July 29, 1997

Animal Patenting Accelerates in US

The hesitancy with which the US Patent and Trademark Office (PTO) began granting animal patents in 1988 has all but disappeared, and today the practice is accelerating dramatically (see chart). The recent trend is fueled by a backlog of patent applications, rapid advances in biotechnologies and the promise of commercial markets for transgenic animals and the therapeutic proteins they produce. Based on the US trend, the European Union can expect hundreds of backlogged animal patents to begin issuing if the European Patent Directive is adopted - as expected - by the European Parliament's Council of Ministers later this year.

A total of 69 animal patents have issued in the US as of July 22, 1997. The number of animal patents granted by the PTO during the first 7 months of 1997 has already exceeded the total number of animal patents issued in 1996 (see chart). Based on projections from the first half of this year, RAFI predicts that the number of animal patents issued in 1997 will more than double the previous years' total. The animal patent stampede is not likely to slow down anytime soon. According to the US PTO, over 355 animal patent applications are now being considered by patent examiners.

The majority of animal patents issued in the US cover mice or rats that have been genetically altered to mimic human conditions or diseases. The animal models" can then be used to study a human disease, or experiment with possible therapies.

A review of animal patents illustrates that the lines between animal genomes and human genomes are blurring. Patented animal models with human ailments/conditions include, for example:

  • guinea pigs with asthma;
  • transgenic animal model for human cutaneous melanoma;
  • rat or mouse exhibiting behaviours associated with human schizophrenia;
  • transgenic mouse carrying a non-infectious HIV genome;
  • nude mouse model for human neoplastic disease;
  • transgenic animal model for neurodegenerative disease.

While most patents cover rodents, one lower invertebrate - a nematode (round worm) - has been patented. Patents have also issued on 2 avian species, 1 rabbit, 1 sheep, 1 guinea pig, and 1 fish. With recent advances in the creation of transgenic sheep using cloning technology, more patents can be expected on livestock (sheep, cows and pigs) that produce human proteins or organs for human transplant.

Not all animal patents claim transgenic animals. Some patents do not specify what type of animal or mammal is covered, leaving the door open to broad claims covering many species - including humans.

As of July 22, 1997 not a single animal patent has issued to an individual. Over 25% of all animal patents issued are held by three companies:

  • Genpharm International (recently acquired by Medarex, Inc., a company that has collaborations with Novartis and Merck KGaA)
  • Systemix, Inc. (a wholly owned subsidiary of Novartis),
  • Ontario Cancer Institute (a hospital-based Canadian research institute).

Other major pharmaceutical/biopharmaceutical companies that hold animal patents include Bristol Myers Squibb, Novo Nordisk, Eli Lilly & Co., Takeda Chemical, Nippon Zoki Pharmaceutical, and Amgen, Inc.

Cautionary words for farmers and civil society organizations in the EU: Although there have been several legislative attempts in the US to curtail the impact of animal patents on small farmers (to exempt farmers from having to pay royalties on the offspring of patented livestock), none have passed. Ultimately the patenting of animals enables the life industry to stake greater corporate control over agriculture and a rapidly diminishing livestock gene pool.

Special thanks to RAFI's Student Intern, Kimberly Wilson, who conducted background research for this GENO-TYPES."

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