Does isolating genomic DNA transform it into a man-made invention that can be patented?

MX: The Myriad Case and the Future of Gene Patenting

Patent lawyers and the biotech industry are anxiously awaiting a ruling this year by the United States Court of Appeals for the Federal Circuit in the case of The Association for Molecular Pathology v. United States Patent and Trademark Office and Myriad Genetics Inc.

The Myriad case involves two types of claims in patents owned by Myriad Genetics (Salt Lake City, UT).The first type of claim covers isolated genes BRCA1 and BRCA2, a particular form of which is present in women who face increased risk of breast cancer. The second type of claim covers methods of comparing the isolated genes with the genes of a patient and screening compounds for activity against cells containing the genes. The first type of claim—the one involving isolated DNA—has drawn the most interest.

The Association of Molecular Pathology, along with other plaintiffs, sued to invalidate Myriad’s patent claims covering isolated BRCA DNA. The plaintiff group challenges the validity of the BRCA gene patents and more broadly the propriety of issuing patents on genes. The group comprises various not-for-profit organizations involved in genetic testing and research as well as individual researchers. The plaintiffs also include women diagnosed with breast cancer who allege that the patents impede their options for diagnosis.

The Federal Circuit court is being asked to resolve two main issues. The first addresses whether the plaintiffs have standing to bring litigation, and the second centers on what constitutes patentable subject matter. A ruling in the plaintiffs' favor on the issue of standing could have a negative impact on medical device manufacturers and pharmaceutical companies by opening the door to additional litigation.

The Trial Court Ruling
The trial court issued its decision in March 2010. The judge ruled that Myriad’s patent claims were invalid because they cover subject matter that is not eligible for patent protection as set out in 35 U.S.C. § 101. That section of the patent law defines patent-eligible subject matter as “any new and useful process, machine, manufacture, or composition of matter.” In 1980, the United States Supreme Court held that genetically engineered bacteria were patentable under § 101, which effectively opened the door to the modern era of biotechnology patenting. For the past 25 years the United States Patent and Trademark Office has routinely granted patents on isolated DNA. In its analysis, however, the trial court gave primary emphasis to Supreme Court authority defining the scope of patentable subject matter, notwithstanding the relatively routine patenting of such subject matter for the last 25 years.

The trial court determined that the product claims to isolated BRCA DNA were not patentable, since the isolated DNA was not markedly different from naturally existing BRCA1 and BCRA2 DNA. According to the trial judge, despite certain physical differences, the characterizing property of both the isolated DNA and the natural DNA is the information encoded by the DNA.

In contrast to isolated DNA, the invention upheld as patentable by the Supreme Court in 1980— a microorganism engineered to consume oil—was different in such properties from the naturally occurring precursor microorganism and could not be obtained by simply “purifying” a natural material.

The Appeal
In the first issue on appeal, Myriad asserts that the plaintiffs who challenged the Myriad patents did not have the legal standing to bring the litigation in the first place. As a general matter, only persons who are directly and immediately affected by the outcome of a case have standing to bring a lawsuit. In the Myriad case, the plaintiffs include patients who assert that—but for the patents—the cost of testing would be lower, as well as researchers who allege they are ready to engage in research on the BRCA1 and 2 genes if the patents are invalidated. Myriad argues that these parties are not directly impacted, in part because their plans are speculative and not concrete. Although not much attention has been focused on this matter of “standing,” resolution of the issue could, as discussed below, have a significant impact on the industry.

Myriad’s appeal on the substantive merits of the case asserts that, contrary to the trial court’s ruling, the patent claims cover subject matter that is patentable under 35 U.S.C. § 101.  Specifically, Myriad argues that an isolated DNA molecule is a patentable “composition of matter” and is not so similar to naturally occurring DNA as to be unpatentable. Furthermore, Myriad argues that its method claims are patentable because they require, inter alia, extracting, processing, and analyzing human tissue using nucleotide sequences that are molecules.

Not surprisingly, the Association for Molecular Pathology and other plaintiffs have a different view of the issues. As to standing, they assert a real and immediate interest in practicing the inventions. On the substantive grounds, they argue that the trial court correctly interpreted Supreme Court precedent to conclude that isolated DNA is not patentable subject matter. In regard to the method claims, the plaintiffs argue that, in essence, the Myriad claims merely require comparing one DNA sequence with another to identify differences or mutations. The plaintiffs assert that such a comparison is not a patentable “process” under 35 U.S.C. § 101.

Third-Party Interest
In view of the significance of the Myriad case, a relatively large number of third parties have filed comments with the appeals court, some in support of Myriad and some in support of the plaintiffs. For example, the brief filed by the U.S. government argues that complementary DNA (cDNA) is a patentable, human-made invention, whereas unmodified genomic DNA is not human-made and therefore not patentable. In the government’s view, the act of isolation does not transform the DNA into a man-made invention, which is essentially the rationale the trial court applied to both cDNA and genomic DNA. In making this argument, the government acknowledged that in the past the National Institutes of Health and other governmental agencies sought patents for isolated genomic DNA, and the U.S. Patent and Trademark Office granted such patents. Nevertheless, the government has since reevaluated its position and concluded that isolated genomic DNA is not patentable.

Among the other third parties weighing in on the issues in the Myriad case were two intellectual property law organizations, the Intellectual Property Owners Association (IPO) and the American Intellectual Property Law Association (AIPLA). Both address the jurisdictional and substantive issues in the appeal. The IPO takes the view that the trial court did not have jurisdiction over the case, because Myriad had made no contemporary threats to enforce its patents, and because the plaintiffs did not have specific plans to engage in any conduct that would infringe the patents. The AIPLA took a more limited view of the asserted jurisdictional problems, arguing only that jurisdiction was absent with respect to the “consumer” plaintiffs, i.e., the plaintiffs who were interested in being tested but for one reason or another felt that Myriad’s patents impeded their access to the tests. Both organizations agree, however, that isolated DNA—whether it is genomic or cDNA—is patentable. The IPO warns that a ruling that isolated DNA is not patentable would have broad implications and could impact numerous other human therapeutics (including vaccines and antibodies) that are based on natural products. The AIPLA further warns that such a ruling would change settled law and interfere with the expectations of patent owners and inventors.

Other third parties having interests similar to Myriad support reversal of the invalidity decision by the trial court. For example, Alnylam Pharmaceuticals and Rosetta Genomics submitted a brief arguing that, under existing Supreme Court precedent, isolated DNA is patentable. Alnylam also argues that excluding isolated DNA from patentability would breach U.S. treaty obligations under the World Trade Organization (WTO) and the Agreement on Trade-Related Aspects of Intellectual Property (TRIPS). In particular, Alnylam asserts that abrogating isolated DNA patents would breach the treaties because such a holding would discriminate against a particular field of technology.

The Biotechnology Industry Organization and the Association of University Technology Managers also expressed support of Myriad’s claims. In addition to arguing the legal merits of whether isolated DNA qualifies for patent protection (which in their view it does), these entities also address the policy argument that patents on isolated DNA promote innovation and benefit the public. They argue that this viewpoint is consistent with the policy of the patent laws to promote the useful arts to the benefit of society.

The plaintiffs also have their third-party supporters. Both AARP and Universities Allied for Essential Medicines filed briefs asserting that Myriad’s patents were correctly held to be invalid, making policy-grounded arguments that “gene patents” raise the cost and limit the availability of genetic testing. Universities Allied for Essential Medicines, a student-based nonprofit advocacy organization, further argued that gene patents actually block progress in medical research, because researchers must stop research based on blocking gene patents. The advocacy group also points out that the European Union prohibits enforcement of patents that prevent research.

As the examples discussed above make clear, the Federal Circuit will not lack for viewpoints to weigh as it approaches this appeal. There are fundamental legal and policy issues at stake. For example, as the various arguments on appeal reveal, there is disagreement as to whether granting of gene patents helps or hurts the advance of useful science.

Impact of the Appeals Ruling
A ruling on these questions from the Federal Circuit is expected in 2011. Both the jurisdictional issue and the substantive patentability issue are significant. The Federal Circuit could rule that the trial court lacked jurisdiction, vacating the trial court’s decision and leaving the issue of the patentability of isolated DNA and associated methods undecided. In that event, the U.S. Patent and Trademark Office would most likely continue its current policy of granting patents on isolated genes, (although as most practitioners are aware, the patentability standard for gene patents under the non-obviousness requirement has been raised substantially in recent years.) On the other hand, if the Federal Circuit holds that all the plaintiffs in the Myriad case have standing, patent owners could potentially be subject to far more suits seeking a declaration that their patents are invalid. For example, an insurer might have standing to sue a pharmaceutical or medical device company for invalidity on the theory that if the patents for a drug or device were invalid, the costs of the drug or device would be lower.

If the Federal Circuit upholds jurisdiction and decides the patentability issue, the court could rule either way—either “yes” or “no” as to gene patents, or perhaps as the U.S. Government has urged, “yes” to some but not all types of gene patents. Regardless of how the Federal Circuit rules, many commentators agree that, in view of the public interest questions being raised, the next stop for the case will be the U.S. Supreme Court. In recent years, the Supreme Court has not been reluctant to hear cases arising under the patent laws.

If the Federal Circuit (or the Supreme Court) ultimately affirms that claims to isolated DNA are not patentable subject matter, scientific and business entities that have been built on the basis of patents to isolated DNA will no doubt lose value. As noted, this subject matter has been widely assumed to be patent-eligible for several years. On the other hand, research and public interest parties have credibly argued that research and development in derivative products will actually increase if isolated DNA is not patentable, resulting in a net increase in economic activity and benefit to the public.

Some of the more dire predictions being voiced—that the future patentability of all biological products is in jeopardy—are not well founded in view of the trial court’s actual holding and rationale. For example, as the U.S. Government’s brief explains, a decision that isolated DNA is not patentable subject matter does not mean that products made from the isolated DNA, such as vaccines and recombinant antibodies, are also unpatentable. This is an important distinction, since a product claim to a DNA per se covers any use of the DNA in any product or process. Claims that are drawn to specific combinations of the DNA with other materials—such as a DNA array or non-naturally occurring uses of the DNA—will by and large remain patent-eligible. As such, little effect is expected on apparatus claims regardless of the outcome of the Myriad case.

Going forward, the biotech industry will have to emphasize creative drafting of patent claims in order to protect the innovations associated with using isolated DNA. If an isolated DNA molecule itself cannot be patented, the still-permissible types of patent claims must be carefully drafted to cover the important practical aspects of using the isolated DNA. However, there is no doubt that possession of isolated DNA enables the practice of methods of assembling and using the DNA in various ways that will remain patent-eligible.

Bruce Chapman (left) is a partner in the Los Angeles office of Connolly Bove Lodge & Hutz. He specializes in patent- and IP-related litigation in the medical device, electronics, software, and other high-tech industries. Chapman can be reached at [email protected].

Robert McMorrow Jr. (right), a partner in the firm’s Delaware office, represents clients in patent counseling, patent opinions, and related areas in the chemical and biotechnology fields. He can be reached at [email protected].

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