Intellectual Property

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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. 

In order to prepare and prosecute utility, design, and plant patent matters in front of the United States Patent and Trademark Office (“USPTO” or “Office”), the USPTO requires practitioners to demonstrate possession of the legal, scientific, and technical qualifications necessary to render valuable service to clients. See 37 CFR 11.7(a)(2)(ii).

Cell therapy products in the U.S. are estimated to be worth approximately $4.5 billion currently and expected to grow to over $30 billion in the next ten years. As market value increases litigation is bound to heat up.

Recently, Fate Therapeutics and the Whitehead Institute sued Shoreline Biosciences in the Southern District of California for allegedly infringing six patents directed to composition and methods relating to induced pluripotent stem cells (iPSCs) directly under 35 U.S.C. §§ 271(a) and (g), and for inducing infringement. Fate’s infringement theories included both literal infringement and infringement under the Doctrine of Equivalents. The court granted summary judgment of noninfringement to Shoreline for all asserted claims.

The Court of Appeals for the Federal Circuit recently addressed the issue of “analogous prior art,” a patent law doctrine fundamental to the legal determination of whether a patent is invalid as obvious over the prior art. The decision illustrates the importance of carefully considering whether asserted prior art is analogous to the challenged patent, as the use of non-analogous art can result in dismissal of any obviousness argument based on that art.

Generative AI has taken the world by storm since OpenAI launched ChatGPT in November 2022. But the buzz and excitement of GAI has come with difficult legal questions that threaten the new technology. Several lawsuits—some of which we have discussed in detail—have been filed against companies whose GAI products have been trained on copyrighted materials. Up until now, we have only been able to speculate how courts will handle GAI as the industry has held its collective breath.