Last week, the Federal Circuit handed down a pair of non-precedential decisions affirming the Patent Trial and Appeal Board (PTAB) in inter partes review (IPR) proceedings. This post concerns the decision in Cardiovalve Ltd....more
Last week the Federal Circuit handed down a pair of non-precedential decisions affirming the Patent Trial and Appeal Board (PTAB) in inter partes review (IPR) proceedings. This post concerns the decision in Medtronic, Inc....more
Last week, the Federal Circuit handed down its opinion in Pfizer Inc. v. Sanofi Pasteur Inc., affirming the Patent Trial and Appeal Board's (PTAB) determination that all claims of U.S. Patent No. 9,492,559 challenged in...more
After taking most of a decade to approve its first interchangeable biosimilar (Semglee (insulin glargine-yfgn), the U.S. Food and Drug Administration has approved three interchangeable biosimilars since the beginning of this...more
The Federal Circuit's In re Cellect decision has caused a great deal of commentary and proposals to avoid its consequences, including changing prosecution strategies and filing prospective, precautionary terminal disclaimers...more
A consequence (predominantly negative) of the Supreme Court's recent foray into defining (however inadequately) the contours of patent-eligible subject matter is to give the district courts (and to a somewhat lesser extent,...more
On October 3, 2023, the U.S. Food and Drug Administration (FDA) announced approval of Biogen's Byooviz (ranibizumab-nuna) as an interchangeable biosimilar to Genentech's Lucentis (ranibizumab injection). The drug was...more
One of the characteristics of patent infringement litigation in the aftermath of the Supreme Court's decision in Markman v. Westview Instruments, Inc. (holding that claim construction was a matter of law to be reviewed de...more
The importance of claim construction, and how construing the same term facing a challenge based on different prior art in separate inter partes review proceedings can result in contrary findings on invalidity, was illustrated...more
On January 10th, the U.S. Patent and Trademark Office published a Notice in the Federal Register (89 Fed. Reg. 1563) regarding proposed Guidance on how the Office will apply the enablement requirement under 35 U.S.C. § 112(a)...more
One of the many changes introduced into U.S. patent law by the Leahy-Smith America Invents Act were provisions for post-grant review (PGR) and inter partes review (IPR). There have been thousands of these proceedings...more
1/8/2024
/ America Invents Act ,
Inter Partes Review (IPR) Proceeding ,
Noncompliance ,
Oil States Energy Services v Greene's Energy Group ,
Opioid ,
Patent Trial and Appeal Board ,
Post-Grant Review ,
Purdue Pharma ,
Return Mail Inc v United States Postal Service ,
SCOTUS ,
Thryv Inc v Click-To-Call Technologies LP
Not surprisingly, the Federal Circuit visited upon Plaintiff/Appellant PureCircle two of the Four Horsemen of the Biotech Patent Apocalypse* in a decision affirming the District Court's invalidation of the claims asserted...more
Earlier this year, the U.S. Food and Drug Administration announced approval of Amgen's Wezlana (ustekinumab-auub) as an interchangeable biosimilar to Janssen Biotech's Stelara (ustekinumab). The drug was approved for...more
The provisions of U.S. regulatory law regarding FDA approval for less than all the indications for which an innovator drug was approved under 21 U.S.C. § 355(j)(2)(A)(viii) (the so-called "skinny label) has in the recent past...more
In the shadow of its recent, precedent-challenging In re Cellect decision, the Federal Circuit illustrated the pedestrian application of its obviousness-type double patenting jurisprudence in affirming the Patent Trial and...more
Although merely exemplifying the burden imposed on an appellant by the Federal Circuit's substantial evidence standard of review over decisions by the U.S. Patent and Trademark Office regarding the facts underlying legal...more
12/8/2023
/ Claim Construction ,
Entitlements ,
Intellectual Property Protection ,
Inter Partes Review (IPR) Proceeding ,
Nonobvious ,
Obviousness ,
Patent Trial and Appeal Board ,
Patent-Eligible Subject Matter ,
Patents ,
PTAB Precedential Opinion Panel (POP) ,
Trademark Litigation ,
Trademarks ,
USPTO
Proper construction of claim limitations reciting the chemical property of pH (which denotes the concentration of hydrogen ions in a solution as an indication of acidity) has arisen several times in district court and Federal...more
12/8/2023
/ Abbreviated New Drug Application (ANDA) ,
Appeals ,
Claim Construction ,
Innovation Patent ,
Intellectual Property Protection ,
Inventions ,
Inventors ,
Mylan Pharmaceuticals ,
Patent Litigation ,
Patents ,
Pharmaceutical Patents ,
SCOTUS ,
Teva v Sandoz
The Federal Circuit dismissed an appeal from an unsuccessful challenger in an inter partes review (IPR) proceeding based on failure to satisfy the standing requirements for appeal in Allgenesis Biotherapeutics Inc. v....more
In what was an otherwise run-of-the-mill affirmance of a decision by the Patent Trial and Appeal Board (PTAB) (albeit somewhat noteworthy in affirming the Board's determination that the challenged claims were not invalid),...more
It came as something of a shock in May, 2021 when the Biden administration voiced support for waiver of intellectual property protection mandated under the TRIPS agreement for COVID-19 vaccines (see "Biden Administration...more
11/9/2023
/ Biden Administration ,
China ,
Compulsory Licenses ,
Coronavirus/COVID-19 ,
Diagnostic Tests ,
Enforcement ,
Healthcare ,
India ,
Intellectual Property Protection ,
International Trade Commission (ITC) ,
Popular ,
Research and Development ,
Tariff Act of 1930 ,
Therapeutic Services ,
Trademarks ,
TRIPS Agreement ,
Vaccinations ,
Waivers ,
WTO
Ever since Watson and Crick ended their seminal Nature paper in 1953 by saying that: "It has not escaped our notice that the specific pairing we have postulated immediately suggests a possible copying mechanism for the...more
On September 29, the U.S. Food and Drug Administration announced approval of Biogen's Tofidence® (tocilizumab-bavi) as a biosimilar to Genentech's Actemra®, a drug approved for treating COVID-19, rheumatoid arthritis, giant...more
In view of the unprecedented uncertainty in patent law generated by counter-doctrinal Supreme Court decisions over the past decade or so and a cowed Federal Circuit relegated to complaining that their hands are tied on most...more
Section 112 of the patent statute, which in earlier years was something of a backwater in patent law, has had a tumultuous quarter century beginning with the Federal Circuit decision in Regents of the University of California...more
Over the past few years the drumbeat regarding the cost of healthcare in general and drugs in particular has steadily mounted (see "Faux-Populist Patent Fantasies from The New York Times"). Patents are often (and quite...more