- Posts by Konstantin M. LinnikPartner
Konstantin Linnik is a partner in Nutter’s Intellectual Property Department. He works with biotechnology and pharmaceutical companies on various matters involving intellectual property, such as IP strategy, building and ...
When would a company undergo intellectual property due diligence?
Konstantin Linnik: Any corporate transaction involving IP assets necessitates diligence: merger, acquisition, IPO, investment (such as a venture capital financing), in-license, partnering, co-development, or distribution agreements. The buyer who is evaluating the Target could be a licensee, business partner, investor, banker, or underwriter. IP due diligence analyzes patent issues, trade secrets, trademarks, copyrights, freedom to operate, IP litigation, licensing, reps, warranties, disclosures, and even employment agreements. The process will examine the Target’s IP, such as how well the existing and potential IP protects the Target, what projected revenues will be based on the exclusivity period and geographic scope, and the current and projected expenses, including prosecution, maintenance, royalties, and enforcement. Because the diligence is expensive and is typically charged off as the overall transactional cost, the diligence is conducted as close to pre-closing as possible.
On February 22, 2017, the U.S. Supreme Court addressed the issue of whether the supply of a single component of a multicomponent invention qualifies as an infringing act under 35 USC §271(f)(1) of the U.S. Patent Act. In its decision in Life Technologies Corp. v. Promega Corp., the Court found that “a single component does not constitute a substantial portion of the components that can give rise to liability under §271(f)(1).” In doing so, the Court overturned the Federal Circuit’s prior holding that a single component could be sufficiently important to the invention to meet the criteria for being a “substantial portion.”
As discussed in the latest memorandum, the Federal Circuit in McRO held that the claims at issue are patent eligible under 35 USC § 101 because they are not directed to an abstract idea under the first prong of the two-part Alice test. Under Alice, all claims having an abstract idea are analyzed in two steps:
The United States Patent Office (USPTO) is implementing a new program that provides prioritized examination of patent applications relating to cancer immunotherapy (Cancer Immunotherapy Pilot Program or Program). The new patent examination program, which will run June 29, 2016-2017, reinforces the White House’s $1 billion “National Cancer Moonshot” initiative and follows on the heels of recent significant advances in cancer treatment with a new class of drugs known as immune check point inhibitors, such as Keytruda® and Opdivo®.
In view of the U.S. Supreme Court’s decisions in Alice, Myriad, and Mayo, the United States Patent and Trademark Office (USPTO) has issued a series of guidance documents on patent subject matter eligibility under 35 U.S.C. § 101. These documents are collected on the Subject Matter Eligibility page of the USPTO website. The USPTO’s “May 2016 Subject Matter Eligibility Update” (88 Fed. Reg. 27381), announced the newest in this series of guidance, including new life science examples, a memorandum to the patent examining corps with instructions on formulating subject matter eligibility rejections, an index of eligibility examples, and an appendix of subject matter eligibility court decisions.
Foreign filing licenses do not typically require much attention in daily practice since the license is routinely applied for and granted as a matter of course in new application filings. However, in certain situations ignoring the license may cause severe damage. 35 U.S.C. § 184 states that a person shall not file or cause or authorize to be filed a patent application (among other things) in any foreign country unless six months have passed since the United States application was filed unless otherwise authorized by a license obtained from the Commissioner of Patents, i.e., unless a foreign filing license is received from the United States Patent and Trademark Office (USPTO). A purpose for this rule is that it allows the U.S. government to protect national security by approving or disapproving the export of sensitive technologies, such as technology associated with warfare, nuclear, or security-related measures.
On February 5, 2016, the Patent Trial and Appeal Board (PTAB) issued a decision to institute an Inter Partes Review (IPR) of Genentech’s “Cabilly II” patent (U.S. Patent No. 6,331,415). This triggered the one-month deadline for third parties to request joinder under 37 CFR § 42.122(b). Whether you are a licensee, or otherwise have a stake in the outcome of the Cabilly II, it may be prudent to consider your options before the March 5, 2016 deadline.
The blog post discusses how legal provisions, such as a simple confidentiality agreement, a consulting agreement or a multi-billion dollar license, are often a source of misunderstanding, confusion and frustration.
On July 30, 2015, Drew Hirshfeld was appointed to the position of Commissioner for Patents for the United States Patent and Trademark Office (USPTO). Mr. Hirshfeld reports directly to Michelle Lee, the Director of the USPTO, and according to the USPTO website, he “is responsible for managing and directing all aspects of this organization which affect administration of patent operations, examination policy, patent quality management, international patent cooperation, resources and planning, and budget administration.”
In Ariosa Diagnostics, Inc., et al. v. Sequenom, Inc. et al., Nos. 2014-1139 and 2014-1144 (Fed. Cir. June 12, 2015), the Federal Circuit affirmed a district court’s finding on summary judgment that certain method claims of Sequenom’s U.S. Patent No. 6,258,540 (the ’540 patent) are invalid as being directed to patent ineligible subject matter under 35 U.S.C. § 101, finding that using conventional methods of detecting a naturally occurring phenomenon did not transform the natural phenomenon into a patentable invention. Judge Reyna wrote the opinion for the panel which included Judges Linn and Wallach. Judge Linn concurred.
Maximizing the protection and value of intellectual property assets is often the cornerstone of a business's success and even survival. In this blog, Nutter's Intellectual Property attorneys provide news updates and practical tips in patent portfolio development, IP litigation, trademarks, copyrights, trade secrets and licensing.