The Legal Landscape
The life sciences, especially the biotechnology and organic chemistry sectors, have been particularly affected by the recent spate of § 101 jurisprudence that started with Bilski v. Kappos, 561 U.S. 593 (2010) and ended with Alice Corporation v. CLS Bank, 573 U.S. ___ (2014), although there are still cases dealing with the implications of these decisions working their way through the courts. Before Bilski, the standard test for determining whether a process claim was subject-matter eligible was the machine or transformation test, which held that a claim to a process is patentable if it is implemented on a particular machine or it transforms a particular article into a different state or thing. The Supreme Court stated in Bilski that this is not the sole test for determining patent eligibility, but merely a useful guideline. This decision set off a series of cases touching on the judicial exceptions to § 101 that included Mayo Collaborative Services v. Prometheus Laboratories, 566 U.S. ___ (2012) and Association for Molecular Pathology v. Myriad Genetics, 569 U.S. ___ (2013), which dealt with the laws of nature and natural phenomena exceptions.
Mayo, decided on March 20, 2012, involved patents that claimed a diagnostic test to find the right dose of thiopurine drugs for patients undergoing treatment for autoimmune disorders. The claims involved the steps of (1) administering the drug to the suspect, (2) determining metabolite levels, and (3) being warned that an adjustment in dosage may be required. The Court found the patents claimed ineligible subject matter under § 101, holding that this process claim added nothing to the natural law underlying it. In Myriad, which was decided on June 13, 2013, the patents at issue involved claims covering isolated DNA sequences used to diagnose propensity for cancer by looking for mutated DNA sequences. The Court held that naturally-occuring DNA sequences are products of nature and are not patent eligible merely because they have been isolated.
These two cases prompted the USPTO to issue guidance to examiners instructing them on how to examine claims directed to the judicial exceptions to § 101 in light of these decisions. The guidance instructed the examiners to ask, (1) are the claims directed to patent ineligible subject matter, and (2), if so, do they recite something significantly more than the judicial exception? If no, the claims are not patent-eligible. This framework became the standard legal test to determine whether process claims directed to the § 101 judicial exceptions are patent-eligible, and was officially adopted by the Supreme Court in the Alice decision.
The Top Firms
The Myriad and Mayo decisions have made it significantly more difficult to obtain patents on diagnostic methods and gene sequences and, more generally, have made patent prosecution in the life sciences practice groups at the USPTO more challenging. These practice groups are found in technology center 1600, in the art units groups spanning the 1610s to the 1670s. The average allowance rate for all of these art unit groups is about 62%, which is well below the USPTO average of 72%.
This number is deceptive, however, as several practice groups within the 1600s have significantly lower allowance rates than the tech center's average. For example, the 1630s (molecular biology, bioinformatics, nucleic acids, recombinant DNA and RNA, gene regulation, nucleic acid amplification, animals and plants, combinatorial/computational chemistry) have an allowance rate of only 50%, while the allowance rate in the 1610s (organic compounds: bio-affecting, body treating, drug delivery, steroids, herbicides, pesticides, cosmetics, and drugs) is only 53%. The plant patents group in the 1660s, on the other end of the spectrum, has been comparatively unaffected by the Myriad and Mayo decisions, having an allowance rate of over 90%.
Against this backdrop, several firms stand out as having done particularly well in the affected art units. To be considered for inclusion in this list, a firm must have had at least 100 patent applications disposed of in the relevant art units during the one-year period (June 13, 2014-June 13, 2015) following the Myriad decision--the latter of the two cases affecting the 1600s. The firms are ranked by their average allowance rates in TC 1600. Congratulation to all the firms on the list for their outstanding commitment to patent prosecution in the life sciences sector.