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.
The Supreme Court recently heard oral argument in TC Heartland LLC v Kraft Food Brands Group LLC. The case concerns the application of part of the general venue statute which allows a corporation to be sued in multiple districts. If the court rules in TC Heartland's favour, the venue in patent cases could potentially be limited to those districts where the defendant is incorporated or has a regular and established place of business.
The Supreme Court recently heard oral argument in Impression Products Inc v Lexmark Int'l Inc on whether a patentee's US patent rights may be exhausted by certain conditional US sales or by foreign sales of a patented item, acknowledging that these would disrupt settled expectations and present serious consequences.
While federal copyright laws unquestionably allow protection for original works of art, copyright eligibility has been less clear in situations where artistic designs are incorporated into articles with utilitarian features. In a recent decision, the Supreme Court clarified the test for determining whether artistic elements incorporated into a useful article are eligible for copyright protection.
The Supreme Court recently reversed the Federal Circuit's interpretation of an infringement liability statute in litigation over whether shipping a single component of a patented multi-component invention to be assembled overseas qualifies as infringement under 35 USC Section 271(f)(1). In doing so, the Supreme Court clarified that Section 271(f)(1) does not cover the supply of a single component of a multi-component invention.
The US Supreme Court recently heard oral argument in Lee v Tam. The decision in this case will address whether Section 2(a) of the Lanham Act, which permits the US Patent and Trademark Office to refuse to register 'disparaging' trademarks, is constitutional under the First Amendment. It is difficult to tell from the oral argument how the Supreme Court will decide this case.
In a recent case, petitioner Phigenix challenged the validity of a patent which related to antibody-maytansinoid conjugates for the treatment of cancer. The Federal Circuit dismissed Phigenix's appeal for lack of standing under Article III of the Constitution. In dismissing the appeal, the Federal Circuit, among other things, reiterated the minimum requirements for Article III standing.
The Supreme Court recently heard oral argument on the interpretation and application of a statutory provision which imposes infringement liability on US manufacturers that supply components of patented inventions for use abroad. At issue is whether the export from the United States of a single component of a patented multi-component invention, which is later assembled outside the United States, qualifies as an infringing act.