API and IP Newsletter
Contents
Johnson & Johnson follows Gilead with lawsuit targeting alleged HIV drug counterfeiters
Working for both opioid maker and FDA wasn’t conflict, McKinsey tells committee
DMFs filed in March 2022
We analyze DMF filings by Indian companies. Some DMFs filed by the Indian companies and our analysis is as below.
General information
Johnson & Johnson follows Gilead with lawsuit targeting alleged HIV drug counterfeiters
In the J&J suit, the company says it was alerted to the counterfeit drugs through customer complaints and from the voluntary return of hundreds of bottles of counterfeit drugs from ProPharma Distribution. J&J filed its lawsuit earlier this month.
ProPharma is one of the defendants named, along with Safe Chain Solutions, Scripts Wholesale and I Care Pharmacy 14. J&J is seeking $25 million in damages from each of the defendants and for them to be banned from selling any of the company’s products.
News here.
Working for both opioid maker and FDA wasn’t conflict, McKinsey tells committee
McKinsey & Co managing partner Bob Sternfels told a congressional committee Wednesday that his consulting firm did not have a conflict of interest when it gave advice both to Oxycontin manufacturer Purdue Pharma LP and the government agency charged with regulating opioid sales.
News here.
Intellectual Property
Claim construction decision for trabectedin 1 mg-vial Janssen Prods. v. eVenus Pharm
Generic companies (including eVenus, Natco and Sun) brought this patent infringement suit against Janssen for infringement of US 8, 895, 557 (“the ‘557 Patent”).
These companies filed ANDAs and were seeking to market a generic version of Yondelis® trabectedin 1 mg/vial product before expiration of the patents in suit.
OB listed patent is below.
The claim:
A lyophilised anti-tumor composition comprising a single active anti-tumor compound and a disaccharide selected from sucrose, lactose and a combination thereof, wherein the anti-tumor compound is ET-743 and wherein the disaccharide is present in a sufficient amount to inhibit conversion of the ET-743 into ET-701, such that the ET-743 composition comprises less than 2% ET-701 after storage of the ET-743 composition at 5° C. for 3 months.
Trabectedin is a member of the ecteinascidin family of compounds, used to treat certain types of soft tissue cancer. It is also referred to as “ET-743.”
From a formulations perspective, ET-743 is a challenging compound insofar as it has limited aqueous solubility and, once dissolved, it has poor stability in solution.
As part of a drug product, ET-743 is therefore sold as a sterile, lyophilized composition that must be reconstituted prior to its administration by injection.
Prior art lyophilized compositions included ET-743, a phosphate buffer, and mannitol as a bulking agent.
One downside of these compositions was that they needed to be stored at -20°C to prevent decomposition. Another downside was that the freeze-drying process and subsequent storage tended to hydrolyze the ET-743 into an impurity, identified as “ET-701.”
To address these problems, the inventors developed an ET-743 formulation that included a disaccharide.
The Generic companies/ANDA filers asked the Court to construe one claim term from the ‘557 patent: “single active anti-tumor compound.” ie “single compound possessing anti-tumor properties”
Janssen wanted court to consider plain and ordinary meaning (no construction needed) or “a single compound providing the anti-tumor activity of the composition”
The Court said, the crux of the parties' dispute appears to be at what point a compound with anti-tumor activity that is present in an accused product transitions from being an impurity to being a second active ingredient.
Term “Comprising” in the claim is important here, and I will write sometime about different Transitional Phrases. The term ‘Comprises” means that at least all of the listed elements must exist but other elements that are not mentioned in the claim may also be present.
ANDA filer sought to rewrite the claims to create a noninfringement argument, Because Janssen’s construction seeks to cover a lyophilized composition containing two or more of ET-743, ET-745, and ET-770, each of which possesses anti-tumor properties, such a construction should be rejected
In fact, Janssen’s construction appears to allow any amount of a second active anti-tumor compound as long as Janssen also call that second active anti-tumor compound an ‘impurity.'
The Court opined, the ANDA filer’s claim construction disregards the intrinsic evidence and has a single litigation-inspired purpose-to read out the word ‘active' from the claim in an attempt to capture known, impossible impurities of ET-743 as alleged second, third and fourth active anti-tumor compounds.
The Court said, this is a meritless bid for noninfringement. This is not an issue of claim construction. It is an infringement issue that would be premature for the Court to address at this stage of the proceedings.
Court’s construction: Plain and ordinary meaning. The Court concluded, its claim construction of “a single active anti-tumor compound” by giving its ordinary meaning of “a single active anti-tumor compound” and declines to proceed into what it perceives as an advisory infringement analysis. ”
Decision here.
