BRCA1 Gene US Patents Judged Too Broad

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Some basic patents covering human genes and gene technology have recently been challenged in the US courts. Despite a clear judgement having been handed down, the overall impact of the case is still unclear.

The Patents

The BRCA1 and BRCA2 genes are both associated with hereditary breast and ovarian cancer.

Myriad Genetics Incorporated own 7 different patents issued by the US Patent & Trade Mark Office and covering the BRCA1 and BRCA2 genes. The patents are:

US 5,747,282

US 5,837,492

US 5,693,473

US 5,709,999

US 5,710,001

US 5,753,441

US 6,033,857

Industry and academic commentators had alleged that almost all research on the BRCA1 gene in the United States since 1998 has infringed these patents held by Myriad, and that research has gone ahead only because the company has voluntarily refrained from taking action against institutions performing basic gene research.

In the 7 patents, there are 15 individual independent claims.

Claim 1 of the ‘282 patent was held out as being representative of the group of composition claims. That claim read:

"An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID number: 2."

Claim 1 of the ‘999 patent was held out as being representative of the group of method claims in the Sweet of patents. Claim 1 of the ‘999 patent read:

"A method for detecting a germ line alteration in a BRCA1 gene, said alteration selected from a group consisting of the alterations set forth in tables 12A, 14, 18 or 19 in a human which comprises analysing a sequence of BRCA1 gene or BRCARNA from a human sample or analysing a sequence of DRCA1 c DNA made from mRNA from said human sample with the proviso that said germ line alteration is not a deletion of four nucleotides corresponding to base number 4184-4187 of SEQ ID number: 1."

This claim 1 of the ‘999 patent covered the process of identifying the existence of certain specific mutations in the BRCA1 gene by analysing the sequence of the BRCA1 DNA, RNA or CDNA made from BRCA1 RNA obtained from a human sample.

Most of the remaining method claims in patents were similarly structured and directed to the comparison of gene sequences.

Opponents to the patents

The plaintiffs in the case included the Public Patent Foundation, which is a not for profit legal services organisation whose mission is to protect freedom in the patent system. The organisation is based on the fundamental concept of protecting freedom from illegitimate restrain, which includes particularly patents and particularly those which the organisation considers unfairly monopolised areas of human endeavour which should be openly available for exploitation for all researchers, without the need to page royalties or obtain licences.

Other plaintiffs include:

  • The Association for Molecular pathology, a not for profit scientific society dedicated to the advancement, practice and science of clinical molecular laboratory medicine, translational research based on applications of genomics and proteomics;
  • The American College of Medical Genetics, a private non-profit voluntary organisation of clinical and laboratory geneticists;
  • The American Society for Clinical Pathology, the largest and oldest organisation representing the medical speciality of pathology and laboratory medicine;
  • The College of American Pathologists, a national medical society representing more than 17,000 pathologists who practice anatomic pathology and laboratory medicine in laboratories world wide;
  • Dr. Kazazain, M.D. a professor of molecular medicine in the department of genetics at the University of Pennsylvania School of Medicine
  • Dr. Ganguly, an associate professor in the department of genetics at the hospital of the University of Pennsylvania;
  • Dr. Wendy Chung, M.D., Ph.D., an associate professor of paediatrics and professor of paediatrics and medicine in the division of molecular genetics at Columbia University;
  • Dr. Ostrer, professors of paediatrics, pathology and medicine and director of the Human Genetics program in the department of paediatrics at New York University School of Medicine;
  • Dr. Ledbetter, Ph.D., professor of human genetics and director of the Division of Medical Genetics at the Emory University School of Medicine;
  • Dr. Warren, Ph.D., professor of human genetics, professor of biochemistry and professor of paediatrics at Emory University;
  • Ms Matloff, director of the Yale Cancer Genetic counseling program;
  • Ms Reich, professor at the department of paediatrics at New York University, Breast Cancer Action, a national organisation of approximately 30,000 members based in San Francisco California and representing the voices of people affected by breast cancer;
  • The Boston Women’s Health Book Collective, a non-profit public interest womens health education, advocacy and consulting organisation;
  • Professor Teriani, a 43 year old single mother who was diagnosed with cancer;
  • Amicus Curiae Rosetta Genomics Incorporated, a wholely owned subsidiary of Amicus Curiae Rosetta Genomics Limited, a molecular diagnostics company which provides diagnostic tests for cancer and which itself owns several patents; and
  • Dr. Noonan, a patent attorney who contends that isolated human DNA constitutes patentable subject matter.

Overall this patent family has its share of critics and person who consider the patent rights should not have been granted.

The Decision

On March 29, 2010, Judge Sweet ruled in the case of "Association for Molecular Pathology Et al. -v- USPTO and Myriad Genetics" that Myriad Genetics’ patents on the BRCA1 and BRCA2 genes which are linked to breast cancer were invalid for the reason that in Judge Sweet’s opinion, genes do not constitute patentable subject matter.

The key basis of the judgement was that the BRCA1 and BRCA2 genes constituted a "product of nature", that was not significantly different from their original form. Judge Sweet noted that "[were] the isolated BRCA1/2 sequences different in any significant way, the entire point of their use – the production of BRCA1/2 proteins – would be undermined".

The claims in suit were declared invalid on the basis that "as determined above, the patents issued by the USPTO are directed to a law of nature and were therefore improperly granted.".

Commentary

Around 20% of all human genes are patented. This case challenges whether genes in general can be patented, and may have far reaching effects for the biotechnology industry.

However, as a general question on the impact of this case on the patentability of genes in general, the outcome is non conclusive. Taking as an example, US 5,747,282, this US patent is at the time of writing still showing on the US Patent Database as patented and in force. The fact that the US Court has judged the broad independent claims to be invalid does not necessarily mean that the patent as a whole is invalid, since there are many sub-claims in addition to the main independent claim. However, the main claim is judged as too broad, and the US court has made some wide ranging comments on the patentability of the subject matter which may have a destructive effect on enforceability of the US patents for similar subject matter.

The corresponding European patents EP 0 699 754 B, EP 0 705 902 B2, and EP 0 705 903 B2, are each still in force in individual European countries including France, Germany, UK and Spain, after having successfully survived opposition at the European Patent Office by several opponents.

Interestingly, Myriad Genetics is not recorded as the owner of the European patents, but rather the United States of America is the patentee, as represented by the University of Utah Research Foundation.

Ironically, rather than this case being about academics and the public sector complaining that individual private enterprises and corporations are stitching up the field of basic gene research, so that the university research and small company research is suppressed, because the US Government actually owns at least the European patents, the case could be interpreted that academics in the public sector, and private enterprise corporations are complaining that the US Government, as owner of the patents has created monopoly rights in this field, and is using the patent system to suppress academics and private enterprise in the US and elsewhere, from exploiting basic gene research.

Case citation: United States District Court Southern District of New York, Association for Molecular Pathology et al – against – United States Patent & Trade Mark Office et al 09.civ.4515 filed March 03, 2010 (156 page judgement).

Article Published May 7, 2010