Confirm favorite deletion?
Patent Law Keyed to Adelman
Aventis Pharma S.A. v. Amphastar Pharmaceuticals, Inc.
Facts
Plaintiff held the '618 patent, which was surrendered when Plaintiff received the '743 patent. Both patents related to a composition made up of low molecular weight heparins. The drugs, marketed as Lovenox in the United States and Clexane in Europe, work to prevent blood clotting and to minimize the chance of hemorrhaging, especially during high-risk surgery. The advantage claimed by the patented drugs is that they exhibit a longer half-life compared to heparin. At first, the patent claims were rejected based on obviousness and anticipation because the prior art, especially European Patent '144, taught a product that was almost identical. Plaintiff disputed the rejections arguing that the half-life of the new drugs was significantly longer, which demonstrate a difference in structure. Plaintiff continued to rely on the difference in half-life in the appeals that followed until the patent was allowed. Plaintiff later sued Amphastar Pharmaceuticals, Inc. (Defendant) for patent infringement claiming they made and marketed the drug in generic versions. The district court considered Defendant's argument that the patent was invalid, and held the half-life improvement to be relevant to patentability because that was the reason the patent was finally issued by the examiner. The district court found Plaintiff had intent to deceive the examiner because Plaintiff provided no credible explanation for its reliance on an allegedly improved half-life when it had compared half-life at different doses without disclosing this dosage information. When compared at the same doses, the half-life was about the same. The district court granted summary judgment to Defendant and declared the patent was not enforceable due to inequitable conduct, which was intent to deceive. Plaintiff appealed to this court claiming the dose information was not relevant to the patentability because otherwise the examiner would have requested it when half-life data was presented to her. Plaintiff also claimed its expert, Dr. Andre Uzan, informed the examiner of the difference in dose when his declaration stated "it enables the same effect to be achieved with lower dosages." This court held Dr. Uzan's statement did not completely inform the examiner and the absence of dose information was a failure to disclose relevant information. The dose information was relevant to the issue of patentability. However, this court remanded for the district court to determine intent to deceive if the different dose comparison was reasonable within the field and therefore failure to disclose was unintentional. On remand, regarding the limited issue of intent to deceive, the district court held a bench trial and again found Plaintiff had intent to deceive the examiner. Plaintiff appealed again.
Only StudyBuddy Pro offers the complete Case Brief Anatomy*
Access the most important case brief elements for optimal case understanding.
*Case Brief Anatomy includes: Brief Prologue, Complete Case Brief, Brief Epilogue
- The Brief Prologue provides necessary case brief introductory information and includes:
Topic:
Identifies the topic of law and where this case fits within your course outline.Parties:
Identifies the cast of characters involved in the case.Procedural Posture & History:
Shares the case history with how lower courts have ruled on the matter.Case Key Terms, Acts, Doctrines, etc.:
A case specific Legal Term Dictionary.Case Doctrines, Acts, Statutes, Amendments and Treatises:
Identifies and Defines Legal Authority used in this case.
- The Case Brief is the complete case summarized and authored in the traditional Law School I.R.A.C. format. The Pro case brief includes:
Brief Facts:
A Synopsis of the Facts of the case.Rule of Law:
Identifies the Legal Principle the Court used in deciding the case.Facts:
What are the factual circumstances that gave rise to the civil or criminal case? What is the relationship of the Parties that are involved in the case.Issue(s):
Lists the Questions of Law that are raised by the Facts of the case.Holding:
Shares the Court's answer to the legal questions raised in the issue.Concurring / Dissenting Opinions:
Includes valuable concurring or dissenting opinions and their key points.Reasoning and Analysis:
Identifies the chain of argument(s) which led the judges to rule as they did.
- The Brief Prologue closes the case brief with important forward-looking discussion and includes:
Policy:
Identifies the Policy if any that has been established by the case.Court Direction:
Shares where the Court went from here for this case.