Patent Law Weblog
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- Why the Alice Test is Stupid, Part IV: The Usefulness Paradox
- Teva Capitulates to Federal Trade Commission Coercion
- USPTO Issues Memoranda on Subject Matter Eligibility
- USPTO Revokes Guidance on AI-Assisted Inventorship, But Rules Remain Basically the Same
- Why the Alice Test is Stupid, Part III: Eligible Independent Claims Can Have Ineligible Dependent Claims
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Category: Hatch-Waxman
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By Kevin E. Noonan — The question of the proper court for a branded pharmaceutical maker to bring suit against an Abbreviated New Drug Application filer under the Hatch-Waxman Act is surprisingly unsettled seeing as the Act was enacted in 1984. The Federal Circuit brought some measure of clarity to the question recently when it…
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By Kevin E. Noonan — The Federal Trade Commission (FTC) spent the better part of a decade attacking the practice of innovator drug companies settling ANDA litigation by providing payments to generic applicants challenging the validity of Orange Book-listed patents (see "The FTC's Thinking Does Not Make It So Regarding Reverse Payment Agreements"; "Federal Trade…
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By Kevin E. Noonan — ANDA litigation, pursuant to the Hatch-Waxman Act, has become more complicated over the years since enactment of the statute in 1984, with more patents being asserted and more parties participating over the opportunity to market a generic version of a branded, innovator drug. Particularly under circumstances where there are several…
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By Kevin E. Noonan — In 1984, Senator Orrin Hatch (R-UT) and Rep. Henry Waxman (D-CA) shepherded a grand legislative compromise through Congress that balanced the rights and solved inefficient regulatory consequences for both branded and generic drug makers. Forever known as the Hatch-Waxman Act (formally, the Drug Price Competition and Patent Term Restoration Act),…
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By Donald Zuhn –- After reflecting upon the events of the past twelve months, Patent Docs presents its 13th annual list of top patent stories. For 2019, we identified fifteen stories that were covered on Patent Docs last year that we believe had (or are likely to have) a significant impact on patent practitioners and…
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By Kevin E. Noonan — "You consider that to be important?" he asked."Exceedingly so.""Is there any point to which you would wish to draw my attention?""To the curious incident of the dog in the night-time.""The dog did nothing in the night-time.""That was the curious incident," remarked Sherlock Holmes. "The Adventure of the Silver Blaze," The…
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District Court Awards Attorney Fees for Plaintiff's Use of Discovery to Police Defendants' Future Conduct By Donald Zuhn — Last month, in Par Pharmaceutical, Inc. v. Luitpold Pharmaceuticals, Inc., Senior District Judge William H. Walls of the U.S. District Court for the District of New Jersey issued an amended opinion granting the motion for attorney…
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By Kevin E. Noonan — The Supreme Court denied certiorari today in Amphastar Pharmaceuticals, Inc. v. Momenta Pharmaceuticals, Inc., thereby leaving intact the Federal Circuit's fractured precedent on the question of whether post-approval activities are properly within the scope of the Hatch-Waxman "safe harbor" (as set forth in 35 U.S.C. § 271(e)(1)). This was the…
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By Kevin E. Noonan — Perhaps one of the most influential first year law school classes for the task of learning how to "think like a lawyer" is civil procedure. Particularly when the professor is bold enough to engage students on the intricacies of the topic, those intricacies can make for a challenging final exam. …
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By Kevin E. Noonan — Last week, co-sponsors Senators Leahy (D-VT), Grassley (R-IA), Klobucher (D-MN), and Lee (R-UT) introduced a bill (S. 3056), entitled the "Creating and Restoring Equal Access to Equivalent Samples Act of 2016" or the "CREATES Act of 2016". According to Senator Grassley: [C]oncerns have been raised that some brand-name companies are…
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