of the Madras High Court judgment and to know as to why this judgment is important, we need to get into the genesis of Section 126 and the legislative history of its amendments.

The original 1970 draft of Section 126 clearly said that Citizens (and not Advocates), who are Indians, over the age of 21 and had a ‘degree from any university’ in India could be registered as Patent Agents provided they clear the qualification exam conducted by DIPP. And as far as Advocates, those enrolled with the Bar Council had the prospect of getting registered and practice as a Patent Agent.

The 2002 Patent (Amendment) Act brought with it a slight change in Section 126, changing the words ‘degree from any university’ to ‘degree in science, technology or engineering’ and other than that everything else remained the same as the original 1970 version.

And then came the 2005 Patent (Amendment) Act, which in the course of amending Section 67(a), deleted Section 126 (1)(c)(i), due to which the Advocates with Science and Engineering backgrounds also, now no longer had the liberty as a ‘matter of right’ to be qualified directly as Patent Agents. Instead they were now required to clear the qualifying examination just as other citizens had to.

Pained by the amendments (though I am not completely sure whether the anguish was for the amendment of 2005, or for both 2002 and 2005 amendments!), Advocate Chockalingam in 2006, filed a Writ Petition under Article 226 of the Constitution before the Madras High Court in quest of a writ declaring the deletion of the amendment of 2005. What the petitioner contended was that the amendment of 2005 which omitted ‘advocates’ from Section 126’s domain was unconstitutional with reference to Section 30 of the Advocates Act, read with Articles 14, 19(1)(g), and 21 of the Constitution of India. It was also very correctly pointed out by the Petitioner that when the Patents Act does not provide any qualifications for being an inventor, then how is it that there could be a qualification for an inventor’s inscribe.  The present system meant that, where in one hand Advocates are allowed to argue Patent Matters, on the other hand they cannot file patents for his/her clients. Thus proving his point that there was no application of mind while omitting the word ‘advocates’ from Section 126.

The Judge, after listening to the contentions of the Petitioner, met the ends of justice by finding it equitable to allow the writ petition and declare that the impugned amendment as illegal, unconstitutional, ultra vires, void and unenforceable.

Now there are certain humble observations that I would like to make, which tells me that this decision passed by the Madras High Court is actually not completely correct.

I identify with the point that asking Advocates with Science backgrounds to clear qualifying examination to be registered as a Patents Agent is unfair towards them, when other citizens with just the Science background can go ahead and get registered as Patent Agents by clearing the same qualification exam. But the fact of the matter is that Patents being a field very different from other fields of law, makes it hard for ‘social engineers’ to file Specifications (complete or provisional) as explained in the Patents Act. A registered Patent Agent, in this case being a ‘social engineer’ with no knowledge of how to file a Specification (and trust me when I opine this that an ordinary case draft filed by an Advocate which he is taught during his LLB or BL degrees is poles apart and much less complex if compared to a Patent Specification explained in the Patents Act) will eventually prove to be a grave matter of concern to an inventor who will probably have to lose out on his hard worked and hard thought invention, just because now according to the Madras High Court every ‘social engineer’ who has a Science Background, has with him/her, “as a matter of right” the liberty to file a Specification.

Also in addition to the above point, what is observed by me is the fact that from a bare reading of the judgment, it can also be concluded that the Madras High Court even wanted to hold Section 53 of the 2002 (Amendment) Act as unconstitutional, but perhaps failed just because there was no challenge made for the said provision by the Petitioner.

And now after several months have passed since the Judgment by Honorable Madras High Court, the IPO has neither Implemented the decision nor has it Appealed against it. And on the other hand, there are several Advocates who are getting inquisitive to know as to how they can get registered as Patent Agents. Meanwhile, the only development regarding the case being an RTI filed by Mr. S. Venkatesh to the IPO, to which he was given the reply by IPO that the decision has been appealed for and since it is pending, nothing can yet be operationalized. This comes at a time when Advocates around the nation are wondering as to how they would be getting a ‘Patent Agent Number’ for themselves and as to why there is no information regarding the appeal filed by IPO (no information is coming from the Petitioner either regarding receiving of appeal papers!). Whoever is pursuing this matter and is contacting IPO for the same is being given the similar reply as was given to Mr. S. Venkatesh.

So basically as things stand today, Advocates with science backgrounds can automatically get registered as a Patent Agent. And the sheer absurdity in it being that they don’t even need to know how a Patent Specification is filed! But given the fact that the Respondents in the case are Controller of Patents and Union of India, the Petitioner can soon expect an appeal (actually it is just not the Petitioner who is expecting, but several other ‘curious’ Advocates too!) since it would highly be unlikely of the Respondents to let go of the monopoly they had been enjoying for such a long period of time!

About the Author: Mr. ABIN SAM, interns at Khurana and Khurana, Advocates and IP Attorneys.

NPDC Supplementary Details

Patents are a major area of business proficiency nowadays and recently in India too, it has become as important as marketing, finance, corporate governance, and manufacturing economics. India’s growing R&D operations have taken a beating due to lack of in-house professionals to file patents applications. Even then, the numbers clearly indicate that there is a great deal of patenting activity going on among companies across India. Patent Specification, besides being the most important document in the entire patent registration procedure, is also considered to be one of the most complex Techno-Legal documents. Drafting of Patent Specification is a device of great importance and thus should not be left to a layman to design it. It is extremely important to use carefully selected language to describe an invention to satisfy requirements both in legal terms as well as in technical terms. Selection of the right words may prove tricky when the draft-person is an amateur. Unclear and indefinite languages used in the specification are always likely to draw competitors, or any person concerned to invalidate or oppose the patent or the patent application. And not only is the language significant, satisfying the requirements of patentability is equally vital.

And here is exactly where the National Patent Drafting Competition (NPDC) plays a crucial role in bringing greater awareness and respect for Patents in a coveted and competitive way. NPDC through its nationwide reach will aim to promote development of Patent Drafting as a Skill Set, encouraging more and more technical people to take up Patent Drafting as a Professional Competency and also identifying and honoring Top Patent Drafters in the Country. This initiative of NPDC comes with an earnest effort by IIPRD, its associates, leading sister Law Firm, Khurana & Khurana IP and Attorneys (K&K) and Sughrue Mion. Other partners serving us in this endeavour are TIFAC, PAAI, Spicy IP, IBLJ and Lex Witness.

NPDC commences on 1st of September 2015, when IIPRD and K&K will put forth on their respective websites (www.iiprd.com and www.khuranaandkhurana.com) three invention disclosures, one each in three different domains (Electronics/ Hi-Tech, Mechanical and Chemistry/Pharmaceuticals). The NPDC will be active till 20th September 2015, within which timeframe, Eligible Participants would need to write Complete Patent Specifications (along with Drawings, if applicable) which complies with the Indian Patent Act. Please note that one participant can file only one Patent Specification which will be one domain of his choice.

Complete details of the modus-operandi of the Competition can also be seen here.

Any Practitioner having a Technical/Science Background is eligible to participate in the Competition. So for instance, the Participant could be a student, a practicing Attorney, an in-house counsel, a scientist, a faculty, or any other stakeholder having a technical qualification.

In order to make sure only serious participants submit their Specifications, a Participation Fees of Rs. 1000/- is to be submitted by each Participant, which can either be paid by means of Bank Transfer (Bank Name: IIPRD, Account No. 19620210002476, UCO Bank, Greater Noida Branch, IFSC Code: UCBA0001962) or through Cheque/DD in favor of “IIPRD”. The Draft should reach IIPRD’s Office (E-13, UPSIDC Site IV, Behind Grand Venice, Greater Noida, 201310) by 20th September 2015. Each fee submission must be accompanied with the correct Name, Address, and Contact Details of the Participant so that Participation Certificate can be sent at the given Address to Each Participant.

Drafted Patent Specifications can either be sent to competition@iiprd.com or can be sent in Hard Copy to Physical Office of IIPRD, which is at “E-13, UPSIDC Site IV, Behind Grand Venice, Greater Noida”. In either of the ways, the Patent Specification Draft must be received by IIPRD on or before 20th September 2015.

Evaluation of the Drafts would be done collectively by representatives from each International Law Firm and Khurana & Khurana, IP Attorneys, coordinated by IIPRD. Their collective decision on selection of the Winners will stand final and shall not be open to change in any manner. The Winners will be decided based on a combination of numerous factors (such as flow of the Specification, Scope covered through embodiments, Claim drafting strategy and Accurary of technical coverage).

Two Winners shall be announced from each Domain (a total of 6 Winners) on 25th September 2015, through the websites of IIPRD, K&K, and its affiliates/associate. Prize Distribution Ceremony shall take place on 8th October 2015, at the Hotel Hilton, Mumbai at 1700hrs during the Annual International Pharmaceutical/Biotech Symposium organised by IIPRD. The First Winner for each technology domain would be given a Cash Prize of Rs. One Lakh Only (Rs.100000/) and the Second Winner,a Cash Prize of Rs. Fifty Thousand Only (Rs. 50000/-). All Winners will also get a chance to attend the Symposium as Honoured Guests and will also be awarded suitable Certificates. The travel cost and stay however, shall be borne by the Winners personally. If in any case the Winners are not able to come over for the Conference and Prize Distribution Ceremony, the Winners’ Amount shall alternatively be credited to their respective Accounts.

For any of your query/question, please feel free to write to competition@iiprd.com, and/or call 0120-4296878/2342010 and speak with Ms. Meenakshi Khurana.

About the Author: Mr. ABIN SAM, interns at Khurana and Khurana, Advocates and IP Attorneys.

CIPLA & BMS may settle patent dispute over Entecavir in India

US based pharma major Bristol-Myers Squibb (BMS) and Indian pharma company Cipla Ltd. are heading towards an amicable settlement on a long-stretched patent dispute concerning BMS’ hepatitis B drug Entecavir, a leading anti-viral drug for Hepatitis B patients that brings in more than a billion dollars each year globally for BMS.

Entecavir, being a pre-1995 molecule, was not patented in India as the Indian patent law did not provide patent protection for “products” till 1995. However, BMS filed a patent application for its once daily composition comprising Entecavir and got a patent in India for the same. The patent application (IN/PCT/2002/00891/MUM) was filed at Mumbai patent office by BMS in 2001 and it was granted (IN213457) in the year 2008.

Claim 1 of IN ‘457 read as:

  1. A pharmaceutical composition effective for once a day oral administration to treat Hepatitis B virus infection in a human adult patient comprising up to 1 % of entecavir, adhered to a carrier substrate of kind such as herein described, and pharmaceutically acceptable excipients such as herein described in an amount as herein described, wherein the said percentage is based on a total composition weight of 100 mg.

Claim 12 of IN ‘457 read as:

  1. A method of preparing a pharmaceutical composition of entecavir as claimed in claim 1 comprising (a) dissolving said entecavir and an adhesive substance in a solvent wherein said solvent is water or water having an acidic or basic pH, (b) spraying said solution obtained in step (a) onto a carrier substrate while said carrier substrate is in motion, (c) drying said coated carrier substrate from step (b) to remove said solvent, and (d) combining said dried coated carrier substrate from step (c) with other excepients as claimed herein above to form said pharmaceutical composition.

In 2010, Cipla, had filed a revocation application with the India’s Intellectual Property Appellate Board (IPAB) against BMS’ patent IN ‘457 covering a pharmaceutical composition comprising up to 1% of Entecavir effective for once a day oral administration to treat Hepatitis B virus infection in a human adult patient.

When the case came up before the IPAB, the counsel representing Bristol-Myers Squibb informed the patent tribunal that both the drug makers are in negotiations to settle the patent dispute. The IPAB bench comprising chairman justice KN Basha and DPS Parmar, technical member, patents, adjourned the matter since both the parties were exploring the possibilities of an amicable settlement.

BMS previously reached a settlement with Indian generic firm Natco Pharma concerning the drug. Natco and BMS had entered into a similar settlement over the Entecavir composition patent, after Natco had applied for revocation of the patent at the IPAB.

Generic drug producers such as Dr. Reddy’s and Cadila launched their generic versions of Entecavir (Baraclude) in India earlier in 2010 by designing around the once daily composition patent. Ranbaxy had also launched a generic product of the drug earlier in the Indian market.

US scenario of Entecavir: (Patent dispute between BMS & Teva)

Entecavir is protected by two patents in United States viz. US 5206244, product patent which covers the Entecavir molecule and US 6627224 which covers Entecavir compositions effective for once a day oral administration. Teva Pharmaceutical, an Isreal based generics major, challenged the Entecavir product patent in a US court and launched its generic version of Entecavir in US market. Teva successfully invalidated the Entecavir product patent based on obviousness ground and an appeal by BMS was denied by the US Court of Appeals for the Federal Circuit, in 2014.

About the Author: Antony David, Senior Patent Associate at Khurana & Khurana, Advocates and IP Attorneys and can be reached at: antony@khuranaandkhurana.com

Part 3 of 3: Patent Term Extension laws for Europe and the United States of America: compared and contrasted

This is third and last part of the three part series dedicated to the discussion on the comparison of the Patent Term Extension laws of Europe and the United States of America (USA). While part one of three, which discussed the comparison of terms used for the extension of patent term in Europe and the USA, relevant regulations, effective date of the regulations, authority to grant extension, and provisions of negative or zero extension, was more a kind of introductory one, second part took care of comparison on the basis of statutory requirements for the grant of extension along with possible interpretations of the relevant terms, scope of protection during the extended period of term, maximum number of extensions per product, maximum number of extensions per patent, calculation of period of extension, and this part is giving comparison of the total combined duration of market exclusivity of a general patent and extension, further extension of ‘extension of patent term’, patent term adjustment (PTA), period within which request for extension should be made, interim extension, application fees/ renewal fees, combination product, provision which may reduce the period of extension, terminal disclaimer and extension of patent term.

This table is continuation of the table 1 from part 1 and part 2

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About the Author: Swapnil Patil, Patent Associate at Khurana & Khurana, Advocates and IP Attorneys and can be reached at: swapnil@khuranaandkhurana.com

Part 2 of 3: Patent Term Extension laws for Europe and the United States of America: compared and contrasted

This is second part of the three part series dedicated to the discussion on the comparison of the Patent Term Extension laws of Europe and the United States of America (USA). While part one of three, which discussed the comparison of terms used for the extension of patent term in Europe and the USA, relevant regulations, effective date of the regulations, authority to grant extension, and provisions of negative or zero extension, was more a kind of introductory one, this part takes care of comparison on the basis of statutory requirements for the grant of extension along with possible interpretations of the relevant terms, scope of protection during the extended period of term, maximum number of extensions per product, maximum number of extensions per patent, calculation of period of extension, and third and last part of the series will give comparison of the total combined duration of market exclusivity of a general patent and extension, further extension of ‘extension of patent term’, patent term adjustment (PTA), period within which request for extension should be made, interim extension, application fees/ renewal fees, combination product, provision which may reduce the period of extension, terminal disclaimer and extension of patent term.

This table is continuation of the table 1 from part 1

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About the Author: Swapnil Patil, Patent Associate at Khurana & Khurana, Advocates and IP Attorneys and can be reached at: swapnil@khuranaandkhurana.com

Part 1 of 3: Patent Term Extension laws for Europe and the United States of America: compared and contrasted

Many people love comparing and contrasting and I am one of those (at least for study purposes). This time, I am comparing Patent Term Extension laws for Europe and the United States of America (USA). Though there are other provisions that may extend the life of patent such as patent term adjustment to compensate the delays due to patent offices, and paediatric exclusivity, I am specifically focusing on the patent term extension intended when the patent owner loses patent term during the early years of the patent because the product cannot be commercially marketed without approval from a regulatory agencies. Though Patent Term Extension laws in both the USA and Europe serve the same purpose, you will agree with me when I say that there are notable differences in the provisions of both. Products eligible for extension of patent term are not limited to human drug products, but this blog focuses more on them, somewhere references may also be found to medical devices, food additives, or color additives, animal drug products, and plant protection products. Unless otherwise specified, details discussed in this blog are related to human drug products/medicine products.  In the table 1, the Patent Term Extension laws for Europe and the USA are compared for easy understanding. Table 2 is for regulations governing Supplementary Protection Certificate and Table 3 is for calculation of extension period for the USA. As the discussion of this topic is quite lengthy one, I thought it fit to post it in series of three. While part one of three, which discusses the comparison of terms used for the extension of patent term in Europe and the USA, relevant regulations, effective date of the regulations, authority to grant extension, and provisions of negative or zero extension, is more a kind of introductory one, part two will take care of comparison on the basis of statutory requirements for the grant of extension along with possible interpretations of the relevant terms, scope of protection during the extended period of term, maximum number of extensions per product, maximum number of extensions per patent, calculation of period of extension, and third and last part of the series will give comparison of the total combined duration of market exclusivity of a general patent and extension, further extension of ‘extension of patent term’, patent term adjustment (PTA), period within which request for extension should be made, interim extension, application fees/ renewal fees, combination product, provision which may reduce the period of extension, terminal disclaimer and extension of patent term.

Table 1: Comparison Patent Term Extension laws for Europe and the USA

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Table 2: Regulations governing Supplementary Protection Certificate
 

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Table 3*: Calculation of extension period for the USA
 

*This table is for other than animal drug or veterinary biological products. Term of the patent shall be extended from the original expiration date of the patent, which shall include any patent term adjustment (PTA) granted under section 154 (b)

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The patent term extension of a patents that were issued before September 24, 1984, where the regulatory review period began and ended before September 24, 1984, were only function of the regulatory review period could be extended for more than five years.

About the Author: Swapnil Patil, Patent Associate at Khurana & Khurana, Advocates and IP Attorneys and can be reached at: swapnil@khuranaandkhurana.com

Recent Patent Litigation Cases (2014-15): India

Patent Litigation in India has steadily increased over last 2-3 years. Dramatic swift has been observed in the innovator’s perspective from the mere aspect of invention to gaining patent protection for their respective invention. Patent owners have adopted aggressive approach towards their patent protection and enforcing their proprietary rights as businesses, are now well-positioned in the realm of patent litigation.  The patent owners are not at all hesitant to challenge the validity of patent rights of their rivals. There has also been gradual increase in the understanding of the complex patent infringement and validity issues.

We will now deal with some of the recent and important patent litigation cases in India.

Merck vs. Glenmark over “Sitagliptin”

In an interesting note, Hon’ble Supreme Court of India on Special Leave Petition filed by Glenmark stayed the Delhi High Court order which passed injunction against Glenmark for the generic drug Sitagliptin till 28th April 2015. Merck Sharp & Dohme filed an application for an ad interim injunction restraining the respondent/defendant Glenmark Pharmaceuticals from using its patented product Sitagliptin (Indian Patent No. 209816) at the Supreme Court. The Delhi high court conclusively held that all the three ingredients (Prima facie, Irreparable injury and balance of convenience) for passing the order of injunction were established by MSD and hence injuncted Glenmark from manufacturing and selling of Zita and Zitamet.

Ericsson vs. Xiaomi

In December 2014, Ericsson had filed a suit against Xiaomi in India for the alleged infringement of the 8 standard-essential patents. The Delhi High Court granted an ex-parte injunction on the sale, manufacture, advertisement, and import of Xiaomi’s devices.

Xiaomi claimed that its latest devices in the Indian market (as of December 2014), the Mi3, Redmi1S and Redmi Note 4G, contained Qualcomm chipsets, which implemented technologies licensed by Ericsson. Xiaomi subsequently challenged the injunction before a Division Bench of the Delhi High Court, which issued temporary orders to allow Xiaomi to resume the sale, import, manufacture, and advertisement of its mobile devices subject to the following conditions:

  • Xiaomi would only sell devices having Qualcomm chips.
  • Xiaomi would deposit Rs. 100 towards royalty for every device it imported to India from the date of the launch of the device in India toJanuary 5, 2015. This amount was to be kept in a fixed deposit for three months during the proceeding of the case.

Novartis vs. Cipla

In another patent litigation case, Delhi High court barred Indian generic drugmaker Cipla from making or selling generic copy of Novartis’s “Onbrez” by giving temporary injunction to Novartis. Citing famous Roche vs Cipla case, the court observed that Novartis has a strong prima facia case and as the validity of the patent is not seriously questioned, there is a clear way out to grant injunction. Further, the court observed that Cipla did not provide any figures about the “inadequacy or shortfall in the supply of the drug.” Earlier Cipla lunched its generic version of Indacarterol in October claiming “urgent unmet need” for the drug in india.

Without going conventional way, Cipla, also approached the Department of Industrial Policy and Promotion (DIPP) to exercise its statutory powers under Section 66 and Section 92 (3) to revoke Indian Patents IN222346, IN230049, IN210047, IN230312 and IN214320 granted to Novartis AG for the drug Indacaterol. Cipla argued on the basis of 3 main points i.e. “epidemic” or a “public health crisis” of COPD, unable to manufacture the same in India by Patentee and high cost of patented drug.

Vringo Vs. ZTE

In January 2014, Vringo and Vringo Infrastructure filed a patent infringement suit in the Delhi High Court against ZTE, over the alleged infringement of its patent IN200572.

In February 2014, the Delhi High court granted an ad-interim ex-parte injunction restraining ZTE from importing, selling, advertising, installing or operating devices that comprise the infringing components. The High court also appointed local commissioners to inspect ZTE’s premises and instructed customs authorities to detain ZTE’s shipments that may contain such devices and to notify Vringo. In March 2014, ZTE appealed against the injunction, which was vacated on August 5 the same year with ZTE being ordered to deposit Rs. 17.85 crore to the court.

The suit is sub judice now. As of August 2014, ZTE had filed for the revocation of IN200572 on grounds of it not being innovative as well as for violating some statutory provisions under Section 64 of the Indian Patents Act.

Reference: http://inpublic.globenewswire.com/2014/09/02/VRINGO+PROVIDES+UPDATE+TO+SHAREHOLDERS+HUG1853040.html

Vringo vs. Asus

In April 2014, Vringo filed a patent infringement suit against AsusTek Computer Inc. in Delhi High Court. As per public updates issued by Vringo to its shareholders, Vringo has alleged the infringement of patent IN223183 entitled “Method and system for providing wireless communication using a context for message compression” by Asus in India.

Asus had claimed that in the context of IN 223183 it was using technology licensed to it by Google. In August 2014, Google filed a request to become a party to the proceedings.

Vringo had requested for an injunction on Asus’ use of the technology in India. The injunction has not been granted yet. No further information about the lawsuit is publicly available.

Reference: http://inpublic.globenewswire.com/2014/09/02/VRINGO+PROVIDES+UPDATE+TO+SHAREHOLDERS+HUG1853040.html

SYMED Labs vs. Glenmark Pharmaceuticals

In another case of SYMED Labs vs. Glenmark Pharmaceuticals, Symed Labs Ltd. had sued Glenmark Pharmaceuticals Laboratories before the Delhi High Court for allegedly infringing two of its patents: IN213062 & 213063. First patent was granted for “Novel intermediates for Linezolid and related compounds” while the ‘063 patent was granted for “A novel process for the preparation of linezolid and related compounds. While declaring the judgment on 9th Jan 2015, the judge convinced that the Plaintiff has got good prima facie case in favour of SYMED. Further the judge decided that protection to the patent processes ought to be granted to the Plaintiff as damages will not be an efficacious remedy. Thus, there will be irreparable loss and injury because of the long uninterrupted use of patents, the balance of convenience also lies in favour of the Plaintiff. Thus the judge granted an ad interim injunction restraining Glenmark from manufacturing, selling, offering for sale, advertising or directly or indirectly dealing in the production of Linezolid manufactured in a manner so as to result in infringement of the Plaintiff’s registered Patents.

Maj. (Retd.) Sukesh Behl & Anr. vs Koninklijke Phillips

In this litigation case, Sukesh Behl made a counter claim for revocation of the suit Patent No. 218255 under Section 64(1)(m) of the Patents Act, 1970 (for short “the Patents Act”) for non-compliance of the provisions of Section 8. Earlier in another suit Koninklijke Phillips sought for permanent injunction restraining Sukesh Behl from infringing its patent and for other incidental reliefs. While delivering the judgement, the judge answered the question of whether the failure to comply with the requirement of Section 8 of the Patents Act would invariably lead to the revocation of the suit patent under Section 64(1)(m) of the Patents Act, the word “may” employed in Section 64(1) indicates that the provision is directory and raises a presumption that the power of revocation of patents conferred under Section 64(1) is discretionary. Citing Chemtura case, the judge hold that the power to revoke a patent under Section 64(1) is discretionary and consequently it is necessary for the Court to consider the question as to whether the omission on the part of the plaintiff was intentional or whether it was a mere clerical and bonafide error. Finally, the judge dismiss the plea of Sukesh Behl for revocation of said patent under section 64 (1)(m).

Enercon vs. Dr. Aloys Wobben

In this land mark decision, Hon’ble Supreme Court of India addressed the multiplicity of patent proceeding cases with respect to Invalidation, opposition and revocation. Dr.Aloys Wobben has filed around 19 infringement suits before the High Court and Enercon India Limited have filed around 23 “revocation petitions” before the Appellate Board, praying for the revocation of the patents held in the name of the Dr. Wobben. The respondents had also filed “counter claims” to the “patent infringement suits” filed by the appellant.  Even though some revocation petitions have been settled by the IPAB, the same issues were being re-agitated by Enercon before the High Court. The Supreme Court of India following rules – firstly, if “any person interested” has filed proceedings under Section 25(2) of the Patents Act, the same would eclipse all similar rights available to the very same person under Section 64(1) of the Patents Act. This would include the right to file a “revocation petition” in the capacity of “any person interested” (under Section 64(1) of the Patents Act), as also, the right to seek the revocation of a patent in the capacity of a defendant through a “counter-claim” (also under Section 64(1) of the Patents Act). Secondly, if a “revocation petition” is filed by “any person interested” in exercise of the liberty vested in him under Section 64(1) of the Patents Act, prior to the institution of an “infringement suit” against him, he would be disentitled in law from seeking the revocation of the patent (on the basis whereof an “infringement suit” has been filed against him) through a “counter-claim”.  Clearly, this judgement laid a smooth road for complex patent litigation practices in India.

It would be interesting to note the developments that would take place in the Patent protection scenario in India and the gradual increase in the patent litigation cases in India.

About the Author: Mr Sitanshu Singh, Patent Associate at Khurana & Khurana, Advocates and IP Attorneys and can be reached at:Sitanshu@khuranaandkhurana.com

ROLE OF DOCUMENTATION IN PROTECTING TRADITIONAL KNOWLEDGE

Domestic and International laws prohibit patenting of traditional knowledge of any local community. However, the traditional knowledge, such as unique plants and their use is being usurped by unscrupulous players by patenting them in different countries. Only way to stall such moves is by providing prior art evidences proving that the knowledge was already available and practiced. Documentation of old references/books, therefore plays an important role in protecting the traditional knowledge.  The challenge exists with protecting the undocumented or the traditional knowledge available in local/ancient scripts.  In some cases, the traditional knowledge are also available in local stories, legends, folklore, rituals and songs, which are not property documented.

Importance of documentation can be appreciated by the fate of a patent application number CA2454171, filed by a US multinational firm, Metaproteomics LIc, at the Canada Intellectual Property Office. The application was titled “Curcuminoid compositions exhibiting synergistic inhibition of the expression and/ or activity of Cyclooxygenase-2″. The priority date of the application no CA2454171 was 17-Jul-2001 that was published on 30-Jan-2003. It claimed the usefulness of turmeric, apple, basil, kalamegha and licorice for the treatment of inflammation, psoriasis, gastritis and as anti-inflammatory to be novel.  The Traditional Knowledge Digital Library (TKDL), a unit of Council of Scientific & Industrial Research (CSIR), submitted prior art evidences in the form of references in books from 18th century to the 20th century citing evidences that turmeric, apple, basil, kalamegha and licorice have been used alone or in combination with a few other ingredients for the treatment of inflammation, psoriasis, gastritis and as anti-inflammatory in the Indian systems of medicine. The books that were used by TKDL for citing prior art of evidences includes  Khazaain-al-Advia,  Muheet-e-Azam, Vaidyamanorama, RasayogaSagara, Rajanighantauh, Bhavaprakasa, Siddhabhesajamanimala and Ilaaj-al-Amraaz.

By presenting these prior art references, India was successfully able to foil the firm’s bid to patent the medicinal use of turmeric.Based on TKDL evidences filed for the application no. CA2454171, CIPO declared the application as ‘Dead’ on 28-Sep-2012.

The Traditional Knowledge Digital Library has been playing a crucial role in protecting traditional Indian knowledge. The chronology to build up of the TKDL and their related activities is as under:

In Nov 2002, internationally recognized specifications and standards for setting up of Traditional Knowledge (TK) databases and registries based on TKDL specifications was formed that included TK experts from China, Philippines, India.

Access Policy Issue Committee (APIC) was constitution in August 2002, their responsibilities included:

  • Frame policies on accessing TKDL database
  • Decide on matters relating to dissemination of TKDL
  • Meet defensive and positive objectives of TKDL

In March 2003, the data abstraction work on 36,000 Ayurveda formulations for creating TKDL in five languages, i.e. English, German, Spanish, French and Japanese was completed. It was followed by a demo CD containing a sample of 500 formulations in October 2003.

A meeting held in June 2004 with the Health and Family Welfare Minister on providing access to TKDL database to European Patent Office (EPO). EPO requested access to TKDL in July 2005.

An approval on access to TKDL database was granted to International Patent Offices (IPOs) by Cabinet Committee on Economic Affairs in June 2006.The Access Agreement was sent to EPO in July 2006.

The US Patent and Trademark Office (USPTO) requested for access to TKDL database in December 2006. USPTO agreed in principle to TKDL Access Agreement in May 2009.

TKDL Access Agreement concluded with Canadian Intellectual Property Office (CIPO) in Sep 2010.

An international conference was held in Mar 2011 on ‘Utilization of the Traditional Knowledge Digital Library (TKDL) as a Model for the Protection of Traditional Knowledge’ that was organised by World Intellectual Property Organization (WIPO) and Council of Scientific & Industrial Research (CSIR).

First Amending Agreement to TKDL Access Agreement with EPO concluded in Jul 2012 and with CIPO in Aug 2012.

Similar to India’s TKDL, several other countries are creating libraries of their traditional knowledge, which is being actively used by patent authorities while deciding the patentability of new applications.

As can be observed from the activities of different organization working to protect the traditional knowledge from being patented, the primary issue lies with undocumented traditional knowledge or the documents existing in local languages.  Government institutions interested to protect the traditional knowledge of the local communities need to create a proper team for proactively documenting the undocumented practices/traditional knowledge. They should interact with local communities including tribal who poses huge traditional knowledge, collect the evidence of early uses and document it as per the specified format.  The instructions, such as Archaeological Survey of India can be used effectively to validate the early usage or to establish the claims of traditional knowledge.

References from:-http://www.csir.res.in/%5Ccsir%5Ctkdl%5Cmilestones.asp

About the Author: Mr Rakesh Kumar Gupta, Senior Patent Associate at Khurana & Khurana, Advocates and IP Attorneys and can be reached at: Rakesh@khuranaandkhurana.com

Improving Regulatory Transparency for New Medical Therapies Act

A new act passed in the U.S. house of representative: What will it protect? Patent exclusivity, non-patent exclusivity, or both? Anything else also it deals with?

The bill titled ‘A bill to amend the Controlled Substances Act with respect to drug scheduling recommendations by the Secretary of Health and Human Services, and with respect to registration of manufacturers and distributors seeking to conduct clinical testing, and for other purposes’ was passed on March 16th, 2015, in the U.S. House of Representatives, by voice vote H.R. 639, for an act which may be cited as ‘‘Improving Regulatory Transparency for New Medical Therapies Act’’.

The first comment which I give on this bill is, it will protect both Patent exclusivity and non-patent exclusivity in case of New Chemical Entities (NCEs) which that required scheduling decisions by the Drug Enforcement Administration (DEA) under the Controlled Substances Act (CSA) before the drug products could be placed on the market. How? Before I explain this, I would like to take you with me to the events in the recent past, which made essential to pass this bill.

But even before that read this:

Form FDA 356h without which NDA applications for controlled substances can’t be filed with FDA, prevents commercial marketing for controlled substances till they are scheduled by the DEA under the CSA, developers of controlled substances claim. If this is the case, what happens if FDA approves NDA before they are scheduled under CSA? When all important NCE exclusivity is triggered for that NCE? On the date of NDA approval by FDA itself? Or FDA waits till they are scheduled under CSA? Let’s find out what FDA should do on this (and also what it has done before). Let’s untravel to the past.

For three drug products having controlled substances as the Active Pharmaceutical Ingredient, Lacosamide tablets (VIMPAT, NDA no- N022253, approval date- October 28, 2008) by UCB INC and Perampanel tablets (FYCOMPA, NDA no- N202834, approval date- October 22, 2012) and Lorcaserin HCl tablets (BELVIQ, NDA no- N022529, approval date- June 27, 2012) by EISAI INC, NCE exclusivity was triggered by FDA on the date of approval. Yes, even before UCB INC and EISAI INC could place the drug on the market. For three products referred above dates on which they could be actually be marketed were June 09, 2009, January 02, 2014 and June 07, 2013 respectively. This led to UCB INC and EISAI INC filing citizen petitions to FDA, petition numbers FDA-2013-P-1397-0001 and FDA-2013-P-0884-0001 respectively. This was not surprising because, (erroneous) triggering of NCE exclusivity before one can market the drug was leading to reduction in the all valuable NCE period. For a blockbuster drug, this can lead to significantly high monetary loss. Though I do not intend to discuss importance of NCE exclusivity in depth here, would like to appreciate the importance of the same by drawing your attention to the fact it is the only exclusivity (amongst both patent and non-patent exclusivities) which blocks submission of ANDA and 505 (b) (2) applications at least for four years once it is triggered (those who knew this, please consider it as a reminder). It means shortening of NCE exclusivity caused due to erroneous triggering can lead to early entry of generics into the market. In fact, in case of Lacosamide, shortening of NCE exclusivity has lead to early filing of ANDA applications for its generic version.

In the petition dated July 25, 2013, filed by Eisai, it requested FDA to trigger NCE exclusivity only when FDA approves labeling incorporating the final schedule permits commercial marketing of the products. It also claims that FDA’s letters approving the products as safe and effective reinforce this requirement, stating “when the scheduling is finalized, you will need to make appropriate revisions to the package insert, the patient package insert and the carton and the immediate-container labels through supplementation of your NDA”.

Further in its petition, Eisai provided two solutions to resolve the issue at hand:

  1. First what FDA can opt is , if a Changes Being Effected (“CBE”) supplement is used to reflect DEA’s scheduling decision, “the day the CBE supplement is submitted with the necessary label changes is the day the sponsor can commercially market the product, and accordingly, should be the date for triggering the NCE exclusivity period, or
  2. FDA could determine that the date for triggering the NCE exclusivity period is the date the DEA scheduling order becomes effective as this is the date when a CBE supplement could be submitted to permit the sponsor to commercially market the product.

And in the petition dated November 18, 2013, UCB adopted the same rationale and requested FDA to start clock running on the NCE exclusivity from the date which it could actually enter the market.

In reply, FDA issued Citizen Petition Denial Response dated April 30, 2014 to Eisai and UCB, being firm by its stand that NCE exclusivity will be triggered only on the date at which FDA approves NDA. In doing so it gave reference of § 505(j)(5)(F)(ii) which deals with ANDA applications and § 505(c)(3)(E)(ii) (505(b)(2) which deals with 505(b)(2) application, which provides for the start of NCE on the date of the approval.

What followed this is, Eisai filed suit dated August 08, 2014, Eisai filed a Complaint in the U.S. District Court for the District of Columbia alleging that FDA erroneously triggered periods of 5-year NCE exclusivity for its two products at issue.

Meanwhile aggrieved by the slow speed of DEA to provide scheduling decisions, Eisai filed petition to Order Scheduling of FYCOMPA on August 19, 2013, which was denied by the U.S. Court of Appeals for the D.C. Circuit on October 22, 2013.

While litigation between Eisai and FDA is still pending, the bill “Improving Regulatory Transparency for New Medical Therapies Act” has been passed, which was first introduced on February 2, 2015.

This act with three sections has amended Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), Section 351 of the Public Health Service Act (42 U.S.C. 262), Section 512 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b), Section 571(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360 ccc(d)), Section 572 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360ccc–1), Section 573(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360ccc–2(c)) while dealing with ‘EFFECTIVE DATE OF APPROVAL’. These amendments seem to favor NCE developers. In order to improve practices related to ‘SCHEDULING OF NEWLY APPROVED DRUGS’, this bill has amended Section 201 of the Controlled Substances Act (21 U.S.C. 811). To ensure that no one who deserves patent exclusivity should miss out it, ‘EXTENSION OF PATENT TERM’ related procedures have also been taken care in the same section of the act (section no-2) along with ‘EFFECTIVE DATE OF APPROVAL’ and ‘SCHEDULING OF NEWLY APPROVED DRUGS’. Amendments to the 35 U.S. Code § 156 while dealing with ‘EXTENSION OF PATENT TERM’ touch the period during which application for Patent Term Extension may be submitted (within the sixty-day period beginning on the ‘covered date’), definition of which (covered date) has newly been inserted.

While section 1 of gives the title, section 3 offers provisions related to ‘ENHANCING NEW DRUG DEVELOPMENT’ by introducing amendments to Section 303 of the Controlled Substances Act (21 U.S.C. 823).

Once this bill is enacted, we can expect Orange book page for Perampanel and Lorcaserin HCl to display NCE exclusivities expiring on January 02, 2019 and June 07, 2018, respectively, beginning on the date when they actually could be marketed (unless FDA determines to offer the advantages to only those applicants who file their NDA after the date of the enactment).

Reference:

http://www.fdalawblog.net/

About the Author: Swapnil Patil, Patent Associate at Khurana & Khurana, Advocates and IP Attorneys and can be reached at: swapnil@khuranaandkhurana.com

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