Patents litigation

A chemical patent attorney could take a position with a medium- or large-sized firm and become involved in patent litigation. In this phase of the profession, the lawyer is required to match wits with an opponent in what is really an adversary contest. For those who find satisfaction in intellectual competition, this can be an exciting career avenue. 

As a result of a lot of thinking by a lot of people, there has emerged an alternative proposal that attempts to consolidate the best of the opposition and reexamination procedures to achieve the beneficial effects and yet to reduce the costs of not only oppositions but also patent litigation. This alternative proposal has provided the focus for attempts to improve S.2255. This proposal has come to be known as "Chapter 31 because that was its place in a bill introduced in the Senate by Senator Fong. It had broad support from industry and bar associations, but it didn t carry in the Senate in its original form. 

Yes. If a brand-name company lists an additional patent in the Orange Book after the generic applicant has filed its AND A, more than one 30-month stay may be generated. The generic applicant is required to re-certify to this later-listed patent, and if, upon notice of the generic s re-certification, the brand-name company sues within 45 days, then FDA approval of the generic s previously filed ANDAis stayed for an additional 30-months from the notice date or until a court decision in the newly instituted patent litigation. 

The expiration of the 30-month stay may have more significance in the future, if ANDA-related patent litigation begins to last... 

Yes. During the time period of the study, there were 20 final settlements of ANDA-related patent litigation. Fourteen of the 20, at the time they were executed, had the potential to delay the start of the first generic applicant s 180-day exclusivity. If the 180-day exclusivity for the first generie applicant does not run, then the FDA may not approve any subsequent eligible generie... 

In addition to the 20 final settlement agreements, there were 4 interim settlement agreements pursuant to which the patent litigation continued, but the parties agreed upon certain conditions in the meantime. 

Filing of the lawsuit stays the FDA s approval of the ANDA until the earliest of (1) the date the patents expire (2) a final determination of non-infringement or patent invalidity by a court in the patent litigation or (3) the expiration of 30 months from the receipt of notice of the paragraph IV certification. This chapter reviews the frequency and outcome of these patent infringement lawsuits. 

For the 75 dmg products where patent litigation was brought, the median net sales in the year the first generic applicant filed its ANDA were 190 million per year. By contrast, the majority of the 29 NBAs for which no suit was filed had net sales of less than 100 million in the year the generic applicant filed its application. ... 

In addition to these 22 cases, there are 2 more pending cases on a dosage strength of a drug product for which the patent litigation on another strength has been resolved. The resolution of these cases is discussed in the following section. 

In one pending case, the FDA determined that the brand-name company failed to submit the required information for a particular patent in a timely manner. Therefore, the generic applicant was not required to submit a patent certification to address that patent, the 30-month stay was dissolved, and the FDA subsequently approved the ANDA. Commercial patent litigation was still pending as of June 1, 2002, however, and the generic applicant has not yet entered the market. 

Resolution of Patent Litigation with First Generic Applicant Number of NBAs... 

Table 2-3 Resolution of Patent Litigation with Second Generic Applicant if the First Generic Applicant Settled its Litigation...

For Those Patent Litigations that Resulted in a Court Decision, How Often Did Generic Applicants Prevail for All of the Drug Products in the Study ... 

There were court decisions on 40 different drug products. Table 2A presents the resolution of the patent litigation derived from five sources (1) litigation with the first generic applicant (Table 2-2), (2) litigation with the second generic applicant if the first... 

Table 2-4 Patent Litigation Results per Drug Product...

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. ... 

Whether the FDA actually was prevented from approving subsequent eligible generic applicants depends on specific facts, including whether there were subsequent generic applicant(s) and the result(s) of any patent litigation with those applicants. 

I 132.5 million (in part to settle additional patent litigation) 1 year, 9 months Greater than 1 billion... 

In re Buspirone Patent Litigation/In re Buspirone Antitrust Litigation, Memorandum of Law of Amicus Curiae the Federal Trade Commission in Opposition to Defendanf s Motioii to Dismiss available at . The Commission first raised concerns about the potential... 

Prior to the Mova court of appeals decision on April 14, 1998, the FDA had granted the 180-day exclusivity to 3 generic applicants for dmg products covered by 3 NDAs. In each case, a court had decided that the patent was invalid or not infringed such that the generic applicant had successfully defended the patent litigation suit. Each of these grants of the 180-day... 

In 8 of the 19 instances, the brand-name company and the generic applicant settled the patent litigation and the generic applicant s commercial marketing triggered the 180-day exclusivity. These 8 settlements can be grouped into 4 categories ... 

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