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

On September 15, 2015, the USPTO announced the “Streamlined, Expedited Patent Appeal Pilot for Small Entities.” This program allows small entities to expedite an ex parte appeal to the PTAB, similar to the program announced on June 19, 2015, for parties with multiple appeals pending at the PTAB.
Continue Reading PTAB Pilot Program for Small Entities to Expedite Ex Parte Appeals

The Federal Circuit, in Dome Patent L.P. v. Lee, further clarified the standard for a person of ordinary skill in the art’s motivation in deciding obviousness contentions under U.S.C. §103(a). The court decided that the district court properly determined whether a person of ordinary skill in the art would have been motivated to combine conflicting prior art references that taught all the elements of a claim. In sustaining the district court’s decision, the court looked to both the need for the claimed product and the prior art as a whole, while also noting that “the burden of overcoming the district court’s factual findings is, as it should be, a heavy one.”
Continue Reading Teaching Away Negated by References Disclosing How to Offset Disadvantages

The recent decision in Dow Chemical confirmed the Federal Circuit’s earlier position in Teva Pharma, that in instances where multiple methods of measurement exist for a parameter, a patentee must make sure to tell the public which one is being used.
Continue Reading Dow Chemical Confirms, “Measure Twice — Just Make Sure to Define Once”

For BioPharma patents, we were curious whether art that formed the basis for IPR institution was “newly discovered” prior art, or whether it was art that had previously been of record during prosecution. The answer to this question may help companies decide to take affirmative steps to discover and cite the most important art during prosecution of the patent application. If “newly discovered” prior art is generally used in IPR institution decisions, companies may be more likely to conduct affirmative prior art searches prior to prosecution to get all available art in front of the examiner. By conducting affirmative prior art searching, an examiner would possess the most important art, and theoretically the claims would be more resistant to an IPR. However, if art previously known during prosecution is generally used in IPRs, companies may feel justified in filing applications without conducting extensive prior art searches, believing that the presumption of the Examiner being aware of the prior art does not immunize the patent against a later IPR challenge.
Continue Reading For BioPharma, Citing Relevant Art During Prosecution Does Not Appear to Minimize IPR Risk

In a previous blog post, we discussed the Federal Circuit’s reluctance to relinquish control of claim construction after the Supreme Court’s Teva1 ruling as exemplified in the Enzo2 decision. The trend continues with the Federal Circuit’s decision in Teva on remand from the Supreme Court just last month. A divided panel still found the asserted claims, specifically the term “molecular weight,”3 indefinite and therefore invalid, reversing the district court.4 The Supreme Court in Teva agreed with Teva that the Federal Circuit precedent5 of reviewing all aspects of claim construction de novo is inconsistent with Fed. R. Civ. P. 52(a)(6), which provides that factual findings of the district court may only be set aside if “clearly erroneous.”6 The Court explained that claim construction is ultimately a question of law, but subsidiary factual findings must be given deference and reviewed under the “clear error” standard of review.7 Also, while Teva was pending, the Supreme Court issued the Nautilus II8 decision, which modified the Federal Circuit’s “insolubly ambiguous” standard for indefiniteness under 35 U.S.C. § 112, ¶2 to a more stringent “reasonable certainty” standard.9
Continue Reading The Federal Circuit’s Continued Reluctance to Give Deference to the District Court Despite Expert Testimony

In a case involving Google’s “very cool”1 Street View technology, Google convinced the district court that its technology did not infringe four Verderi’s patents.2 But Google’s victory was short lived. The Federal Circuit disagreed with the district court on claim construction, and remanded the case to the district court to determine infringement based on the Federal Circuit’s own claim construction. Google applied for, and was recently denied, Supreme Court review.3
Continue Reading During Claim Construction, Claim Amendments Need Not Be Strictly Construed Against Applicant

On June 12, 2015, the Federal Circuit invalidated Sequenom’s patent on fetal DNA testing (U.S. Patent No. 6,258,540; “the ’540 patent”) holding that the subject matter was not eligible for patent protection under 35 U.S.C. § 101. This is the first time that a lower court applied the Supreme Court’s ruling in Mayo Collaborative Services v. Prometheus Laboratories.
Continue Reading Federal Circuit Deals Blow to Biotech Industry and Diagnostic Method Patents