Federal Circuit Reaffirms Gene Patents in AMP v Myriad

On August 16, 2012, biotechnology patent owners breathed a short sigh of relief, as the US Court of Appeals for the Federal Circuit issued a highly anticipated decision in Association for Molecular Pathology v. Myriad Genetics, finding that DNA sequences are indeed eligible for patent protection.  However, not all biotech innovators will be happy with the Myriad decision since diagnostic method claims were again struck down as ineligible for patent protection.   Additionally, one of the three judges on the panel dissented on the patentability of isolated DNA, arguing, “extracting a gene is akin to snapping a leaf from a tree.”  The final word on this subject may need to come from the Supreme Court.

The Myriad case had been on the Supreme Court docket briefly last year but was sent back down to the Federal Circuit for reconsideration in view of the Supreme Court decision earlier in its term in Mayo Collaborative Services v. Prometheus Laboratories.  In Mayo, the Supreme Court held that diagnostic claims essentially claiming a natural principle are not patent eligible under § 101 of the Patent Act.

On remand, in a 2-1 decision, the Federal Circuit upheld Myriad’s “isolated DNA” claims and the method claim directed to screening potential cancer therapeutics, but also held that certain method claims directed to “analyzing” or “comparing” gene sequences are not patent eligible subject matter under § 101 in view of Mayo. Judge Lourie, writing for the majority, clarified that the issue is “patent eligibility, not patentability,” and that policy questions – such as whether DNA warrants special treatment under the patent laws – are best left to Congress. 

In finding isolated DNA to be patent-eligible subject matter, the Judge Lourie noted that the Supreme Court precedents in Chakrabarty and Funk Brothers, and not Mayo, controlled patent eligibility for composition claims.  The Federal Circuit essentially followed its earlier logic in distinguishing these claims:  isolated DNA molecules are not found in nature, are man-made and the product of human ingenuity.  Both Judges Lourie and Moore drew a distinction between products of nature and products of man that “follow[], as all materials do, laws of nature.”  In her concurring opinion, Judge Moore indicated that the chemical difference between the in situ gene and the isolated gene was not by itself sufficient to justify protection, but that change in combination with the “enlargement of the range of . . . utility” derived from the isolation” led to patent eligibility.  Judge Moore also appeared to place considerable weight on the USPTO’s long-standing practice of granting patents on such subject matter.

In a dissenting opinion, Judge Bryson disagreed with this majority on this issue of patent eligibility for genes.  He concluded that the Mayo decision handled down by the Supreme Court earlier this year was instructive because the Court found that the method claim at issue in the Mayo case was not directed to patent-eligible subject matter because it contributed nothing “inventive” to the law of nature.  Judge Bryson likewise concluded that Myriad’s claims to isolated DNA were not patentable because the Myriad had not done “enough” to distinguish the alleged invention from a similar product of nature.  He dismissed the act of isolating the DNA from the in situ gene as merely a matter of breaking covalent bonds.

Upon reconsideration of the method claims also at issue in this case, the three-judge panel came to the same conclusions it had previously – albeit by different logic to take into account the Supreme Court’s reasoning in the Mayo case.  With regard to the method of comparing or analyzing claims, the Court held that there was no putatively transformative step to make each claim something other than a claim to a natural law, and that the methods were simply directed to the abstract mental process of comparing two sequences. 

The Federal Circuit judges also found the claimed method for screening of therapeutics to again be patentable subject matter, holding that even though a method includes known steps it can be sufficiently transformative if the steps are to create novel, i.e., transformed, subject matter.  The fact that the claim includes the steps of determining and comparing the cells growth rates “does not change the fact that the claim is based on a man-made, non-naturally occurring transformed cell – patent-eligible subject matter.”

The Federal Circuit’s application of the Mayo case to Myriad’s claims on diagnostic methods provides little guidance on how to draft such diagnostic claims to secure allowance – and survive future patentability challenges.  It is clear that the claims must recite something "transformative."  However, what constitutes a transformation in a diagnostic method remains to be elucidated.

Moreover, the discussion of patentability for DNA sequences is far from being over.  Should parties appeal in the next 90 days, the Supreme Court could again grant certiorari or there could be an en banc rehearing by the full Federal Circuit.

- Tom Engellenner

This entry was prepared with the help of Padma Choudry.  This blog is for information purposes only and should not be construed as legal advice on any specific facts or circumstances.  Under the rules of the Supreme Judicial Court of Massachusetts, this material may be considered as advertising.

New First to File (or Publish) Rules for US Patents

The America Invents Act (AIA) largely closes the gap between the U.S. patent laws and those of the rest of the world, where the general rule is that absolute novelty is required to seek patent protection for an invention.  Under the new U.S. rules (which will apply to all applications having an effective filing date after March 16, 2013), if an invention is made available to the public or on sale – anywhere in the world – before the effective filing date of a patent application, then no patent protection may be sought for the invention.  (Under our existing law, use or sale in a foreign country does not necessarily invalidate a patent.)

Additionally, a patent will not be granted to a second inventor to file a patent application if another inventor has already filed a patent application and such patent application matures into a patent or is published.  This is the first-to-file rule that applies almost everywhere else in the world.  However, to preserve the “grace period” that is deeply enshrined in the U.S. system, there are some exceptions, which can be explained by the following illustration:

Under our new system (for filings after March 16, 2013), A will still be entitled to a patent, despite an earlier disclosure and an earlier filing by another (B) because of the AIA’s exceptions to the first-to-file rule.  

The first exception (section 102(b)(1)) is that your own public disclosures will still not count against you so long as you file within one year.  (This will also be true if the earlier disclosure was by someone who derived the invention from you.)  Likewise, disclosures by others – even independent discoveries – will not count against you, if your own disclosure precedes the other disclosure (and again you file within a year).  Thus A can overcome both his own earlier disclosure and B’s earlier disclosure by virtue of the first exception.

The second exception is also applicable to this scenario.  Under section 102(b)(2), the second to file can overcome an earlier filing by another, if the second filer made a public disclosure prior to the first applicant’s filing date.  Hence A can overcome B’s earlier filing date because his or her disclosure preceded B’s filing date.

Thus, our new system is commonly being referred to as a “first inventor to file” system, but it might also be called a “first to file or publish” system.

- Tom Engellenner

This advisory is for information purposes only and should not be construed as legal advice on any specific facts or circumstances. Under the rules of the Supreme Judicial Court of Massachusetts, this material may be considered as advertising.

Supreme Court Remands Myriad

Following close on the heels of last week’s controversial decision in Mayo Collaborative Services v. Prometheus Laboratories, the United States Supreme Court sent another hotly contested biotech case back down for further consideration by a lower federal court. In Association for Molecular Pathology v. Myriad Genetics, the Supreme Court granted certiorari to the parties in the Myriad case, vacated the decision of the Court of Appeals for the Federal Circuit, and then promptly remanded the case to the Federal Circuit for reconsideration in accordance with the Supreme Court’s March 20th decision in the Mayo case, which held that a diagnostic method claim that simply recites a law of nature is unpatentable subject matter under 35 U.S.C. §101.
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The patents being challenged in the Myriad case also contain diagnostic method claims. These claims, which recite “comparing” or “analyzing” BRCA1 and BRCA2 gene sequences, had been deemed ineligible for patent protection by the Federal Circuit. This conclusion is unlikely to change upon remand.

However, the Myriad case raises several other issues. Also at issue in Myriad are method claims for screening of therapeutics and composition of matter claims for isolated DNA. Prior to the remand, the Federal Circuit had found these claims to be patentable subject matter, holding that the claimed screening methods were also patentable because they include the transformative step of “growing cells” and that isolated DNA is patentable subject matter since it is chemically distinct from native DNA. The Federal Circuit’s reconsideration of and application of the Mayo decision to the screening method claims and to the composition of matter claims will be worth watching. 

The Federal Circuit will have to review the method claims for screening of therapeutics to determine whether the step of “growing cells” in the presence of a potential cancer therapeutic is still transformative in light of the Mayo decision. The question will be whether the step “transformed the process into an inventive application of the [law of nature].” 

How the Federal Circuit applies the Mayo case to Myriad’s claims on isolated gene sequences will also be of great interest to the biotechnology community. One consideration from the Mayo decision that will likely be important to the analysis of isolated gene claims is whether the term “isolated” is a “feature[] that provide[s] practical assurance that the process is more than a drafting effort.” 

The Federal Circuit’s earlier detailed discussion that these “isolated DNA molecules do not exist as in nature” and must be “chemically cleaved” from their natural environment, and thus are “distinct chemical entit[ies],” may indicate one basis by which the Federal Circuit can distinguish these claims from Mayo. A second, countervailing, consideration from Mayo may be whether the “isolation” of DNA should be considered a “well-understood, routine, conventional activity previously engaged in by scientists who work in the field.” While this argument was unpersuasively made before the Federal Circuit in 2011, it may now garner more support.

The Federal Circuit’s treatment of the Myriad claims on remand may provide better guidance on how to ensure that biotechnology patent claims survive future patentability challenges. Both Mayo and Myriad will undoubtedly have long-term ramifications in the pharmaceutical and biotechnology industries. Any potentially affected or interested parties should continue to follow the developments in this area, but it seems this may be just the beginning of a much longer conversation.

- Tom Engellenner

(This advisory was prepared with help from Padma Choundry, Konstantin Linnik and Lydia Olson, members of the Life Sciences and Intellectual Property Department at Nutter, McClennen & Fish, LLP.)  This advisory is for information purposes only and should not be construed as legal advice on any specific facts or circumstances. Under the rules of the Supreme Judicial Court of Massachusetts, this material may be considered as advertising.

Mayo v. Prometheus: Fire But No Light

Law professors are apt to say "hard cases make bad law" and the U.S. Supreme Court's recent decision in Mayo v. Prometheus Laboratories certainly falls into this category. In a unanimous decision issued on March 20, two patents that Prometheus had sought to enforce against Mayo Laboratories were struck down because the Court concluded that the patent claims were directed to natural laws and, hence, not eligible for patent protection. 



The decision, authored by Justice Stephen Breyer, has sent a shockwave through the biotechnology industry because the Court's reasoning may lead to the demise of diagnostic-method patents and remove the financial incentives that are currently propelling the growth of personalized medicine. If Breyer's reasoning is broadly applied, it is also hard to see how any diagnostic or even medical treatment method claim can survive scrutiny. 



The principal claim at issue in the Mayo case recited a first step of administering a drug to a patient and a second step of measuring the level of a particular metabolite in the patient's blood and a "wherein" clause that described a level above which there is a likelihood of harmful side-effects and below which the drug dosage may be ineffective. The claim was drafted this way to cover any supplier of an assay that would measure the particular metabolite. 



The Court found this "wherein" clause to be, in essence, an appropriation of a law of nature and not the sort of thing that should be patentable. Breyer compared the claim to Einstein trying to patent E=MC² or Newton trying to capture the law of gravity in a patent. Relying on a decision from the early days of the age of computers that found claims to a mathematical algorithm to be unpatentable because the claims were "so abstract and sweeping as to cover both known and unknown uses" of the formula, Breyer reasoned that the Prometheus claims would likewise "risk disproportionately tying up the use of underlying natural laws, inhibiting their use in making further discoveries." 



But was the discovery claimed in the Prometheus patent truly an abstract law of nature? The patent solved a known problem, namely selecting the right dosage for a very specific class of drugs that patients metabolize differently. Because of the metabolic differences, a dosage that is good for one patient is not necessarily good for another. The patent claim recited the metabolite levels that were too high and those that were too low — in essence identifying the sweet spot for therapeutic efficacy. This was a practical application of science, not an abstraction like the law of gravity. 



The problem with the Court's reasoning is that every diagnostic invention is at its core a discovery of a natural correlation between a biomarker or other analyte and a medical condition. Historically, the question that governed patentability of diagnostic methods, such measuring prostate-specific antigen as an indicator of prostate cancer or high-density lipoprotein as sign of unheathy cholesterol, has been whether the correlation discovered by the inventor was new and unobvious to one skilled in the art — not whether the correlation embodied a law of nature. How can any diagnostic method claim still be eligible for patent protection if the law now precludes diagnostic methods that rely on a scientific principle or law of nature? Would Breyer prefer diagnostic methods be based on lucky guesses or Ouija board results? 



Though not at issue in the Mayo case, the Court's logic in the Mayo decision also casts a shadow on method-of-treatment claims. For more than 200 years, the U.S. patent laws have allowed patent protection — in the form of method claims — for new and unobvious medical treatments with known drugs or agents. Many other countries do not allow patent claims for human treatment but the U.S. laws do — or did. Congress has from time to time debated the value of allowing method of treatment claims. Several years ago Congress did impose some limitations on surgical methods (requiring that the claims also recite a novel surgical instrument) but Congress did not abolish medical-treatment claims. 



However, the logic of the Mayo decision may put medical treatment claims into the "patent ineligible" category, as well. For example, a claim such as "treating a retroviral infection with an effective amount of AZT" (to paraphrase the famous first AIDS drug patent) could be suspect since it could also be considered to be a claim to a law of nature. AZT works by inhibiting reverse transcriptase, an enzyme necessary to the retroviral replication. The AZT inventors discovered this "law of nature." 



A less ominous reading of the Mayo decision is that the Supreme Court simply felt that there wasn't enough meat in the Prometheus claim and perhaps a more specific recitation of the assay steps would have passed muster. If so, then the decision leaves to the lower courts the dirty work of sorting out how much more specific a diagnostic claim must be. 



This process of leaving it up to the lower courts to divine the meaning of the Mayo case has already begun. A few days after its Mayo decision, the Supreme Court granted a petition to review another hotly contested case involving Myriad Pharmaceutical's patents on isolated breast cancer gene sequences — and then immediately remanded the case back to the U.S. Court of Appeals for the Federal Circuit, from whence it came, to reconsider its decision in light of the Mayo ruling. 



It is most unfortunate that the Supreme Court's decision in the Mayo case only discussed one claim of the Prometheus patents. There were several more specific dependent claims in the Prometheus patents that explained how the assay should be conducted, e.g., by measuring metabolite levels in red blood cells or by use of high pressure liquid chromatography. The biotechnology industry and patent practitioners would have benefited from some explanation as to why these claims were likewise unacceptable. Instead, the Supreme Court just kicked the can down the road.

- Tom Engellenner (adapted from my recent article in the National Law Journal)
This blog is for information purposes only and should not be construed as legal advice on any specific facts or circumstances. Under the rules of the Supreme Judicial Court of Massachusetts, this material may be considered advertising.