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No Infringement For Generic Version of Pepcid Complete
March 3, 2019
The Federal Circuit Court ruled that a generic version of Pepcid Complete heartburn medication doesn’t infringe the Pepcid patent and a jury wrongly awarded $10 million.
Brigham & Women’s Hospital Inc. owns the Pepcid Complete patent, U.S. Patent No. 5,229,137, which covers a method for treating heartburn by administering both H2 blockers and antacids. Perrigo Co. notified Brigham that its abbreviated new drug application (ANDA) submission to market a generic version of Pepcid Complete.
Brigham sued Perrigo Co.
for patent infringement.
The District Court of Massachusetts interpreted the phrase “immediate and sustained relief” in the patent to require heartburn relief “within about 5-10 minutes following ingestion of the active ingredients.” A jury awarded Brigham $10 million for infringement. The district court judge later vacated the jury award, finding that Perrigo didn’t infringe because Pepcid Complete didn’t provide “immediate relief” after all. The Federal Circuit affirmed the judge’s ruling for Perrigo, saying that Pepcid Complete provided “adequate relief” of heartburn not "immediate relief."
The District Court of Massachusetts interpreted the phrase “immediate and sustained relief” in the patent to require heartburn relief “within about 5-10 minutes following ingestion of the active ingredients.” A jury awarded Brigham $10 million for infringement. The district court judge later vacated the jury award, finding that Perrigo didn’t infringe because Pepcid Complete didn’t provide “immediate relief” after all. The Federal Circuit affirmed the judge’s ruling for Perrigo, saying that Pepcid Complete provided “adequate relief” of heartburn not "immediate relief."
Promoting Drug Market Competition
March 3, 2019
Lawmakers introduce a bill called the CREATES Act (S. 340) to stop big pharmaceutical companies from preventing the entrance of cheaper generic drugs into the market.
Lawmakers introduce a bill called the CREATES Act (S. 340) to stop big pharmaceutical companies from preventing the entrance of cheaper generic drugs into the market.
The bill would facilitate generic companies’ lawsuit against the pharmaceutical companies for blocking access to the samples needed to make copies of the patented drugs.
The bill also seeks to end brand-name companies’ tactics to pay generic drug makers not to make low-cost copies of their products.
The bill also seeks to end brand-name companies’ tactics to pay generic drug makers not to make low-cost copies of their products.
Patent Drug Transparency Scrutinized by Senate
March 6, 2019
A group of bi-partisan Senator Susan Collins plan to unveil today a
bill
requiring drug makers to disclose the patents they hold. The legislation is meant to shine a light on “patent thickets,” when drug makers get numerous patents around a single product to make it harder for other companies to create low-cost generic versions. The proposal wouldn’t change the patent system or forbid the practice in any way, but would create a searchable database of drug patents.
Advocates for changing the patent system say such a change would be a small but important step to enhance transparency of biologic patents. Patent law is increasingly becoming central to the discussion around drug pricing in Congress.
Companies including AbbVie Inc. have come under scrutiny for their patent strategies. That company has more than 100 patents around its best-selling drug Humira, a treatment for inflammatory diseases such as rheumatoid arthritis and psoriasis.
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