Pharma Almanac
Companies seeking to market a branded or generic pharmaceutical in the US, and patent attorneys associated with multiple aspects of that process, will see how use of Pharma's Almanac© can assist in identifying and prioritizing the most promising drugs to market, how to develop a strategy of non-infringement or invalidity for patents listed in the Orange Book for a specified drug, and how to evaluate the significance of non-Orange Book patents.
For those individuals who are not trained as patent attorneys or agents will find that many of the legal aspects and analytics of the patents listed in the Orange Book have been made more visible and transparent, thereby obviating the need to include a patent attorney in the non-legal aspects involved in the commercialization and marketing in the US of a pharmaceutical or biological.
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Leading U.S. pharmaceutical patent attorneys, in collaboration with FDA regulatory attorneys, pharmaceutical executives, patent litigators and software developers, have recently developed a proprietary software tool (Pharma's Almanac©) to assist with the core aspects of the Abbreviated New Drug Application (ANDA) process. Pharma's Almanac© now serves as the "gold standard" for rendering legal opinions to support Paragraph IV certifications for ANDAs. The tool has also been used by bio-pharmaceutical companies to identify and target suitable "biologicals" to genericize.
Pharma's Almanac© is a proprietary software tool that was developed exclusively at Schwegman, Lundberg & Woessner (SLW). In-house and outside patent attorneys use the software tool to assist their clients in identifying and selecting financially viable drugs to commercialize in the US, while cost-effectively avoiding the technical and legal pitfalls typically encountered with the patents listed in the Orange Book for that drug. Outside patent attorneys also use the tool to render non-infringement and invalidity "Paragraph IV" opinions, in an accurate, cost-effective and timely manner. Litigators handling a Hatch-Waxman litigation use Pharma's Almanac© to more efficiently and cost effectively develop positions to advance during litigation. Corporate counsel and executives use Pharma's Almanac© to coordinate the financial, legal, regulatory and technical obstacles necessary to overcome in marketing a generic pharmaceutical.
