A number of district court decisions have held patent claims to be ineligible under Section 101 during motions brought at the start of litigation or on motions for summary judgment. However, two recent Federal Circuit decisions indicate that factual disputes over aspects of the two-step test for assessing patent eligibility established by the Supreme Court, including the tangibility of claims, may hinder such early or summary Section 101 determinations.
In a recent case, the US Court of Appeals for the Fourth Circuit held that an internet service provider (ISP) was not entitled to the safe harbour of 17 USC Section 512(a) of the Digital Millennium Copyright Act. In so holding, the Fourth Circuit rejected the ISP's argument that the safe harbour requires that an ISP take action only against subscribers who are adjudged in court to be 'repeat infringers'.
The Federal Circuit recently handed down a decision in which it clarified that wilful infringement is an issue to be decided by a jury, rather than a district court. It held that the district court had erred in excluding as unreasonable prior art evidence concerning the defendant's litigation defences, because that evidence may also have been relevant to its subjective intent or knowledge at the time of the alleged infringement.
The US Court of Appeals for the Federal Circuit sitting en banc recently issued a majority opinion holding that a determination made by the Patent and Trademark Office concerning whether a petition for an inter partes review is time barred is subject to judicial review. Specifically, the majority held that the limit on judicial review pertaining to institution decisions does not apply to time bar determinations under 35 USC Section 315(b).
A three-judge panel of the Court of Appeals for the Federal Circuit recently held that although the mark FUCT comprises immoral or scandalous matter, it is still federally registrable because the bar on registering such marks set out in Section 2(a) of the Lanham Act is an unconstitutional restriction of free speech, thereby violating the First Amendment.
The Supreme Court recently heard oral argument in Oil States Energy Services, LLC v Greene's Energy Group, LLC. The Supreme Court's decision in this case will either spare or strike down inter partes review as a means for challenging the validity of issued patents in the United States.
The Federal Circuit recently held that TC Heartland represented a change of law and that Micron Technology Inc's failure to raise a venue objection in its initial motion to dismiss did not waive the objection under Rule 12 of the Federal Rules of Civil Procedure. However, the court also explained that there may be other bases on which a defendant could be found to have forfeited a venue objection.
As of July 2017 there had been at least 363 inter partes review petitions filed against patents listed in the Food and Drug Administration's Orange Book and 74 filed against patents that have been identified as reading on Purple Book Centre for Drug Evaluation and Research-listed biologic drugs. Of these 437 inter partes reviews, 116 resulted in a final written decision. There are a number of lessons to be learned from these.
There has been some concern regarding the statistics periodically issued by the US Patent Trial and Appeal Board, owing to the fact that the reported numbers overlook multiple inter partes review challenges to the same patents and, potentially, different outcomes in those challenges. While certain drug patents have been challenged in multiple inter partes review petitions, concern as to different outcomes appears to be unfounded.
A divided en banc Federal Circuit recently issued several opinions addressing the burden of proof concerning a motion to amend claims in inter partes review proceedings. While none of the opinions garnered a full majority, the leading opinion placed the burden of persuasion with respect to the patentability of amended claims on the petitioner.
The verdict in a recent patent infringement case between two pharmaceutical companies is the first instance in which a patent owner has recovered significant infringement damages under the Biologics Price Competition and the Innovation Act. It is also the first time that a patent owner has recovered damages under the act for infringement that a competitor carried out before the commercial marketing of the competitor's biosimilar.
In a recent patent infringement case, a Federal Circuit panel rejected an Eastern District of Texas judge's proposed four-factor test for determining whether venue is proper over a defendant in a patent infringement action under the 'regular and established place of business' prong of the US patent venue statute. In its place, the Federal Circuit introduced its own three requirements to determine what constitutes a 'regular and established place of business'.
The Federal Circuit recently reversed a district court's determination that a patent for a computer memory system was invalid because it was directed to a patent-ineligible abstract idea. Referring to other recent decisions on computer-related claims, the Federal Circuit majority instead concluded that the patent was directed to a patent-eligible "improvement to computer functionality".
The US Patent Trial and Appeal Board (PTAB) recently released updated statistics showing the fate of resolved inter partes review proceedings. These statistics show that a total of 4,563 inter partes review petitions were resolved as of March 31 2017, including 1,577 final written decisions. In 81% of these final written decisions, at least some instituted patent claims were found unpatentable. This statistic has contributed to concerns that the PTAB is a patent 'death squad'.
The Supreme Court recently held that the Lanham Act's disparagement clause is unconstitutional under the First Amendment's free speech clause. The court explained that the disparagement clause "offends a bedrock First Amendment disparagement principle". Trademarks cannot be denied federal registration or be cancelled merely because they offend. Assuming that they otherwise qualify, offensive trademarks are entitled to the substantial benefits of federal trademark registration.
The Supreme Court recently ruled that biosimilar makers can give notice of commercial marketing before Food and Drug Administration (FDA) licensure. The ruling resolves an ambiguity in the text of the Biologics Price Competition and Innovation Act, which gave rise to a presumption that biosimilar makers had to wait until 180 days after FDA licensure before providing notice of the commercial marketing of those products.
In a recent panel decision, the Federal Circuit suggested that an 'insubstantial differences' test may be more suitable than a 'function-way-result' test for evaluating infringement under the doctrine of equivalents in patent cases involving the chemical arts. The decision arises from unusual procedural circumstances.
The Supreme Court recently issued a decision limiting venue in patent cases to districts in which the defendant is incorporated or where the defendant has committed acts of infringement and has a regular and established place of business. The decision overturns decades-long Federal Circuit precedent under which patent defendants have been sued in states other than those in which they are incorporated or have regular places of business.
The Federal Circuit panel recently held four pharmaceutical patents invalid under the on-sale bar of 35 USC Section 102(b). Under the post-America Invents Act version of Section 102(b), public disclosure of the existence of the sale of a patented item may suffice to invalidate a patent under the on-sale bar, even if the details of the invention are not publicly disclosed in the terms of sale.
The Supreme Court recently heard oral argument in Sandoz Inc v Amgen Inc on two questions regarding the Biologics Price Competition and Innovation Act. If the court affirms Sandoz's position on these issues, sponsors will need to carefully consider how to prepare for and undertake declaratory judgment actions, perhaps within a compressed time frame and with little knowledge at the outset of the proposed biosimilar or its manufacturing process.