Konstantin M. Linnik, Ph.D.

Konstantin M. Linnik, Ph.D.

Konstantin works with biotechnology and pharmaceutical companies on various matters involving intellectual property, such as IP strategy, building and leveraging patent portfolios, competitive analysis, product design and development, licensing and negotiations, due diligence and IP audits, and patent enforcement and litigation. Konstantin serves as co-chair of the Massachusetts Biotechnology Council’s Legal & Regulatory committee and on the board of directors of Seeding Labs, a non-profit organization that provides lab equipment and resources to scientists in the developing world. Read more.

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5 Must-Ask IP Due Diligence Questions in Corporate Transactions

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 … Continue Reading

The Supreme Court Chooses Quantity over Quality – Supplying a Single Component of a Multicomponent Invention Does Not Constitute an Infringing Act

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 … Continue Reading

USPTO Provides Guidance to Examiners on Recent Federal Circuit Decisions Relating to Patent Eligibility of Software Claims

Over the past six years, the U.S. Supreme Court has issued a series of decisions—Bilski, Mayo, Myriad, and Alice—that have significantly impacted patent eligibility law, particularly in the areas of software and biotechnology. On November 2, 2016, the United States Patent and Trademark Office (USPTO) published a memorandum to patent examiners, discussing two recently-issued Federal … Continue Reading

USPTO Offers a Fast Track to Cancer Immunotherapy Patents

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 … Continue Reading

U.S. Patent Office Updates Subject Matter Eligibility Guidance, Including Life Science Examples

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 … Continue Reading

II Ca-Be-lly or Not II Ca-Be-lly: Is The Famous Cabilly II Antibody Patent Near Extinction?

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 … Continue Reading

Nutter attorneys author guest post “Who Owns Your Brain According to the Contract You Signed” on MassBioHQ blog

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. In the post, Konstantin Linnik, who serves as co-chair of the Legal & Regulatory Working Group at MassBio, and his co-author Isaac Hubner relay the … Continue Reading

Latest in the § 101 Saga: Sequenom Requests En Banc Rehearing, Indicating Biomedical Research Will Be Stymied Otherwise

Arguing that its invalidated diagnostic patent claims were “collateral damage in what is properly a war on frivolously broad claims directed to things like correlation tables and actual strands of human DNA,” on August 13, 2015, Sequenom petitioned the Federal Circuit for an en banc review of its June 12 holding in Ariosa Diagnostics, Inc. … Continue Reading

Update Your USPTO Filing Templates – There’s a New Commissioner

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 … Continue Reading

Federal Circuit Finds Sequenom’s Diagnostics Patent Claims Patent Ineligible Subject Matter Under Mayo

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 … Continue Reading

USPTO Issues Revised Guidelines Refining the Test for Patent Eligibility

On December 16, 2014, the United States Patent and Trademark Office (USPTO) published long-awaited guidelines intended to help examiners determine the patent eligibility of a wide range of inventions from isolated genetic materials to computer-implemented methods. The new guidelines revise those published by the office earlier this year (discussed here), which drew heated criticism from … Continue Reading

FDA Issues Draft Guidance on Regulatory Exclusivity for Biologics

On August 4, 2014, the US Food and Drug Administration (FDA) released Draft Guidance on determining eligibility of a biological drug for regulatory exclusivity. Under the Public Health Service Act (PHS Act), as amended in 2010, an abbreviated biosimilar application can be accepted by the FDA, but not until 4 years after the first licensure of … Continue Reading

Consumer Watchdog Puts a Leash on Appealing USPTO Decisions to Federal Court

Despite being dismissed by the Federal Circuit before reaching its highly anticipated substantive issues regarding patent eligibility, the ruling in Consumer Watchdog v. Wisconsin Alumni Research Foundation nonetheless significantly alters the patent litigation landscape. Consumer Watchdog (CW), a nonprofit waging a seven-year campaign to invalidate the Wisconsin Alumni Research Foundation (WARF) stem cell patent, saw its … Continue Reading

FDA Issues Draft Guidance on How to Demonstrate Biosimilarity

New draft guidance released by the FDA on May 13, 2014 will assist drug companies in determining whether a proposed therapeutic biological product is “biosimilar” to its reference product. “Biosimilarity” under Section 351(k) of the Public Health Service Act is defined as “highly similar to the reference product notwithstanding minor differences in clinically inactive components” with … Continue Reading

Supreme Court Unanimously Rules That “Gene Patents” Are Invalid

In a highly anticipated decision issued today in Association for Molecular Pathology v. Myriad Genetics, the Supreme Court unanimously ruled that isolated DNA sequences are not eligible for patent protection. The Court simultaneously held that cDNA can be patent eligible subject matter – as long as it is distinguishable from natural DNA. Justice Thomas, writing for the … Continue Reading

After the AIA – Strategies for Expediting Patent Filings

While the America Invents Act (AIA) brought many significant changes to the U.S. patent laws, there is arguably no more impactful change than the shift from a “first to invent” system to a “first inventor to file” system that occurred on March 16, 2013. This shift has significant effects on patent applications having an effective … Continue Reading

Federal Circuit Reaffirms (Again) Gene Patents in Myriad

On August 16, 2012, biotechnology patent owners breathed a short sigh of relief, as the US Court of Appeals for the Federal Circuit issued the highly anticipated decision in Association for Molecular Pathology v. Myriad Genetics, finding that DNA sequences are indeed eligible for patent protection. However, not all biotech innovators will be happy with the … Continue Reading

USPTO Issues Patentability Guidelines Under Mayo v. Prometheus

On July 5, 2012, the United States Patent and Trademark Office issued a memorandum to all patent examiners providing guidelines for examining process claims for patent eligibility in view of the Supreme Court decision Mayo v. Prometheus. Entitled “2012 Interim Procedure for Subject Matter Eligibility Analysis of Process Claims Involving Laws of Nature,” the much-anticipated guidance … Continue Reading

Supreme Court Remands Myriad for Reconsideration in Light of Mayo

Following close on the heels of last week’s controversial decision in Mayo Collaborative Services v. Prometheus Laboratories, the United States Supreme Court sent another hotly contested biotech case back down for further consideration by a lower federal court. In Association for Molecular Pathology v. Myriad Genetics, the Supreme Court granted certiorari to the parties in … Continue Reading

Supreme Court Holds Prometheus’ Diagnostic Method Claim Unpatentable

On March 20, 2012, the United States Supreme Court unanimously reversed the Federal Circuit in a long-awaited decision that may have broad-reaching effects on diagnostic method patents, as well as personalized medicine patents. At issue in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. ___ (2012) was whether the correlation between blood levels and … Continue Reading

FDA Issues “Biosimilars” Draft Guidelines

On February 9, 2012, the U.S. Food and Drug Administration (FDA) issued three draft guidance documents– the first since the Biologics Price Competition and Innovation Act passed in March 2010 – for the development of biosimilars. The biosimilars market is expected to reach $8 billion by 2020. The three guidance documents are: Scientific Considerations in … Continue Reading
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