Alnylam filed suit against Silence Therapeutics, seeking a declaration that its Patisiran RNA interference product does not infringe five Silence patents. Patisiran is awaiting approval from the FDA for treatment of hereditary transthyretin-mediated ATTR amyloidosis, a genetic disease in which misformed proteins accumulate as deposits in the heart, erves, GI tract, and other organs, bringing forth a number of different symptoms. Currently, other than liver transplants for early-stage sufferers, there are no FDA-approved treatments for the disease. Alnylam asserts that it has spent hundreds of millions of dollars in developing Patisiran. Alnylam alleges that Silence, which has no products on the market or in advanced clinical trials, has claimed that Alnylam infringes the patents by correspondence in the United States as well as by filing infringement suits in Europe and challenging Alnylam patents on the technology in Europe. These disputes are on-going. Alnylam seeks declarations of non-infringment and injunctions prohibiting Silence from asserting infringement of the patents.
Judge Hillman dismissed all counts of James Fischer’s amended complaint with prejudice for failure to state a claim. Fischer, acting pro se, brought claims of false association, false advertising, violation of rights of publicity, unfair competition, and tortious interference with prospective economic advantage in connection with online communications criticizing his theories relating to beekeeping made between the defendants and the Organic Beekeepers Discussion Group and BeeSource Forum. The gist of the complaint is that defendants Dean Stiglitz and Laurie Anne Herboldsheimer fabricated and published negative reviews, which they attributed to Fischer, of their book “The Complete Idiots Guide to Beekeeping” in an attempt to gain attention and notoriety within the beekeeping community for the book – Fischer himself being an oft-published beekeeper. Fischer had previously been allowed to amend his complaint to add additional factual pleadings relating to damages and supporting the elements of his claims, but Judge Hillman found (in fairly summary fashion) that the amended complaint failed to factually assert all of the elements of any of the asserted claims; there was no likelihood that the public would perceive Fischer as sponsoring or endorsing the book, no discussion of Fischer’s commercial activity in anything other than a satirical way, no allegations that the defendants sought to exploit Fischer’s name to exploit its value for advertising or trade purposes, no indication of any actual or prospective actual customer that was lost by Fischer, and with respect to the unfair competition claim, no allegation that Fischer is located in Massachusetts or claims an injury occurring in Massachusetts.
In one of the more salacious intellectual property filings I have seen, Martha’s Vineyard-based artist Leah Bassett filed suit against Mile High Media and a number of individuals associated with the company for copyright infringement, breach of contract, trespass, civil conspiracy, RICO violations, and a number of additional claims relating to the defendants’ alleged use of her Aquinnah house to shoot pornographic movies. Ms. Bassett designed the house, and decorated it with numerous works of art that she created, including paintings, sculptures, and the like. She alleges that one of the defendants rented the house during the winter of 2014 – 2015 for the purpose of making porn, without telling her of the planned use of the property and in violation of the lease agreement. When he vacated the premises before the expiration of the lease, she discovered considerable damage to the house. Subsequent investigations revealed that the house had been used as the set of a number of porn films made and distributed by Mile High Media, in which her artwork is visible – according to the complaint, some of her art was moved from room to room “in order to ‘aesthetically enhance’ their porn scenes…” She asserts willful copyright infringement, based on the defendants’ knowledge that she was a professional artist whose work would be protected by copyright law from the unauthorized reproduction of the same in the films. Ms. Bassett seeks monetary damages as well as injunctive relief to prevent further dissemination of films that include her copyrighted works of art. Judge Saris is the lucky winner of this case.
Judge Young issued findings of fact, rulings of law, and an order for judgment following the bench trial in this litigation involving Abhai’s Abbreviated New Drug Application for a generic version of the extended-release ADHD drug Adderall XR. Judge Young found Abhai infringed Shire’s RE42,096 and RE41,148 patents, and that the patents were valid. He also determined that Abhai had conducted litigation misconduct in failing to reveal errors in its stability dissolution testing or supplement its discovery responses with the corrected data in a timely fashion. Abhai’s 30(b)(6) witness, Dr. Namburi, was deposed in October, 2016, and was questioned at length about the dissolution data, showing how much drug dissolved over time. This questioning triggered concerns in Dr. Namburi’s mind over the veracity of the test results (and thus of his testimony). Over the next several days, he and others at Abhai determined that the testing was conducted improperly, as a result of ambiguities in the written protocol Abhai was using. By the end of the month, the protocols had been revised and the samples retested. Abhai withheld this revised protocol in discovery responses made in November, and Dr. Namburi did not make note of this error when signing an errata report for his deposition that month. Abhai also failed to supplement its prior discovery responses to include the revised protocol or new test data, apparently because no one at Abhai informed Abhai’s attorneys of these errors. Abhai’s attorneys were not notified until March 31, 2017, of the mistakes; the notified the court (and, for the first time, the FDA) the following business day, after five trial days had occurred. Judge Young determined that Dr. Namburi knew of the importance of the dissolution data to the case, as he was central in assisting Abhai’s attorneys in preparing for the trial, and that as a member of Abhai’s management, his actions were attributable to the company as a whole. Judge Young ordered sanctions in the form of attorney’s fees for time Shire spent dealing with the inaccurate data and other alleged litigation misconduct, and for dealing with the revised dissolution data that Abhai sought to introduce mid-trial. He further sanctioned Abhai $30,000 to be paid to the court as a sanction for wasting five days of the court’s valuable time and resources. Finally, he ordered the clerk to send a certified copy of his opinion to the General Counsel of the FDA for their further consideration.
DUSA, a New Jersey company, accuses Biofrontera of infringing U.S. Patent Nos. 8,216,289 and 9,723,991 by making and selling their BF-RhodoLED product, an LED lamp used for treatment of actinic keratosis and other non-melanoma skin cancers. Both patents are directed to “photodynamic therapy” lamps and methods of using the same, which involve combining photosensitizer drugs with light sources in a way that targets only the cancer cells being treated, and not healthy cells. Willful infringement is alleged, based on statements in Biofrontera’s annual reports that identify DUSA as a direct competitor and indicate that Biofrontera regularly reviews “the current patent situation” and that Biofrontera is aware of the DUSA products covered by the two patents. Inducement and contributory infringement are claimed in addition to direct infringement. The two patents claim a priority date of May 1, 1998, putting them near the end of their lifespans; DUSA is nevertheless seeking injunctive relief in addition to damages.
Oomph Hair filed suit against Hair Illusions and its founder, Salvatore Passariello, accusing them of infringing Oomph’s trademark, cybersquatting, falsely disparaging Oomph products, and other forms of unfair competition, as well as seeking declaratory judgment that Hair Illusion’s “hairline enhancement” trademark application is invalid as merely descriptive. Hair Illusions is purported to control 90% of the real hair fiber market (real hair fiber is, as near as I can tell, small hair fibers, that are temporarily adhered to natural hair, making thinning hair look fuller). Oomph claims that Hair Illusions uses unfair and tortious means to maintain this market share, such as threatening Oomph and Oomph customers with patent lawsuits, despite having no patent to assert (Passariello had a pair of application undergoing prosecution at the time; they have since gone abandoned). Oomph also asserts that Hair Illusion registered domain names confusingly similar to Oomph’s registered HAIR FUSION trademark, which disparage Oomph’s product (e.g., alleging that the product contains parasites) and redirect customers to Hair Illusion’s on-line store. Oomph seeks preliminary and permanent injunctive relief, transferal of the offending domain names, and monetary damages. Oomph filed a motion for a preliminary injunction concurrently with the filing of the complaint. Judge Zobel scheduled a hearing on the motion for March 28.
Schneider Electric USA and Keysight Technologies were sued by Great Boston Authentication Solutions, LLC (“GBAS”). In separate filings, GBAS accuses the two of infringing U.S. Patent Nos. 5,982,892, 6,567,793 and 7,346,583, all directed to remote authorization for unlocking electronic data. GBAS asserts that license management and authentication software employed by the two infringe each patent. All of the patents, which are related as family members to one another, expired in December; accordingly, while damages are sought, there is no prayer for injunctive relief. These new cases appear to be a part of a concerted effort to assert the patents that began just after they expired; for example, three additional cases were filed in Massachusetts in February. The Schneider case is before Judge Casper, while the Keysight case has been assigned to Judge Talwani.