*  Written by Kristel Schorr and Jackie Wright Bonilla, both partners in the Washington, DC office of Foley & Lardner LLP

As most in the biotech industry know by now, the Federal Circuit recently issued its decision in Assn. Molec. Path. et al. v. USPTO et al., a case otherwise known as Myriad or the “gene patenting” case.  For more discussion, see July 29 post and July 31 post. The majority (Judge Lourie, joined by Judge Moore) held all “isolated DNA” claims at issue patent-eligible under 35 U.S.C. §101. The majority (joined by both Judges Moore and Bryson) also held as patent-ineligible certain diagnostic method claims that in effect recited only “comparing” or “analyzing” DNA sequences. Notably, each of the three judges on the panel wrote a separate opinion. In doing so, each expressed a different view, even if two of the three judges agreed on the ultimate holding regarding “isolated DNA,” and all judges agreed regarding the method claims at issue.

Although the ACLU/Plaintiffs may request en banc review at the Federal Circuit, or more likely, directly petition for certiorari at the Supreme Court, the Myriad decision is likely to have an impact regardless. Unlike Judge Sweet’s district court decision in 2010, this Federal Circuit decision is precedential and binding on courts until or unless the Federal Circuit says otherwise, or the Supreme Court steps in. On that note, no one knows exactly if/when the Supreme Court might take the case, and what Justices will say if they do. Another interesting tidbit that the Supreme Court has already grant certiorari for the Prometheus case, which also has the potential to impact diagnostic method claims and personalized medicine patents, irrespective of Myriad. For more discussion, see June 20 post.

In the meantime, however, what does the recent Myriad decision mean for patent practitioners? Assuming for the moment that this decision remains the law of the land, some initial thoughts come to mind.

Product Claims

The product claims at issue in Myriad are directed to isolated DNA. That said, the case may have broader implications. One could read statements in the judges’ opinions, albeit dicta, as potentially impacting a wider range of subject matter, such as, for example, polypeptides, proteins, antibodies, stem cells and other biologics, as well as pharma small molecule compounds.

As discussed in our previous posts, Judge Lourie indicates that one should consider whether “human intervention has given ‘markedly different,’ or ‘distinctive,’ characteristics” to the claimed subject matter, i.e., the claimed molecule has “a markedly different chemical structure” or “a distinctive chemical identity and nature” from a molecule that exists in nature. Judge Moore follows up by suggesting that one should also consider whether the chemical differences impart a significant new utility, i.e., “markedly different” characteristics or properties. Thus, a use of the claimed product that is unrelated to intrinsic features of the natural compound may be a sufficient to establish that one claims a “markedly different” compound.

Notably, both Judges Lourie and Moore, again in dicta, distinguish between “purified” and “isolated” molecules that otherwise exist in some form in nature. Judge Lourie states that “[p]urification makes pure what was the same material, but was previously impure,” potentially implying that purification may be insufficient to impart patent eligibility. On the other hand, “isolated” molecules are “manipulated chemically,” e.g., “chemically cleaved from their chemical combination with other [] materials” as exists in nature, and therefore patent-eligible.

Judge Moore similarly indicates that “mere purification of a naturally occurring element is typically insufficient to make it patentable subject matter,” especially if purification does not result in a molecule with any new properties. Like Judge Lourie, she also finds that DNA isolation “is more than separating out impurities” because “isolated DNA is a distinct molecule with different physical characteristics” compared to a natural molecule, and the differences “are directly related to the change in chemical bonds.” That said, she is influenced by the fact that the USPTO “has allowed patents on isolated DNA sequences for decades, and, more generally, has allowed patents on purified natural products for centuries.”

While Judge Bryson disagrees that isolated genomic DNA is patent-eligible, he appears to agree with Judge Moore’s proposed test, i.e., that a compound with both a different chemical structure and a new utility/function passes §101. According to Judge Bryson, “the test employed by the Supreme Court in Chakrabarty requires us to focus on two things: (1) the similarity in structure between what is claimed and what is found in nature and (2) the similarity in utility between what is claimed and what is found in nature.”

Method Claims

Although the Supreme Court in Bilski rejected the “machine or transformation test” as the sole test for determining patent eligibility, this test is still a useful tool for assessing patent-eligible subject matter. Myriad and Prometheus are consistent with this decision, because the Federal Circuit upheld Prometheus claims as satisfying the test, while invalidating certain Myriad claims for reciting only abstract mental processes. Indeed, these cases together indicate that patent claims that merely recite abstract mental steps without anything more, such as at least one active non-mental step, may not be patent-eligible.

Likewise, a method claim reciting mental steps, however, is in itself not problematic, so long as the claim requires more, such as a transformation step. For a recited step to be truly transformative, for instance, it should not be carried out by mere inspection. Myriad and Prometheus suggest that a method claim should recite, expressly or inherently, some physical action or manipulation for a transformation to occur. In addition, one can tie a recited step to the purpose of the claimed process (i.e., directly relate to the “goal” recited in the claim) so as to not be construed as “data gathering.” In Myriad, for example, the invalidated “comparing” or “analyzing” claims could have, but did not, include a physical step carried out before, or in light of information received from, doing the sequence analysis or comparison.

In fact, even Judge Bryson (who dissented regarding the isolated DNA claims) suggested that “analyzing” method claims at issue in Myriad might have been patent-eligible if they recited additional steps. He pointed out that a company is “free to patent applications of its discovery.” He noted that many of Myriad’s unchallenged claims were limited to such applications, including, for example, method claim 21 of U.S. Pat. No. 5,753,441. Claim 21 depends on claim 20 reciting an “analyzing” step, but further recites “wherein a germline alteration is detected by hybridizing a BRCA1 gene probe … and detecting the presence of a hybridization product” (emphasis added).

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With this analysis in mind, we prepared a top twelve “practice tips” list that may support patentability of certain product and diagnostic/screening method claims, at least in view of current case law. We note that our list is not intended to be exhaustive, and there may be other issues or factual considerations that impact patent-eligibility. In addition, we do not mean to suggest that any particular patent claim fails to meet 35 U.S.C. §101 if one does not follow one or more of our tips. Our “practice tips” are mere suggestions, which we hope provide ideas to those wondering how to proceed in light of Myriad.

Top Twelve Practice Tips

Product Claims

1. Consider drafting claims to “isolated” products instead of “purified” products. Also consider describing in the specification how the “isolated” product is structurally and chemically distinct from what is found in nature. Highlight distinct characteristics that show how the claimed product is not identical. If relevant, also consider describing how an “isolated” version of the product differs from a “purified” one.

2. Consider describing in the specification any new uses or functions of the claimed product as compared to a natural product in its natural environment.

3. For claims directed to isolated DNA and other nucleic acid with sequences that exist in nature, consider including in the specification at least some relevant descriptions presented by Judges Lourie and Moore in their opinions.

4. For claims directed to other isolated products, such as polypeptides, proteins, antibodies or cells, consider describing in the specification any structural and chemical features that distinguish the claimed product from what is found in nature. Consider pointing out any new uses/functions of the claimed product, especially those based on the chemical differences, or at least on the isolated state, and describing how the natural product in its natural setting does not have such uses/functions.

5. For claims directed to nucleic acids generally, don’t forget to include relevant claims directed to commercial embodiments. For example, be sure to include claims reciting relevant products that comprise a modified version of the nucleic acid and/or any nucleic acid of interest plus something else. Examples include cDNA and non-naturally occurring sequences (even if different by one nucleotide), hybrid and fusion molecules, vectors, recombinant cells, labeled nucleic acids (e.g., probes), nucleic acids in combination with a reagent or buffer or any other “non-naturally” occurring combinations, assays and kits comprising the nucleic acid (e.g., primer) in a relevant form, etc.

     6. For claims directed to polypeptides or proteins generally, think similarly. Consider including claims directed to relevant products that comprise a modified version of the product and/or the product of interest plus something else. Examples include polypeptides or proteins with non-naturally occurring sequences (even if different by a single amino acid), as well as molecules missing or gaining a glycosylation, methylation or other chemical modification, as compared to a native molecule. Likewise, include any relevant hybrid and fusion molecules, vectors and/or recombinant cells expressing the polypeptide or protein, labeled molecules, molecules in combination with a reagent or any other “non-naturally” occurring combinations (e.g., polypeptide plus an excipient, inactive ingredient, buffer, storage solution, etc.), assays and kits comprising the molecule in a relevant form, etc.

Method Claims

7. For genetic screening process claims, consider explicitly reciting at least one active, physical transformative step associated with the process, such as isolating or purifying a sample, determining a sequence, or detecting hybridization. In drafting such claims, however, take care to avoid a joint infringement situation wherever possible, i.e., try to provide claims that are likely to be infringed by a single infringer, or recite steps that will be directed by a single entity.

8. For other process claims, likewise consider including at least one active, physical transformative step, such as an aspect of a laboratory or clinical technique, e.g., purifying, labeling, detecting, administering, etc. Again, take care to provide claims that are likely to be infringed by a single infringer, or recite steps that will be directed by a single entity.

9. Consider drafting claims that involve the use of a machine in the method step, e.g., an apparatus used to sequence a nucleic acid or protein, or to measure a particular parameter.

10. Although a “determining” step may not be considered a mental process step if it cannot be performed by mere inspection, consider bolstering a claim that merely recites “determining,” or adding a separate claim, so that the claim specifically also recites a manipulation that enables the determination step.

11. For diagnostic/screening method claims, consider including at least one end result step that follow an analysis or comparison, e.g., adjusting a dosage or treatment protocol. Again, take care to provide claims that are likely to be infringed by a single infringer, or recite steps that will be directed by a single entity.

Issued Patents

     12. For issued patents of particular significance within a portfolio, consider filing a reissue application, as needed, to add or amend claims to recite additional features to support patent-eligibility.