BIO recently generated a letter to the PTO on the March 6th Guidelines on the patent-eligibility of subject matter in the life sciences, particularly “natural products.” BIO invited a group of in-house and private practitioners to comment on the Guidelines and a number of them – including myself – signed off on the letter. Following appearances by a Mr. Hirschfeld at a number of industry conferences and symposia, the biotech/pharma community felt that there is a realistic chance the initial Guidelines will be released in revised form in the near future.
Posts Tagged ‘biotechnology’
Last Sunday’s episode of “The Good Wife” featured a Christian mediation between a farmer (Robert Joy) sued by a Pioneer-like company, represented by the actor Richard Thomas, for saving GMO corn seed for replanting. The facts were a mash-up of J.E.M. Ag Supply v. Pioneer Hi-Bred., 534 U.S. 124 (2001), and Monsanto Canada v. Schmeiser, 1 S.C.R. 902 (2004). In the former case, JEM was selling Pioneer’s hybrid seed that had been “saved” by farmers from a previous crop of the seed, in violation of the shrink wrap-type license on the original Pioneer seed they had purchased at JEM. In Monsanto-Canada, a farmer saved and replanted glyphosate-resistant canola seed from a field he claimed was contaminated by “GMO” pollen from neighboring fields.
On Friday, in American Calcar v. Amer. Honda Motor Co., App. No. 2013-1061 (Fed. Cir., September 26, 2014) a divided Fed. Cir. panel affirmed the district court’s ruling, following remand, that three patents on a multimedia system for vehicle information and control were invalid due to inequitable conduct (IC) by Calcar’s founder, Mr. Obradovich. The patents were all part of one family and the “priority patent” is U.S. Pat. No. 6,009,355. The primary evidence of inequitable conduct was the failure by Obradovich to disclose the owner’s manual of an Acura model that Calcar used as the basis of its specification. (A copy of the decision can be found at the end of this post.)
The Fed. Cir. had reversed the court’s earlier finding of inequitable conduct for a number of reasons, including judicial error in relying on jury findings of IC rather than ruling from the bench on equitable grounds, applying the “reasonable examiner” standard instead of the “but for” Therasense standard to resolve materiality, and use of a “sliding scale” to find intent based on a strong showing of materiality.
In Tyco Healthcare Group v. Mutual Pharm. Co., App. no. 13-1386 (Fed. Cir. August 6, 2014), a divided panel of the court reversed a district court’s summary judgment ruling dismissing antitrust charges brought by ANDA filer Mutual against patent-holder Tyco. (A copy of the decision can be found at the end of this post.) In what appears to be routine Hatch-Waxman litigation, the majority of the panel ruled that the NDA holder’s (the patent-holder’s) initiation of an infringement action following the ANDA filer’s para. IV certification could give rise to antitrust violations as “sham litigation.” The majority further held that the Citizen’s Petition–urged to contain baseless allegations of non-equivalence, filed by the NDA holder, following a finding of non-infringement by the proposed generic product, could also give rise to antitrust liability.
Judge Newman wrote a well-reasoned dissent that basically said that the patent/NDA holder has a statutory right to file an infringement suit after it receives notice of an ANDA filed with a para. IV certification. Judge Newman also wrote that the patent/NDA holder has a constitutional right (to petition), that should trump any speculative antitrust-based claims for damages.
It would take pages to walk through all the factual bases for the parties’ arguments, but if you just read Judge Newman’s dissent, you will get a good refresher course on the historically (limited) role of antitrust law in patent litigation. Maybe I’m getting too sensitive, but this seems like one more decision that is essentially anti-patent. At least the majority followed Therasense and did not find that plaintiff potentially liable for antitrust violations because it asserted a patent that the defendant urged was obtained by fraud committed by the patent owner, Sandoz.