Question

Association for Molecular Pathology v. Myriad Genetics, Inc. 133 S.Ct. 2107, 2013 U.S. Lexis 4540 (2013) Supreme Court of the United States

“Laws of nature, natural phenomena, and abstract ideas are not patentable.” —Thomas, Justice

Facts

After substantial research and expenditure of money and resources, Myriad Genetics, Inc. (Myriad) dis-covered the precise location and sequence of two naturally occurring segments of deoxyribonucleic acid (DNA) known as BRCA1 and BRCA2. Mutations in these genes can dramatically increase a female’s risk of developing breast and ovarian cancer. The average American woman has a 12 to 13 percent risk of developing breast cancer, but in a woman with the genetic mutations discovered by Myriad, the risk can range between 50 and 80 percent for breast cancer and between 20 and 50 percent for ovarian cancer. Before Myriad’s discovery of the BRCA1 and BRCA2 genes, scientists knew that heredity played a role in

establishing a woman’s risk of developing breast and ovarian cancer, but they did not know which genes were associated with those cancers. For women who are tested and found to have the dangerous muta-tions of BRCA1 and BRCA2, medical measures can be taken to reduce the risks of breast and ovarian cancer developing.

Myriad obtained a patent from the U.S. Patent and

Trademark Office based on its discovery. The Asso-ciation for Molecular Pathology sued Myriad, seek-ing a declaration that Myriad’s patent was invalid. The U.S. district court held that Myriad’s claim was invalid because it covered a product of nature and was therefore not patentable. The Federal Circuit Court of Appeals held that the isolated DNA was pat-ent eligible. The U.S. Supreme Court granted review.

Issue

Is a naturally occurring segment of DNA patent eligible ?

Language of the U.S. Supreme Court Laws of nature, natural phenomena, and abstract ideas are not patentable. It is undis-puted that Myriad did not create or alter any of the genetic information encoded in the BRCA1 and BRCA2 genes. The location and order of the nucleotides existed in nature before Myriad found them. Nor did Myriad create or alter the genetic structure of DNA. Instead, Myriad’s prin-cipal contribution was uncovering the precise location and genetic sequence of the BRCA1 and BRCA2 genes. Myriad did not create anything. To be sure, it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention.

137

Decision The U.S. Supreme Court held that a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been iso-lated. The U.S. Supreme Court reversed the deci-sion of the Federal Circuit Court of Appeals on this issue.

Critical Legal Thinking Questions Will the Supreme Court’s decision affect the amount of research that is conducted to find naturally occurring, disease-causing DNA sequences? Should Myriad be compensated by the government for its research costs?

Patent Period

In 2011, Congress passed the Leahy-Smith America Invents Act (AIA).4 The act stipulates a first-to-file rule for determining the priority of a patent. This means that the first party to file a patent on an invention receives the patent even though some other party was the first to invent the invention. Previously, the United States followed the first-to-invent rule, whereby the party that first invented the invention was awarded the patent even if another party had previ-ously filed for and received the patent. The adoption of the first-to-file rule is a major change in U.S. patent law. Utility patents for inventions are valid for 20 years. The patent term begins to run from the date the patent application is filed. After the patent period runs out, the invention or design enters the public domain, which means that anyone can produce and sell the invention without paying the prior patent holder.

Example January 12, 2018, an inventor invents a formula for a new prescription drug. On March 1, 2018, the inventor files for and is eventually granted a 20-year patent for this invention. Twenty years after the filing of the patent application, on March 1, 2038, the patent expires. The next day, the patent enters the public domain and anyone can use the formula to produce the same prescription drug.

Patent Infringement

Patent holders own exclusive rights to use and exploit their patents. Patent infringement occurs when someone makes unauthorized use of another’s patent. Patent infringement claims must be brought in the U.S. district court that has jurisdiction to hear the case. Patent decisions of the U.S. district courts can be appealed to the U.S. Court of Appeals for the Federal Circuit. In a suit for patent infringement, a successful plaintiff can recover (1) money damages equal to a reasonable royalty rate on the sale of the infringed articles, (2) other damages caused by the infringement (e.g., loss of customers), (3) an order requiring the destruction of the infringing article, and (4) an injunction preventing the infringer from such action in the future. The court has the discre-tion to award up to treble damages if the infringement was intentional. It costs between several hundred thousand dollars to several million dollars to bring an infringement case to trial.

patent infringement Unauthorized use of another’s patent. A patent holder may recover damages and other remedies against a patent infringer.

Leahy-Smith America Invents Act (AIA)

A federal statute that signi

Answer 1

Summary:

Breast cancer (BRCA1) and Breast cancer (BRCA2) genes that cause breast and ovarian cancer were identified in company M genetics. This disease affects an average of 12 to 13% of women in Country A. There are increases in the probability of 50-80% breast cancer and 20-5% ovarian cancer for women with genetic mutations. He also said that these diseases play a significant role in inheritance.

The patent for this finding is received from the Country U Patent and Labeling association. The molecular pathology Association sued the Company M which claims that the natural product (DNA) is not patentable.

Determine whether the Supreme Court ruling affects investigations:

It is stated by the Supreme Court that natural phenomena and the legislation of nature can not be patented. The research center is thus de-motivated to undergo research on the natural causes and effects of DNA. The Supreme Court ruling would impact natural disease research.

Determine if Company M will obtain government compensation:

The government will pay company M money for its study expenses, according to Person X. Even though natural agents are not eligible for a patent, the cancer causing deoxyribonucleic acids has been discovered as an invention. In future, no company will be ready to undergo research which will save lives but will not be patented if government does not compensate the company.

Conclusion:

According to the words of the Supreme Court, anything which naturally happens can not be patented. Company M says nothing was made. While it is an essential gene, it is not an innovation to distinguish it from the genetic material.