Life Sciences, Biotechnology & Pharmaceutical

On December 16, 2014, the US Patent Office issued its eagerly-awaited Interim Guidance on Patent Subject Matter Eligibility ("the Interim Guidance").  The Interim Guidance relaxes the test for patent eligibility of nature-based products.  The test requires a determination of whether the claimed product has "markedly different characteristics" than what occurs in nature.  While the prior guidance only considered structural differences in this analysis, the new guidance recognizes that markedly different characteristics can be in structure, function or "other properties."

The Interim Guidance was released with a significantly-expanded set of training examples.  The previous version of the guidance contained only 8 examples with 14 exemplary claims, which tended to be overly-specific.  As a result, the prior examples proved to be difficult to generalize to other claims.  The new training materials contain 10 examples with a total of 37 claims, which provide a higher-resolution picture of how the Office may apply the Interim Guidance to common types of nature-based claims.

Applicants would do well to consider the following claim strategies, suggested by the training examples, when pursuing claims to nucleic acids, proteins, antibodies, cells and methods of treatment.

Nucleic Acids and proteins (Examples 4 and 7)

• As little as a single nucleotide or amino acid difference between a claimed sequence and its naturally occurring counterpart is considered to be "markedly different," regardless of whether the sequence difference results in a functional difference.
• Labelled nucleic acids and amino acids are considered to be markedly different, and therefore patent eligible.
• A vector comprising a naturally-occurring nucleic acid sequence is patent eligible if the vector includes a heterologous sequence.
• For proteins, a difference in crystal structure is considered a "markedly different characteristic" that would support patent eligibility.
• A recombinant protein may also be patent eligible if recombinant expression produces different glycosylation of the protein.

Antibodies (Example 8)

• Antibodies to a given protein are patent eligible provided that such antibodies do not exist in nature.  Notably, the burden is on the USPTO to show that a claimed antibody exists in nature.  The "mere possibility" that an antibody exists in nature is not enough to support a rejection under 35 U.S.C. §101.
• Even where naturally-occurring antibodies are known to exist, an antibody comprising specific complementarity determining regions (CDRs) is patent eligible unless the Office can demonstrate that the specific antibody exists in nature.
• Modified antibodies (e.g., chimeric, humanized and non-naturally occurring variant forms) are patent eligible.

Cells (Examples 5 and 9)

• Phenotypic differences (structural or functional) that distinguish a claimed cell from its naturally occurring counterpart will be considered "markedly different," rendering such cells patent eligible.  These phenotypic differences can arise through various means, such as genetic engineering (Example 5) or cell culture methods (Example 9).

Methods of Treatment/Use (Example 3)

• Under the prior guidance, many examiners rejected claims to methods of using products of nature on the basis that the method itself did not amount to significantly more than the judicial exception.
• The new Guidance makes it clear that process claims should not be subject to the markedly different analysis.  Therefore, according to Example 3, a method of treating a disease using a naturally-occurring compound should no longer be rejected as patent ineligible.

The Effect of Myriad v. Ambry Genetics?

The Interim Guidance warns that examination guidance for patent eligibility will be "an iterative process" with periodic revisions based on developing case law and public comments.  One day after the Interim Guidance was released, the Federal Circuit issued an opinion in In re BRCA1- and BRCA2-based Hereditary Cancer Test Patent Litigation (Fed. Cir. 2014) ("Myriad v. Ambry Genetics").  The Court held that DNA primers having the same sequence as naturally occurring genes were not eligible because they lack sufficient structural or functional differences from the naturally occurring gene.  The court also held that a diagnostic method that compared a patient BRCA1 sequence with a wild-type sequence constituted an abstract idea, and that additional claim features reciting specific methods of carrying out the comparison were merely routine, and failed to make the claim patent eligible.  In view of this new decision, the next version of eligibility guidance may include additional training examples directed to DNA primers and diagnostic methods (surprising omissions from the current examples), but it remains to be seen whether the USPTO will apply the new holdings broadly, or limit them to their facts

This alert was written by Joseph J. Schuller, Counsel and Susan McBee, Principal, members of the Intellectual Property & Technology Group. To view the full list of lawyers in this group, click here.

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