IP Connect

Monday, 15 June 2015

INDIA - Opposition Against Gilead’s Patent “Sovaldi”

We had previously reported in our newsletter Vol. VII, Issues 06 and 10 dated February 09, 2015 and March 09, 2015 respectively that Gilead’s patent application for hepatitis C drug, Sovaldi was opposed by NATCO Pharma Ltd. (an Indian Generic drug manufacturing company), Delhi Network of Positive People (DNP+) and Initiative for Medicines, Access & Knowledge (I-MAK), and the said patent application was rejected by the Indian Patent Office on January 13, 2015. However, Gilead filed a writ petition against the same and the order was set aside by the Hon'ble Delhi High Court on January 30, 2015. (Click here to access the news reported by us)

Later, Gilead Sciences entered into a non-exclusive licensing agreement with NATCO Pharma Limited, allowing NATCO to manufacture and sell generic versions of its chronic hepatitis C medicines in 91 developing countries. (Click here to access the news reported by us)

Now, Initiative for Medicines, Access & Knowledge (I-MAK) has released a statement on May 20, 2015 that it has challenged Gilead’s patent application for hepatitis C medicine, Sovaldi (sofosbuvir) in China and also worked with its partners, Fundación Grupo Efecto Positivo (Fundación GEP) of Argentina, Grupo de Trabalho sobre Propriedade Intelectual (GTPI) of Brazil, Treatment Preparedness Coalition of Russia and the All-Ukrainian Network of People Living with HIV/AIDS of Ukraine, details of the same are given below:

These countries together account for about 30-40% hepatitis C patents in the world and were excluded from the list of countries where NATCO could sell its generic version of the medicine.

I-MAK reasoned that- if Gilead is awarded unjustified patents in the aforesaid countries, based on the likely prices that will be set for these countries, they could be faced with an overspend of US$270 billion to treat all people with hepatitis C. Click here to access I-MAK’s statement

INDIA - Draft National Medical Device Policy-2015 -Department of Pharmaceuticals

Source: https://plus.google.com/108903930289578506501

On June 03, 2015, the Department of Pharmaceuticals (DoP) has issued the draft of the National Medical Device Policy-2015 delineating the objective, responsibilities, initiatives, framework and implementation of the “National Medical Device Authority (NMDA)” and invited comments from stakeholders by June 30, 2015.

The objective of the National Medical Device Policy is to strengthen the 'Make in India' drive in the medical device sector by reducing dependence on imports and setting up a strong base for medical devices in terms of affordability and availability for patients.

Following are the highlights of the Policy:

An autonomous body, "National Medical Device Authority"(NMDA), to be created under the DoP which shall:

identify and prevent creation of unnecessary and unjustified technical barriers to trade, especially by new or changing technical regulations;
support and prepare indigenous businesses to face competition, access foreign markets, and find new business partners abroad;
promote networking of national and international organizations within and outside India with the aim of facilitating scientific co-operation, coordination of activities, exchange of information, implementation of joint projects and exchange of expertise;
take all such steps to ensure that the public, medical professionals and interested parties receive rapid, reliable, objective and comprehensive information through appropriate methods and means.

The Government on the recommendations of NMDA, subject to availability of Budgetary resources, may consider the following incentives for both Greenfield and Brownfield units:

Preference in government procurement may be considered for medical devices which are being manufactured in India with an additional preference for medical devices manufactured under the MSME sector.
R&D by agencies like ICMR, DBT, CSIR, DIETY & DoP should be supported/ coordinated through the single window facilitating body.
Low cost funding like interest subsidy to MSME
Concessional power tariff for up to 5-10 years
Provide seed capital, viability gap funding and co-fund start-up projects
Provide longer term view (10 years window) for 200% weighted tax deduction on approved expenditure on R&D as the gestation period is high in this industry.
Tax/ duty structure to be designed to promote local manufacturing of quality medical devices and diagnostic equipment
Minimum/ zero duty on the import of raw materials and manufacturing equipment for production of medical devices.
Restrictions on import of second hand diagnostic equipment/ tools
Higher taxes after 5-7 years of usage for imported second hand devices

Institutional framework:

Set up a Skill Development Committee under National Medical Devices Authority with representatives from Medical devices Industry, academia (NIPERs) and Healthcare Sector Skill Council (HSSC) under National Skill Development Council (NSDC).
To create a system where Industry may place/make available their IP in non-core activities available to the exchange which may help technological up-gradation of the sector.

Affordability:

The medical devices may be included as a separate entry in the list of commodities controlled under the Essential Commodities Act.
The Government may announce a separate policy enunciating the principles for regulating the prices of identified medical devices and implement the same by notifying a separate Medical Devices Prices Control Order (MDPCO).
A separate division may be created in the National Pharmaceuticals Pricing Authority for pricing of the devices by suitably amending the resolution constituting NPPA.

INDIAN Government Approves Proposal for Negotiable Instruments (Amendment) Bill 2015

The Union Cabinet, chaired by the Prime Minister Shri Narendra Modi, approved the long-pending Negotiable Instruments (Amendment) Ordinance, 2015 on June 10, 2015. The corresponding Bill was passed in the Lok Sabha, earlier this year in May, seeking to overturn a Supreme Court 2014 ruling.

The ruling in question is the controversial case of Dashrath Rupsingh Rathore vs. State of Maharashtra, whereby the Hon’ble Apex Court, in a bid to overcome the legal lacunae, had ruled that for a case of cheque bouncing under Section 138 of the Negotiable Instruments Act, 1881, the suit is to be initiated where the cheque-issuing branch was located. The said ruling was also covered by us in our September 8, 2014 issue, which can be accessed here.

To refresh our readers’ minds, according to the aforesaid ruling, for prosecuting a person under Section 138 of the Negotiable Instruments Act, 1881 (i.e. for presenting a cheque which bounced for insufficiency of funds), the case has to be initiated at the place where the branch of the bank in which the cheque was drawn is located. The earlier rule allowed such a case to be initiated by the holder of the cheque at his place of business or residence. But as per the 2014 ruling, for instance, if a person from Delhi gave a cheque drawn on a Delhi bank for buying goods in Kerala and it bounced for insufficiency of funds, then the aggrieved person would have to travel all the way from Kerala to Delhi just to initiate prosecution against the defaulter under Section 138. Moreover, this judgment demanded a retrospective application, thereby, directly affecting the lakhs of cheque bouncing cases pending in various courts all over the country which would now have to go through interstate transfers. However, since this order is not Payee-friendly (who is the victim), the Government of India has brought the present amendment bill to by-pass the Court’s order.

Necessity of the NI (Amendment) Bill 2015

The Negotiable Instruments Act, 1881 defines promissory notes, bills of exchange, cheques etc. and creates penalties for issues like bouncing of cheques. The Act specifies the circumstances under which cheque bouncing complaints can be filed, however, it fails to specify the territorial jurisdiction of the courts where such a complaint is to be filed.

The Statement of Objects of the bill stated that following the aforementioned apex court ruling, representations have been made to the government by various stakeholders, including industry associations and financial institutions, expressing concerns about the wide impact the judgement would have on the business interests as it will offer undue protection to defaulters at the expense of the aggrieved complainant.

The objective of the proposed amendments is to clarify the jurisdiction related issues for filing cases under Section 138 of the NI Act. Such a clarification is a much desired one from the equity point of view, as this would be in the interests of the aggrieved complainant and would also ensure a fair trial. It would also increase the credibility of the cheque as a financial instrument, and allow lending institutions, including banks, to continue to extend financing to the economy, without the apprehension of the loan default on account of bouncing of a cheque. Therefore, the entire move would help the trade and commerce in general.

The new law is also intended to help consolidate the already pending cases and aid the judicial system, which currently has 21 lakh cheque-bounce cases pending with 259 courts hearing them exclusively.

Israeli Patent and Trademark launches Design Database

The Israeli Patent and Trademark Office (ILPTO), on June 9, 2015, announced the launch of a new database of registered designs which can be accessed at http://designsearch.justice.gov.il/

The said database is bilingual and provides information in both English and Hebrew and also comprises of an instructional video for tutorial purposes. The Database provides results in parameters like 'By details of a person who has title or rights in the design' and 'By priority details'.

The launch of Design search database is an appreciable move by the ILPTO and remarked as a milestone in IP digitization.

Wednesday, 10 June 2015

Unwittingly Licensing IP on Social Media? India

Former BJP leader K. N. Govindacharya put the Modi government on the stand for their recent action of opening accounts on social media for governmental departments.

K.N. Govindacharya filed a writ petition[1] with the Delhi High Court in 2012 to raise various issues associated with regulation of social media sites such as Facebook, Twitter, Google etc. in India. The most prominent issues were the use of such sites by underage children, use of the sites by government departments, recovery of taxes from the websites on their income from operations in India.

All issues were adjudicated on by the bench consisting of Justice Badar Durrez Ahmed and Justice Sanjeev Sachdeva. The only issue that is left in this petition is with regard to the social media network usage by the Government/Government Departments. A point has been raised with regard to the nature of contracts entered into by the Government/Government Departments with social media sites such as Facebook, Twitter, Goggle +, etc. when they sign up on these accounts and click on ‘I Agree’ to their ‘Terms of Service’ absent-mindedly.

Govindacharya contended that the making account on various social media site for government departments is illegal. The terms and conditions of these sites clearly state that the data uploaded with them could be used by the networking sites for their gain. The issue of licensing of IP Rights in photographs and videos and other content was brought to the notice of the Court.

The Court in its order dated May 7, 2015 said “it appears that there are certain settings which the users of social media networks can opt for to restrict the usage of IP rights but it is also apparent that there could be grant of a royalty free license insofar as those IP rights are concerned.”

The Court questioned the Government on its awareness on this subject. The court also said when the government gives royalty free license to Facebook without anything in return, “it was akin to (giving) state largesse” and asked Mr. Sanjay Jain, the learned Additional Solicitor General to place before it, by July 30, the exact nature of the contract it has entered into with the social media sites.

Our Inquiry

To bring clarity to this debate, a general review of the Facebooks ‘Terms of service’ was conducted and the following clause was uncovered:

2. Sharing Your Content and Information

You own all of the content and information you post on Facebook, and you can control how it is shared through your privacy and application settings. In addition:

For content that is covered by intellectual property rights, like photos and videos (IP content), you specifically give us the following permission, subject to your privacy and application settings: you grant us a non-exclusive, transferable, sub-licensable, royalty-free, worldwide license to use any IP content that you post on or in connection with Facebook (IP License). This IP License ends when you delete your IP content or your account unless your content has been shared with others, and they have not deleted it.

The above clause makes the picture quite clear. Whether governmental data or personal, everything is licensed to Facebook, royalty free unless the government is taking certain specific steps to safeguard their IP. The ASG appearing on behalf of Union of India requested for some time to place before the Court the exact nature of the contracts which have been entered into by the Government/Government Departments with the social media sites on the internet.

It shall be interesting to read the government’s reply in this regard on July 30, 2015.

Sources:

[1] W.P.(C) 3672/2012.

India: Two-Letter Domain Released on June 10, 2015

In October last year, the Internet Corporation for Assigned Names and Numbers (ICANN) had decided to allow new gTLD registries to release all two-character domain names in their zones. In their decision pertaining to the same they instructed the ICANN’s executive to “develop and implement an efficient procedure for the release of two character domains currently required to be reserved in the New gTLD Registry Agreement”. All two-character domains were initially reserved due to the potential for confusion with two-letter ccTLDs.

Pursuant to the decision, registries representing over 200 new gTLDs have already filed Registry Service Evaluation Process requests for the release of some two-character strings. The newly available domain names will be released in 13 groups starting June 10, 2015 and each extension will go through an Early access phase in which the applicant can register the name of his choice ahead of General Availability for an increased fee.

GOI relaxed FDI policy in India in respect of NRIs

On June 03, 2015 the Ministry of Commerce and Industry notified that Non-repatriable investments by NRI’s, OCI’s and PIO’s would be treated as investments by resident Indians (or domestic investments).

The ministry has widened the scope of Non-Residential Indian to include Overseas Indian Citizens and Persons of Indian Origin.

The Government has decided to amend the definition of NRIs thereby investment by NRIs under Schedule 4 of FEMA will be deemed to be domestic investments.

In May, 2015 the Cabinet, chaired by Prime Minister Narendra Modi, had cleared these amendments.

The decision is expected to result in increased investments across sectors and greater inflow of foreign exchange remittances leading to higher economic growth.

The government has also notified increase in FIPB’s power to recommend foreign investment proposals of up to Rs 3,000 crore from the earlier Rs 2,000 crore.

Beyond this limit, proposals will go to the Cabinet Committee on Economic Affairs for approval.

The Department of Industrial Policy and Promotion (DIPP), which deals in FDI related matters, issues provisions in the form of press notes or consolidated circular.

In April-February of 2014-15, FDI rose 39 per cent to USD 28.81 billion as against USD 20.76 billion in the same period previous fiscal.