A recent decision by the International Trade Commission (“ITC” or the “Commission”) improves intellectual property holders’ ability to prove that they have a “domestic industry” and obtain relief for infringement from the Commission. Specifically, the ITC ruled that investments in “non-manufacturing activities,” including engineering and research and development activities related to a domestic industry protected article under section 337(a)(3)(C), can support a finding of domestic industry under sections 337(a)(3)(A) or (B)—the sections traditionally associated with manufacturing. The Commission also ruled that manufacturers could use certain investments in components and contract employees to support a finding of domestic industry. The Commission’s opinion removes uncertainty for companies relying upon research and development activities and expenditures to establish a domestic industry. It also helps parties relying on manufacturing expenses to establish a domestic industry.
In the time since the Federal Circuit issued its Vanda Pharma decision in April, Vanda Pharm. Inc. v West-Ward Pharm. Intl. Ltd. 887 F.3d 1117 (Fed. Cir. 2018) the US Patent and Trademark Office (USPTO) has issued two memos to the examining corps which provide increased clarity and predictability in the determination of patent eligibility which is more good news for the eligibility of claims relating to diagnostic or similar tests utilized in treating patients. If you’re not familiar with the Vanda Pharma decision, and want more detail, see my previous post HERE.
On May 14, 2018, the United States Court of Appeals for the Federal Circuit, In re: ZTE (USA) Inc., No. 2018-113, held that Federal circuit law governs the burden of proof for venue challenges under 28 U.S.C. § 1400(b) and that the burden of proof rests on the plaintiff to demonstrate proper venue upon a defendant’s motion to dismiss for lack of venue. Accordingly, the Federal Circuit granted defendant ZTE USA’s petition for mandamus and vacated an order from the United States District Court for the Eastern District of Texas denying ZTE USA’s motion to dismiss for lack of venue.
The Federal Circuit’s decision in Vanda Pharm. Inc. v West-Ward Pharm. Intl. Ltd. (2016-2707, 2016-2708 April 13, 2018) provided some good news on the subject matter eligibility front for innovators and other stakeholders in the personalized medicine space, as discussed in a previous post. So there is some hope for getting issued claims that will withstand a validity challenge under the Mayo/Alice framework. But what about enforcement? How does one prove infringement of claims that require various discreet steps that can, and typically are, performed by separate actors?
On April 16, 2018 in a precedential opinion, the United States Court of Appeals for the Federal Circuit, Sumitomo Dainippon Pharma v. Emcure Pharms., Nos. 2017-1798, -1799, -1800, affirmed the United States District Court for the District of New Jersey by construing the claimed chemical structure diagram to encompass at least the specific enantiomer depicted, refusing to limit the claim to only cover a racemic mixture of the (+) and (–) enantiomers, absent clear indication that the depicted enantiomer should be excluded from the claim.
The Federal Circuit provided a welcome boost for stakeholders in the field of personalized medicine with its recent decision in Vanda Pharm. Inc. v West-Ward Pharm. Intl. Ltd. (2016-2702, 2016-2708 April 13, 2018). Vanda Pharma’s asserted claims relate to a method of treating schizophrenia patients with iloperidone in which the dose is adjusted based upon the patient’s CYP2D6 genotype. The Federal Circuit agreed with the court below that these claims were both directed to patent eligible subject matter and infringed.
We thank Gary Gutzler, of AlixPartners, for co-authoring this post.
On January 12, 2018 in Exmark Manufacturing Co. Inc., v. Briggs & Stratton Power Products Group, LLC, the Federal Circuit once again addressed the issue of apportioning damages, an area of the law that continues to evolve. The parties in Exmark are competitors in the commercial lawn mower market. The patent-in-suit related to a lawn mower with an improved “baffle” that more efficiently directed air flow and grass clippings when the mower was operating. At the conclusion of the jury trial, the defendant’s mower was found to infringe and the jury awarded the plaintiff over $24 million in damages. On appeal, the Federal Circuit affirmed the method of apportionment utilized by the Plaintiff’s expert, but rejected the expert’s application of that method.
The Medicines Company (“MedCo”) appealed findings of no infringement made by the United District Court for the District of Delaware. Hospira cross-appealed the district court’s finding that a distribution agreement did not constitute an invalidating “offer for sale” under 35 U.S.C. § 102(b). In a decision rendered by United States Court of Appeals for the Federal Circuit on February 6, 2018, the Court affirmed the district court’s non-infringement findings and remanded the case for the district court to determine if the on-sale bar applies.
MedCo asserted two patents, U.S. Patent Nos. 7,582,727 and 7,598,343, covering its Angiomax drug product against Hospira, a generic drug maker who filed Abbreviated New Drug Application (“ANDA”) with the Food and Drug Administration. Although Angiomax has been available for decades, MedCo developed a new method of formulating Angiomax to reduce impurities. This formulation was the subject of the asserted patents, both of which were filed on July 27, 2008. Prior to filing the patents, MedCo entered into a distribution agreement on February 27, 2007 with Integrated Commercialization Solutions, Inc. (“ICS”) to distribute the new Angiomax formulation. The agreement stated that MedCo “desire[d] to sell the Product” to ICS and ICS “desire[d] to purchase and distribute the Product.” Under the agreement, title passed to ICS upon receipt of the Product at the distribution center. The district court concluded that the patents were neither infringed nor invalid. The district court found that the invention was ready for patenting at the time of the agreement, but was not sold or offered for sale before the critical date of July 27, 2008 because the distribution agreement between MedCo and ICS did not constitute an offer to sell. Both parties appealed.
When trying to overcome an obviousness rejection of a patent claim, an argument that two or more cited references cannot be combined may be used. For example, it can be argued that the combination is improper because the modification of a reference completely changes its “fundamental principle of operation.” However, it can be difficult to overcome obviousness rejections using this argument, which is highlighted in a recent Federal Circuit decision in University of Maryland v. Presens. In this case, the court affirmed an inter partes reexamination (IPR) decision of the Patent Trial and Appeal Board (PTAB) that affirmed the examiner’s rejection of claims in U.S. Patent 6,673,532 (“’532 patent) as obvious despite the plaintiff’s “changes the principle of operation” argument. Although the decision is non-precedential, it provides helpful information to patent practitioners and litigators for arguing obviousness based on changes to a reference’s fundamental principle of operation.
The ’532 patent discloses an optical method of monitoring various cell culture parameters. Claim 1 of the ’532 patent, deemed as representative, reads as follows: Continue Reading Overcoming Obviousness Rejections: Arguing Changes to Fundamental Principle of Operation
The Federal Circuit’s damages apportionment jurisprudence is an ever-evolving area of the law. On January 10, 2018, a three judge panel of the Federal Circuit revisited the issue in connection with a patent covering a method for providing computer security in the case Finjan, Inc. v. Blue Coat Systems, Inc. While the Federal Circuit affirmed the damages award for 2 of 4 asserted patents, it reversed as to one computer security patent which was found to be infringed by a product that performed both infringing and non-infringing functions.
In calculating damages, the plaintiff sought the reasonable royalty they “would have received through arms-length bargaining.” Lucent Techs., Inc. v. Gateway, Inc., 580 F.3d 1301, 1324