Intellectual Property Science, Computers & Technology

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Amgen and Allergan Report Progress in Herceptin® Biosimilar Clinical Trial

In the late 1980's, Dennis Slamon discovered a new oncogene, Her2/neu,that was amplified in 25-33% of human beast cancers. Slamon et al., "Studies of the HER2/neu ProtoOncogene in Human Breast and Ovarian Cancer," Science...more

Supreme Court Reinvigorates Effectiveness of Obtaining an Opinion of Counsel to Defend against Potential Enhanced Damages for...

On June 13, 2016, the U.S. Supreme Court again reversed a decision of the Federal Circuit—the Circuit specially designated to hear all patent appeals—this time, in articulating the test for determining whether to award...more

Software Inventions See More Help in Bascom Decision

Since the Supreme Court decided Alice Corp. v. CLS Bank International, patent examiners and the courts have been working to better define patent eligibility. Following closely on the heels of their Enfish, LLC, v. Microsoft...more

En Banc CAFC Requires UCC Sale For On Sale Bar

In an en banc decision issued in The Medicines Company v. Hospira, Inc., the Federal Circuit determined that in order for a commercial transaction to trigger the on-sale bar of § 35 USC 102(b), it must “bear the general...more

Can FDA Implement The BPCIA As The CAFC Suggested?

In Amgen v. Apotex, the Federal Circuit held that under the Biologics Price Competition and Innovation Act (“BPCIA”), “an applicant must provide a reference product sponsor with 180 days’ post-licensure notice before...more

Federal Circuit Confirms Post-Licensure Notice of Commercial Marketing Is Mandatory in Biosimilar Litigation

On July 5, 2016, a unanimous Federal Circuit panel held that Apotex failed to give Amgen proper notice of commercial marketing required by the Biologics Price Competition and Innovation Act (“BPCIA” or “Biologics Act”) and...more

BioPharma Patents Quick Tips & News – July 2016

U.S. FDA Orange Book Refresher Edition - What types of patents can be listed on the FDA’s Orange Book? Listable = Pharmaceutical-related patents are allowed in the FDA’s Orange Book only if they’re “composition” or...more

Federal Circuit Patent Updates - July 2016 #2

WBIP, LLC v. Kohler Co. (No. 2015-1038, -1044, 7/19/16) (Moore, O'Malley, Chen) - Moore, J. Affirming denial of JMOL that patent was invalid as obvious and lacked an adequate written description, affirming finding of...more

Subsequent Employment Agreement Assigning Inventor's Intellectual Property Rights Does not Defeat Standing for Inventions Created...

The plaintiff, Odyssey Wireless ("Odyssey") filed four separate actions for patent infringement against Defendants Apple, Samsung, LG, and Motorola, alleging infringement of U.S. Patent Nos. 7,881,393; 8,199,837; 8,576,940;...more

HP Inc. v. Big Baboon, Inc. (PTAB 2016) - Business Method Patent Not Invalid under 35 U.S.C. § 101

HP Inc. and SAP America, Inc. filed a Petition seeking a covered business method (CBM) patent review of claims 15 and 20–34 of U.S. Patent No. 6,343,275 owned by Big Baboon, Inc. The PTAB, however, determined that the...more

2016 Chemical Data Reporting – New TSCA Requirements Apply for Confidential Business Information Claims

On June 22, 2016, President Obama signed into law the Frank R. Lautenberg Chemical Safety for the 21st Century Act (the Act). Passed with significant bipartisan support, the Act is the first major update to a federal...more

USPTO Joins Cancer Moonshot Effort, Expedites Immunotherapy Patent Applications

On January 12, 2016, President Obama announced a "National Cancer Moonshot" in his State of the Union Address. The Moonshot aims to achieve ten years of progress in cancer research within the next five years. The U.S. Patent...more

Federal Circuit: A Biosimilar Applicant Must Provide Notice of Intent to Market a Biosimilar Product, No Exceptions

On July 5, 2016, in Amgen v. Apotex (No. 2016-1308), the Federal Circuit again held that a biosimilar applicant must provide its biologic competitor with 180 days’ notice of intent to commercially market a biosimilar product....more

When Stealing in Baseball Can Land You in Jail: Computer Fraud Sentencing Announced in MLB Case

Although stealing bases, and even signs, in baseball may be part of the game, stealing another team’s trade secrets can land you in federal prison, as one executive recently learned the hard way. As we previously...more

Federal Circuit’s Application of Mayo Revives Biotech Patent

In Rapid Litig. Mgmt. Ltd v. CellzDirect, Inc., the Federal Circuit reversed a ruling of patent invalidity under Section 101, reviving a biotech patent to a method of preserving hepatocytes, liver cells, for medical use. The...more

Revenge of the Present Invention

Patentees suing alleged infringers have learned from a long history of federal district court and Federal Circuit rulings that (paraphrasing the Miranda warning given to criminal suspects) “anything you say [in the patent or...more

USPTO Implements Pilot Program to Support President's National Cancer Moonshot

Last month, the U.S. Patent and Trademark Office published a notice in the Federal Register (81 Fed. Reg. 42328) regarding the implementation of a new pilot program that will provide for earlier review of patent applications...more

PTO Provides Additional Guidance on Patent Eligibility of Life-Sciences Method Claims

On July 14, 2016, the PTO sent a memorandum to the examining corps regarding the recent rulings in Rapid Litigation Management Ltd. v. Cellzdirect, Inc., Appeal No. 2015-1570 (Fed. Cir. July 5, 2016), and Ariosa Diagnostics,...more

Amgen v. Apotex: District Court Decides that the ’138 Patent is Not Invalid on Some Grounds; Enablement is Still an Open Issue

As we previously reported, on July 5, the Federal Circuit affirmed the district court’s grant of a preliminary injunction enjoining Apotex from launching its biosimilar version of Amgen’s Neulasta (pegfilgrastim) until it...more

Brexit May Stall Implementation of EU’s New Unitary Patent and Patent Court Systems

New unified patent grant and patent court systems, which were to have taken effect in early 2017, will likely be stalled because of Britain’s June vote to leave the EU, commentators and member nations fear. BACKGROUND...more

Where’s My %$^&# Dollar?

The issue of consideration in an assignment is always in the background, but only occasionally comes up. In Memorylink Corp. v. Motorola Solutions, Inc., 773 F.3d 1266, 113 USPQ2d 1088 (Fed. Cir. 2014), the Federal Circuit...more

Packing Your Patent Application for Europe: Avoiding Problems Under European Patent Law

Planning an extended European vacation for your patent application? A lengthy stay in Munich with possible outings to The Hague, Berlin, Vienna, or Brussels? While your patent application won’t be strolling through the...more

FDA Issues Complete Response Letter for Sandoz’s Neulasta® Biosimilar

As we’ve previously reported, Sandoz is seeking approval of an aBLA for its proposed biosimilar to Neulasta® (pegfilgrastim), which is currently the subject of a BPCIA litigation (Civil Action No. 3:16-cv-02581 (N.D. Cal.)) ...more

Security Interest v. License Agreement: Low Tech Precautions for the High Tech Investment

In this exciting age of startups, the market is brimming with opportunities for individuals and entities alike to invest in emerging companies. Today’s rapid rate of technology development justifies investors’ eagerness to...more

Sale of Manufacturing Services Does Not Trigger On Sale Bar Under Pre-AIA §102

In The Medicines Company v. Hospira, Inc., [2014-1469, 2014,1504] (July 11, 2016), the en banc Federal Circuit reversed a panel decision finding that U.S. Patent Nos. 7,582,727 and 7,598,343 were invalid under the on-sale bar...more

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