By Andrew Williams --
On March 31, 2017, the Patent Trial and Appeals Board ("PTAB" or "Board") granted a motion to amend claims in Amerigen Pharmaceuticals Ltd. v. Shire LLC (IPR2015-02009). This is, of course, an uncommon event. Depending on how you keep score, the PTAB had previously only granted less than ten such motions (at least in part). Almost a year ago, on April 30, 2016, the PTAB reported in its Motion to Amend Study that only 6 motions to amend had been granted (or granted-in-part). This was out of a total of 118 motions filed in 1539 instituted and completed AIA proceedings, which amounts to a positive outcome for the patent owner in 5% of the cases in which a motion was filed. Moreover, since that time, only two additional motions were granted prior to the Amerigen case: CBM2015-00040 (Google Inc. v. ContentGuard Holdings, Inc.) on June 21, 2016; and IPR2015-01225 (Globel Tel*Link Corp. v. Securus Technologies, Inc.) on December 14, 2016. The situation has garnered so much attention that the Federal Circuit sitting en banc is even considering the Board's motion to amend practice. On December 9, 2016, the Court heard oral arguments in In re Aqua Products, Inc. The Federal Circuit is reconsidering whether the patent owner bears the burden of persuasion regarding the patentability of amended claims, and whether the Board can sua sponte raise challenges to the proposed claims when the petitioner does not challenge their patentability (and if so, where do the burden's lie). A decision should be rendered shortly in that case.
In the present one, IPR2015-02009 relates to Shire's reissue patent RE42,096. This patent is listed in the Orange Book for Adderall XR®, a treatment for Attention Deficit Hyperactivity Disorder (ADHD). Shire had asserted this patent in several district court cases, including one against Amerigen Pharmaceuticals that was terminated on March 2, 2017 because of settlement. The papers in the IPR proceeding explained that ADHD is conventionally treated by administering two separate doses of medication, one in the morning and one 4-6 hours later. As can be imagined, this is problematic because it is time-consuming, inconvenient, and because some children have difficulties swallowing the tablets. The '096 patent disclosed compositions comprising "an oral multiple pulsed dose delivery system for amphetamine salts and mixtures thereof . . . in which there is immediate release of drug and enteric release of drug" that "retards or delays" the release for a predetermined time, at which time the release is rapid and complete.
Petitioner Amerigen Pharmaceuticals challenged claims 1-3, 5, 8, 9, 11, 18-21, 23, and 25 of the '096 patent. Independent claims 1 and 18 were highlighted as representative:
1. A pharmaceutical composition for delivery of one or more pharmaceutically active amphetamine salts, comprising:
(a) one or more pharmaceutically active amphetamine salts covered with an immediate release coating; and
(b) one or more pharmaceutically active amphetamine salts that are covered with an enteric release coating that provides for delayed pulsed enteric release,
wherein said enteric release coating releases essentially all of said one or more pharmaceutically active amphetamine salts coated with said enteric coating within about 60 minutes after initiation of said delayed pulsed enteric release;
wherein the pharmaceutically active amphetamine salts in (a) and (b) comprise mixed amphetamine salts.
18. A pharmaceutical composition for delivery of one or more pharmaceutically active amphetamine salts comprising:
(a) one or more pharmaceutically active amphetamine salts covered with an immediate release coating;
(b) one or more pharmaceutically active amphetamine salts that are covered with an enteric release coating that provides for delayed pulsed enteric release, wherein said enteric release coating releases said one or more pharmaceutically active amphetamine salts coated with said enteric coating within about 60 minutes after initiation of said delayed pulsed enteric release; and
(c) a protective layer between the at least one pharmaceutically active amphetamine salt and the enteric release coating.
One of the key references cited by petitioner was U.S. Patent No. 5,837,284 ("Mehta"), which was alleged to both anticipate and render obvious in combination both of these claims. In its institution decision, the Board pointed out that claim 1 and related claims contain the limitation that "essentially all" of the enteric coated amphetamine salts is released within about 60 minutes. However, Mehta did not disclose that any formulation reached 80% released in about 60 minutes. Therefore, because inherency "may not be established by probabilities or possibilities," the Board was not persuaded that Mehta's disclosure necessarily met the claim limitation. Therefore, it did not institute trial with regard to claims 1-3, 5, 8, 9, and 11.
Claim 18, and related claims, had a different outcome. Whereas the claim language does require that "said enteric release coating releases said one or more pharmaceutically active amphetamine salts coated with said enteric coating within about 60 minutes," the Board found that this did not require "essentially all" be released. As such, Mehta's disclosure did not need to satisfy the "essentially all" hurdle for petitioner to establish a reasonable likelihood that it would prevail on its anticipation and obviousness challenges. Correspondingly, trial was instituted on claims 18-21 and 23 for anticipation and 18-21, 23, and 25 for obviousness.
Shire's motion to amend only related to one claim (claim 25), which read:
25. The pharmaceutical composition of any one of claims 2, 13 or 18 to 20 wherein the pharmaceutically active amphetamine salt in (a) and (b) comprises mixed amphetamine salts.
This claim depended from instituted claims 18-20, but also depended from two of the claims (2 and 13) for which institution was denied. Therefore, Shire sought only one substitute claim which removed the multiple dependencies to the instituted claims:
26. The pharmaceutical composition of any one of claims 2[[,]] or 13 or 18 to 20 wherein the pharmaceutically active amphetamine salt in (a) and (b) comprises mixed amphetamine salts.
At the same time, Shire sought to cancel claims all of the other claims that were instituted. It argued that because claim 26 only depends from non-instituted claims, it should itself not be subject to trial (in other words that it was patentable). Petitioner instead argued that the motion should be denied because Shire did not separately demonstrate the patentability of claim 26. Even though the Board has lessened the Idle Free requirement that patent owners demonstrate patentability over all prior art known to it, patent owners are still required to address all prior art of record. Amerigen Pharmaceuticals asserted that Mylan had identified additional art in a related IPR proceeding (IPR2016-01033), and that Shire had not addressed this art. Nevertheless, the Board accepted Shire's position that "[e]ffectively, no claim is being amended, and claims are only being cancelled, because claims 18-24 are being removed, and proposed claim 26 removes three multiple dependent claims (claim 25 as it depends from claims 18-20) . . . ." As such, there was no requirement that Shire prove "that originally non-amended claims are patentable over all potential prior art, especially non-instituted claims." Correspondingly, the Board granted the motion.
It is unclear if the experience of Shire will be useful for other patent owners, although if in a similar situation, the strategy should be successful. Nevertheless, the rules for motions to amend could be rewritten by the Federal Circuit in the In re Aqua Products case, so patent owners may not need the roadmap presented by the Amerigen Pharmaceuticals case. We will continue to report on the status of motions to amend before the PTAB, especially with regard to the outcome of the Aqua Products case.