The Supreme Court’s rulings in Mayo, Myriad,
Alice and others have left IP practitioners exasperated at how
Section 101 is now interpreted by courts and the USPTO.
At the BIO International Convention in Philadelphia last
week, David Kappos, partner at Cravath Swaine & Moore,
described the situation around 101 as a "state of chaos", and
outlined concerns that investment would not flow to the life
science industry as a result.
Also speaking at the convention, former Chief Judge of the
Federal Circuit Paul Michel said: "The 101 test is not
scientific; it is not rational; it is not systematic. So once
you go down the road of accepting the idea that we can have
this gut feel test for eligibility or anything else, you are
upon the road to doom."
In response, people are beginning to talk about amending
101. The AIPLA and CPIP have both discussed proposals. Kristin
Neuman of MPEG LA and Konstantin Linnik of Nutter McClennen
& Fish also noted at the BIO convention that the 101TT
group had been founded as a think tank to address the issue,
with 16 members from pharma, biotech, molecular DX, BioAg, and
BIO. They urged attendees to send them ideas for proposals.
Kappos said this was all positive, but emphasised that the
move to amend 101 should be industry agnostic, rather than
"This fix-101 initiative needs to be broad based and cross
industry," he said. "It needs to be about American industry per
se not just one industry. The key will be putting life
sciences, which are being hurt by it, along with technology,
which is also being hurt by it."
For those that need a refresher,
101 states: "Whoever invents or discovers any new and
useful process, machine, manufacture, or composition of matter,
or any new and useful improvement thereof, may obtain a patent
therefor, subject to the conditions and requirements of this
Linnik noted that the problem lays more with the Supreme
Court’s interpretation of 101, rather than the
wording of 101. "So one suggestion was that 101 should just say
what it says and add 'and we mean it!" at the end," he
He gave some other examples of published ideas for amending
- Amending 101 to expressly take out novelty and
non-obviousness parts of 101 analysis.
- Deleting 101 or renumbering to 999 to give more weight to
102, 103 and 112 and to change the order of patentability
- Reworking other sections at play:
100 definitions – "new and useful process, machine,
manufacture, or composition of matter", "law of nature",
"natural product:", "abstract idea".
282 presumption of validity, defences – presumption of
"patent-eligibility"; claim to be assessed as a whole.
Others have suggested harmonizing with European regulations,
though Linnik conceded this was unlikely.
Some of these proposals were included in a February blog
post by Robert Sachs of Fenwick & West on the widely-read
Bilski Blog that listed
"22 Ways Congress Can Save Section 101".
Bob Armitage, former general counsel at Eli Lilly, outlined
a proposal for overhauling 101 at the convention. The
conclusions from proposal this were:
- 'Inventions" to be defined co-extensively with the
Constitution’s definition of power to Congress
to enact patent laws.
- A new section 102 analysis will confirm information
content or its presentation, untied to functioning, cannot be
the basis for novelty – and codifies the rubric
"that which infringes if later, anticipates if earlier".
- Section 112 claiming standards are tightened: Has the
claim been expressed in terms of a product or a process,
defined by its constituent structures or materials or, if a
process, its (non-mental) acts? Has it been limited so as not
to preempt a law, a principle or other relationship
- Valid patents are constrained to disclosed structures,
materials and acts (and their equivalents) and/to
functionally defined "established categories".
- Patents rights will never preempt use of the basic tools
Armitage conceded that it would take a long time to change
"The best thing I can say today is that we are at the very
early stages looking at what can be done," he said. "The
problem is urgent enough that we don’t have 10
years. Hopefully, we can work across these groups and come up
with one proposal – although we are probably several
hundred drafts away from that one proposal!"