Posts in Business

Curing the Drug Label as Prior Art Malady at the PTAB

Petitioners challenging patents covering pharmaceuticals and biologics often use drug product labels as prior art in the Patent Trial and Appeal Board (PTAB). To effectively use a label as prior art, a petitioner must show that it is a “printed publication” under 35 U.S.C. §§ 102 and 311(b). Past PTAB cases demonstrate, however, that proving drug product labels as prior art can be fraught with danger. But practitioners can employ best practices to guard against this. In Celltrion, Inc. v. Biogen, Inc., IPR2016-01614, Paper 65 (Feb. 21, 2018), the Petitioners relied on a copyrighted label for Rituxan that was published on the internet and available on the Food and Drug Administration’s (FDA’s) and on Biogen’s website all before the critical date. The Board held that the Petitioners did not provide sufficient evidence establishing that the drug label was indeed the one disseminated with Rituxan at the time it was proposed to be publicly available or that “persons interested and ordinarily skilled in the subject matter or art exercising reasonable diligence, can locate it.” Similarly, the Board held in Mylan Pharmaceuticals Inc. v. Boehringer Ingelheim International GMBH, IPR2016-01563, Paper 16 (Feb. 3, 2017), that a relied-upon Glucophage label had no source identifying information or indicia of when it became publicly available and the declaration attesting to its publication was not based on personal knowledge, but was merely conclusory.

Amazon Primed to Disrupt Legal Field with Launch of IP Accelerator Program

E-commerce giant Amazon is “known for its disruption of well-established industries,” as the company’s Wikipedia entry will tell you. What started out as a humble online bookstore has become one of the world’s premier e-commerce sites. Along the way, it has expanded into cloud computing, consumer electronics, and film production, among other diverse ventures. It is responsible for the U.S. Post Office delivering packages on Sundays, and recently sent countless states and municipalities into a frenzy over a competition to host the company’s second headquarter site. Now, Amazon seems primed to disrupt the market for IP legal services with the launch of its IP Accelerator.

This Week in Washington IP: Antitrust Regulators Discuss Online Platforms, NASA’s Moon-Mars Program and Reauthorizing Compulsory Satellite Copyright Licenses

This week in tech and innovation hearings in Washington, D.C., the U.S. House of Representatives gets underway on Wednesday by exploring rulemaking at the Environmental Protection Agency (EPA), regulating online platforms through antitrust law, preparing the medical workforce for innovation and checking the progress of NASA’s plans to put American astronauts on the Moon and Mars. Later in the week, House committees focus on innovation in water and geothermal energy as well as the impact of big tech on small businesses across America. Over in the Senate, the Senate Environment Committee holds a hearing to look at expanding commercial nuclear power and the Senate Commerce Committee will mark up various pieces of legislation, including one bill that would reauthorize compulsory licenses for satellite broadcasts under STELAR despite Copyright Office opposition to such reauthorization. Elsewhere in D.C., The Brookings Institution holds an event today to discuss potential biases that can develop through the use of algorithms in AI technologies.

Rules on Copyright Infringement for Inline Linking Developing in the United States and Abroad

As the relationship between copyright and the internet continues to develop and technical distinctions are increasingly cast aside for more practical perspectives, new licensing opportunities are becoming available for content owners and creators. Two recent developments concerning online service providers’ use of so-called “inline linking” and those providers’ potential liability for publicly displaying unlicensed content from third-party websites open the way for this new vein of potential income.Inline linking occurs when a service provider “embeds” on the provider’s website content that is hosted at another location or “destination URL” on the internet. This is achieved using HTML coding, which retrieves content from the destination URL and shows that content to visitors on the service provider’s site. The inline link in the code of the service provider’s website thus constitutes a sort of window or “frame” to content maintained at another location on the internet. This is in contrast to the use of a standard text hyperlink, which, after a click, simply directs users to a destination without showing the content hosted there. A new European Union copyright law and recent decisions from the Southern District of New York and the Northern District of California suggest that what was once thought to be non-infringing inline linking may now require service providers to obtain licenses or face claims of infringement.

IP Lessons Learned from WeWork: A Unicorn in Pursuit of Technology

In an article we published on this blog in November 2015, we documented the findings of a study of Unicorns (startups with valuations of over $1 billion) and their patent holdings. In that study, we discovered that over 60% of Unicorns held immaterial patent portfolios (10 assets or less). We have subsequently concluded that these Unicorns are likely to fill the gap in their patent holdings through organic filing and patent acquisitions, as they approach an exit event or as they enter a major new market. Fast forward to October 2019, and WeWork, a member of our Unicorn “Class of 2015”, has been in the news under very unpleasant circumstances. The WeWork planned IPO was called off in October 2019, after questions emerged related to, among other things, the viability of the company’s business model following financial and operating disclosures included in its S-1 filing with the SEC. This led to a series of events where, eventually, SoftBank acquired a controlling interest in the company at a valuation of $8 billion, a fraction of its most recent valuation of $47 billion, while in the process removing Adam Neumann, the company’s co-founder and CEO, and buying out his shares.

Other Barks & Bites, Friday, November 8: SCOTUS Hears Allen v. Cooper Copyright Case, U.S. Government Sues Gilead, Amici Submit Briefs to CAFC in Chrimar

This week in Other Barks & Bites: the Trump Administration sues Gilead for infringement over HIVE PrEP treatment patents; Senators Inhofe and Wicker ask President Trump to show no leniency on Chinese IP theft; the Supreme Court hears the Allen v. Cooper copyright appeal; the Federal Circuit issues precedential opinions on PTAB evidence admissibility and limitation in patent claim preamble; the Copyright Office says that its digital recordation pilot project is on track for Spring 2020; the PTAB Precedential Opinion Panel (POP) will review the Board’s rejection of substitute patent claims in a motion to amend; “This Is Spinal Tap” creators settle copyright suit; and T-Mobile announces December launch for nationwide 5G network.