Indian tribes ability to shield patents from review at the United States Patent and Trademark Office’s (“USPTO”) Patent Trial and Appeal Board (“PTAB”) took another blow at the Federal Circuit.  The Federal Circuit in a precedential decision, affirming the decision of the PTAB, held that tribal sovereign immunity cannot be asserted in inter partes review (“IPR”) proceedings before the PTAB.[1]

The Federal Circuit based the decision on two principles extrapolated from Supreme Court decisions.  First, the general proposition that “immunity does not apply where the federal government acting through an agency engages in an investigative action or pursues an adjudicatory agency action.”[2]  Second, the Supreme Court’s recognized distinction between adjudicative proceedings brought by a private party against a state, on the one hand, and federal agency-initiated enforcement proceedings, on the other.  According to the Federal Circuit, immunity may generally be invoked in the private party actions, but not in the federal agency-initiated enforcement proceedings.
Continue Reading Tribal Immunity Cannot Be Asserted to Escape IPR Proceedings

On June 25, 2018, the Food and Drug Administration (“FDA”) approved Epidiolex (cannabidiol), the first marijuana derived drug for use in the United States, to treat two rare forms of epilepsy. This decision for the FDA could have sweeping effects for the marijuana industry. While the FDA has previously approved drugs comprising synthetic (manufactured) cannabinoids,

The U.S. Patent and Trademark Office (“USPTO”) has renewed the hopes of applicants looking to patent method of treatment claims. A recent memo from the USPTO (the “Memo”) provides guidance on method of treatment claims, suggesting that when correctly drafted, such claims should generally be considered patent eligible subject matter.

The Memo comes

The USPTO announced today proposed rulemaking for changing its policy related to claim interpretation in Patent Trial and Appeal Board (“PTAB”) proceedings (not including patent examination). Currently, the broadest reasonable interpretation (“BRI”) standard is applied when analyzing claims. The proposed new rules would result in “the same as the standard applied in federal district courts and International Trade Commission (“ITC”) proceedings;” i.e., “ordinary and customary meaning” according to “a person of ordinary skill in the art in question at the time of the invention,”[1] and “reasonable certainty” for definiteness analysis[2]. In addition, it is proposed that the USPTO/PTAB “will consider any prior claim construction determination concerning a term of the involved claim in a civil action, or an ITC proceeding, that is timely made of record in an IPR, PGR, or CBM proceeding.”
Continue Reading USPTO Announces Notice of Proposed Rulemaking for Claim Construction Standard used in PTAB Proceedings

SAS Institute Inc. v. Iancu

As we recently noted in our companion piece Part 1 of 2: Supreme Court and Inter Partes Review, the Supreme Court issued decisions in two intellectual property appeals relating to inter partes review (“IPR”) before the U.S. Patent and Trademark Office. In Oil States Energy Services LLC v. Greene’s Energy Group LLC, No. 16-712, the Court decided 7–2 that the inter partes review process does not violate Article III of the Constitution or the Seventh Amendment. In SAS Institute Inc. v. IANCU, No. 16-969, the Court decided that the Patent Trial and Appeal Board (“PTAB”) must decide the patentability of all of the claims the petitioner has challenged rather than selectively picking and choosing which claims to review. In response to the Court’s decision in SAS, the PTAB has already issued new guidance regarding the institution of IPRs.
Continue Reading Part 2 of 2: Supreme Court and Inter Partes Review

Oil States Energy Services LLC v. Greene’s Energy Group LLC

On April 24, 2018, the Supreme Court issued decisions in two intellectual property appeals relating to inter partes review (“IPR”) before the U.S. Patent and Trademark Office. In Oil States Energy Services LLC v. Greene’s Energy Group LLC, No. 16-712, the Court decided 7–2 that the inter partes review process does not violate Article III of the Constitution or the Seventh Amendment. In SAS Institute Inc. v. IANCU, No. 16-969,  the Court decided that the Patent Trial and Appeal Board (“PTAB”) must decide the patentability of all of the claims the petitioner has challenged rather than selectively picking and choosing which claims to review.  In response to the Court’s decision in SAS, the PTAB has already issued new guidance regarding the institution of IPRs.
Continue Reading Part 1 of 2: Supreme Court and Inter Partes Review

The Federal Circuit on Wednesday reversed Court precedent and long held belief that inter partes review (“IPR”) institution decisions were categorically non-reviewable. The Court, sitting en banc, held that the issue of whether a petitioner is time-barred from filing an IPR petition  under 35 U.S.C. § 315(b) is in fact reviewable.[i]

This case arose

The ability to facilitate the regeneration of parts of the human body is “no longer the stuff of science fiction” according to FDA Commissioner Scott Gottlieb.[i] According to Commissioner Gottlieb, the cell based therapies and their use in regenerative medicine is one of the most promising fields of science already producing “improbable advances.” At

The Federal Circuit in Shire v. Amneal, a Hatch-Waxman case, reaffirmed that the burden rests with the defendants to prove motivation for a person of ordinary skill in the art to arrive at a claimed chemical compound. The ANDA filer asserted that 18 claims of four Shire patents (U.S. Pat. Nos. 7,105,486; 7,655,630; 7,659,253; and 7,662,787) covering L-lysine-d-amphetamine (LDX) dimesylate (marketed as Vyvanse® to treat ADHD) were invalid due to obviousness. The court also considered whether an API supplier should be held liable for induced infringement for supplying the ANDA filers with the patented API.
Continue Reading Shire v. Amneal – Compound Claim Not Obvious and API Supplier Not Liable Under FDA Safe Harbor

The Patent Trial and Appeals Board (“PTAB”) recently ruled in IPR2015-00822 (“the ‘822 IPR”) that contractual estoppel, wherein the petitioner has signed a settlement agreement including a “no challenge” clause, cannot be asserted to preclude the institution of an inter partes review where the potential prejudice to the patent owner does not outweigh the prejudice to the petitioner of losing an opportunity to challenge the claims of a patent before the office.
Continue Reading Patent Licensors Beware – No Challenge Clause Does Not Bar Challenge Before the PTAB