Tag Archives: novartis

News Snippet: Novartis sues Cipla for infringement of patents covering “Onbrez”

In a latest update, Novartis has sued Cipla for infringing its patents on “Onbrez” (Indacaterol) after Cipla lunched its generic version for Indacaterol in October claiming “urgent unmet need” for the drug in India.

Earlier, as we have reported here, Cipla approached Govt. of India to exercise its statutory powers to revoke the five patents covering Indacaterol granted to Novartis, which is yet to be decided.

Novartis requested high court to permanently restrain Cipla from manufacturing Indacaterol in any form and selling it in India. It also sought damages for infringing the five Indian patents covering Onbrez.. In reply, Cipla contended that “Onbrez” sold by Novartis is too expensive and is not easily available to the public. Delhi High Court has reserved its verdict on January 9 after hearing detailed arguments by both parties.


CIPLA’s plea for revocation of Novartis Patents for Onbrez may face major set back by the Government

As reported in TOI, the Indian Government has found very little merit in Cipla’s plea for waiver and cancellation of Patent rights for chronic obstructive pulmonary disease (COPD) drug over which Novartis has exclusive rights. We have reported on Cipla’s plea here.


Cipla, previously 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 and is currently selling under the brand name Onbrez. The said drug is one of the preferred medications for COPD.

The relevant sections 66 and 92 of the Indian Patents Act are as follows:

  1. Revocation under section 66:

Section 66 states “Where the Central Government is of opinion that a patent or the mode in which it is exercised is mischievous to the State or generally prejudicial to the public, it may, after giving the patentee an opportunity to be heard, make a declaration to that effect in the Official Gazette and thereupon the patent shall be deemed to be revoked”.

  1. Special provision for compulsory licences on notifications by Central Government

Section 92 (3) states Notwithstanding anything contained in sub-section (2), where the Controller is satisfied on consideration of the application referred to in clause (i) of sub-section (1) that it is necessary in—

(i) a circumstance of national emergency; or

(ii) a circumstance of extreme urgency; or

(iii) a case of public non-commercial use,

which may arise or is required, as the case may be, including public health crises, relating to Acquired Immuno Deficiency Syndrome, Human Immuno Deficiency Virus, tuberculosis, malaria or other epidemics, he shall not apply any procedure specified in section 87 in relation to that application for grant of licence under this section:

 Provided that the Controller shall, as soon as may be practicable, inform the patentee of the patent relating to the application for such non-application of section 87.”

Cipla’s Contention in the Representation:

  • Cipla argued that the causes of COPD are several and the sheer magnitude of the disease as per the publicly available data which is sufficient for the Central Government to invoke the provisions of Section 92 and to treat it as an “epidemic” or a “public health crisis”. Such exercise of power in the present case would be in consonance with the avowed purpose for which Section 92 has been enacted.
  • Cipla also contended that Novartis has been granted these patents since 2008-09 but has chosen not to manufacture the same in India. However, Novartis merely imports a negligible quantity of these products manufactured in Switzerland through its licensee Lupin Pharma as per its own data filed before the Patent office. As submitted by Novartis in IPO in Form 27, the import for the year 2013 is a meagre 53,844 units which do not satisfy even 4,500 patients annually which is a shortage is more than 99.97 percent.
  • Further Cipla contended that cost of the drug is also very high for a patient in India. The estimated cost of the drug Indacaterol as imported and sold by Lupin Limited, under the trademark Onbrez is about Rs.2000/- per month per patient. On the contrary, the proposed drug of Cipla under name UNIBREZ would be costing approximately Rs. 400 per month.

 It is pertinent to note that Section 66 has been invoked only on two occasions earlier. Firstly it was invoked for the case of a process patent granted to Agracetus, an American company for genetically engineered cotton cell lines. The said patent was revoked by the Central Government in the year 1994 keeping in mind public interest and the fact that genetically engineered cotton, being a product of concern for the national economy, particularly for agriculturists, ought not to be the subject matter of a patent monopoly. Secondly in 2012, a patent granted to Avesthagan Limited for a “synergistic ayurvedic/ functional food bioactive composition” i.e. the composition consisting of Jamun, Lavangpatti and Chandan to be used for treatment of Diabetes. In light of the public interest in using traditional knowledge for curing and treating Diabetes, the said patent was also revoked under Section 66 of the Act. However pertinently, both the patents were revoked due to cloud over patentable subject matter.

It would be prejudiced to comment on the fate of the matter at this stage. However as per TOI the Govt. may turn down the plea of Cipla for revocation of Novartis patent.

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

Cipla Files Representation with Govt. Seeking Revocation of Novartis’ Patents

It has been recently reported in Economic times that Cipla has filed representation with the government (Department of Industrial Policy & Promotion) seeking revocation of five patents of Novartis on indacaterol, a respiratory drug for the treatment of chronic obstructive pulmonary disease (COPD) and marketed as Onbrez by Novartis. The central government, under section 66 of the Indian Patent Act, has the power to revoke patent in public interest, after giving patentee an opportunity to be heard.

According to section 66,

“Where the Central Government is of opinion that a patent or the mode in which it is exercised is mischievous to the State or generally prejudicial to the public, it may, after giving the patentee an opportunity to be heard, make a declaration to that effect in the Official Gazette and thereupon the patent shall be deemed to be revoked.”

Cipla has launched its generic version of indacaterol and alleged that Novartis held patents on indacaterol since 2008-09 without manufacturing in India and importing only in negligible amounts, as a result of which there is an urgent and unmet need to provide this drug to patients at affordable prices. According to Cipla, it has potential to manufacture adequate quantities of the drug to make available in the country.  Cipla’s launched generic version of indaceterol is reported to be 1/5th of the price of Novartis’ Onbrez.

This is the first time that an Indian generic company has asked the government to revoke patents on the ground of public interest under section 66. Otherwise, the revocation has always been sought on grounds under section 64 (for example obviousness, anticipation, insufficient disclosure, violation of section 8, 3d etc.), whether an Indian company has filed a revocation petition or a counter claim in an infringement suit. However, public health and drug price play significant role in deciding a patent’s fate in India especially in context of Compulsory Licensing of patent as it happened in Natco’s case. Even in Roche v. Cipla, public health and pricing issues were considered by the India courts, although the decision at the High Court was based on merits of the case and not in public interest.

It is highly expected that Novartis will take a legal course to challenge Cipla’s launch. Novartis has been very active to protect patents for its one of the blockbuster anti-diabetic drugs vildaglipton in India. Novartis has sought, just a few months ago, quia timet interim injunctions against several Indian generic companies including Glenmark generics, Bajaj healthcare, Cadila healthcare, Alembic pharmaceuticals against alleged patent infringement of vildaglipton even before they actually launched their generic versions and after they obtained marketing approvals from DCGI.

Thus Novartis will most likely file patent infringement suits seeking interim/permanent injunctions restraining Cipla from manufacturing and selling generic version of indacaterol in India.

On another note, Cipla could also have applied to obtain a compulsory license to manufacture and sell indacaterol before launching the drug. All three grounds of granting compulsory license under section 84(1) viz. reasonable requirements of public not being met, drug non-affordability and non-working of patent in India could have been proved by Cipla. According to Cipla, Novartis declared import of meagre 53,844 units for the year 2013 which do not satisfy even 4500 patients annually where there are more than 1.5 crore patients in need of the drug. Cipla also urged the government to consider COPD as an epidemic worthy of being qualified as a “public health crisis” as it claims 50 lakh lives annually in India, which is more than the toll from HIV-AIDS, malaria, cancer and tuberculosis.

Till now, we are not aware of any case in India wherein the government has revoked the patent in public interest under section 66. The outcome of government opinion to revoke said patents is thus eagerly awaited. This would act as precedent for all similar future cases. And if the government decides to revoke the patent under this section, the ongoing conflict between multinational innovator companies and Indian generic companies is going to intensify. Innovator companies criticize that India has weak patent laws not in compliance with international standards, whereas Indian government takes a stand that its patent laws are in compliance with TRIPs standards and are designed to meet the objectives of drug availability, affordability and accessibility.

 About the Author: Meenakshi Khurana, Partner at Khurana & Khurana, Advocates and IP Attorneys and can be reached at: meenakshi@khuranaandkhurana.com

The Glivec saga in India is finally over

As it has been widely covered by media in and outside India, it is no new news to pharmaceutical and patent fraternity that Novartis has lost about 7 year long legal battle to secure a patent protection for its invention on beta crystalline form of imatinib mesylate in India.

A 112 page long Supreme Court judgement delivered by a Supreme Court (SC) bench comprising Justice Aftab Alam and Justice Ranjana Prakash Desai details a complete account of all events leading to appeal to Supreme Court and a historical account of India’s patent regime including policy decisions leading to amendment of section 3d in 2005, in addition to providing detailed discussion on entire facts of the case.

The whole pharmaceutical community around the world were eagerly waiting for the decision and particularly to know how the Supreme Court construes a controversial section 3d. We would discuss herein SC’s discussion and decision especially on section 3d.

Events leading to appeal to the Supreme Court

  1. Novartis filed a patent application 1602/MAS/1998 at the Indian Patent Office.
  2. Five pre-grant oppositions were filed by various Indian generic companies and the Cancer Patient Aid Association (CPAA).
  3. The Application was rejected by the Controller in 2006 after hearing 5 pre-grant oppositions.
  4. Novartis filed an appeal to Madras High Court. The appeal was eventually transferred to the Intellectual Property Appellate Board (IPAB) after its formation. Novartis also filed writ petitions challenging section 3d of the Indian Patent Act which were dismissed by the High Court after which no further action was taken by Novartis.
  5. IPAB upheld the Controller’s decision in 2009.
  6. Novartis filed an appeal to the Supreme Court in later in 2009.

What is Section 3d?

This case mainly revolves around whether the beta crystalline form of imatinib mesylate is hit by section 3d and thus unpatentable in India. There was a detailed discussion in the judgement on how section 3d is introduced and amended and how section 3d is a part of patentability criteria.

So, let us first see what section does section 3d mean: Section 3d bars patent protection to new forms (including salts, esters, polymorphs, crystalline forms, derivatives etc.) of known substances unless the new forms result in an enhancement of the known efficacy.

Supreme Court held that in this case, “known substance” is imatinib mesylate and not imatinib in free base

SC held that that the prior art patent US Patent No. 5,521,184 (Zimmermann patent) claiming imatinib, also discloses imatinib mesylate and the known substance with which the beta crystalline form must be compared to show enhanced efficacy thus should be imatinib mesylate and not imatinib in free base form.

Novartis in its arguments had compared beta crystalline form of imatinib mesylate with imatinib in free base form to prove enhanced efficacy (Novartis showed 30% enhanced bioavailability in beta crystalline form over imatinib in free base plus other physico-chemical properties as discussed hereinafter).

Evidence that proved that imatinib mesylate is disclosed in Zimmermann patent :

Zimmermann patent discloses imatinib in free base form and further discloses a broad coverage of pharmaceutical acceptable salts (including acid addition salts) generally where explicit disclosure of mesylate salt is not there. The patent is granted in 1998.

Novartis filed a new US patent on beta crystalline form of imatinib mesylate. The patent is granted in 2005.

NDA (New Drug Application) for Glivec or Gleevec was filed in 2001, where the active ingredient of the drug was stated as Imatinib mesylate.  Active ingredient, composition and method of use were also declared by Novartis to be covered by the Zimmermann patent.

Further, when Novartis sent a legal notice in 2004 to Natco, the company selling generic version of Glivec in UK, Novartis stated in the notice that the Zimmermann patent (EP equivalent) claims imatinib and its acid addition salts such as the mesylate salt.

The judges concluded based on the above evidence that imatinib mesylate is disclosed in Zimmermann patent and thus is a known substance with which beta crystalline form must be compared to show enhanced efficacy over the known substance.

Supreme Court held that “efficacy” in case of chemical substances, especially medicine, is “therapeutic efficacy”

Madras High Court earlier in this case held efficacy to mean therapeutic efficacy.

SC re-clarifies the meaning by saying,

“Efficacy means“the ability to produce a desired or intended result”….. Therefore, in the case of a medicine that claims to cure a disease, the test of efficacy can only be “therapeutic efficacy”……..What is evident, therefore, is that not all advantageous or beneficial properties are relevant, but only such properties that directly relate to efficacy, which in case of medicine, as seen above, is its therapeutic efficacy.”         (emphasis added)

Novartis tried to prove enhanced efficacy by showing better physico-chemical properties (such as better flow properties, better thermodynamic stability, lower hygroscopicity etc.) over imatinib in free base form. However SC held that these properties can give better processability, storability, stability etc. but cannot be said to possess enhanced efficacy (that is therapeutic efficay) over Imatinib Mesylate under section 3d.

Whether 30% increase in bioavailability is enhancement in therapeutic efficacy in this case?

SC clarifies that

“…just increased bioavailability alone may not necessarily lead to an enhancement of therapeutic efficacy. Whether or not an increase in bioavailability leads to an enhancement of therapeutic efficacy in any given case must be specifically claimed and established by research data.”

It was held that no evidence was provided by Novartis to prove that the beta crystalline form of Imatinib Mesylate shows an enhanced therapeutic efficacy (on molecular basis) over Imatinib free base in in vivo animal model.

SC thus finally concluded and held that the beta crystalline form of Imatinib Mesylate fails the test of section 3(d) and thus is unpatentable.


1. Efficacy in section 3d would be construed as the “therapeutic efficacy”, especially in case of inventions pertaining to chemical compounds in medicine.

2. How much “enhancement” in efficacy makes the new form to overcome 3d, is still open-an ended question?

3. Whether an increase in bioavailability is an increase in therapeutic efficacy would depend on a case to case basis. If a fact that an increase in bioavailability increases a therapeutic efficacy, is claimed and is established by research data (preferably in vivo), then section 3d could be overcome.

4. The judgement sets a legal precedent to all pending and forthcoming patent cases involving section 3d in India. However it is being discussed and speculated that judgement will act as only limited precedent because the judgement is very fact-specific.

5. (An obvious point) Generic companies, health activist groups and patients in India are very happy with the decision, whereas MNCs and innovator companies around the world condemned the decision.

About the Author: Ms. Meenakshi Khurana, Patent Attorney at Khurana & Khurana and can be reached at: Meenakshi@khuranaandkhurana.com

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Indian Pharmaceutical Industry Licensing Deals: Case Studies

  • Glenmark Pharmaceuticals

Glenmark, research-driven, global, integrated pharmaceutical company with Research Focus on Inflammatory Diseases, Metabolic Disorders and Pain has a presence in over 80 countries around the world.

The Company has a proven track record of entering into Licensing deals with Big Pharma and entered into Outlicensing deals in 2004 with Forest laboratories for Oglemilast, a drug that was potentially indicated for chronic obstructive pulmonary disorder (COPD) and asthma and was still in the Development Phase at the time of entering into the deal. The potential value of the deal was $ 190 million in US. Glenmark later entered into an agreement with Teijin Pharma Ltd in Japan for the same molecule where the deal value was $53 million. Till date, Glenmark has received $35 million from Forest and $6 million from Teijin.

In a case of In-licensing, Glenmark announced in 2005 a collaborative agreement with Napo Pharmaceuticals for Napo’s proprietary molecule Crofelemer, indicated for four distinct disease categories. Glenmark has Crofelemer rights for diarrhea Indications in 140 Countries. Currently the drug is into the Phase 3 trial and the product launch is expected to happen sometime in mid-2010.

Glenmark entered into an outlicensing agreement with Merck in 2006 for Melogliptin, an anti diabetes target. Glenmark received $ 31 million as upfront payment for the same. But, in an unfortunate development Merck decided to drop off the agreement due to a shift from the focus on anti diabetes segment (2008). Currently, Glenmark is developing the drug on its own and have completed the Phase IIb trials.

In 2007, Glenmark’s in-house developed molecule for a potential treatment of pain was outlicensed to Eli Lilly for an upfront payment of $ 45 million. Only a year after the deal, work on the clinical trial of the molecule was stalled. Both Glenmark & Eli Lilly are currently working on the way forward on the molecule.

Despite suffering setbacks from 2 out of 3 key licensing deals, spirits at Glenmark are high, courtesy the success it is enjoying in the Generics segment. Only last week, Glenmark Generics ltd, was able to ink 3 key agreements that has not only strengthened its position in the global generics market but also established Glenmark as an aggressive player that knows how to make maximum from an opportunity.

Following two patent law suits filed by Glenmark, Medicis Pharmaceutical came to an agreement with Glenmark to let the latter launch the former’s dermatological product Vanos in 2013, long before the patent is set to expire in 2023. In a separate arrangement, Glenmark and Medicis have agreed to jointly develop a product from the former’s pipeline to treat acne. Glenmark is to receive an upfront of $5 million from Medicis. Apart from this, Glenmark had entered into a licensing deal with Sanofi-Aventis for the development and commercialization of novel molecules to treat chronic pain. It has also announced a licensing deal with Par Pharmaceutical to market Ezetimibe tablets.

Very clearly, Glenmark’s business model involve a lot of in-licensing and out-licensing arrangements and the Company wish to ride upon the success of such deals to project itself as an innovation driven global pharmaceutical player. Add to it the rapidly rising of clout of Glenmark in Generics space and its deal-signing spree with pharma majors and it is not difficult to understand on why Glenmark is set to make its mark in the Global Pharmaceutical domain.

  • Dr Reddy’s Laboratories

Dr Reddy’s has been a frontrunner in many aspects of the Indian Pharmaceutical Industry Growth Story that has been witnessed by the globe. Licensing is one of such aspect. In fact, even during the times when India had just opened its gate to a global economy, Dr Reddy’s had inked its first Outlicensing deal.

In 1997, an in-house developed anti-diabetic molecule, DRF 2593 (Balaglitazone), was licensed to Novo Nordisk. In fact, with this deal Reddy’s became the first Indian pharmaceutical company to out-license an original molecule. But, late in 2004, after phase II studies, Novo Nordisk decided to terminate further clinical development of balaglitazone, as the phase II results did not suggest a sufficient competitive advantage for balaglitazone compared to existing products. Post this development, Dr Reddy’s entered into an agreement with Rheoscience for Balaglitazone (DRF 2593). As on January 2010, Blaglitazone (DRF 2593) Phase III clinical trials were announced.

A year later, Dr Reddy’s licensed another anti-diabetic molecule, DRF 2725 (Ragaglitazar), to Novo Nordisk. In 2003, Novo Nordisk, which had suspended trials on Ragaglitazar in 1999 on finding tumors in long-term animal studies, decided to terminate further trials on the molecule completely.

In 2001, Dr Reddy’s Out-licensed DRF 4158, a potential dual-acting insulin sensitizer, to Novartis for an upfront payment of US $55 million. Later in 2003, Novartis decided to discontinue working on DRF 4158, but continued collaborating with Reddy’s for additional development compound that is a dual-acting insulin sensitizer.

Despite a low success rate from its licensing deals, Dr Reddy’s went ahead with one of its molecule and despite criticism from its original licensing partner, Reddy’s now have successfully completed Phase III trials of the same molecule. This clearly depicts the conviction and faith in one’s abilities that Dr Reddy’s has demonstrated for its first in-house developed drug molecule. This in itself stands as a testimony to Dr Reddy’s capabilities to mark new beginnings for Indian Pharma Sector.

About the Author: Mr. Abhishek Sahay is a Senior Patent Consultant at Institute of Intellectual Property Research & Development (IIPRD). Currently, He is working on Patent Licensing Issues in the Life Sciences domain and some of his success stories can be found at http://iiprd.com. He can be reached at abhishek@iiprd.com.

Actavis and Novartis



The High Court, Court of Appeal has recently upheld a decision on Appeal from the High Court, Patents Court, that the Novartis’s European Patent (UK) 0948320, a sustained release formulation of Fluvastatin (a Cholesterol lowering drug), is invalid on the ground of obviousness.

Earlier in the Patents Court

Actavis claimed for the revocation of Novartis patent on grounds of obviousness and insufficiency in the Patents Court. There was also a counterclaim by Novartis for infringement of its patent. Novartis conceded that the claims as granted could not be granted and applied for their amendment.   The claim and counterclaim before Justice Warren is reported at Actavis UK Ltd v Novartis AG [2009] EWHC 41 (Ch) (16 January 2009) . The teaching of the patent was compared to the pleaded prior art and common general knowledge and the judge found that the patent was obvious. The claim on insufficiency however failed.  The Actavis’ preparation would have infringed the defendant’s patent had it been valid but in view of the finding of obviousness the counterclaim failed.

Advances In A Case And Analysis


Solubility: high and very high

Fluvastatin was a well-known statin available in an immediate release formulation in 1996 (priority date of the patent is October 1996). A dosage regime of a 40 mg capsule to be taken twice a day was well known by that date plus there was extensive knowledge of sustained release formulations generally. The patent suggests that there is a need for a sustained release formulation of Fluvastatin and in creating such a formulation, there is a problem of its high water solubility and that any of the conventional methods would not work.

Judge Lloyd says “the problem presented in the Patent was illusory”.

Patent is seeking to deal with a problem of high water solubility of Fluvastatin. However, there would be problem only at very high and very low solubility. The solubility of the drug is high and not very high and therefore Fluvastatin is not so highly soluble that the skilled person would expect it to be impossible or difficult to make a sustained release form.

Common General Knowledge and an Expectation of success

Although there was lurking in the Patents Court about some arguments about other claims namely 2, 3, 10 too, however, the only claim which really matters is claim 1, which is permitted to be amended by Justice Warren.

Claim 1 is as follows:

“A sustained release pharmaceutical composition comprising a water soluble salt of Fluvastatin as active ingredient and being selected from the group consisting of matrix formulations, diffusion-controlled membrane coated formulations and combination’s thereof, wherein the sustained release formulation releases the active ingredient over more than 3 hours.”

Actavis advanced a case that a sustained release form of Fluvastatin would be expected not only to be a more convenient formulation for patient compliance (the common perception in October 1996 was that a reduction from 2 doses daily to a single dose would result in improved patient compliance) but would be likely to have significant medical advantages, namely improved therapeutic effect and fewer side effects and hence there was a strong motive to create a sustained release form and a strong expectation that all three types of benefits would be obtained, the two medical and the convenience. The Judge rejected the “medical advantage” but accepted the “more convenient” advantage point.

The fact that an immediate release formulation was already available which could be taken at a dose of up to 40 mg once a day and up to 80 mg per day in two doses, was a part of the common general knowledge of the skilled team. As a result, the skilled team would have an expectation of being able to develop an 80 mg sustained release formulation with some clinical efficacy. It would however be uncertain about clinical efficacy, and there would be no strong expectation that it would be achieved. It would be unable to predict with anything approaching certainty that any reduction in the risk of side-effects would be achieved. The team might get better efficacy or fewer side effects, but it would certainly get better compliance.

The problem and solution gave the same answer and the Judge affirmed the invalidity of the Novartis Patent on the ground of obviousness. The problem was to produce a sustained release of fluvastain. And the solution was provided by any of the standard methods for such formulations, which was obvious. The problem is not to look for better medical effect as discussed above and thus the decision of the Patents Court was rightly upheld.

There was some dispute between the parties about the effect in the case of the decision of the in Conor Medsystems Incorporated v Angiotec Pharmaceuticals Incorporated.

In Conor, The patent claim in question was a taxol coated stent for treating restenosis and prior art claimed a use of stent coated with one of the drugs of the class of drugs to which taxol belonged to. The House of Courts held the patent to be not obvious as it was not obvious for taxon to show the same therapeutic effect.

However, this should always be kept in mind that the obviousness is a question of fact and is a multifactorial question. “The question of obviousness must be considered on the facts of each case. The court must consider the weight to be attached to any particular factor in the light of all the relevant circumstances. These may include such matters as the motive to find a solution to the problem the patent addresses, the number and extent of the possible avenues of research, the effort involved in pursuing them and the expectation of success.” Generics v Lundbeck[2007] RPC 32.

In Pozzoli terms the only difference between the prior art and the claim is the idea of making a sustained release formulation and for that there was a technical motivation. [Pozzoli v BDMO [2007] FSR 37)].  The “Problem and Solution approach” gave the same answer. The problem was to produce a sustained release form of Fluvastatin, which would be solved by any of the standard methods for such formulations. The problem was not to look for better medical effects and the Judge affirmed the invalidity of the Novartis Patent on basis on the ground of obviousness. Since this was one of the first cases after Conor, it is to be seen further whether the Conor would make any change in interpreting the issue of obviousness or not.

Case No: A3/2009/0675

About the Author: Ms. Meenakshi Khurana, a Senior Patent Consultant in Institute of Intellectual Property Research & Development (IIPRD) and can be reached: meenakshi@iiprd.com.