Intellectual Property

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The Federal Circuit’s decision in Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. Ltd., has garnered significant attention, especially concerning the application of the “safe harbor” provision under 35 U.S.C. § 271(e)(1). The Federal Circuit’s ruling, and the subsequent denial of Edwards’s petition for rehearing en banc, underscores the breadth of the safe harbor, putting to bed the question of whether “solely” means “only” in the context of the safe harbor.

An American Arbitration Association arbitrator recently awarded Black Knight, Inc. (BK) $155M stemming from Pennymac Loan Services, LLC’s (Pennymac) alleged use of its mortgage-loan servicing platform to develop its own competing product. Though the arbitrator did not find Pennymac liable for trade secret misappropriation, they found that the use of BK’s product accelerated the development of Pennymac’s product and caused BK to lose licensing profits.

We previously discussed the United States Supreme Court’s June 2023 Jack Daniel’s Properties, Inc. v. VIP Products, LLC decision, which altered the way the “Rogers test,” a doctrine designed to protect First Amendment interests in the trademark context, should be applied. A recent decision out of the Ninth Circuit, Punchbowl, Inc. vs. AJ Press LLC (“Punchbowl II”), applies the Rogers test for the first time following Jack Daniel’s.

Litigators in the life sciences field are no doubt familiar with the so-called “artificial” act of infringement established by 35 U.S.C. § 271(e)(2)(A)-(B): namely, that a party can be sued for patent infringement by merely filing an Abbreviated New Drug Application (“ANDA”) for a generic drug or a Biologics License Application (“BLA”) for a biosimilar drug. The filing of such an action can allow for, among other things, the resolution of patent infringement disputes before the generic (or biosimilar) drug enters the market. 

Recently, in Purdue Pharma L.P. v. Collegium Pharmaceutical, Inc., the Federal Circuit held for the first time that the Patent Trial and Appeal Board (“the Board”) has the authority to issue a Final Written Decision even after the statutory deadline has passed.

Congress introduced post grant review (“PGR”) and inter partes review (“IPR”) in 2011 as part of the America Invents Act (AIA). Parties can use these processes to ask the Board to review the patentability of a patent’s claims. Under the AIA, the Board must provide a Final Written Decision within one year of instituting the PGR or IPR; this can be extended for good cause for an additional six months.

Judge Jeffrey White of the Northern District of California recently dismissed toy manufacturer Tangle’s copyright and trade dress suit against fashion retailer Aritzia. The suit was brought over Aritzia’s use of sculptures resembling Tangle’s toys in its window displays. Judge White’s decision serves as a reminder that copyright protection only extends to works that have been “fixed” in a tangible medium of expression; an artist’s “[s]tyle, no matter how creative, is an idea, and is not protectable by copyright.” Tangle Inc. v. Aritzia, Inc.

In an unprecedented PTAB decision involving Spectrum Solutions LLC (“Spectrum”) (Petitioner) and Longhorn Vaccines & Diagnostics (“Longhorn”) (Patent Owner), the Board found all five challenged patents invalid and imposed sanction against patent owner Longhorn for failure to meet the duty of candor and fair dealing. The board determined that Longhorn selectively disclosed testing results to support its claim construction and misled its technical expert with incomplete laboratory data, thereby failed to meet its duty of candor and fair dealing in its actions before the Board. The claims and substitute claims in all five patents asserted by Longhorn were unpatentable due to its sanctionable misconduct. Longhorn was also ordered to provide Spectrum compensatory expenses including attorney fees. On one hand, it is a reminder that duty of candor is a continuing obligation that cannot be ignored even during the IPR proceeding.  On the other hand, it does raise the question whether the PTAB has the authority to invalidate a patent for misconduct. 

With Hollywood celebrities speaking out both in favor of and against the use of drugs like Ozempic and Wegovy for weight loss, it was only a matter of time before demand outpaced supply. Although most might believe that increased demand is a good problem to have, a recent case involving Ozempic shows that pharmaceutical companies with popular drugs might face increased competition, without the ability to obtain legal remedies against their competitors.