Intellectual Property Rights - News Letter Issue No:2020--079
January 2020 Issue
1. BioDelivery Sciences International, Inc. v. Aquestive Therapeutics,(Fed. Cir. 2020)
The Federal Circuit issued a per curiam Order in BioDelivery Sciences International, Inc. v. Aquestive Therapeutics, Inc., denying a petition for a panel rehearing or rehearing en banc filed by Appellant BioDelivery Sciences International, Inc. Judge Newman dissented from the denial of the petition for rehearing en banc. More
2. Genentech, Inc. v. Hospira, Inc. (Fed. Cir. 2020)
The Federal Circuit affirmed invalidation of claims to methods for reducing Protein A leaching in affinity column chromatographic methods important inter alia in purifying monoclonal antibodies, in Genentech, Inc. v. Hospira, Inc. In doing so, the panel majority (over a dissent by Judge Newman) illustrated anew the importance of the deference the U.S. Patent and Trademark Office (and particularly the Patent Trial and Appeal Board) is due under the Administrative Procedures Act, and how that deference can be outcome determinative under the right circumstances. More
3. Hospira, Inc. v. Fresenius Kabi USA, LLC (Fed. Cir. 2020)
It seems that memes can be as compelling in the law as in social media, and the meme of the moment in patent law is inherency, particularly as applied to obviousness determinations (see, for example, Persion Pharmaceuticals LLC v. Alvogen Malta Operations Ltd.; Acorda Therapeutics, Inc. v. Roxane Labs., Inc.). This tendency was most recently illustrated in the Federal Circuit's decision in Hospira, Inc. v. Fresenius Kabi USA, LLC. More
4. Becon Medical, Ltd. v. Bartlett (E.D. Pa. 2019)
In Becon Medical, Ltd. v. Bartlett, Senior District Judge Jan E. Dubois of the U.S.IDistrict Court for the Eastern District of Pennsylvania denied a motion to stay filed by Defendants Scott P. Bartlett, M.D. and TalexMedical, LLC ("TalexMedical"). In denying TalexMedical's motion, the District Court concluded that all three factors for determining whether to stay an action pending inter partes review weighed against granting a stay. More
5. Amgen Inc. v. Amneal Pharmaceuticals LLC (Fed. Cir. 2020)
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 "closed" (consisting). But how should a court construe instances where these terms seem to be at odds with one another? The Federal Circuit provided an answer, at least with regard to the interplay between "comprising" and Markush group language ("selected from the group consisting of") in one of its first opinions of the New Year, Amgen Inc. v. Amneal Pharmaceuticals LLC. More
6. Persion Pharmaceuticals LLC v. Alvogen Malta Operations Ltd. (Fed. Cir. 2019)
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 impairment with extended release opioid formulations, in Persion Pharmaceuticals LLC v. Alvogen Malta Operations Ltd. In reaching this obviousness determination, Judge Bryson made recourse to the concept of inherent disclosure in questions of obviousness, which while limited in scope, the Federal Circuit found their colleague properly applied. More
7. CG Technology Development, LLC v. Fanduel, Inc. (Fed. Cir. 2019)
CG Technology Development, LLC (CG Tech) appealed the Patent Trial and Appeal Board's Final Written Decision holding that the claims of U.S. Patent RE39,818 would have been obvious. The Federal Circuit found that even though the disputed limitations in the claims were improperly construed, the claims were nevertheless invalid under the proper construction. More
8. Gilead Hit With Another Antitrust Suit Over HIV Drugs
Gilead Sciences Inc., already facing political pressure and lawsuits over alleged anti- competitive behavior, was hit with a proposed class action accusing the pharmaceutical giant of conspiring with other drugmakers to block the use of generics in HIV treatment regimens. More
9. Hospira Says Its $70M Loss Makes IP Safe Harbor 'Illusory'
The Federal Circuit’s decision to uphold a $70 million infringement verdict against Hospira Inc. tied to its biosimilar version of Amgen Inc.'s Epogen "calls into question the continuing viability" of a safe harbor for drug development and approval,
Hospira has told the full court. More
10. UK Pharma Co. Scores Patent For Magic Mushroom Treatment
A U.K.-based mental health care company announced it has been granted a U.S. patent for a formulation that includes an active ingredient in psychedelic mushrooms, which the company is researching as a treatment for drug-resistant depression. More
11. Split Fed. Circ. Backs PTAB Ax Of Genentech Cancer Drug IP
A split Federal Circuit affirmed the Patent Trial and Appeal Board’s decision
invalidating parts of Genentech Inc.’s patent on the blockbuster cancer drug Avastin for being anticipated or obvious in light of prior patent publications. More
12. Fed. Circ. Casts Doubt On Novartis MS Drug PTAB Win
A Federal Circuit panel appeared skeptical of Novartis’ argument that the written description of a patent covering multiple sclerosis drug Gilenya doesn’t need to explicitly say the treatment excludes a loading dose prior to starting a daily dose regimen. More
13. Full Fed. Circ. Won't Eye PTAB Order Junking Suboxone IPRs
The Federal Circuit has refused to revisit an earlier ruling that upheld a Patent Trial and Appeal Board decision not to review a patent on the opioid addiction treatment Suboxone, drawing a strong dissent from a circuit judge that called the board’s action “seriously flawed.” More
14. Fed. Circ. Affirms Patent Wins For Coffee Pod Maker
The Federal Circuit handed a win to Eko, which makes reusable filters for Keurig machines, in a multifaceted patent case against rival Adrian Rivera MaynezMore
15. Full Fed. Circ. Won't Review Nix Of 23andMe Patent
The Federal Circuit denied a petition from 23andMe that asked for a rehearing on its decision affirming the invalidity of the company's patent for a way to compare sets of DNA to find relatives. More
16. Fed. Circ. Backs Fresenius Win Over Hospira Sedative Patent
The Federal Circuit upheld an Illinois federal court decision invalidating Hospira Inc.'s patent for the sedation drug Precedex, paving the way for Fresenius Kabi USA LLC to move forward with its planned generic version. More
17. Fed. Circ. Affirms PTAB Ax Of AbbVie's Humira Patent
The Federal Circuit summarily affirmed the Patent Trial and Appeal Board's inter partes review decisions invalidating a key patent for AbbVie Biotechnology Ltd.'s top-
selling Humira, an immunosuppressant drug that brought in more than $13.6 billion in
U.S. sales revenueMore
18. Allergan To Pay $300M To End Birth Control Antitrust Case
Allergan said that it has agreed to pay several groups of Loestrin buyers a total of $300 million and will avoid a looming trial over claims that a pair of its subsidiaries delayed generic alternatives to the birth control drug. More
19. Fed. Circ. Says Bryson Rightly Axed Zohydro ER Patents
An Circuit Judge William C. Bryson rightfully invalidated claims from two patents covering the opioid painkiller Zohydro ER during an infringement trial against Alvogen in Delaware federal court, the Federal Circuit has ruled. More