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New IP resource for Pharma, Biotech and Chem Finding the right model for Research & Development Collaboration

Duncan — Tue, 21 Jun 2011 05:15:16 +0000

Another quick excerpt from the new book, Pharmaceutical, Biotechnology and Chemical Inventions: World Protection and Exploitation published by Oxford:

“It is quite common in the fields dealt with in this text for there to be research and development collaborations, many of which involve multiple parties…

Many of the jurisdictions covered in this text have state-owned research organizations which may fund or conduct their own research, and care must be taken in deciding the best methods to engage with them. For example, much research in Australia is conducted under a programme of funding and collaboration termed ‘Co-operative Research Centres’. These centres have sometimes onerous regulatory and contractual requirements which can make them unattractive.

Research collaborations have recently been the subject of litigation in Australia due to uncertainties around the ownership of employee inventions, particularly where the employer is a university. This is obviously always a key issue in any country. In addition, in Japan employee inventors have the right to be compensated beyond their usual salary for inventions that are commercialized, and this compensation can be quite considerable indeed.

Chinese contract law governs the agreements which can be made in research and development collaborations and, as usual, there are some key issues to be aware of. For example, if one party to a collaboration agreement does not agree to file a patent application, then none of the parties may file.

A key issue to consider in the United States is the operation of the Bayh-Dole Act which amongst other things allows non-profi t organizations party to a federal funding agreement to retain intellectual property arising from the funding but confers a non-exclusive irrevocable licence to the federal funding body.”

As before, this is a short excerpt from one of the overview summary sections.

Just to recap, it’s a detailed and strategic look at intellectual property and related issues in the pharmaceutical, biotechnology and chemical industries. It covers 11 jurisdictions, has a Europe overview section and will be published by Oxford University Press. It is topic based, so that you can see how the same issue is dealt with across the globe in one spot.

Oxford has kindly granted a 20% discount for readers of IP Think Tank. To claim your discount, just click this link (Pharmaceutical, Biotechnology and Chemical Inventions and enter the code ‘ALBUCK10′ , or call the team at Oxford on +44 (0) 1536 741727 and use the code ‘ALBUCK10’. (Note: this offer is only available on orders placed direct with Oxford University Press and is not available through any other supplier.)

Just to give you a little more background, the book will be published in a 2 volume set, with about 1,800 pages. It’s designed for the in-house team – to make things way easier than they are today.

Finally, thanks again to our incredible contributor team, each of whom are amongst the very best in the world:

Pravin Anand, Anund and Anund, India
John Bateman, Kenyon & Kenyon, USA
Susan Beaubien, Moffat & Co, Macera & Jarzyna LLP, Canada
Theo Bodewig, Humboldt University, Germany (Consultant Editor)
Simon Cohen, Taylor Wessing, UK
Wayne Condon, Griffith Hack, Australia
Marina Couste, Howrey LLP, France
Robert A. Dormer, Hyman, Phelps & McNamara, P.C., United States
Atsushi Hakoda, Nakamura & Partners, Japan
Juany Huang, Panawell and Partners LLC, China
Reuben E. Jacob, R. G. C. Jenkins, UK
Fabrizio Jacobacci, Studio Legale Jacobacci & Associati, Italy
Kurt R. Karst, Hyman, Phelps & McNamara, P.C., United States
Klaus Kupka, Taylor Wessing, Germany
David C. Musker, R. G. C. Jenkins, UK
Cyra Nargolwalla, Cabinet Plasseraud, France
Nina Resinek, Taylor Wessing, Germany
Toshio Takizawa, Nakamura & Partners, Japan
Koichi Tsujii, Nakamura & Partners, Japan
Klaus Schweitzer, Plate Schweitzer Zounek, Patentanwaelte, Germany
Deborah Somerville, Kenyon & Kenyon, USA
Paul Steinhauser, Arnold Siedsma, Netherlands
Nigel Stoate, Taylor Wessing, UK
Rosie Stramandinoli, Griffith Hack, Australia
Otto Swens, Steinhauser Hoogenraad, Advocaten, The Netherlands
Andreas Walkenhorst, Tergau & Pohl Patentanwälte, Germany
William Yang Panawell & Partners LLC, China
Federico Zanardi Landi, Studio Legale Jacobacci & Associati, Italy

New IP resource for Pharma, Biotech and Chem – Confidential information protection and jurisdictional differences

Duncan — Thu, 19 May 2011 04:45:53 +0000

Another quick excerpt from the new book, Pharmaceutical, Biotechnology and Chemical Inventions: World Protection and Exploitation published by Oxford:

“There are many aspects to the field of confidential information which vary, sometimes subtly, between jurisdictions. For example, a key touchstone for protecting and enforcing rights in relation to confidential information is that there must be an obligation of confidence as between the parties. However, the way that such a relationship is created and its meets and bounds can vary considerably. Similarly, the information must have the requisite character of secrecy which is to be protected. This does not always mean that it must have been kept absolutely secret in the past.

For these reasons and the usual ones associated with legal certainty and prudence, it is almost always best to enter into a written agreement which clearly delineates the obligations of confidence between the parties. Such agreements should, of course, not only deal with issues such as what disclosures (if any) are permissible, but also what types of uses of the information are allowed.

Some jurisdictions, such as the United States, define ‘trade secrets’ as a subset of confidential information which provides a competitive business advantage. Some jurisdictions, such as France, refer to commercially valuable confidential information as ‘know-how’.

In many jurisdictions, a breach of confidence action is a civil matter between the parties. However, in some, such as China, Italy, and Germany, it may be a criminal offence.

In recognition of the grave importance of confidential information in the context of litigation, the courts of some (but not all) jurisdictions provide for court-ordered protection of confidential information which is brought before the court as part of the litigation. This commonly occurs in the context of pharmaceutical patent litigation where, for example, the precise nature of certain aspects of one of the litigant’s products is sought to be kept confidential.”

As before, this is a short excerpt from one of the overview summary sections.

Finally, thanks again to our incredible contributor team, each of whom are amongst the very best in the world:

New IP resource for Pharma, Biotech and Chem – Tie-in / tie-out clauses and competition

Duncan — Tue, 19 Apr 2011 05:12:38 +0000

Another quick excerpt from the new book, Pharmaceutical, Biotechnology and Chemical Inventions: World Protection and Exploitation published by Oxford:

“A tie-in clause requires the licensee or acquirer of an intellectual property right also to purchase some other good or service which is not protected by the licensed intellectual property rights. A tie-out clause is one which prohibits the licensee or acquirer from acquiring certain goods or services (for example those of a competitor). The high risk of an anticompetitive eff ect of tying clauses is readily apparent and as a consequence they are tightly regulated in each of the jurisdictions dealt with in this text.

In some jurisdictions, such as Australia, Canada, Japan, and the European Community tying clauses are not per se illegal, but close restrictions apply to them. In general a key factor which will determine the legality of the conduct in any given situation is the impact that it has on the competition in the market (which is of course a basic principle of competition law). In many jurisdictions the prohibitions against tying clauses appear not only in the relevant competition law, but also in the intellectual property legislation. In the United States, certain tying arrangements are held to be per se illegal while others require scrutiny to ascertain their impact on the market.

Tying clauses are per se illegal in China in relation to agreements which import technology into China or where the intellectual property owner has a dominant market position. (This latter category is akin to the situation in some other countries where the offence is not per se illegal but depends on the effect on competition in the market.) India’s position is even more strict and holds tie-in and tie-out clauses to be per se illegal.”

As before, this is a short excerpt from one of the overview summary sections.

Finally, thanks again to our incredible contributor team, each of whom are amongst the very best in the world:

New IP resource for Pharma, Biotech and Chem – Compulsory licences, comparing national requirements

Duncan — Tue, 22 Mar 2011 04:14:11 +0000

Another quick excerpt from the new book, Pharmaceutical, Biotechnology and Chemical Inventions: World Protection and Exploitation soon to be published by Oxford:

“The hurdles which must be overcome in order to obtain a compulsory licence vary considerably amongst the jurisdictions covered in this text. For example, in order to obtain a non-use compulsory licence in Australia, China, France, Germany, India, and Japan one must wait three years after the patent has been granted and establish that the reasonable rights of the public have not been met. There are various other requirements such as, for example, that one may have to attempt to obtain a licence directly for a reasonable period and demonstrate that the patentee has not satisfactorily explained the reason for failing to exploit. However, in Canada one has to prove that the patentee has abused the patent monopoly in order to obtain a compulsory licence and a similar compulsory licence exists in the United Kingdom. There are no provisions for the grant of compulsory licences in the United States apart from those governed by the Bayh-Dole regime.

There are also different types of compulsory licence which may be granted according to differing procedures in each jurisdiction. Thus, for example, a compulsory licence to manufacture and export for humanitarian purposes is available in Canada and Germany. Some jurisdictions also allow a compulsory licence to be granted where access to patented technology is required in order to work the invention the subject of another patent. A further type of compulsory licence is one that is granted in the public interest.”

As before, this is a short excerpt from one of the overview summary sections.

Finally, thanks again to our incredible contributor team, each of whom are amongst the very best in the world: