Amgen And Apotex Do The Biosimilar Patent Dance

Amgen has filed a complaint under the Biologics Price Competition and Innovation Act (BPCIA), asserting that a biosimilar application filed by Apotex, Inc. infringes two of its patents. Although several complaints have invoked the BPCIA, this may be the first one in which the patent dance provisions have been followed. Continue reading this entry

PTAB Denies Institution Of Kyle Bass's Ampyra Patent Challenge

The USPTO Patent Trial and Appeal Board (PTAB) has put an end to Kyle Bass’s Ampyra patent challenge, by denying institution of Inter Partes Review (IPR) proceedings. While many were hoping the PTAB would render a decision based on the “improper purpose” of the challenge, the PTAB decisions are based on one of the more substantive reasons the patent owner raised in its Preliminary Responses.

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Federal Circuit Expands Direct Divided Infringement

In an en banc, per curiam decision in Akamai Technologies, Inc. v. Limelight Networks, Inc., on remand from the Supreme Court, the Federal Circuit broadened the circumstances under which a party can be liable for direct infringement under 35 USC § 271(a) even if it does not perform all steps of a method claim. While the decision was rendered in a case involving methods for delivering content over the internet, it has important implications for pharmaceutical and biotechnology method patents.

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Sequenom Seeks Rehearing En Banc

Sequenom, Inc. has filed a petition for rehearing en banc of the Federal Circuit decision that held its diagnostic method claims invalid under 35 USC § 101. (You can read my synopsis of that decision here). Stakeholders in the diagnostic and personalized medicine space will be watching to see if the court grants the petition and reaches a different decision on the merits.  Continue reading this entry

The Value Of Prophetic Examples

In Allergan, Inc. v. Sandoz, Inc., the Federal Circuit affirmed the district court decision that upheld the validity of the Allergan patents relating to Lumigan® 0.01% glaucoma eye drops against obviousness, written description, and enablement challenges. I previously wrote about the obviousness analysis. Here, I look at the court’s discussion of the written description and enablement issues, and note its citation of prophetic examples.

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