Tag Archives: On Sale

Uncertainty: Helsinn Foreshadows Trouble with AIA Patents

By Dennis Crouch

The AIA was passed back in 2011 and the changes have gradually been implemented through the patent system.  We are finally at the point where most newly issued U.S. patents are post-AIA patents whose patentability is individually based upon the first-to-file provisions of re-drafted 35 U.S.C. § 102.  We’re talking here about hundreds-of-thousands of patents interpreted under the new rules with millions on their way.  As this huge stone is slowly building momentum, the PTO has faced a startup problem: The Agency must apply the new law even though it has almost no guidance from the courts as to how the new portions of the statute will be interpreted.  Because the PTO interpretation is given no deference and because of the many drafting holes in the AIA, I expect that the PTO interpretation will be repeatedly found incorrect.

The only substantive area that has been thus-far decided by the Federal Circuit involves the recent Helsinn decision.  In that case, the Federal Circuit rejected the PTO approach to on-sale prior art and ruled that a pre-filing sale whose existence was disclosed to the public counts as 102(a)(1) prior art even if the elements of the invention were not publicly disclosed (just the fact of the sale).  In its incorrect interpretation of the statute, the PTO had judged the statute as only counting sales as public if the elements of the invention were also disclosed publicly.[1]

There are many other potential examples of questionable language from the AIA first-to-invent provisions that will eventually come to a head:

  • Effective Filing Date: In a patent claiming priority to a prior application, does the claim’s ‘effective filing date’ depend upon whether the relied-upon filing discloses and enables the claimed invention? Section 100(i) suggests that we look only to whether there is a claimed right for priority or benefit. This could impact many written description cases.
  • On Sale: Does a purely private sale or offer to sell count as prior art? Helsinn reserves this question for a later date.
  • Public Use: Does non-disclosing public use count as prior art? Helsinn suggests yes.
  • Commercialization: Does non-disclosing commercialization of the invention by the patentee count as prior art?
  • Otherwise available to the public: Under what conditions apart from the listed publications and uses will we consider an invention to be “otherwise available to the public?” How much further does this go beyond publication and public use? Is public knowledge of the existence of the invention sufficient, or must the public be made aware of the inventions elements and how to make and use the invention? Does the invention need to be discoverable in some way?
  • Grace Period: What level of proof is required for the patentee to show its prior disclosure?
  • Disclosure: For an inventor’s disclosure to trigger the grace period, must it enable the entire invention?
  • Public Disclosure: What counts as a pre-filing ‘public disclosure’ under 102(b)(1)(B) sufficient to knock-out prior art? Is the publicness the same as 102(a)(1)?
  • Changed Disclosure: For intervening third-party disclosures or patent applications that differ from an inventor’s disclosure, what scope (if any) is knocked-out from the scope of prior art? This may be different depending upon whether focusing on 102(b)(1)(a); 102(b)(1)(b); 102(b)(1)(c); or 102(b)(1)(d).
  • Date of 102(a)(2) prior art: 102(d) modifies the 102(a)(2) prior art date for published applications and patents by looking to whether the application claims priority / benefit to a prior filing. Congress certainly intended that the priority date only counts if the priority filing disclosed the subject matter being relied upon in the rejection.  However, the statute is not so clear and suggests instead that all we need is a proper claim of priority or benefit. .

These are a handful of examples, and more certainly exist.

I have some thoughts on how provisions of the statute should be interpreted – both as a matter of statutory interpretation and a matter of patent policy.  My larger concern, however, is that we are still years away from seeing court decisions interpreting these elements in ways that settle the law.  Up to now, for instance, there are not even any public PTAB decisions interpreting the new elements of 102(b).  With the disposing of more than 500,000 patent applications per year, the office is likely to churn through millions before these issues go before the Federal Circuit.  If the first case on point (Helsinn) is any indication, the Federal Circuit is likely to disagree with at least several of the PTO’s statutory interpretations – potentially creating swaths of improperly issued patents or improperly rejected applications depending upon whether the PTO interpretation is too broad or too narrow.  Although temporary, we have the potential here of creating a real bubble that will give us another 20+ year headache in similar fashion to the PTO’s low-quality examination of software and business methods in the late 1990s and early 2000s.

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[1] MPEP 2152.02(d) (“The phrase ‘on sale’ in AIA 35 U.S.C. 102(a)(1)  is treated as having the same meaning as ‘on sale’ in pre-AIA 35 U.S.C. 102(b), except that the sale must make the invention available to the public.”).

Helsinn: Post-AIA Public Sales are Prior Art Even Without Disclosing the Invention

Helsinn v. Teva (Fed. Cir. 2017) [HelsinnDecision]

In an important decision, a Federal Circuit has interpreted the post-AIA on-sale bar of 35 U.S.C. § 102 to include sales made available to the public (i.e., noticed in an SEC filing), even if the published portion does not fully disclose the invention.

[Post-AIA On sale bar attaches] if the existence of the sale is public, the details of the invention need not be publicly disclosed in the terms of sale.

The court here refused to particularly decide whether truly secret sales still qualify as prior art under Section 102, but (in my view), appears to strongly suggest that the on sale bar will continue to apply in the truly secret cases as well.

The AIA did not directly change the pre-AIA “on sale” language, but did linguistically suggest that only public offers for sale should be considered as prior art.  This change from prior law comes from the rewritten Section 102 that bars patentability of an invention that “was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.” 35 U.S.C. § 102(a)(1).  Here, the linguistic argument is that the “otherwise available to the public” clause limits on-sale activity to those that are also available to the public.  This is the interpretation taken by the USPTO.  However, the PTO’s interpretation is given no deference by the Federal Circuit.  And, although some congressional history supports the change, the linguistic argument is not strong (in my opinion).

In the present case, the pre-filing sale was actually publicly announced in an SEC filing, and that filing included a redacted version of the contract.  According to the court, the disclosed agreement included “all the pertinent details of the transaction other than the price and dosage levels.”  Although the dosage levels were a key element of the claimed invention, the Federal Circuit ruled that the sale nonetheless created prior art:

Requiring such disclosure as a condition of the on-sale bar would work a foundational change in the theory of the statutory on-sale bar. Indeed, the seminal Supreme Court decision in Pennock addressed exactly such a situation— the public sale of an item but the withholding from “the public the secrets of [the] invention.” Pennock v. Dialogue, 27 U.S. (2 Pet.) 1, 19 (1829). Failing to find such a sale invalidating, said the Court, “would materially retard the progress of science and the useful arts, and give a premium to those who should be least prompt to communicate their discoveries.” Id.
It will be interesting to see how this develops moving forward.  PTO needs to immediately change its rules, and some prosecutors will need to start disclosing again.