CHEMICAL PRACTICE COMMITTEE MEETING SUMMARY- SPRING 2015
At the 2015 AIPLA Spring Meeting, the chemical practice committee presented a one-hour
program on functional claim elements in the unpredictable arts. The program opened with Ken
Jenkins, a member of Mintz Levin, highlighting the written description case law. Simply put, the
written description requirement was satisfied when a patent specification shows that the inventor
had possession of his/her invention from the perspective of one skilled in the art. There were no
bright-line rules governing the number of species that must be disclosed. Mr. Jenkins then
discussed the details of the Federal Circuit’s opinion in Abbvie Deutchland v. Janssen Biotech.
From the court’s opinion, he pointed out that “[i]f the disclosed species only abide in a corner of
the genus, one has not described the genus sufficiently to that the inventor invented or had
possession of, the genus. He only described a portion of it…” Mr. Jenkins concluded, however,
if crafted carefully, functional language in the chemical arts can serve to prevent an easy design
around, cover optimization based on fundamental principles disclosed in the specification, and
deter competitors.
Mr. Jenkins further discussed Par Pharm, Inc. v. TWi Pharms, Inc. to highlight instances where a
functional “wherein clause” can assist to render a claim nonobvious. Here, the Federal Circuit
reversed the district court and held the “wherein clause” rendered the claims non-obvious,
indicating that functional language in chemical use claims was an acceptable way to distinguish
over the prior art. Therefore, practitioners should continue using functional language for tying
the desired result with the function of a substituent of the chemical entity, provided, of course,
that the enablement and written description thresholds are met.
Having years of experience in the pharmaceutical industry, Robert Titus, Senior Director at Eli
Lilly, then began his presentation acknowledging that the AbbVie decision has important
implications for the use of functional elements in claims encompassing inventions in the
chemical arts. Mr. Titus remarked that the pharmaceutical industry’s business model relies
heavily on robust patent exclusivity to sustain drug discovery and development. Intellectual
property rights to every product will be challenged, typically in multiple countries. Experience
with patent validity challenges and recent IPR proceedings have now demonstrated that not all
patent claims can withstand post-grant review. But that the question remains as to what level of
written description is required to support the desired scope breath. There is no bright-line rule
that governs the number of species that must be disclosed to describe a genus claim. He
remarked that the impact of AbbVie depends on the field of technology of the claimed invention
and the relationship of the functional claim element to the theory of patentability of the claimed
invention as a whole. Mr. Titus then provided illustrative examples of what claim scope might
be pursued for various type of pharmaceutical patent claims.
The committee meeting concluded with many questions and comments from the attendees and an
informal cocktail reception in the hotel lobby afterwards. The presentation slides from this
committee meeting are posted on the AIPLA chemical practice committee webpage.
There is an effort underway to expand this topic to include a biotech component and offer the
presentation in an upcoming AIPLA webinar.
Also discussed, during the committee-business portion of the meeting, were plans to offer a boot
camp before next year’s spring meeting and a road show for next summer.