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In contrast to the US District Court’s decision, the Technical Board of Appeal of the European Patent Office ruled in favour of Myriad’s European BRCA gene patents.

Te board considered the patentability of

claims which sought protection for: isolated DNA containing portions of the BRCA1 gene sequences, and methods for ‘comparing’ or ‘analysing’ BRCA1 gene sequences to identify the presence of mutations correlating with a predisposition to breast or ovarian cancer.

Patentability of isolated DNA

In considering the patentability of nucleic acid probes containing part of the BRCA1 gene sequence, the board affirmed that an element isolated from the human body or otherwise produced by means of a technical process may constitute a patentable invention.

It did not consider the patentability as such of gene sequences isolated from their natural environment to be a debatable issue.

However, a recent decision from the European Court of Justice (ECJ) held that a claim directed to a DNA sequence may only cover that sequence when it is performing the function for which it is patented. Tus, while it is possible to obtain patents for DNA sequences, the court’s decision potentially reduces the scope of protection given to DNA patents. It remains unclear what is meant by the DNA’s ‘function’. It will certainly be interesting to see how national courts accommodate this decision in future litigation in this area.

Patentability of diagnostic methods

In Europe, discoveries, schemes, rules and methods for performing mental acts are not patentable. However, inventions concerned with the application of excluded subject matter, for example the application of a discovery, may be patentable.

It was alleged that Myriad’s method of diagnosis claims were not patentable because they were based on:

• Discovery of a mutation

• Discovery of relationship that exists in nature between mutation and disease, and/or

• A purely mental act that a human having this mutation has a predisposition to the disease.

Te board held that Myriad’s claims were not excluded from patentability on these grounds. It affirmed that, in Europe, an element isolated from the human body or otherwise produced by means of a technical process may constitute

Simon O’Brien is a partner at D Young & Co LLP. He can be contacted at:

David Gass is a partner at Marshall, Gerstein & Borun LLP. He can be contacted at:

a patentable invention. While this concerns claims relating to products (in this case genes), the board stated that this provision is a fortiori applicable to the diagnostic method claims.

Further, the board held that as features of the diagnostic method claims were considered to require working steps of a technical nature, they did not fall within the method of performing a mental act exclusion from patentability. Terefore the diagnostic method claims were found to relate to patentable subject matter.


While the patenting of genes and diagnostics is now becoming established in Europe, the situation in the US is more uncertain. Whether the US District Court’s decision in respect of the Myriad patents signals a change in attitude towards patents to DNA and diagnostic methods remains to be seen. However, given the long-standing practice of the USPTO that genes isolated for their natural environment may fall within the scope of patentable subject matter, many observers are confident of a reversal of the decision.

For as long as society relies largely on private entities to invest in developing new genetic research-based treatments and diagnostics, biopharmaceutical companies will continue to require some degree of exclusivity over these technologies as a means of obtaining a return on their investment. Tere can be little dispute that patents for therapeutics are important to stimulate the significant investment required to get them to market. Of greater political concern is whether the same applies to diagnostics. For example, the Secretary’s Advisory Committee on Genetics, Health, and Society (SACGHS) has

recently issued a report suggesting that

patents protecting diagnostic testing play a less important role in stimulating investment and, indeed, may be used to narrow or clear the market of already developed competition, thus limiting access.

Any move to inhibit the patent protection available for research aimed at improving the health of society must not be taken lightly. Te patent system has played a very important role in the significant medical advances seen over recent decades.

NOTICE: Tis article is intended to be informative and should not be construed as legal advice for any specific fact situation. Opinions expressed herein are those of the author and not necessarily the opinions of D Young & Co LLP or Marshall, Gerstein, & Borun LLP or any of their respective clients. Readers should not act upon the information presented without consulting professional legal counsel. ©2011 D Young & Co LLP and Marshall, Gerstein & Borun LLP All rights reserved

Simon O’Brien is a partner in the D Young & Co LLP Biotechnology, Chemistry & Pharmaceuticals Group. D Young & Co provides highly acclaimed intellectual property services for clients in a range of technologies spanning many industrial sectors. Te firm is ranked as a top tier IP firm by Legal 500, which refers to D Young & Co LLP as ‘consistently excellent’ and ‘very customer focused’, with ‘business acumen and industry knowledge of the patent attorney landscape [that] is very impressive’. For more information about the firm, visit

David Gass is a partner in the biotechnology practice group of Marshall, Gerstein & Borun LLP in Chicago. For more than 50 years, Marshall, Gerstein & Borun LLP has maintained an exclusive focus on the practice of intellectual property law. Clients include Fortune 250 corporations, multinational businesses,

start-up organisations, non-

profits and companies in industries from material science to biotechnology. Marshall, Gerstein & Borun has been recognised as a top IP law firm by Fortune, Intellectual Property Today and Managing IP magazines. For more information about the firm, visit

Life Sciences Intellectual Property Review 2011


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