Isaac A. Hubner, Ph.D.

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Continuation Patent Applications: 10 Reasons You Should Consider Filing

If you’ve filed for patents in any industry – be it biotech, high tech, manufacturing, or another sector altogether – you’ve likely been faced with a decision on whether to file a “continuation” application at the US Patent and Trademark Office (USPTO). In simple terms, a “continuation” application is a new patent application allowing one … Continue Reading

Zircore v. Straumann: A Method of Manufacturing a Physical Object Is Not an Abstract Idea

In Zircore, LLC v. Straumann Manufacturing, Inc. (E.D. Tex. 2017), as in many patent litigations since Mayo, Myriad, and Alice, the defendant moved to dismiss the infringement allegations contending that the patents in suit are ineligible subject matter under 35 USC § 101. Here, despite Straumann’s assertion that Zircore’s U.S. Patent No. 7,967,606 was invalid … Continue Reading

U.S. Commerce Department Releases Updated Report Showing Intellectual Property-Intensive Industries Contribute $6.6 Trillion and 45.5 Million Jobs to U.S. Economy

The U.S. Commerce Department recently released a comprehensive report, entitled “Intellectual Property and the U.S. Economy: 2016 Update” (the “Report”). The Report, which was co-authored by the Economics & Statistics Administration and the United States Patent and Trademark Office, builds upon an earlier 2012 report, finding that “IP-intensive industries continue to be a major, integral … 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

Recognicorp v. Nintendo: Invalidating software claims under 35 U.S.C. § 101

The U.S. District Court for the Western District of Washington held, in Recognicorp, LLC v. Nintendo Co. Ltd., et al, that claims to certain methods and systems for encoding/decoding image data are not patent-eligible under 35 U.S.C. § 101. Recognicorp is an illustrative example of the use of preliminary motion practice to dispose of patent … 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

Method Claims of a Medical Device-Based Patent Found Invalid under Section 101 in Further Erosion of Patent Rights

On August 28 and September 15, 2015, certain asserted claims of Exergen’s United States Patent No. 7,787,938 (the “‘938 patent”) were found invalid under 35 U.S.C. § 101 on two separate summary judgment motions. See Exergen Corp. v. Brooklands Inc. (“Brooklands”), No. 12-cv-12243-DPW (August 28, 2015) and Exergen Corp. v. Thermomedics, Inc. (“Thermomedics”), No. 13-cv-11243-DJC (September … Continue Reading

Kimble v. Marvel Enterprises, Inc. – A Reminder to Think Carefully and Broadly when Drafting Patent Licenses

Summary: In Kimble v. Marvel Enterprises, Inc. 576 U.S. __ (2015), the Supreme Court relied on stare decisis, declining to overrule its 1964 Brulotte v. Thys Co. decision and holding that a patent owner cannot charge royalties for the use of an invention after the patent expires. Justice Kagan’s June 22, 2015 opinion affirmed the … 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

Revisions to the AIA Technical Corrections Act Affecting Patent Term Adjustment Published by the U.S. Patent Office on May 15, 2014

On May 15, 2014, the U.S. Patent and Trademark Office (USPTO) published rules to implement the patent term adjustment (PTA) provisions of the Leahy-Smith America Invents Act (AIA) and the AIA Technical Corrections Act, the latter of which was summarized in the January 2013 issue of the Nutter IP Bulletin. Under the new rules, the fourteen … Continue Reading

Patentees Bear the Burden of Proving Infringement in Declaratory Judgment Actions

In the recent case of Medtronic v. Mirowski, the Supreme Court held that “when a licensee seeks a declaratory judgment against a patentee to establish that there is no infringement, the burden of proving infringement remains with the patentee.” This decision extends the Court’s MedImmune ruling, which allows licensees to challenge the validity and/or infringement of … Continue Reading
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