The pharmaceutical and biopharmaceutical industries are engaged in a business environment which is witnessing a dramatic escalation of R&D costs, key patent expiries, and sustained high attrition rates for new molecules in development. In response, pharmaceutical companies have recognized the need to expand the range of creative stimuli for their research processes in order to reinvigorate their drug discovery pipelines. Consequently the industry has sought to develop external collaborations not only with other companies but also more frequently with academia, to obtain access to new technologies to enhance their drug discovery capabilities and to in-license candidates for further development. Indeed, collaboration is becoming an essential component of today’s drug discovery efforts and it is commonly undertaken with multiple partners through an often iterative, continuous, and long lasting process, which adds to the complexity of efficiently managing both the collaboration itself and the data generated. This report explores the opportunities and challenges that are presented by collaboration with university researchers as well as identifying the key inputs from both the industrial and academic partners. The different organizational cultures and structures are examined along with consideration of the goals for each institution and the issues these create. The report discusses the various types of agreement which can be used, highlights legislation of importance to the appropriate protection of intellectual property, and presents case studies of notable collaborations In addition the report offers thoughts on the future for collaborative agreements and the benefits they will bring to both parties. Key features of the report • Describes the different types of collaboration between academia and the pharmaceutical/biopharmaceutical industries, the cultural issues and organizational conflicts presented by these forms of collaborations, and the management processes required to overcome these challenges. • Reviews the international and national legislation governing the intellectual property rights for owners of the technology (the university) and the technology transfer partner that will exploit the technology (the pharmaceutical industry).. • Identifies a variety of different collaborative agreements and groups these into two main categories • Provides a number of case studies illustrating the important features of these collaborations, the practical implications and complexity of the agreements reached, and the pitfalls encountered in some cases. • Focuses on the evolving nature of collaborations between the pharmaceutical industry and academic institutions, developing the emerging themes and exploring the opportunities for drug discovery using novel collaborative models and approaches.

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Key benefits of the report • Provides the executive with an insight into the complex nature of the issues and challenges facing both academia and the industry when establishing the terms and conditions of any collaborative agreement together with the problems associated with the differences in management styles and cultures of individual parties in the collaboration. • Describes the methods used to identify a suitable collaboration candidate and helps the reader to understand the factors that affect partner selection and the dynamics of the resulting network. • Highlights the problems associated with knowledge and technology transfer between collaborating partners as well as the common challenges to be overcome before companies are able to exploit the new technologies. • Identifies and describes the various emerging quasi institutions, such as research clusters, that take advantage of developments in communication technologies. • Provides an insight into the future of academic–industry collaborations and the importance that information and communication technologies is having on the development of the next generation of collaborative partnerships.Key highlights While academic institutions have attempted to remain true to the principles of open inquiry and intellectual freedom, political-economic forces such as globalization, an increasingly conservative political agenda, a tightening of public financial support for higher education and their changing role in society have resulted in the emergence of the corporate and entrepreneurial universities. The traditional view that there should be separation between the “ivory tower” academic based sciences and the more commercial and applied developmental research conducted in industry is now obsolete. Instead there is considerable synergy between basic research carried out in academia and applied research that is undertaken in the pharmaceutical industry. Major collaborations have a broad range of stakeholders, and failure to take all viewpoints into account can lead to significant opposition which ultimately may undermine the value of the partnership to both parties. Both the exact terms of the agreement and the presentation of those terms to the wider community are of crucial importance to a successful collaboration. Key questions answered by this report • What are the key drivers influencing change to a more collaborative approach to R&D in the pharmaceutical industry? • What are the latest developments in the collaborative approach to R&D and which models represent the best opportunities for the pharmaceutical industry. • What are the issues and concerns over the evolving collaborative R&D paradigms? • What are the intellectual property management issues that should be considered by each party? • Which changes in patent legislation are of greatest relevance to the formation of collaborations in different countries? • What are the different types of academia–industry collaborations? • What are the pros and cons for each party in academia–industry collaborations? • What are the critical success factors for academia–industry collaborations? • What are the main factors to take into account when negotiating academia–industry collaborations? • What are the cultural, change management and goal alignment challenges? • What are the future directions for academia–industry collaborations?

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Copyright (c) 2010 Ask The Business Lawyer

Partnering with another business on a project is a powerful way to raise your company’s profile, boost creativity, and get new clients. However, such partnerships more often than not give rise to intellectual property, which needs to be adequately protected. Many business owners overlook, until it’s too late that (1)they generated valuable intellectual property, and (2) steps they could have taken to protect it.

For example, “Vivienne,” was a former school psychologist who worked for years with disadvantaged children. Her friend, Fiona, wrote about financial education and financial management for adults. Together, they developed an interactive financial literacy workshop and board game for children called, “Show Me the Money!” The collaboration hit a snag when Vivienne wanted to use the workshop for her own project with at-risk adults. Fiona then realized that “Show Me the Money!” – if used with a general adult population – could steal her thunder . . . and profits. So what steps can they take to move forward smoothly?

1. Maintain open communication. In the ideal, self-preservationist world, Fiona would have thought through the ramifications of collaborating before she started freely sharing her wonderful ideas. But life is rarely ideal. The solution: Fiona should sit down with Vivienne and explain her concerns. Working out a fair, written agreement concerning your intellectual property is always better belatedly, than never.

2. Make known what’s at stake. Even if they did not have a written agreement, Fiona and Vivienne have some copyright protection. Copyright legislation protects all artistic and literary original work. As “joint authors”, each of them has the right to make full use of the game without needing the other’s permission. However, one would have to supply an accounting of the money earned to the other, which can develop into a difficult situation. The solution: They should both make clear where and how each can use the game, and decide if either can make alterations to the game without first consulting the other.

3. Explore future possibilities: “Show Me the Money” could turn out to be wildly successfully and become well known through its trademark. (Trademark is defined as a word, phrase, symbol, design or any combination, that identifies and sets apart the goods of one party from another). It could spawn multiple merchandising spin-offs such as CDs and workbooks, notebooks, teleclasses, ebooks, books, coffee mugs, and any type of related product or service. Each and any of these can be trademarked, (in case of a product) or servicemarked (for a service) by Vivienne or Fiona. Undoubtedly, this would give lead to later issues, most importantly, “who owns it?” The solution: Sidestep a nasty legal battle through agreement on the ownership of the trademark, and establish terms and conditions of use.

4. Protection against other interlopers. Assuming Fiona and Vivienne move forward with the project they need to be sure that no one misuses the “Show Me the Money” trademarks and design. The solution: They could formally apply for copyright protection for the game (there’s a lot of great information and forms available on the U.S. Copyright Office website, http://www.copyright.gov). Second, any designer they hire (for the game and any other Hard Knocks graphics or website) should create the designs as a “work for hire.” Why? Because rights in a design belong to the creator (designer), unless there is a written agreement that they have been created for the benefit of another (called “work for hire” in copyright terminology). Finally, in dealing with any manufacturer of the game, Fiona and Vivienne will want to confirm all of the pricing, quantity, and quality terms, plus ensure that the manufacturer will keep their game confidential. This is important because, while they cannot protect the general idea (of a board game that teaches life skills), they are entitled to protect their particular expression of the idea. So, confidentiality provisions are key.

It was just as well that Vivienne and Fiona knew each other well enough that they could jointly address these issues in a manner that worked for both of them. Other business owners may be less fortunate. Recognize that in any collaboration, issues of joint intellectual property may arise. Ensure that you are protected by seeking advice from an attorney, or risk your “brain child” being hijacked by another.

 

Intellectual property (IP) forms the mots important sement in Projects Life, so that no one claims the product as his own, whne the service only been given, and the laws covering patents, trade marks, copyright, designs, circuit layouts, and plant breeder’s rights.

 

Intellectual property laws protect the property rights in creative and inventive endeavors and give creators and inventors certain exclusive economic rights, generally for a limited time, to deal with their creative works or inventions.

POME recommends to learn more about these different types of intellectual property, which involves in daily Operations Life, more than what been illustrated below:

A patent is a right granted for any device, substance, method or process, which is new, inventive and useful.

A patent is legally enforceable and gives the owner the exclusive right to commercially exploit the invention for the life of the patent. You have to apply for a patent in order to protect your invention, as it isn’t automatically protected. All applications for patents are examined to ensure they meet the necessary legal requirements for granting a patent.

There is also the option of applying for an innovation patent. An innovation patent is generally granted within one month and can give you legal ownership over your inventions.

 

A trade mark can be a letter, number, word, phrase, sound, smell, shape, logo, picture, aspect of packaging or any combination of these.

A registered trade mark gives you the exclusive legal right to use, license or sell your goods or services. It distinguishes your goods and services from others in the marketplace.

Anyone who claims to be the owner of a trade mark can apply for registration of that trademark. The registration period is initially for few years and continues indefinitely as long as the renewal fees are paid.

Remember that registration of a business name does not in itself give you any proprietary rights – only a trade mark can give you that kind of protection. Ensure you have exclusive use of your name now and in the future by registering a trade mark.

 

Copyright provides legal protection for people who express ideas and information in certain forms that include writing, music, visual images, moving images and computer programs.

It is designed to prevent the unauthorized use by others of a work that is the original form in which the idea or information has been expressed by the creator.

Copyright protection is free, there is no registration system. But it is advisable for copyright owners to place a copyright notice in a prominent place on their work.

 

Common law protects you from people stealing your trade secrets, breaching confidentiality agreements and passing off trade marks.

Make sure you back up your trade secret with a signed confidentiality agreement with every person who has knowledge of the secret. A confidentiality agreement can stop your employees from revealing your secret or proprietary knowledge during and after their employment or association with your business.

 

If you are the owner of a product then you can register its design to protect the visual appearance. Registration protects your design from being used without your permission. You can register your design for up to certain period.

Your design must be new and distinctive to be registered.

 

Circuit layout rights automatically protect original layout designs for integrated circuits and computer chips. There is no requirement for registration for the granting of rights to the owner of a layout design.

The Attorney-General’s Department generally administers the legislation for automatic rights to circuit layout rights.

 

Plant Breeder’s Rights (PBR) are exclusive commercial rights to a registered variety of plant. Varieties protected by PBR may only be produced for sale, sold, imported, exported or conditioned with the authority of the owner.

If you are the original breeder of a new variety of plant, or have acquired ownership rights from the original breeder, then you can apply for Plant Breeder’s Rights. Please note that only new or recently exploited varieties can be registered. Apply for the rights using application forms available from the PBR Office.

POME Prescribe:

The Zen of Project Management

 

ü  Zen is a form of self-investigation that has its roots in China and Japan.  It is a merging of Indian Buddhism and Taoism.  The Zen approach is one that cuts through complexity to go straight to the heart of a matter.  Zen promotes knowing through inner experience.  It promotes discipline from within.  In the Zen way, the individual comes to fully know his or her own nature by cutting through intellectualism, cultural barriers, conditioned responses, rules and any other “extras” that get in the way of seeing the essence.  One who sees the essential nature of things has wisdom.  Wisdom leads naturally to compassion.  Wisdom and compassion are at the heart of our essential nature.

ü  What is a wise approach? It is an approach that gives us the ability to see things clearly and minimize the probability that we will be reactive and ineffective in achieving our goals and objectives.  Wisdom is the synthesis of knowledge into active, practical use.  A wise person moves through life with equanimity, un-phased by the chaos surrounding her.  A wise person has choices.  He is not unconsciously driven and reactive.

ü  “Only the person who learns to relax is able to create, and for them, ideas reach the mind like lightning.” Even in face of chaos, pressure and stress, relax! How? Relaxation is not the same as tuning out and turning off. It is not somnabulence. Learn to rest in the moment. Cultivate the ability to quickly focus on your breath and body just long enough to find your “center”. Then engage.

ü  Serve someone. Serve everyone. That is the secret of wise leadership. There is a difference between a leader who serves and one who just leads. “The difference manifests itself in the care taken by the servant-first to make sure that other people’s highest priority needs are being served.” Such a leader asks if “those served grow as persons; do they, while being served, become healthier, wiser, freer, more autonomous, more likely themselves to become servants?” When the motivation is to serve, posturing, politics and self-serving gains are replaced by useful effective action.

ü  Mental models are deeply ingrained assumptions, generalizations … that influence how we understand the world and how we take action. ” They may be useful, or they may lead to habitual, reactive behavior. What paradigms condition your behavior? Do they help or hinder you? Do you have the courage to question them? Do they provide established basis for analyzing problems, or do they limit your ability to act in the way that is best for the current situation.

ü  Desiring the impossible gives rise to suffering It is also the root of many failed projects. When undertaking a project, you have the duty to question authority, to push back. Ask questions, rather than voice objections. Why is this deadline? What if it isn’t met? What do you really need, and by when? What assumptions are you making? What would you give up to get what what you really need? Will we have the right resources at the right time?

ü  The Good, The Bad, The Continuous Improvement: We learn at least as much from bad experience as we do from good. Yet, blaming, fear of punishment and models like “I’m so smart, how can I make mistakes” lead us to avoid looking at and learning from our mistakes. Continuous improvement begins with the candid acceptance of the existing situation, particularly its flaws. If you don’t accept what is, you can’t change it.

How to Push Back when Negotiating: When pushing back to negotiate a rational schedule and budget you need solid footing. Come to the table with a well articulated plan, complete with assumptions. Use your communication, task definition, estimating, scheduling, and risk management skills and knowledge to offer realistic alternatives. Seek win-win solutions. What if you are forced to accept an irrational schedule or budget? Try to do your best to negotiate expectations that can be met given the project’s scope, resources, and risks. Do your best to work within the project’s real-world conditions.

Gautam Koppala,

POME Author

In pursuit of globalization, India has responded positively by opening up its economy, removing controls and resorting to liberalization. In quest of increasing the efficiency of the nation’s economy, the Government of India acknowledged the Liberalization Privatization Globalization era. As a result Indian market faces competition from within and outside the country. This lead to the need of a strong legislation to dispense justice in commercial matters and the Competition Act, 2002 was passed.

Healthy and fair competition has proven to be an effective mechanism which enhances economic efficiency. Therefore the purpose of implementing the competition law was to curb monopolies and encourage competition in Indian market. Intellectual property (IP) refers to creations of the mind: inventions, literary and artistic works, and symbols, names, images, and designs used in commerce1.

An Intellectual Property Right (IPR) is, an intangible right “protecting commercially valuable products of the human intellect”; it may comprise patents, copyrights, trademarks and other similar rights2. An IPR includes the right to exclude others from exploiting the non-corporeal asset.

IP is divided into two categories: Industrial property, which includes inventions patents, trademarks, industrial designs, and geographic indications of source; and Copyright, which includes literary and artistic works such as novels, poems and plays, films, musical works, artistic works such as drawings, paintings, photographs and sculptures, and architectural designs. Rights related to copyright include those of performing artists in their performances, producers of phonograms in their recordings, and those of broadcasters in their radio and television programs.

IPRs and competition are normally regarded as areas with conflicting objectives. The reason is that IPRs, by designating boundaries within which competitors may exercise monopolies over their innovation, they appear to be against the principles of static market access and level playing fields sought by competition rules, in particular the restrictions on horizontal and vertical restraints, or on the abuse of dominant positions.

Intellectual Property Rights and Competition Law have been described as an unhappy marriage. The former may be seen to promote monopolies whilst the latter is designed is oppose them. In other words, on one hand, IP laws work towards creating monopolistic rights whereas competition law battles it. In view of this there seems to be a conflict between the objectives of both laws.

Competition laws involves in formulating a set of policies which promote competition in the market. These are aimed at preventing unfair trade practices. It is also framed with the intention of curbing abuse of monopoly in the market by the dominant company. Consumer welfare and a healthy competition in the market are the main objectives of the Competition Law.

On the other side IP Laws are monopolistic in nature. They guarantee an exclusive right to the creators and owners of work which are a result of human intellectual creativity. Also they prevent commercial exploitation of the innovation by others. This legal monopoly may, depending on the unavailability of substitutes in the relevant market, lead to market power and even monopoly as defined under competition law.It is an advantage granted to the owner over the rest of the industry or sector. When this advantage or dominant position is abused it creates a conflict between IPR and competition law.

The provisions3 of the Competition Act, 2002 prohibits the exercise of anti-competitive agreements by the IPR holders since they are in conflict with the competition policies. Further the Act authorizes4 the Competition Commission of India to penalise the IPR holders who misuse their dominant position. Furthermore, Section 45 of the Act the Commission is also authorized to penalize the parties to an anti-competitive agreement, which is in contravention of Section 3 of the Act.

In order to combat with IPR monopolies anti-competition laws often include two major measures like parallel imports and compulsory licensing. A compulsory license is where an IPR holder is authorized by the state to surrender his exclusive right over the intellectual property, under the provisions6 of TRIPS. On the other hand a parallel import includes goods which are brought into the country without the authorization of the appropriate IP holder and are placed legitimately into a market.

Innovation has always been a cause in a growing economy resulting in more innovation. The advent of fresh innovations gives rise to healthy competition at macro as well as micro economic levels. IP laws help protect these innovations from being exploited unlawfully. In view of this IP and Competition laws have to be applied in tandem to ensure that the rights of all stake holders including the innovator and the consumer or public in general are protected.

The common objective of both policies is to promote innovation which would eventually lead to the economic development of a country however this should not be to the detriment of the common public. For this the competition authorities need to ensure the co-existence of competition policy and IP laws since a balance between both laws would result in an economic as well as consumer welfare.6

Intellectual property can be a difficult concept to understand. In it simplest state people understand how a physical product can be patented to ensure that others do not copy its design. However it often becomes more complex when you are trying to protect an idea, a range, brand or piece of software from the public.

International law now has methods of protecting those with bright ideas. The 1967 convention that established the World Intellectual Property Organisation argues that intellectual property protection “shall include rights relating to:

- literary, artistic and scientific works

- performances, phonograms, broadcasts etc

- inventions in all fields of human endeavor

- scientific discoveries

- industrial designs

- service marks, commercial names, designations and trademarks

- protection against unfair competition and it also enforces all other IP rights resulting from the industrial, scientific, artist or literary activities.”

There are several legal avenues to follow, depending on what type of intellectual property you are trying to protect. Copyright can also apply to art work, books and scientific publications; and to performances from artists, phonograms and broadcasts.

Copyright protection is also used in business situations when the intellectual property to be protected might be something such as a trademarks or brand name, which has value in transmitting information to consumers. Another method of doing this is to use trademarking to protect the brand wording.

Intellectual property as a concept can apply equally to new inventions as to new designs. If an invention is clearly unique, or takes known technology a stage further, then it may be possible to use patent law as a route to protect the invention from being copied in the future. As an example, James Dyson’s concept for a better vacuum cleaner, using cyclonic technology, has been protected by the registering of patents; these have enabled Dyson to defend its concept against other vacuum cleaner companies who tried to copy the technology and introduce similar machines of their own.

An early consultation with an IP lawyer will establish the best way to protect your idea or concept against being copied by others. The fact that you will have sought protection, before showcasing your idea to the wider market, will give others who believe they were working on the same idea/project the opportunity to come forward.