Molecular Biotechnology: Principles and Applications - Glick, B. R., & Pasternak, J. J. 2002

Regulation of Research in Molecular Biotechnology and the Patenting of Biotechnological Inventions
Patenting of Biotechnological Inventions
Conclusion

There are several reasons for patenting inventions. Patent owners receive exclusive rights to an invention, which allow them to recoup the efforts spent on creating a new product, process, or device. At the same time, the scientific community gains detailed information about the invention and avoids wasting time and effort on reinventing the wheel. The prospect of generating profit from a patent encourages companies and individual researchers to develop novel ideas. Patents drive innovation and safeguard inventors' rights to their technical solutions. To be granted a patent, an invention must be novel, non-obvious, and useful. In addition, it must not be a naturally occurring product.

The issue of patenting DNA molecules is highly controversial. The U.S. Patent and Trademark Office (PTO) refused to grant patents for partial cDNA sequences due to a lack of specific data on their practical utility in the Applications; patents were also denied for genes identified using Hybridization probes synthesized on The basis of published Amino Acid Sequence data. Later, the PTO decision was overturned in court on the grounds that the degeneracy of METABOLISM/28.html">The Genetic Code makes it impossible to uniquely determine The nucleotide sequence of a cDNA from known amino acid sequence data of the corresponding protein, and therefore the non-obviousness requirement for patenting such inventions is met.

A pivotal moment in recognizing genetically modified microorganisms as patentable was a court ruling regarding recombinant Bacteria created by A. Chakrabarty. In 1980, the U.S. Supreme Court ruled that bacteria produced through genetic manipulation can be patented. Subsequently, U.S. patents were granted for a transgenic mouse with an increased incidence of malignant tumors and for certain Transgenic Plants. However, patenting animals produced via Introduction/32.html">Genetic Engineering Methods is not permitted in all countries.

With the advancement of molecular biotechnology, the question arose as to whether private companies should be allowed to patent organisms produced through Genetic Engineering and be granted exclusive rights to them. On the one hand, without such property rights, biotech companies would lack the incentive to develop and commercialize new products. On the other hand, some argue that such privileges are morally unacceptable and that patenting hinders scientific research and innovation. Finally, it should be noted that patenting influences the trajectory of fundamental science.

References

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Chahine K. G. 1997. Patenting DNA: just when you thought it was safe. Nat. Biotechnol. 15: 586—587.

Crespi R. S. 1997. Biotechnology patents and morality. Trends Biotechnol. 15: 123—129.

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Review Questions

1. What are the necessary conditions for the patentability of an invention?

2. WHAT IS A process patent? A product patent? Provide Examples.

3. What kind of information must be included in a patent application?

4. Why are patents useful to researchers who are not patent holders?

5. What are the goals of patenting inventions?

6. Discuss the issues surrounding EST patenting.

7. Discuss the decisions of the PTO and the U.S. Court of Appeals for the Federal Circuit regarding the patentability of genes identified using hybridization probes designed on the basis of published Amino acid sequences of the corresponding Proteins.

8. Prepare arguments for both sides in a debate on the topic: "Should the Patenting of Multicellular organisms produced by genetic engineering techniques be prohibited?"

9. Discuss how the patenting of inventions may influence the future development of fundamental science.

10. Access the USPTO website network (http://patents.uspto.gov/), use the Boolean search system for recombinant DNA patents (for example, using the keywords "recombinant" and "DNA"), and determine The Nature of the inventions protected by the five most recent patents.