Category: Patents

Some Patent Considerations When Entering into Relationships with Indian Businesses After Novartis AG v. Union of India

Co-Authored by Shreya Ley, Attorney and Owner of Lay Roots

You may have thought that this summer was all about capturing that certain bohemian-chic essence, but the true trendsetters are all talking about recent developments in Indian patent law. In April, the Indian Supreme Court ruled in Novartis AG v. Union of India & Others that Swiss pharmaceutical maker Novartis was not entitled to patent protections for their leukemia treatment drug Gleevec. The Indian Supreme Court’s rationale was heavily based on their efforts to stop pharmaceutical “evergreening” – a practice pharmaceutical companies use to extend the life of a patent by seeking patent protection of subsequent improvements to their drugs or alternative, novel uses for such drugs.

Novartis had been attempting to patent a new and improved version of Gleevec. It had been unable to patent the original version of the drug in India because India did not recognize or grant pharmaceutical patents prior to completing their implementation of their World Trade Organization obligations under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) in 2005. Upon discovering an improved version of Gleevec, Novartis sought to gain patent protection in an effort to halt the rampant manufacturing of generic forms of the drug in India. However, the Indian Supreme Court found that Novartis had not created enough of an improvement in the new Gleevec to qualify the drug as a new invention. Since Novartis’ ruling, Indian courts have subsequently invalidated other similar patent applications as seen last Friday with the invalidation of the Glaxo Smith Kline’s cancer drug Tykerb.

The Novartis decision and other similar Indian court rulings that refused to grant patent protections to pharmaceutical improvements have become the major impetus for foreign businesses and governments to denounce the Indian patent system as being broken, unjust, or perhaps just biased against non-Indian inventors. Around the world, India’s stand against pharmaceutical evergreening has led such entities to decry the general state of innovation in India. Here in the U.S., the Pharmaceutical Research and Manufacturers of America commented that the Novartis ruling was a sign of India’s “deteriorating innovation environment” and the Office of the U.S. Trade Representative remarked that recent Indian patent developments have “raised serious questions about the innovation climate in India and risk hindering the country’s progress towards an innovation-focused economy.” Such rhetoric has inevitably led American and other non-Indian businesses to become weary of working with Indian resident companies and inventors, ”hear ye, hear ye, innovators around the world! Take heed of this warning tale!”

Well, “fear not!” Keep in mind that Novartis and the other related Indian court decisions only apply to pharmaceutical patents as such rulings have been based on a specific provision in the Indian Patent Act relating to incremental innovations in pharmaceuticals. So, given the limited applicability of Novartis and related cases, foreign businesses should simply forge ahead with their Indian business relationships, right?

Not quite so fast. Dealing with any foreign business, inventor, or entity comes with its own challenges and those looking to partner with Indian resident businesses should consider the following before getting too involved.

1.     Get a Comprehensive Agreement in Place Beforehand. Many partnering businesses have a difficult time putting a written agreement together prior to beginning their business relationship. THIS. IS. A. MISTAKE. Getting a clear agreement in place beforehand is important for foreign businesses and their Indian counterparts to prevent future misunderstandings that could potentially derail their objectives and result in substantial costs. Such an agreement should not only clearly outline the parties’ rights and obligations with respect to the Intellectual Property (IP) created in their relationship, it should additionally cover business aspects of the relationship. Although a large part of such relationships is based on the IP, the business side encompasses what happens once IP is created and it is equally important.

Specifically, agreements should address the following:

What is being protected? The agreement should clarify for foreign businesses and their Indian counterparts the types of IP their relationship needs to protect. This can be as simple as designating that both patentable and trade secret innovations will be protected and as complicated as describing protections for each and every potential innovation arising out of the relationship, whether a part of the parties’ original intentions or not. This designation process will not only help to define the scope of the parties’ project, it will also help ensure that the parties seek appropriate protections and enforcement measure for their IP. Completing this exercise is especially important in a cross-border context as the enforcement of IP rights abroad may be more difficult than simply making sure everyone is on the same page from the beginning. India in particular has been notorious for lacking the necessary infrastructure to enforce IP rights efficiently.

Who gets ownership? Establishing ownership of resulting IP from an Indian business relationship is important in an initial agreement because countries vary in the rights they give to owners and inventors. For example, Section 2(p) of the Indian Patent Act uses the term “patentee” for patent owners that is defined as “the person for the time being entered on the register as the grantee or proprietor of the patent.” In contrast, the U.S. does not officially use the term “patentee” and most American inventors would probably assume that patentee refers specifically to inventors. As illustrated above however, “patentee” in India is not necessarily limited to inventors. Therefore, making sure that all parties are clear on who will be named inventors and who will own resulting IP is essential to ensuring a good business relationship with an Indian resident business or inventor.

Who gets paid? This, inevitably, is a difficult topic to discuss, and it is inextricably tied to IP ownership rights. When there is no money coming in, everyone wants to split things down the middle. However, once there is money or it looks like there will be no money, businesses start to quibble. In order to avoid costly, drawn out battles that could prevent businesses from furthering an otherwise fruitful relationship, it is important to outline how all parties are to be compensated for their hard work, time and ingenuity once their relationship has taken off as well as when it has reached its conclusion.

Outlining business plans in writing through an agreement not only forces the parties to talk about their innovation strategy, marketing plans, and production plans; it also enables them to have a clearer direction for their relationship.  If anyone is worried that creating a detailed, written plan will inhibit their creativity, then remember that a good agreement should leave some room for flexibility. Allowing such flexibility can lead to great innovation and profitability. Ultimately, however, having a clear outline of where the parties’ want to go, how they want to get there, and what they need to get to that point (the “what” usually being the IP) can lead to a more profitable and innovative business relationship and can prevent costly future litigation.

2.     Be Conscious of Indian Patent Filing Requirements and Tolling Restrictions. Understanding Indian patent application filing requirements and the interplay between them and other foreign patent filing requirements is essential for businesses to ensure the broadest global patent protections for their resulting innovations. The most important thing for non-Indian businesses to realize is that Section 39 of the Indian Patent Act requires that patent applications for any invention created with the help of Indian residents must first be filed in India. Yes, before filing an international application under the Patent Cooperation Treaty, before filing a U.S. patent application with the United States Patent and Trademark Office (USPTO), and before filing a patent application anywhere else, foreign businesses working with Indian inventors must file a patent application with India’s patent office (The Controller General of Patents, Designs, and Trademarks (Controller)).

Does that sound unreasonable? Foreign businesses may be able to apply for special permission from the Controller to initially file abroad, but don’t bet on the Controller bending the rules.  If no special permission is given, a foreign business must wait for approximately six weeks after filing in India to file elsewhere.

So, if a foreign business has applied with the Controller and waited six weeks, they can now submit applications anywhere else…right?  Sure!  Just make sure not to dilly-dally because filing in India limits the amount of time a business has to file their patent application with the USPTO and other national patent offices. Knowing the timelines from start to finish of the Indian patent application system and how filing dates in India affect the requirements for filing applications in other countries can greatly impact business decisions.

Parting Thoughts. Go forth and innovate with Indian resident compatriots! The considerations above and recent Indian pharmaceutical patent decisions should not stop foreign businesses from doing so. Collaboration enables people to create great innovations, but every business relationship, whether down the hallway or across the world, has its own challenges and limitations. It’s good for businesses to be honest about those challenges and to create a plan for overcoming them before they run into them. These general suggestions don’t apply to everyone and it’s always wise to consult with qualified local counsel and persons who can advise on the particulars of a specific business. In the end, it will save businesses a lot of time, headaches, and money to simply invest in the relationship by setting it up correctly.

Also, no matter how overwhelming the planning process may seem, just remember, at least you’re not going up against Bollywood screenwriters who generously “borrow” from American film. In cases like those, it’s best to pop some popcorn, settle onto the couch, and enjoy the results – because the results ARE rather glorious, are they not?

Understanding Foreign IP Customs Notification Registration Procedures

In recent years, many national customs offices have established notification procedures to allow IP rights holders the ability to alert customs officials of their IP rights in order to assist them in their import inspection activities. Like Internet Service Provider takedown requests on the Internet (more information about these procedures), IP customs office notifications is a tool for IP rights holders to protect their IP rights abroad by reducing the global spread of infringing goods and content by preventing its cross-border transit—and in many cases, assisting in its destruction. However, to utilize such protection measures, an IP rights holder must ask themselves:

  1. Can you submit such a notification in a particular country?
  2. Does the country you wish to enforce your IP rights have an IP customs notification system?
  3. Does such a country’s national IP customs notification system include the type of IP you wish to protect?
  4. What are the particular foreign customs agency’s IP notification requirements?

Can you submit a IP customs notification? Generally, an IP rights holder can only submit an IP customs notification to a foreign customs office if their IP qualifies for protection in that foreign country. Determining if particular IP qualifies for protection in a country depends on the type of IP the rights holder wishes to protect and to what extent the rights holder has secured foreign legal protections. Here is how it breaks down:

Trademarks. If an IP rights holder wants to submit a foreign customs notification to protect a trademark or service mark in another country, they usually need to have registered that mark in the IP office of that specific country or through a centralized international registration mechanism like the Madrid Protocol (more information about the Madrid Protocol). This is because trademark protection is territorial, meaning that a trademark or service mark registration only grants its owner rights in the mark in the territory of the registering country. So for example, if a U.S. company registers its trademark in the U.S. for particular goods or services and wishes to protect that trademark against infringing imports into New Zealand, it must also register that mark through the Intellectual Property Office of New Zealand or the Madrid Protocol in order to submit a trademark notification to the New Zealand Customs Service.

Of course there are some important exceptions to this territoriality requirement to keep in mind. The European Union maintains a community-wide trademark system (Community Trade Mark) allowing one community registration to qualify for customs notification registration in all EU member states (a list of EU member states is available here). The African Intellectual Property Organization (OAPI) also maintains a community trademark system where a single OAPI community mark registration is recognized in 16 African nations (a list of EU member states is available here).

Patents. Like trademarks, a patent rights holder must generally have a registered patent in the country to which they wish to register an IP customs notification. Unlike trademarks, however, there are no current community registration exceptions. As a result, patent rights holders must register their patents in the country to which they wish to register their IP customs notifications.

Trade Secrets: Generally, as trade secrets require that their owners keep the content of their secrets confidential in order to maintain its legal protections, any disclosure of such secrets to customs officials likely eliminates such secrets’ protections. Therefore, there does not appear to be any national customs IP notification systems that permit trade secret notification.

Copyright. Unlike trademarks and patents, a work qualifying for copyright protection in one country may qualify for copyright protection in other countries in order to allow foreign customs notification registration. However, depending on the country, foreign copyright authors may need to file a copyright registration in order to submit an IP customs notification. A work qualifies for international copyright protection under the Berne Convention for the Protection of Literary and Artistic Works (Berne Convention) when it becomes attached. Attachment requires that the author of the work be a national of a Berne Convention country (Berne Convention countries), the author is a habitual resident of a Berne Convention country, that the work is first published in a Berne Convention country, or that the work is published in a Berne Convention country within 30 days after an initial publishing in a non-Berne Convention country. If a work is attached through any of these means, it is treated as if the work originated in each Berne Convention country, and is then subject to each Berne Convention country’s copyright protection requirements in order to qualify for copyright protection in that specific country.

If a work qualifies as an attached work under the Berne Convention and the IP rights holder wishes to register their protected work in a foreign Berne Convention country customs office, they will be able to file a customs registration without having authored the work in the foreign Berne Convention country. Yet, as mentioned above, countries differ on national copyright registration requirements for IP customs notifications. Australia, for example, does not require Australian copyright registration prior to submitting a customs notification application to the Australian Customs Service. However, several major markets, such as the U.S., China and India, require that copyrighted works be registered in their country prior to registering an IP customs notification.

Does the country you wish to enforce your IP rights have an IP customs notification system? Not all countries maintain IP customs notification processes. Some substantial and growing markets, such as Brazil, Canada and Chile, do not currently maintain IP custom notification systems. However, many major markets and transshipment countries maintain various types of IP customs notification systems including Argentina, Australia, China, European Union (EU), Hong Kong, India, Japan, Malaysia, Mexico, New Zealand, Russia, Singapore, South Korea, Taiwan, Thailand, Turkey, Ukraine, United States and Vietnam, among others.

Does such a country’s national IP customs notification system include the type of IP you wish to protect? Several countries only maintain IP notification systems for particular types of IP. For example, The U.S. Customs and Border Protection (CBP) only accepts copyright and trademark notifications, not patent notifications (the CBP only examines imports for patent infringement based on a Section 337 exclusion order from the U.S. International Trade Commission (more information available here)). In contrast, several other countries monitor and detain imports for possible patent and geographical indication infringement. India’s Central Board of Excise and Customs (CBEC) in particular monitors imports for copyright, geographical indication, patent and trademark infringement.

What are the particular foreign customs agency’s IP notification requirements? Once an IP rights holder verifies that their IP qualifies for legal protections in the foreign country they wish to submit an IP customs notification, and that the type of IP they wish to notify customs about can be registered, the IP rights holder’s customs notification must comply with the foreign customs office’s own notification requirements.

Below are the IP customs notification submission requirements for some of the worlds’ major markets.

Governing Law

Types of IP Covered

Notes

Forms/Links

United States 19 C.F.R. 133.1 et seq.
Copyright and Trademark Instructions: Copyright and trademark notification (known as e-Recordation) requires:

-Registering a trademark with the U.S. Patent and Trademark Office or a copyright with the U.S. Copyright Office

-The trademark or copyright’s U.S. registration number

-The name, address and citizenship of the IP rights owner

-The place(s) of manufacture of goods bearing the trademark or copyright

-The name and address of individuals authorized to use the trademark or copyright

-The identity of a parent company or subsidiary authorized to use the trademark or copyright (if any)

Fees: US $190.00 per copyright and trademark (per class of goods and services).

Effective Duration of Notification: 20 years.

e-Recordation Notification Portal
Australia
Copyright Act 1968, Subsection 135(2)

Trade Marks Act 1995, Section 132

Copyright and   Trademark General Notes: Australian IP customs notifications are known as Notices of Objection.To register a copyright or trademark notice with Australian Customs Service, an IP rights holder must submit: (1) a notice of objection form; and (2) a deed of undertaking. Both types of forms as well as further instructions are located in the right column.

Duration of Notification: Four years.

Copyright

Copyright Notice Instructions

Copyright Notice Form

Copyright Deed of Undertaking

Trademarks

Trademark Notice Instructions

Trademark Notice Form

Trademark Deed of Undertaking

China Decree of the General Administration of Customs, No. 183 Copyright, Patent and Trademark Requirements: To file a IP customs notification with the General Administration of Customs (GAC), an application must include:

-a copy of the IP rights holder’s business registration certificate and a Chinese translation

-a copy of the Chinese registration certificate for the copyright, patent or trademark

-Proof of Power of Attorney (if registered by an agent)

-Registration fee (see below)

-Licensing agreements (if any)

-Pictures of the relevant goods and their packaging

Submission: Forms can be filled online or by mail.

Fees:Approximately US $130.00 (800 RMB).

GAC Online Notification Form (In Chinese)
European Union Council Regulation (EC) No 1383/2003, Article 5.5 Copyright, Geographical Indication, Patent and Trademark The EU refers to IP customs notifications as Applications For Action. Applications require: (1) a completed application form; and (2) a completed Article 6 Declaration. Both forms are located to the right.

Note: Individual EU member states may maintain their own IP customs notification systems (a link to individual EU member state customs agencies is available here).

Community Application For Action

Community Article 6 Declaration

India  Notification no. 47/2007 – Customs (n.t.) Copyright, Geographical Indication, Patent and Trademark Registration: The CBEC requires that copyrighted works be registered with Indian Copyright Office, and geographical indications, patents and trademarks with the Office of the Controller General of Patents, Designs & Trade Marks prior to submitting a CBEC customs notification.

Ports of Entry: The CBEC also requires that notifications be submitted to particular ports of entry.

Duration of Notification: Minimum period of one (1) year.

Online Notification Submission Portal

**Note**: The above requirements are meant for comparative educational purposes only. IP rights holders should consult with national customs agencies or qualified attorneys in the jurisdictions they wish to enforce their rights to confirm these and other IP customs notification requirements.

Further Steps. Once an IP rights holder’s IP is registered with a foreign customs office, the foreign customs office will generally notify the rights holder or their representative of any infringing inbound shipments and may detain and potentially destroy infringing imports. However, such detentions may include legal proceedings, as well as additional country-specific enforcement procedures. IP rights holders should obtain qualified local counsel to assist with these enforcement activities.

China Flag

Public Hearing on U.S.-China Relations Expected to Highlight Chinese IP Protection Concerns

The U.S.-China Economic and Security Review Commission (USCC) announced in the Federal Register today that it will host its first public hearing this year on February 7, 2013 in Washington D.C. on national security concerns in the U.S.-China economic and security relationship, which will likely include intellectual property (IP) protection issues. Titled “China’s New Leadership and Implications for the United States,” the hearing is intended to collect input from businesses, academics, and government officials on the current status of the U.S.-China relationship for the USCC’s 2013 Annual Report to Congress. The USCC’s last annual report (2012 Annual Report available here) highlighted multiple Chinese IP concerns including inadequate enforcement of IP rights for foreign goods, inconsistent Chinese IP legislation, the theft and loss of foreign businesses’ IP  for such businesses operating in China and in joint-ventures with Chinese businesses, IP cyber espionage, and other related issues. Such annual reports are intended to provide recommendations to the U.S. Congress for legislative and administrative action.

The USCC is expected to hold other public hearings through 2013 as it compiles its annual report. Interested parties may attend hearings or submit comments. Further information on the February 7th hearing as well as attendance and comment submission procedures are available here.

Making Your IP Licenses U.S. Export Compliant

Export regulations have been in the news recently as U.S. officials pledged during the December U.S.-China Joint Commission on Commerce and Trade to relax technology export controls on exports to China, and the Department of Commerce is currently evaluating several export control reforms. Although these developments may allow U.S. businesses to more easily access foreign markets, it also underscores the need for businesses to understand how their exports, and particularly their intellectual property (IP) licensing, is regulated by U.S. export regulations and what steps they should take to ensure export compliance. Beyond avoiding fines and potential criminal charges, ensuring U.S. export compliance can help businesses develop effective IP licensing procedures to reduce challenges to their international operations and realize foreign market opportunities.

Ensuring U.S. export compliance in IP licensing requires an understanding of what U.S. export regulations are and what issues should be evaluated. With the exception of certain goods and technologies, the Department of Commerce’s Bureau of Industry and Security (BIS) establishes U.S. export controls through the Export Administration Regulations (EAR), which provides requirements and restrictions for IP licenses based specifically on a license’s commodity, software, or technology (Items) and the countries to which the items is being licensed. Particularly, the following four issues should be evaluated when licensing IP:

(1) Is your license subject to EAR? Many acts that would not on first glance be considered an export may be subject to EAR. Generally, any Item transmitted from the U.S. to a foreign country or foreign citizen is regulated by EAR. Not surprising, shipments of U.S. Items from the U.S. to foreign countries are subject to EAR. However, as any transmission of Items to foreign countries or foreign citizens is subject to EAR, the licensing of protected content or technology uploaded online for download abroad or by foreign nationals in the U.S. may be subject to these regulations. Such transmissions also include oral briefings, telephone calls, faxes, and e-mails containing Items to foreign countries and foreign citizens both in the U.S. and abroad. By encompassing these multiple activities, your licensing of copyrighted material, patented technology, or even trade secrets, may be subject to EAR.

(2) What is your EAR classification? If your IP license is subject to EAR, determining what your export compliance requirements are depends on the license’s Items. Such Items and their corresponding export requirements are obtained through identifying the Items’ EAR classifications. BIS classifies all Items for EAR through Export Control Classification Numbers (ECCN), which are available on its Commerce Control List. Establishing a licensed Item’s ECCN number helps to determine whether a licensor needs to obtain an export license prior to licensing.

Often, businesses and rights holders determine which ECCN matches their licensed content or technology for export compliance purposes.  However, it is always worthwhile for a licensor to submit a request to BIS to properly classify their licensed content or technology to ensure export compliance.

(3) Where are you licensing to? In addition to a license’s Items, the country to which the license is being made to establishes what restrictions and requirements a IP licensor will subject to. Those well-versed on current world events might find some of EAR’s restrictions self-evident, yet each country provides different sets of requirements and restrictions for IP licenses, often those one may generally not associate with some of the U.S.’ largest trade partners. Not surprisingly, licensing of IP to Canada, arguably the U.S.’ strongest ally, is exempt from most export licensing requirements, while licensing to countries perceived to be a geopolitical security risk or subject to the U.S. embargoes, such as China and North Korea respectively, may be prohibited. However, licensing of content or technology to some of the U.S.’ largest and most dependable trading partners may pose unexpected export requirements. For example, licensing radiation transport calculation and modeling software to Brazil, one of the U.S.’ top 15 trading partners, is subject to export licensing requirements, while relatively smaller trading partners such as Turkey are exempt from some of these licensing requirements.

As a result of EAR’s country-specific and often divergent export control requirements, licensors should consider the export control consequences of where they decide to license their items to when entering into licensing agreements.

(4) Are there any additional considerations? It is important to note that EAR does not regulate all export controls. Foreign embargoes establish export restrictions beyond EAR, which are governed by the Treasury Department’s Office of Foreign Assets Controls (OFAC), and the Department of Defense, Department of State, and Department of Commerce may maintain their own individual export restrictions. As a result, it is important for licensors to work with their counsel and government authorities to determine whether their IP licensing is subject to these additional export restrictions.

What’s the takeaway? So what lessons should licensors take away from examining these export control issues? Being conscious of the type of licensing being conducted, the content or technology being licensed, and where such items are being licensed to can help ensure compliance with U.S. export controls and ultimately realizing foreign market opportunities.

Are there additional export control issues you face in licensing your IP?

Special thanks to Jennifer Jolley for her assistance.