indian patent office considering disclosure of inn in pharma patent applications

According to the news published in economic times indian patent office is considering mandatory disclosure of inn (international non proprietary names) in patent application for pharmaceuticals.

This is another first of its kind provision patent office wants to include as nobody in the world even considered. The motive behind this consideration is to help examiners, generic industry and public as large as well. They said it would bring more clarity in identifying the pharmaceutical substance in the claimed product. Also it would help to weed out frivolous inventions by filing opposition to the same.

But on the other side body represntating the multinationals has opposed this move. According to them it is another burden  to innovator companies to comply with as they already dealing with section 8 and section 3d requirements. Another point of contention was that it is not always possible to innovator to disclose inn of exact compound, for example at the time of filing basic substance patent. Because hundreds of compounds are disclosed and claimed in patent when these compounds are in pre clinical or even in earlier phase. So it is not possible to exact disclose which one would be the active substance or pharmaceutical product.

The consultation was held on oct 9, where all four patent office and some law firms discused this issue. Patent office has also asked for the submissions regarding the same. Lets wait and watch what would be the next course of action by indian patent office against multinational companies, as ipo is already under pressure by these companies for not complying TRIPS.

Indian patent office starts functioning as ISA and IPEA

Indian patent office (IPO) has now started functioning as International Search Authority (ISA) and International Preliminary Examining Authority (IPEA) under the PCT from 15th October 2013. IPO will search and examine patents filed under the Patent Classification Treaty (PCT). This is a major development and in itself is a huge responsibility for the Indian Patent Office.

The PCT, which currently has 17 nations acting as ISAs and IPEAs, enables inventions to be protected in each of the 148 contracting states. Indian Patent Office has certain advantages like reasonably low official fees charged for different categories as compared to other nations which are designated as ISA and IPEA. Also being the only English speaking nation in the Asian region to be recognized as an ISA/IPEA would mean that several international applications received by WIPO under the Patents Cooperation Treaty would be sent to the Indian Patent Offices for search and preliminary examination purposes.

Fees and Charges to be charged by IPO while functioning as ISA and IPEA:-

Kind of fee or charge Amount (Indian rupees)

Search fee (Rule 16.1(a))                                             10000 (2500)1

Additional fee (Rule 40.2(a))                                       10000 (2500)1

Protest fee (Rule 40.2(e) and 68.3(e))                          4000 (1000)1

Late furnishing fee (Rule 13ter.1(c) and 13ter.2)        4000 (1000)1

Preliminary examination fee (Rule 58.1(b)):

– where the international search report

was issued by the Authority                                         10000 (2500)1

– in other cases                                                             12000 (3000)1

Late payment fee for preliminary examination [amount as set out in Rule 58bis2]

Additional fee (Rule 68.3(a)):

– where the international search report

was issued by the Authority                                         10000 (2500)1

– in other cases                                                             12000 (3000)1

Cost of copies (Rules 44.3(b), 71.2(b) and 94.2)/page   4   
1 - individual entity

But this major leap forward comes with daunting challenge of dealing with the backlog of applications. Already IPO is running very much behind its schedule, it is interesting to see the developments and efforts that would be taken by IPO to deal with the situation. 

 

Claims Involving the Skills of the Physician Fall under Method of Treatment Claims and therefore Unpatentable Subject Matter

In most of the Jurisdictions, claims related to method of treatment and allied human surgical processes are not patentable including Europe, Canada, India etc. Lots of debate is going on what actually the scope of these treatments, what areas come under treatment scope and how claims should be drafted to avoid objection of unpatentable subject matter.

Last month, Federal court-Canada handed down interesting decision in Novartis Vs Cobalt case. Federal court rejected the obviousness ground but dismissed the patent on basis of unpatentable subject matter asserted by Cobalt. This particular case is related to Zoledronic acid and product covered therein. Cobalt seeks approval by way of a Notice of Compliance from the Minister of Health to market a generic version of Novartis ACLASTA drug in Canada. Novartis brought an application for an order prohibiting the Minister of Health from issuing a Notice of Compliance to Cobalt Pharmaceuticals Company for its drug containing zoledronic acid until the expiry of Canadian Patent No. 2,410,201.

As to validity, Cobalt asserted mainly two grounds for the revocation of patent:

1. Obviousness; and

2. Is the subject matter ineligible for patent protection – is it a method of medical treatment?

I would summarize mainly on later part as court rejected the cobalt’s former allegation as to obviousness.

THE CLAIMS OF THE '201 PATENT 

The claims at issue - claims 1 to 36 - can be considered as being in different groups; each with a general claim, followed by more specific claims.

There are 5 types of claims in the Patent:

a. Claims 1-9 are Swiss-type claims, in that they relate to the use of ZA in the manufacture of a medicament;

b. Claims 10-18 are use claims, in that they relate to the use of ZA;

c. Claims 19-27 are claims to a compound (i.e. ZA);

d. Claims 28-36 are claims to a pharmaceutical composition containing ZA; and

e. Claims 37-39 are claims to a kit containing ZA.

Claim construction related to the claims 10 to 18 particularly, together with a rewritten claim 16 are considered to determine whether they fall under medical treatment claims or not?

Claim features were –

      Claim 10: -use of zoledronic acid

-to treat abnormal bone turnover

-intermittent administration of about at least one year

Claim 11: - administration about one year

Claim 12: - intravenous administration

Claim 13: - dosage from about 2 mg to about 10 mg

Claim 14: - dosage of about 5 mg

Claim 15: - condition is osteoporosis

Claim 16 - once-a-year administration intravenously, 5 mg dose, for osteoporosis

Main arguments were whether such claims were directed to a method of medical treatment or for a vendible product having real economic value. According to the previous case laws vendible product claims are patentable subject matter if they are directed to product having economic value.

But federal court rejected Novartis argument regarding vendible product claims and said these claims are actually directed to method of medical treatment because patent claiming a dosage range within which the physician is to exercise skill and judgment was not a vendible product; and thus, not patentable. Claims where actual involvement of physician comes are directed to treatment claims as it is the physician who has to apply his skills to decide the dose, dosage frequency, route of administration depending on the condition of patient.

The '201 patent specifically states that the mode of administration and dosage “may be selected by the attending physician taking into account the particulars of the patient, especially age, weight, life style, activity level, hormonal status (e.g. postmenopausal) and bone mineral density as appropriate”. (page 11, emphasis added)

Further at page 11, the '201 patent states that the “dose mentioned above is typically administered intermittently, with a period of at least 6 months between doses. The period between bisphosphonate administrations may be longer, e.g. conveniently once per year, once per 18 months, or once every 2 years, or even longer, or any period in between.”

Page 12 of the '201 patent describes dosages that depend on the potency of the bisphosphonates and that dosages may be administered in a divided manner, such as 4 mg one day, and a further 1 mg a few days later.

Finally court held that it is in reality, however contrived the wording of the claim may be, a method of medical treatment under Canadian law, unpatentable.

Novartis Pharmaceuticals Canada Inc. v. Cobalt Pharmaceuticals Company et al., 2013 FC 985
 

P-IV filing: Dr reddy’s sued for filing of P-IV to Mozobil®

Genzyme Corporation, a fully-owned subsidiary of drug major Sanofi-Aventis filed a suit against Dr. Reddy's Laboratories for ANDA filing to Plerixafor (Mozobil®).

Genzyme is the holder of New Drug Application (“NDA”) No. 022311, which relates to Plerixafor solution 20 mg/mL for subcutaneous injection. On December 15, 2008, the FDA approved the marketing of the drug product described in NDA No. 022311 for use in combination with granulocyte-colony stimulating factor (“G-CSF”) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin’s lymphoma and multiple myeloma.

Letter dated July 19, 2013, DRL notified Genzyme that DRL had submitted ANDA No. 205182 to the FDA (21 U.S.C. § 355(j)) seeking approval to engage in the commercial manufacture, importation, use, and sale of 20 mg/mL Plerixafor injection (“Plerixafor ANDA Injection Product”) as a generic version of Genzyme’s Mobozil® drug product.

 

the Notice Letter, DRL notified Genzyme that its ANDA contained a “paragraph IV” certification that in DRL’s opinion the ‘152 patent, and ‘590 patent, and the ‘102 patent are invalid or will not be infringed by the commercial manufacture, use, sale, offer to sell, or importation of DRL’s Plerixafor ANDA Injection Product.

Genzyme also filed suit against Teva and Sandoz for the P-IV filing to Plerixafor.

Hatch-Waxman Litigation: Invalidating “Public use” need not be the intended use of the invention, as long as the invention is fully disclosed without restriction

We generally do not see the claims of the patents invalidated under prior public use as it is critically difficult to establish and support the evidence. But in an interesting decision on September 12, 2013, (Pronova Biopharma Norge v. Teva Pharmaceuticals USA, No. 2012-1498), Federal Circuit unanimously held the asserted claims of Pronova's U.S. Patent No. 5,656,667 invalid as anticipated by prior public use, reversing a District of Delaware trial decision in the process. The grounds for reversing the District Court's finding that the defendant had not established invalidity under the public use statutory bar under 35 U.S.C. § 102(b) was based on the Court's determination that Pronova's predecessor in interest had permitted unrestricted use of formulations falling with the scope of the claims and disregarded Pronova's argument that public use was negated because there was insufficient evidence that the use was for the inventions' intended.

The case concerned U.S. Patents Nos. 5,502,077 and 5,656,667 involved in ANDA litigation between Pronova and, in separate ANDAs, Teva and Par Pharmaceuticals, who propounded Paragraph IV letters contending that these patents were invalid and non-infringed by their generic formulations of the branded drug Lovaza®.

The main facts surrounding defendants' arguments for an invalidating public use involved transfer of samples of formulations falling within the scope of the asserted claims by Pronova' predecessor in interest in the patents, all of which occurred prior to the critical date of the '677 patent. These transfers included samples sent to Dr. Victor Skrinska, with disclosure of the contents of the formulations, with no restrictions, confidentiality requirements, or obligations to report the results of any experiments performed using the formulations. Dr. Skrinska analyzed the contents of the formulations but did not perform any testing on the clinical use or benefits of the formulations.

Federal circuit held that the disclosure by transfer of samples of the formulation constituted an invalidating public use. Factors supporting this determination were that the transfer contained no evidence of confidentiality restrictions and the fact that Pronova conceded there was no experimental use involved in this transfer. The panel concluded that the transfer was "with no secrecy obligation or limitation for [Dr. Skrinska's] unfettered use" and that the shipment of the formulations "made public all aspects of the claimed inventions, since it included a certificate of analysis revealing the composition of the supplied products." It was also undisputed that Dr. Skrinska was "one highly skilled in the art, with the full ability to know, understand, and fully disclose the invention to others.

Federal circuit also said that they are not persuaded by Pronova’s argument that “use” of a pharmaceutical formulation cannot occur until it is used to treat the condition it is intended to counteract (to reduce triglyceride level in this case), or at least physically ingested.

Below are the important take away points from the decision regarding “Public Use”:

(1)   Unrestricted Use of the invention falls under Public use;

(2)   Confidentiality Agreement should be in place so as to avoid unrestricted use;

(3)   Strictly Experimental Use may overcome invalidating attack under Public use.

(4)   Public Use not necessarily should be the intended use, as described in patent

Dasatinib (Sprycel) Compulsory License Application Rejected by Indian Patent Office

In recent development in compulsory license domain, as reported by Economic Times, The Indian Patent Office (IPO) has rejected Mumbai-based BDR Pharmaceutical's application for Compulsory Licence (CL) on cancer drug Dasatinib, according to an affidavit filed by Bristol Myers Squibb (BMS), the patent holder for the drug.

As we already aware that BDR had filed CL application in March 2013 with IPO under section 84 of Indian patent Act.  Dasatinib was one of the three drugs considered for compulsory licensing by the government under the section 92 route. Dasatinib, which Bristol-Myers Squibb sells as Sprycel, is used in the treatment of chronic myeloid leukaemia. In India, a month's dose of this drug costs about Rs 1 lakh while BDR Pharmaceutical said its version will cost Rs 8,100/month.

But on May 04, 2013, BDR received notice from IPO that prima facie case has not been made for the making of an order under section 84 of Patents Act. BDR then requested hearing in accordance with rule 97 (1) of the Patent Rule 2003 and hearing scheduled on May 23, 2013. Then petition under Rule 137 on same day was filed to condone the delay in complying with procedural irregularities to make compulsory license application to meet the requirement of prima facie case and further proceed with the application. BDR subsequently submitted written submissions on June 24, 2013 pursuant to the oral gearing held on May 23, 2013. On July 10, 2013, BDR filed correspondence in relation to Voluntary License, sought form BMS and requested patent office to take it on record.

In its affidavit filed in the Delhi High Court last month, the US-based drug maker has accused BDR Pharmaceutical of suppressing information regarding the status of its application and patent.

"It is respectfully submitted that, as per the knowledge of the plaintiffs, the Controller of Patents has not found a prima facie case as regards the defendant's application under Section 84 of the Patents Act, 1970 and the same stands rejected," Bristol Myers has said in its affidavit.

"It is further submitted that the defendants are guilty of suppression as they have not informed this hon'ble court about the aforementioned order of Controller of Patents, nor have they supplied a copy of the application to the court," the affidavit added.

Transformation of Indian Patent Office......In Autobots way

Indian patent office has come long way in terms of technological advances and still has to trade much distance when compared to its counterparts. But it’s never too late to do the right things. Below is the summary of recent developments in terms of functioning of IPO website.

1.      Launch of IPAIRS 2.0 version of website with faster browsing and many more search capabilities (24 Apr. 2012)

2.      Online availability of list of Patent Applications related to Traditional Knowledge  (25, July, 2012)

3.      Launch of online public view of GI documents (14 February, 2013)

4.      Availability of a dynamic utility to view "The Month of Request for Examination for which First Examination Report is being issued" for each examination group of all jurisdiction of Patent Office (17 June, 2013)

5.      Publication of information received from Patentees regarding working of Patented inventions-Form 27 (24 June, 2013)

6.      Reply to the Examination Reports by using the 'Comprehensive e-filing services for Patents', which will result in internal automation and speedy disposal of Applications  (07 July, 2013)

7.      The utility displaying the pending and grant status of Patent applications (19 August, 2013) 

8.      In yet another effort to increase transparency CGPDTM launches a further dynamic utility to view issued First Examination Reports at a glance  (26 August, 2013) 

On could see the vast changes and think the speed with which IPO has transformed itself. But the efforts put by most of IP professional are main driving force behind this. These changes started mainly from the era of one man ie. Mr. Kurian. He literally took the challenge and decided to make over the IPO.

Recently DIPP proposes an increase of fee up to 100% in several categories, with a lower fee for those preferring to take the e-filing route. This suggests many more changes to come in future as patent office decided to go online for literally all the activities. Already patent office grapples with severe manpower crunch, office space and lots of troubles. It would be good change if IPO spends some part of surplus revenue in reforms to increase transparency and shareholders confidence. Hope for the best….

Updates on Herceptin saga in India

Here are some important updates on the Herceptin in India. As I previously reported in my blog about facts about divisional patent applications viz. 3272/KOLNP/2008 and 3273/KOLNP/2008 rejection and negative hype by media.

Now interestingly the basic patent IN205534 on which above divisional are based is lapsed because of non-payment of annuity fees as of 03.05.2013. However Section 53 of the Patents Act reads with Rule 80 allows the Patentee to pay the same within the extended period not more than six months, if the request for such extension of time is made in Form-4. But this request should be made before the expiry of last date of renewal ie 03.05.2013. Patentee still can restore the patent under Rule 60, but patentee has to be able to give the Patent Office a good enough reason to allow the restoration application. Already this patent is under post grant opposition filed by Glenmark. So it seems quite difficult path ahead for Genentech if they wish to restore the patent because Glenmark most likely to oppose the restoration.

And Roche (Genentech) said that it has no plans to seek a restoration of the patent. The decision to let the patent lapse was part of a new strategy it wants to follow in the local market for the high-value biological drug. “Regular reviews of our patent portfolio are a routine business practice. In this connection, Roche has come to the conclusion not to pursue Indian patent for trastuzumab”.

Herceptin contributes close to Rs 127 crore to Roche's annual turnover, according to industry estimates. Roche's decision of giving up its patent is a smart move, say IP experts as there is no Indian company manufacturing this drug due to the complex science involved. So, even after giving up the patent, Roche will be the only company that will be manufacturing this drug, and the company knows it. While the patent for Trastuzumab may no longer be in force, it is important to note that there are currently no approved biosimilars of Trastuzumab in India.

But latest news about Biocon launching the biosimilar of Herceptin could change the game. As announced by Ms. Shaw, Biosimilar version is in phase III studies and they intend to launch in India by end of March 2014. She has not disclosed the price but it would be much cheaper than the current price of Herceptin in India. Herceptin’s price, at around Rs 1 lakh a vial in 2011, was lowered to Rs 92,000 last year and then further Rs 72,000. Treatment cost with Herceptin may be reduced to about half with the launch of the drug’s cheaper version

Apart from Biocon, two other Indian firms, namely Dr. Reddy's Laboratories and Intas Pharmaceuticals are planning to launch their own version of Herceptin biosimilars.

Hue and cry about revocation of Herceptin patents in India Vs. Real facts and analysis of the case

Recent statement by Roche’s spokesperson regarding revocation of Herceptin Patent in India and its (mis)interpretation by world media led to the series of confusions. World media saw this news again through its pre-conceived notion about India’s weak intellectual regime and blindly followed it. Indian Government later opposed this statement and gave clarification about the whole issue.

I would rather put the facts of the present case for your better understanding and would try to clear doubts regarding situation.

First, patent office has not partly revoked any patent on Herceptin as with the present case. The said issue is with the patent applications filed by Genentech (Roche) viz. 3272/KOLNP/2008 and 3273/KOLNP/2008 (both filed on Aug.11, 2008). These are not yet granted, so what media has interpreted was absolutely wrong about revocation. Patent office instead has refused both applications u/s 16 (divisional application) of Indian patent Act.  To qualify as a divisional application, the application in question must be distinct invention and filed before the parent application is granted, abandoned or deemed to withdrawn.

1.      Both these patent application are divisional of 1638/KOLNP/2005, which is again divided out of IN/PCT/2000/00391/KOL (Granted as IN205534 on Apr.05, 2007). According to Indian Patent Act one cannot file the divisional application from divisional application. Therefore these applications cannot be regarded as proper divisional u/s 16(1) of the Act.

2.      Applicant concealed this fact and stated 1638 application as parent application for the both applications (viz. 3272 and 3273) and filed same with patent office. But these applications are considered to be divisional of IN/PCT/2000/00391/KOL. 391’ application was granted on Apr 05, 2007 and both these applications were filed on Aug.11, 2008, much after the grant date. Therefore they cannot be considered as timely filed as per the Act.

3.      For the sake if we consider that both these applications divided out of 1638/KOLNP/2005, but request for examination (RFE) was not timely filed for 1638 application and therefore deemed to withdrawn as of Feb.16, 2006. Therefore any divisional application filed after this date cannot be considered as divisional application according to Act.

4.      Again both these applications (3272 and 3273) cannot stand as their RFE also filed after due date ie Feb. 11, 2009. Therefore as per section 11B(1), these applications cannot be examined further.

The above objections/grounds were also communicated to the applicant before refusing the applications but hearing was not attended by applicant. Therefore both applications viz. 3272/KOLNP/2008 and 3273/KOLNP/2008 are not considered to be divisional applications within the meaning of section 16 of the Act and also they have not been properly filed complying the requirements of Acts.

Fresenius Kabi succeeds in revoking Lapatinib Salt Patent at IPAB

In an order (No. 161/2013) dated July 27, 2013, IPAB-India has revoked the patent of Lapatinib Ditosylate Salt. Fresenius Kabi Oncology Ltd had filed the revocation petition against Patent No.IN221171 entitled “Quinazoline Ditosylate Salt Compounds”, the said patent belongs to Glaxo. In a decision main arguments were focussed on obviousness, S.3(d) and S. 8 in IPAB decision.

Below is the gist of decision and few important clarifications by IPAB on some points.

Section 3(d):

Citing the recent Novartis case judgement by Hon’ble Supreme Court, IPAB stated that efficacy relates to “therapeutic efficacy” and not all advantageous or beneficial properties. More importantly considering the genesis of S.3(d) the words “therapeutic  efficacy” must receive a narrow and strict interpretation.

Patentee argued that ditosylate salt absorb much lower amounts of water when exposed to a broad range of humidities and can be prepared in a stable crystal form. And that “Due to the improved moisture sorption properties of these compounds and increase in stability they exhibit enhanced efficacy in their use as a medicament following storage when compared with the di-HCL salts disclosed in the prior art reference. But IPAB dismissed the argument and said improved moisture absorption property and hence stability of ditosylate salt cannot be considered as enhanced efficacy as per recent supreme case judgement.

 

Obviousness:

By citing F. Hoffman-La Roche Ltd v. Cipla Ltd IPAB stated it was obvious to try for person skilled in the art to choose from different salts disclosed in Exhibit B ie. substance patent of Lapatinib. Out of 19 salts disclosed in Exhibit B, two sulphonyl salts include ditosylate salts. It was submitted that when the problem to be solved was hygroscopicity, it was obvious for a person skilled in the art to try the salts disclosed in Exhibit B which would give the desired result.

Exhibit C teaches the salt of a different active ingredient which is analgesic. Once there is a suggestion that tosylate salt would solve the problem of hygroscopicity, there is definitely an encouragement to try it.

IPAB further explained that in the present case there is a clear indication in Ex.B of the tosylate compound. There is no doubt that zooming in on a correct salt is not easy, if the choice could only have been made by testing each compound one after the other with no clue available. But Ex.C gives a clue. It was reasonable to hope it might, it would not have been a blindman’s buff choice. So we are of the opinion that to the Person Skilled in The Art taught by Exhibits B and C the invention was obvious.

S.8 disclosure and non-compliance:

IPAB gave elaborated explanation for the section 8 requirement and stated that one must carefully apply the provision. S.8 of the Act is not intended to be a bonanza for all those who want an inconvenient patent removed.

The Ayyangar Report makes it clear that the purpose for introducing this provision was to ensure that it would be an advantage for our Patent Office to know the objections raised by the patent offices outside India regarding the patentablity of the invention and the amendment if any made or to be made. It also says that it would be of great use for the proper examination to know if the invention was anticipated.

IPAB also remanded patent office and said that It is unfortunate that the office has failed to understand the importance of the S.8 requirement and leaves it to the Patentee to decide what he will give. IPAB also requested patent office and Controller General to educate and instruct the officers regarding the requirements of law.

Finally IPAB rejected S. 8 ground and stated that In the present case we are rejecting the S.8 objection only because the applicant has not made out the grounds of attack by stating the facts. In this case in the Revocation application, the applicant has merely stated that S.8 has not been complied with and foreign filing particulars have not been given. Nothing more is stated. In the petition filed for receiving additional documents, the affidavit filed by the applicant merely lists the documents were downloaded. We do not think that is sufficient.

If you wish to see the whole decision, you can access the same on IPAB site at http://www.ipab.tn.nic.in/

  

Compulsory licence likely for three cancer drugs	(14/1/13)
MUMBAI, 14 JAN, 2013: The government has appointed a panel to look into issues related to compulsory licensing of drugs and whether cheaper versions of cancer medicines Trastuzumab, Ixabepilone and Dasatinib can be launched under the provision, a person with knowledge of the development said. According to the person, the health ministry has sent its proposal regarding compulsory licensing for the three drugs to the Department of Industrial Policy and Promotion (DIPP), which in turn has sought the opinion of the department of pharmaceuticals. Srikant Jena, Minister of State for Chemicals and Fertilisers, however, denied having received any note. The panel is lead by RK Jain, additional secretary and financial advisor in the health ministry, the person added. Compulsory licensing is a provision under the World Trade Organisation that allows a government to permit a company to manufacture a patented drug without the consent of the innovator company. Each of the three drugs cost over Rs 1 lakh for a month's dose. While Trastuzumab is manufactured by Roche, Ixabepilone and Dasatinib are products of Bristol-Myers Squibb. In March last year, India had allowed Hyderabad-based Natco PharmaBSE -2.06 % to make and sell a cheaper version of Bayer AG's patented cancer drug Nexavar on grounds of affordability. The move had multinational pharma companies worried about property protection. According to intellectual property lawyer Aliasgar Dholkawala, the health ministry could apply for a compulsory licence (CL) under Sec 92 of the Indian Patent Act. "The government can notify a patent for issuance of CL under Sec 92 if any of these three conditions are met: national emergency, cases of extreme urgency, or in case of public non-commercial use," Dholkawala of Wadia Ghandy and Co said. Under Sec 92, the government can issue a compulsory licence on certain patents notified in the gazette. After the same is notified by the government, any company interested in its manufacture is allowed approach the patent controller for a licence. Experts say the move could spark a fresh row in the area of intellectual property. Besides, the government is expected to release a draft report on price control for patented medicines, which may not leave much room for a compulsory licence, they add.