Are patent pools a cure for royalty stacking?

Royalty stacking has become a serious issue for the biotech/pharmaceutical industry. Examples include:

1) AIDS/HIV drugs

2) SARS drugs

3) Stem cell research (see below)

4) Malaria vacine (see below)

5) The Patent Court of Appeals has discussed royalty stacking in the biotech industry (see below)

For item 3 --

In 1995, the Department of Justice (DOJ) and the Federal Trade Commission (FTC) suggested guidelines to be used in determining when a patent pool is pro-competitive and therefore probably acceptable, and when it is anti-competitive and probably unacceptable.

An important aspect to the creation of any patent pool is the identification of a standard.

This standard may have occurred already in the industry without any cooperation among stem cell providers (de facto), or, alternatively, it may be created by a standard setting organization (de jure) such as a standard development organization or a consortium (e.g., the Stem Cell Consortium at the Columbia University Medical Center, the California Institute for Regenerative Medicine or the FDA). One possible standard may consist of a specified method of preparing hES cell cultures so that consistent results may be obtained by researchers. More specifically, the standard may require culturing the stem cells in the absence of animal feeder cells which can give rise to viral contamination.

3

Once a standard has been defined, any patent that is needed to implement that standard would be "essential" to the pool, and, therefore, must be included. In the event that a standard cannot be defined for stem cell technology, a patent pool could still be formed so long as any license offered by the patent pool precisely defines the rights granted by the license and what a licensee needs to practice the technology.

http://www.skgf.com/media/news/news.176.PDF

The stem cell consortium mentioned in the article is at:

http://www.cumc.columbia.edu/stemcell/

For item 4 --

Malaria vaccine --

While there are few commercial data available on the density of patent thickets or the extent of royalty stacking for new products, some not-for-profit groups have revealed how they navigate patent thickets. For example, in considering the development of a malarial vaccine which could be sold at relatively low cost in developing countries, the Programme for Appropriate Technology (PATH) commissioned a study of the patents that might need to be licensed for a vaccine that would rely on the MSP-1 protein of the malaria parasite (Nuffield Council on Bioethics, 2002). From an initial patent map of close to 40 relevant patents (Galloway, 2002), PATH narrowed the relevant patents to five core US patents relating to MSP-1, a dozen patents useful in constructing vaccines, and five specialized patents for the production of MSP-1 vaccines.

From:

Genetic Inventions,Intellectual Property Rights and Licensing Practices

http://www.oecd.org/dataoecd/42/21/2491084.pdf

PRINCIPLES AND BEST PRACTICES FOR THE LICENSING OF GENETIC INVENTIONS

Organisation for Economic Co-operation and Development

http://www.oecd.org/home/0,2605,en_2649_201185_1_1_1_1_1,00.html

For item 5 --

Here is a quote from a CAFC case covering Pharmaceutical issues (Integra v. Merk) where royalty stacking was discussed:

"In addition, the number of patent licenses needed to develop a drug may also affect the value placed on any single technology used in the development process. The cumulative effect of such stacking royalties can be substantial, particularly when reach-through royalties come into play. See Ware, supra, at 295-96. While this court does not opine on the applicability of a reach-through royalty in this case, the presence or absence of stacking royalties for research tools may color the character of a hypothetical negotiation."

From:

http://www.ll.georgetown.edu/Federal/judicial/fed/opinions/02opinions/02-1052.html

The "Ware Reference" is an article written by Foley Hoag's Chairman of the IP Litigation Group. See the following link for his bio and for the reference: http://www.fhe.com/attorney.asp?aID=000320932001

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