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 biotech specific.
“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 title.”
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 said.
He gave some other examples of published ideas for amending 101:
- 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 determinations.
- 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 itself?
- 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 of science.
Armitage conceded that it would take a long time to change 101.
“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!”