Patent Infringement

News & Analysis as of

Post-Approval Quality Control Testing of Pharmaceutical Products: What Constitutes 35 U.S.C. § 271(g) Infringement or Falls Under...

The Federal Circuit recently affirmed that a generic pharmaceutical company’s use of post-approval quality control testing was not “making” under 35 U.S.C. § 271(g). See Momenta Pharmaceuticals, Inc. et al. v. Teva...more

Federal Circuit Review | November 2015

Federal Circuit Declines to Reverse Invalidity, Noninfringement Holdings - In Spectrum Pharmaceuticals, Inc. v. Sandoz Inc., Appeal No. 2014-1407, the Federal Circuit affirmed the district court’s grant of summary...more

Location of Accused Activity Informs Post-Approval Enforceability of “Quality-Control” Process Patents

On November 10, 2015, the United States Court of Appeals for the Federal Circuit issued its decision in two companion cases: Momenta Pharms. Inc. v. Teva Pharms. USA Inc. (14-CV-1274, 14-CV-1277) and Momenta Pharms. Inc. v....more

Court Report - November 2015 #5

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Merck Sharp & Dohme Corp. v. Savior Lifetec Corp. 5:15-cv-00415; filed August 21, 2015 in the Eastern District of North...more

District Court Denies TRO and Preliminary Injunction Where Speculation on Future Harm Did Not Show Likely Irreparable Harm

Plaintiff SATA GmbH & Co. KG ("Plaintiff") sought an ex parte Motion for Temporary Restraining Order and a Motion for Preliminary Injunction. Plaintiff alleged that Defendants Zhejiang Refine Wufu Air Tools Co., Ltd. ("Wufu")...more

Get It in Writing: Even Arguments Prompted by PTAB Questions Must Be in the Briefings

The Patent Trial and Appeal Board (PTAB) continues to strictly enforce its rule that "parties are not permitted to raise new arguments at oral hearing," including in situations where the "new" arguments are provided as a...more

ITC Section 337 Update – November 2015

Federal Circuit Panel Rules Commission Lacks Jurisdiction Over Digital Transmissions – On November 10, 2015, the Federal Circuit issued a 2-1 panel opinion in ClearCorrect Operating LLC v. ITC, Appeal No. 2014-1527, reversing...more

Federal Circuit Interprets Two Important Infringement Provisions

In a single decision issued for companion cases Momenta Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA Inc. and Momenta Pharmaceuticals, Inc. v Amphastar Pharmaceuticals, Inc., the Federal Circuit interpreted two important...more

Claim Construction Ruling Issues In Coffee Brewing Technology Dispute

Robinson, J. Claim construction opinion regarding fifteen terms from three patents. The following terms were considered: - 1. “Brewing reservoir”...more

Federal Circuit Affirms Invalidity of Method Species Claims Over Prior Art Genus

On November 10, 2015, the Federal Circuit issued its opinion in Prometheus Laboratories, Inc. v. Roxane Laboratories, Inc. et al., No. 14-1634, -1635, slip op. (Fed. Cir. Nov. 10, 2015) affirming the district court’s decision...more

Amgen Uses Agreement to Litigate Patents Under the BPCIA to Rebuff Sham Litigation Claims

Last month, in a case under the Biologics Price Competition and Innovation Act of 2009 (BPCIA) involving Apotex’s proposed biosimilar of Amgen’s Neulasta (pegfilgrastim), Apotex accused Amgen of sham litigation for bringing a...more

District Court Administratively Terminates Motion to Dismiss Because of Pending Inter Partes Reviews ("IPRs")

In this patent infringement action, Watson Laboratories, Inc.'s ("Watson") moved to dismiss several counts of the complaint filed by Jazz Pharmaceuticals, Inc. and Jazz Pharmaceuticals Ireland Limited (collectively, "Jazz")....more

Contention Discovery Requests in Texas: Punting in the First Quarter Could Lead to Disaster in the Fourth

It happens every day: one litigant serves discovery requests on another, asking the latter to “identify every fact” or “explain every basis” for the party’s legal contentions in a lawsuit. Usually, the response is standard:...more

ClearCorrect Ruling Keeps ITC From Policing 3D Printing and Other Digital Data Transmission

3D printing has been a common topic of discussion of the blog. We’ve written about it and in a more in-depth review of the legal issues raised by the emergence of 3D printing in the medical device industry in our September...more

5 tips for cutting patent litigation costs

Ever since the U.S. Supreme Court’s Alice Corp. v. CLS Bank decision, the number of patent litigation cases, which for years leading up to that case had been on the increase, have been on the decline. Projections are that the...more

Methods of treating a subset of patients are likely nonobvious if the subset exhibits unexpected results

In Prometheus Laboratories, Inc. v. Roxane Laboratories, Inc., a recent decision involving methods of treating a specific subset of patients, the Court of Appeals for the Federal Circuit (“Federal Circuit”) ruled that,...more

Summary Judgment Decisions Issue In Dispute Involving 10 Patents

Robinson, J. Defendants’ motion for summary judgment of non-infringement of 2 patents is denied and granted in part as to five patents. Defendants’ motion for summary judgment of invalidity of two patents is denied and...more

ITC Has No Jurisdiction to Block Infringing “Electronic Transmissions”

On November 10, a panel of the Federal Circuit reversed a landmark ITC decision blocking the importation of digital information that infringes a patent. This decision has potential ramifications for a wide-range of companies...more

Intellectual Property Update: Distributing patent rights between affiliates: guidelines to support enforcement rights around the...

Picture the scenario – your company creates a new affiliate in Ireland to sell and distribute a product. The parent company holds the legal title to the patents associated with the product. Parent grants the Irish affiliate a...more

Why Business Methods Are Difficult to Patent

Although the general rule (based on 35 USC section 101) is that anything made by humans is patentable, there are exceptions. Laws of nature, physical phenomena, and abstract ideas are not patentable. Inventions that fall in...more

Aylus v. Apple: Apple Moves to Strike Supplemental Expert Report Served After Expert Deposition and at the End of the Expert...

After Aylus timely served the report of its technical expert, Daniel Schonfeld, and Apple deposed the expert, Aylus served a "First Supplemental Expert Report of Dan Schonfeld" at the end of the expert discovery period. Apple...more

Court Report - November 2015 #4

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Vivus, Inc. v. Actavis Laboratories FL, Inc. 2:15-cv-06256; filed August 17, 2015 in the District Court of New...more

Certificate of Correction to Correct Information Not Available When Patent Issued

Cubist Pharmaceuticals, Inc. v. Hospira, [2015-1197, 2015-1204, 2015-1259] (November 12, 2015), the Federal Circuit approved the use of a Certificate of Correction to correct information not available at the time the...more

Don’t Bury the Lede: Failure to Explicitly List Prior Art Witnesses Can Preclude Them from Testifying

Order Striking Witnesses from Supplemental Initial Disclosures, Finjan, Inc. v. Proofpoint, Inc. et al., Case No. 3:13-cv-05808-HSG (HRL) (Magistrate Judge Howard Lloyd) - How much disclosure is sufficient when you want...more

Patent Infringement Safe Harbor and Importation Redefined: Ruling Incentivizes Generic Pharmaceutical Offshore Product Testing

A recent ruling by the U.S. Court of Appeals for the Federal Circuit has provided an apparent loophole for manufacturers to avoid infringement liability for conducting patented manufacturing quality control steps offshore. On...more

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