Myriad Sues Ambry for Offering BRCA1/BRCA2 Breast Cancer Genetic Testing

11 July 2013 PharmaPatents Blog

On July 9, 2013, Myriad Genetics, Inc. brought suit against Ambry Genetics Corporation, alleging that Ambry is infringing ten (10) patents by offering breast cancer genetic testing for the BRCA1 and/or BRCA2 mutations associated with aggressive forms of breast and ovarian cancer. While Association for Molecular Pathology v. Myriad Genetics, Inc. was making its way to the Supreme Court, Myriad said that it has other patent claims protecting its market position. This case could put those claims to the test.

The Patents At Issue

Myriad is asserting specific claims from the following 10 patents, which are owned by or licensed to Myriad:

  • U.S. Patent No. 5,709,999
  • U.S. Patent No. 5,747,282
  • U.S. Patent No. 5,753,441
  • U.S. Patent No. 5,837,492
  • U.S. Patent No. 6,033,857
  • U.S. Patent No. 5,654,155
  • U.S. Patent No. 5,750,400
  • U.S. Patent No. 6,051,379
  • U.S. Patent No. 6,951,721
  • U.S. Patent No. 7,250,497

The asserted claims are generally directed to DNA primers and genetic screening methods that recite concrete method steps. (For a detailed review of the asserted claims, see this PatentDocs article.)

The Accused Conduct 

On June 13, 2013, the same day that the Supreme Court issued its decision invalidating Myriad’s “isolated DNA” claims, Ambry published the following statement:

Ambry Genetics announced today the launch of BRCA1 and BRCA2 analysis as part of their comprehensive cancer-testing menu. Two genes will be offered as a stand alone test comprising of full gene sequencing and deletion/duplication analyses in addition to being incorporated as part of multiple hereditary cancer panels that test cancer susceptibility genes using next-generation sequencing (NGS) technology. Additionally, Ambry Genetics is excited to launch a new high-risk hereditary breast cancer panel (BRCAplus) that simultaneously analyzes six clinically actionable genes: BRCA1, BRCA2, CDH1, PTEN, STK11 and TP53. These additions complement Ambry’s comprehensive menu of single gene offerings and NGS multi-gene panels designed for hereditary cancer syndromes.

*****

“With the launch of BRCA1/2 genetic testing, Ambry Genetics now offers the most comprehensive suite of hereditary cancer testing available,” said Charles Dunlop, Chief Executive Officer of Ambry Genetics. “Ambry’s BRCA1/2 testing includes gene sequence and deletion/duplication analyses at a competitively lower cost and comparable turn-around time to the laboratory that previously controlled BRCA1/2 analysis.”

*****

“The relationship between BRCA1/2 and breast cancer risk was not discovered by a single patent holder, it stood on the shoulders of years of work by our scientific colleagues. Ambry is a beneficiary of these collaborative efforts of the research community both in US and worldwide. We have access to tremendous resources for the classification of BRCA1/2 variants and accurate association with cancer risk,” said Elizabeth Chao, M.D., Chief Medical Officer at Ambry Genetics. “This provides us with a strong basis for a variant classification program that will be second to none.” 

If that wasn’t enough to get Myriad’s attention, they also posted this picture on their home page

According to Myriad, Ambry “indicated that it will offer its BRCAPlus test for $2,280, significantly below the price of Myriad Genetics’ integrated BRACAnalysis® test, which is priced at $4,040.”

Myriad divides Ambry’s allegedly infringing activities into three categories:

  1. Ambry’s preparation of synthetic DNA samples for BRCA1 and BRCA2 sequencing and analysis (alleged to infringe at least claims 16 and 17 of the ’282 patent and claims 29 and 30 of the ’492 patent)
  2. Ambry’s sequencing of the BRCA1 and BRCA2 genes (alleged to infringe at least claim 8 of the ’441 patent, claim 4 of the ‘857 patent, claim 5 of the ’721 patent, and claims 2 and 4 of the ’155 patent
  3. Ambry’s large rearrangement analysis of BRCA1 and BRCA2 (alleged to infringe claim 7 of the ’441 patent and claim 4 of the ‘857 patent)

Myriad’s Motion for a Preliminary Injunction 

Along with its complaint, Myriad filed a motion for a preliminary injunction “enjoining Ambry from any further sales or offers to sell genetic tests including a BRCA1 or BRCA2 panel pending judgment on the merits.”

Myriad supported its motion with arguments to the effect that (i) Myriad has a high likelihood of success on the merits on both validity and infringement; (ii) Myriad will suffer irreparable harm if an injunction is not granted; (iii) the balance of hardships tips in favor of an injunction; and (iv) the public interest favors and injunction.

Likelihood of Success on the Issue of Patent Validity

With regard to its likelihood of success on the issue of patent validity, Myriad makes the following arguments:

  • The asserted patent claims are entitled to a presumption of validity.
  • The asserted patent claims are “of the type endorsed by the Supreme Court.” 

In particular, Myriad cites the Supreme Court’s discussion of artificially created, synthetic DNA in support of the primer claims, and cites the Supreme Court’s discussion of “methods of applying knowledge about the genes” in support of the method claims.

All of Myriad’s patent claims asserted in this case either require the use of inventive DNA synthesized in a laboratory based upon knowledge about the BRCA1 and BRCA2 genes (e.g., gene-specific probes, primers and arrays) and thus are patentable under § 101 based on the Supreme Court’s and Federal Circuit’s analysis, or pertain to such synthetic DNA compositions themselves, which are patentable under the same analysis.

With regard to primers, Myriad states:

While naturally-occurring DNA is double-stranded, primers are single-stranded. Primers are synthetic DNA molecules made in a laboratory. They are man-made, not products of nature.

With regard to the method claims, Myriad states that they ”require the use of synthetic DNA from the BRCA1 or BRCA2 genes, ”  ”involve the synthesis … of artificial DNA molecules” by PCR amplification,  and/or involve “sequencing the synthetic molecules using a particular technology.” Thus, according to Myriad, they ”include much more than merely abstract mental steps” and “pertain not to a law of nature or mere knowledge of that law, but instead to a specific method of applying Myriad’s newly discovered knowledge.”

Public Interest

Perhaps anticipating Ambry’s public interest arguments, Myriad cites the recent Federal Circuit decision in Douglas Dynamics, LLC v. Buyers Products Company, for the proposition that

w]hile the general public certainly enjoys lower prices, cheap copies of patented inventions have the effect of inhibiting innovation and incentive. This detrimental effect, coupled with the public’s general interest in the judicial protection of property rights in inventive technology, outweighs any interest the public has in purchasing cheaper infringing products. In sum, the public has a greater interest in acquiring new technology through the protections provided by the Patent Act than it has in buying “cheaper knock-offs”.

Myriad also asserts that its tests are more accurate than Ambry’s, and are supported by Myriad’s “exclusive access to its proprietary and extensive database of known genetic variants.” Thus, according to Myriad, keeping Ambry’s “less accurate tests” off the market would serve the public interest.

A Race to the Supreme Court?

The Supreme Court’s June 13, 2013 decision in Association for Molecular Pathology v. Myriad Genetics, Inc. is likely to spur additional litigation challenging the validity of claims directed to genetic mutations, genetic screening, and personalized medicine. The specific issues raised in each case, the specific arguments made on each side, and the order in which cases reach the Federal Circuit and Supreme Court could shape the law in this field for yeas to come.
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