On Tuesday, we presented a live webinar on the "Top Patent Law Stories of 2013." The webinar covered ten of the fourteen stories that made it onto Patent Docs seventh annual list of top biotech/pharma patent stories. Posts on our top fourteen stories can be found here (stories #11 to #14), here (stories #7 to #10), here (stories #4 to #6), and here (stories #1 to #3). The ten stories that we addressed during the webinar were:
➤ Supreme Court Decides AMP v. Myriad
➤ Myriad Unbowed, Asserts Patents Broadly Against Competitors
➤ Supreme Court Decides Monsanto v. Bowman
➤ Supreme Court Decides FTC v. Actavis
➤ First-Inventor-to-File Provisions of Leahy-Smith America Invents Act Take Effect
➤ Rules of Practice Revised to Implement Patent Law Treaty
➤ EPO Removes Time Limit for Filing Divisional Applications
➤ Media and Congress Combat Patent Trolls
➤ District Court Finds Prenatal Diagnostic Method Not Patent Eligible
➤ 23andMe Patent and Diagnostic Test Create Controversy
While we tried to answer several questions before the presentation was concluded, we ran out of time to answer every question posed by attendees, and wanted to provide answers to some of the questions we could not get to.
Q: Why don't plaintiffs ever attack Myriad's patents on 103 obviousness grounds?
Kevin: This question has at least two answers:
First, the AMP plaintiffs didn't want to use Section 103 as a basis, because they were trying to obtain a categorical exclusion of DNA patenting (which could only be done under Section 101). Using Section 103, the ACLU would have had to try to invalidate gene patents one at a time.
Second, the defendants in several of the pending Myriad patent infringement suits have asserted invalidity under Section 103; the problem is that applying old methods to new compounds is not generally obvious per se (although in some instances it might be).
Q: Does the Myriad decision mean that naturally occurring cDNA, such as those derived from retroviruses, are not patent-eligible?
Kevin: Probably. The rationale is that what is patented has to be different and different by human agency; I don't think obtaining retroviral cDNA is enough.
Q: Could 35 U.S.C. § 101 be amended to re-define or clarify "Law of Nature"?
Kevin: I think it unlikely (mostly because it is impossible for Congress today to craft language that would cover natural laws discovered in future). In addition, the Supreme Court has a habit of taking Congressional actions to overturn its decisions and coopting them; for example, Graham v. Deere has a statement that Congress "merely included in the statute the limitations on patentability drawn by the Court in its jurisprudence," when the reality was that Giles Rich and P.J. Federico included Section 103 to strip from the Court its ability to judge patentability by the Justices' subjective opinion of whether a claimed invention was sufficiently "inventive." Similar to the standard Justice Breyer resurrected in Mayo v. Prometheus.
Q: Is there any discussion regarding modifying the "directed to or encompassing a human organism" bar enacted as part of the Leahy-Smith AIA?
Kevin: Not that I know of. That provision seems to incorporate the 13th Amendment prohibition on having an ownership interest in a human being and little else.
Q: The patent on Monsanto's Roundup-Ready soybean expired in 2010 but the company seems to have gotten a patent term extension -- how did they do that?
Kevin: The patent (U.S. Patent No. 5,352,605) was granted under the old regime where a patent received a 17-year term from its grant date. This patent was granted October 4, 1994, which suggests that it should have expired on October 4, 2011. The PTO website does not show this patent as having expired.
The only provisions I can think of for this application having a longer term is that some patentees complained to Congress that they would be harmed by the change in patent term provisions under the law and Congress enacted a bill that set the term as either 17 or 20 years, depending on which was longer. 20 years from 10/4/1994 would be 10/4/2014. If that's when it expires we will know I am right.
Q: Is prior case law regarding secret commercial use for more than one year working a forfeiture on the trade secret user's right to patent still good law?
Kevin: Regarding whether the trade secret user will be precluded from patenting by their own commercial use, the answer is in flux. On a policy level the answer should be yes, but it could be that the Federal Circuit could decide that the risk of losing to another under first to file has eliminated the policy basis for the rule (I don't think so, but I am not the CAFC).
And defensively, I think that the prior user rights provisions reduce the need to patent, because the prior user has a defense against a later patentee.
Q: How can one reconcile holding methods as trade secret with FDA disclosure requirements?
Kevin: I have two scenarios; the first is less secure, and the second is more speculative.
In the first possibility, you take all reference to the genes and redact them in any public version of your documents, or perhaps encode them (DNA1, DNA2, etc.) and provide the FDA with a key that is not publicly disclosed. This alternative has the risk that, under FOIA, lawsuit, or Congressional mandate, the Agency will disgorge the information at some point.
The second possibility is that you refuse to disclose the identity of the genes to the FDA, and if they do not grant regulatory approval you take the method abroad and find somewhere that will permit you to market it without disclosure. Once you have a track record (3-5 years) you write to the heads of the relevant disease Patients' Rights Group (PRG) and tell them that people in (country where you are marketing) can predict whether they will get (relevant disease) but the FDA doesn't permit Americans to have access to it. Under some circumstances you could run your business offshore, but in others you could encourage the PRG to write their Congressional representative and tell the FDA to let Americans have the benefits of your method. The distinction between this scenario and scenarios regarding drugs is that for drugs people might believe there is a safety risk, but here disclosure is merely a matter of public policy that the individual is unlikely to care more about than their own health. I have no idea whether this will work; the point is that court decisions and patent "reform" laws have unintended consequences and where we place the incentives often direct the outcome we get.
Q: Under the Patent Law Treaty, does the 2-month grace period relate to the failure to claim priority or the failure to file an application within one year?
Don: The Patent Law Treaty (PLT) and Patent Law Treaty Implementation Act of 2012 (PLTIA) provide for "the restoration of the right of priority to a foreign application or the benefit of a provisional application in a subsequent application filed within two months of the expiration of the twelve-month period (six-month period for design applications) for filing such a subsequent application" (78 Fed. Reg. 62368, emphasis added). The final rule issued by the Patent Office also states that:
[W]ith respect to the right of priority to a prior-filed foreign application that if the subsequent application is filed after the expiration of the twelve-month period (six-month period in the case of a design application) set forth in 35 U.S.C. 119(a), but within two months from the expiration of the twelve-month period (six-month period in the case of a design application), the right of priority in the subsequent application may be restored upon petition and payment of the applicable fee if the delay in filing the subsequent application within the twelve- or six-month period was unintentional. The Office is providing with respect to benefit of a prior-filed provisional application that if the subsequent application is filed after the expiration of the twelve-month period set forth in 35 U.S.C. 119(e), but within two months from the expiration of the twelve-month period, the benefit of the provisional application may be restored upon petition and payment of the applicable fee if the delay in filing the subsequent application within the twelve-month period was unintentional.
(id.; emphasis added). The rules specifying the time for filing a priority claim (37 C.F.R. § 1.55(d)) and making a delayed priority claim (37 C.F.R. § 1.55(e)) remain unchanged under the PLT and PLTIA. In particular, a "claim for priority must be filed within the later of four months from the actual filing date of the application or sixteen months from the filing date of the prior foreign application in an original application filed under 35 U.S.C. 111(a)," and if the claim for priority is not filed within this time frame, "the claim may be accepted if the priority claim was unintentionally delayed," and the applicant submits the required petition, Application Data Sheet, and petition fee (along with a certified copy of the foreign application, if necessary).
Q: When does the revised rule that removes the time limit for filing EP divisional applications come into force?
Don: Amended Rule 36 EPC, in which the 24-month time limits within which divisional applications must be filed, takes effect on April 1, 2014.
Q: Regarding the new claim interpretation standard under the Innovation Act, how is the "ordinary and customary meaning" standard different from the "broadest reasonable interpretation" standard?
Don: The Innovation Act would require that the Patent Trial and Appeal Board construe claims in Post-Grant and Inter Partes Reviews using the same standard as the district courts. In particular, the Act specifies that "each claim of a patent shall be construed as such claim would be in a civil action to invalidate a patent under section 282(b), including construing each claim of the patent in accordance with ordinary and customary meaning of such claim as understood by one of ordinary skill in the art and the prosecution history pertaining to the patent." In Phillips v. AWH Corp., the Federal Circuit noted that "the ordinary and customary meaning of a claim term is the meaning that the term would have to a person of ordinary skill in the art in question at the time of the invention, i.e., as of the effective filing date of the patent application." The Court also noted that:
In many cases that give rise to litigation, . . . determining the ordinary and customary meaning of the claim requires examination of terms that have a particular meaning in a field of art. Because the meaning of a claim term as understood by persons of skill in the art is often not immediately apparent, and because patentees frequently use terms idiosyncratically, the court looks to "those sources available to the public that show what a person of skill in the art would have understood disputed claim language to mean." Those sources include "the words of the claims themselves, the remainder of the specification, the prosecution history, and extrinsic evidence concerning relevant scientific principles, the meaning of technical terms, and the state of the art."
(citations omitted). Section 2111 of the MPEP notes that "[t]he Federal Circuit's en banc decision in Phillips v. AWH Corp., 415 F.3d 1303, 75 USPQ2d 1321 (Fed. Cir. 2005) expressly recognized that the USPTO employs the 'broadest reasonable interpretation' standard," and cites In re Morris, 127 F.3d 1048, 1054-55, 44 USPQ2d 1023, 1027-28 (Fed. Cir. 1997), for the proposition that:
[T]he PTO is not required, in the course of prosecution, to interpret claims in applications in the same manner as a court would interpret claims in an infringement suit. Rather, the "PTO applies to verbiage of the proposed claims the broadest reasonable meaning of the words in their ordinary usage as they would be understood by one of ordinary skill in the art, taking into account whatever enlightenment by way of definitions or otherwise that may be afforded by the written description contained in applicant's specification."
Section 2111 also notes that during patent examination "the focus of the inquiry regarding the meaning of a claim should be what would be reasonable from the perspective of one of ordinary skill in the art."