Patent Infringement Litigation

To What Extent Does 30 Months Approximate the Time Typically Required for FDA Review of a Generic s AND A or for Resolution of the Contemplated Patent Infringement Litigation ... 

Even without an additional 30-month stay, later-listed patents still receive the usual protections of patent infringement litigation. The brand-name company may sue for patent infringement with respect to any of its patents that it believes may be... 

How Have Generic Applicants Fared in Patent Infringement Litigation ... 

For nearly 75 percent of drug products this study covered, brand-name companies initiated patent infringement litigation against the first generic applicant. In the other 25 percent, there was no suit,... 

For 2 of the 29 drug products in which no suit was filed, the brand-name company s patents would have expired during the first several months of the 30-month stay. Because patent expiration terminates the 30-month stay, it may not have made sense in those cases to initiate patent infringement litigation, which takes, on average, 25 months to resolve. 

What Were the Results of Patent Infringement Litigation with the First Generic Applicant ... 

For 8 dmg products, the brand-name company prevailed in the patent infringement litigation. For 7 dmg products, a court held that the generic applicant s ANDA infringed the brand-name company s patents. Two of these decisions were appellate decisions the other 5 were district... 

In 62 percent of the cases involving litigation with the first and second generic applicants, brand-name companies initiated patent litigation in just five federal judicial districts. These were the District of New Jersey, the Southern District of New York, the Southern District of Indiana, the Northern District of Illinois, and the Southern District of Florida. Thus, these courts have more experience with ANDA patent infringement litigation than most other federal district courts. ... 

The FDA has generally resolved the issues raised by the citizen petitions that brand-name companies file about drug products in this study in a timely manner, and in most instances prior to a distriet eourt ruling on the merits of the patent infringement litigation. Thus, for drug products in the study, eitizen petitions that have been answered by the FDA have not delayed generic competition. 

For 11 of the 12 drug products covered by citizen petitions, the brand-name company that had filed the citizen petition also had either settled the patent infringement litigation with an agreement that contained a brand payment see Chapter 3), filed a late-issued patent to obtain a second 30-month stay see Chapter 4), or has patent litigation pending in which the brand company has claimed the ANDA infringes more than one patent see Chapter 4). 

The FDA has addressed the issues raised by those eitizen petitions in a timely manner and prior to the expiration of the 30-month stay related to the underlying patent infringement litigation. 

In the United States, Celanese has obtained a license from Bayer to expand their vinyl acetate production. In addition, National Distillers has developed an alternative vapor-phase process and will use it in a new plant nearing completion. The adoption by Celanese of the Bayer vapor-phase process has led to patent infringement litigation among National Distillers, Celanese, and Bayer (6). 

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