Transitional terms in patent law (conventionally, "comprising," "consisting of," and the more arcane "consisting essentially of") have their own provenance and meaning, denoting limitations that are "open" (comprising) or...more
Last week, the Federal Circuit affirmed a District Court decision (by Circuit Judge Bryson, sitting by designation) in an ANDA litigation, finding obvious claims asserted for treating patients having mild to moderate hepatic...more
The Federal Circuit has grappled with, divisively in some instances, the extent to which the safe harbor provisions of 35 U.S.C. § 271(e)(1) extend to activities not strictly for obtaining regulatory approval, such as...more
As reported in John Carrol's EndPoint News early last month, GlobalData has published a list of the Top 20 Pharmaceutical Companies by market cap as of March 31, 2019. ...more
Section 112 of the Patent Act as codified, entitled "Specification" in the statute, specifies the amount of disclosure required to support a patent claim (among other requirements). Section 112(a) contains three...more
Last week, the Federal Circuit overturned an obviousness determination in an inter partes review by the Patent Trial and Appeal Board in OSI Pharmaceuticals LLC v. Apotex Inc. The Court also reaffirmed its holdings in...more
The Federal Circuit applied the constitutional principle under Article III that there must be a case or controversy for a federal court to enter judgment (in this case, of invalidity) in ANDA litigation that can be vitiated...more
Last week, the Federal Circuit reversed findings of non-obviousness and affirmed (over Chief Judge Prost's dissent) a finding that claims asserted in ANDA litigation were not invalid for failure to satisfy the written...more
In its decision in a consolidated appeal, Eli Lilly & Co. v. Hospira, Inc. and Eli Lilly & Co. v. Dr. Reddy's Laboratories, Ltd., the Federal Circuit had the occasion to apply the Supreme Court's distinction regarding the...more
Those with moderate memories may recall that there was a spate of qui tam actions several years ago for false marking of patented articles, aimed at manufacturers who had neglected to remove patent marking from their products...more
"Solving" the problem of high prescription drug prices has been on the minds of our representatives in Congress lately, and the desire to "do something" about it has reached the point that just doing something (or being...more
The parlous state of patent law as applied to biotechnology (and to a slightly lesser extent, pharmaceuticals) generally over the past several years has been thoroughly explicated, and the recalcitrance engendered by stare...more
There are provisions and interpretations of U.S. patent law that can be in tension depending on the circumstances under which they are argued, whether before an Examiner or during litigation. One of these is the dichotomy...more
The Federal Circuit exhibited the current status of its obviousness jurisprudence in affirming the District Court's determination that the asserted claims of U.S. Patent No. 8,410,131 were obvious in a decision handed down...more
Late last week, the U.S. Food and Drug Administration issued a final version of its "Guidance for Industry," entitled "Considerations in Demonstrating Interchangeability With a Reference Product" regarding the as-yet...more
The International Trade Commission, although having limited jurisdiction, can be a very powerful ally to U.S. industries facing foreign competition. The Commission's power to interdict importation of infringing articles can...more
Rising drug prices is an issue that everyone from the President to both Houses of Congress (Democrats and Republicans), Wall Street, and Main Street can agree must be alleviated, and perhaps the most expensive drugs are those...more
A great deal of faith has recently been given to Congress by the patent community, spurred by efforts to solve the conundrums in patent law created by several recent Supreme Court decisions (and aided and abetted by the U.S....more
FiercePharma reported sales rankings for the top 15 pharmaceutical companies in 2018, in comparison to 2017 sales. As reported today, "the top 15 names are the same against prior year rankings, but the order has shifted." ...more
This decision of the Federal Circuit in Dr. Falk Pharma GmbH v. GeneriCo, LLC involves disqualification due to conflict of interest of counsel representing Mylan Pharmaceuticals in three separate appeals. As set forth in the...more
The Federal Circuit has on several occasions taken the opportunity to address (and in doing so, flesh out) the requirements for Article III standing to appeal an adverse determination in a post-grant review proceeding...more
"Pigs fly!" "Hell has frozen over!" Or less dramatically, "Supreme Court affirms Federal Circuit decision!" all would be apt subtitles for any article discussing the Supreme Court's decision today in Helsinn v. Teva. The...more
1/23/2019
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Patent Infringement ,
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Third-Party Relationships
The Federal Circuit recently reviewed yet another decision by the Patent Trial and Appeal Board (PTAB) of the U.S. Patent and Trademark Office in Amerigen Pharmaceuticals Ltd. v. UCB Pharma GmbH, and once again reviewed...more
Having a court grant a preliminary injunction is frequently an important strategic victory for a patent plaintiff in an infringement suit. The injunction not only eliminates a revenue stream for the accused infringer but...more
The varying appellate fortunes of patentees regarding the question of obviousness is illustrated nicely in the Federal Circuit decision in Orexo AB v. Actavis Elizabeth LLC handed down earlier this month. The statute, 35...more