Second Time Is The Charm For Kyle Bass Challenges Of Ampyra Patents

29 March 2016 PharmaPatents Blog

The USPTO Patent Trial and Appeal Board (PTAB) has decided to institute inter partes review (IPR) proceedings against the Ampyra patents based on the second set of petitions filed by Kyle Bass and the Coalition for Affordable Drugs. This decision shows that even patent owners who successfully avoid institution of one IPR may face a subsequent IPR by the same party as long as it is based on different prior art. 

The Ampyra Patents At Issue

The Ampyra® patents at issue were U.S. Patent Nos. 8,663,6858,007,8268,440,703, and 8,354,437, which constitute four of the five Orange-book listed patents. The fifth patent, U.S. Patent No. 5,540,938 expires in 2018, while the challenged patents expire in 2025, 2026, and 2027.

The asserted grounds of invalidity was obviousness in view of (i) Acorda’s 2013 SEC S-1 Statement; (ii) Hayes et al., “Pharmacokinetic Studies of Single and Multiple Oral Doses of Fampridine-SR (Sustained-Release 4- Aminopyridine) in Patients With Chronic Spinal Cord Injury,” 26(4) CLINICAL NEUROPHARMACOLOGY 185–92 (2003); and, for some patents, (iii) Juárez et al., “Influence of Admixed Carboxymethylcellulose on Release of 4-Aminopyridine from Hydroxypropyl Methylcellulose Matrix Tablets,” 216 INT’L J. PHARM. 115–25 (2001).

Learning From Previous Mistakes

As discussed in this article, Kyle Bass’s first IPR petitions against the Ampyra® patents were denied institution because they did not establish that the cited posters qualified as prior art “printed publications” as required by 35 U.S.C. § 311(b). In this round of challenges, there was a question regarding the “printed publication” status of Acorda’s S-1 Statement, but the PTAB found a “sufficient showing that the S-1 was publicly accessible to the public interested in the art.” The PTAB explained:

[T]he record before us supports Petitioner’s contention that public documents available before September 2003 indicated to an ordinary artisan that Patent Owner’s “lead product” was a sustained release form of 4- aminopyridine, i.e., Fampridine-SR, and that Patent Owner was testing that product in clinical trials to evaluate its effect on walking speed and muscle strength in MS patients. …. We are persuaded that Petitioner is reasonably likely to succeed in showing that such documents would have prompted a person of ordinary skill interested in the art to look for other publicly available information relating to Patent Owner and its activity, including SEC documents, such as the S-1, via EDGAR. Petitioner also establishes sufficiently that an ordinary artisan looking for such documents could have located the S-1 upon exercising reasonable diligence ….

Different Prior Art Prevents Application Of § 315(d)

Acorda argued that the PTAB should exercise its discretion under § 315(d) any deny institution because the same prior art was asserted in the first set of IPR petitions filed by Kyle Bass and the Coalition for Affordable Drugs, but the PTAB found this set of petitions to raise different issues. In this regard, the PTAB emphasized that institution had been denied based on the posters, not the S-1 Statement.

(The PTAB decision refers to § 325(d), which applies to post-grant review proceedings; § 315(d) is the parallel statute for IPRs.)

No Instituion Means No Estoppel

The estoppel provisions of § 315(e) apply only if and when an IPR petition results in a final decision on the merits:

(e)Estoppel.—
(1)Proceedings before the office.—
The petitioner in an inter partes review of a claim in a patent under this chapter that results in a final written decision under section 318(a), or the real party in interest or privy of the petitioner, may not request or maintain a proceeding before the Office with respect to that claim on any ground that the petitioner raised or reasonably could have raised during that inter partes review.

Thus, a petition that does not result in institution does not give rise to estoppel. That means that as long as a petitioner can come up with sufficiently different grounds for invalidity to avoid § 315(d), it can keep trying to challenge the same patent until an IPR proceeding is instituted and decided.

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