API and IP Newsletter
Contents
Patent applications filed by Laurus Labs
We analyse patent applications filed by many companies and assess their development capabilities. We estimate when development would have started for the molecule, stage of the development activity of any particular molecule and try to understand company’s strategy behind that molecule. This week we analysed patent portfolio of Laurus Labs. We studied patent applications filed in last couple of years.
As one would appreciate analysis of all patent applications would be difficult to cover in this newsletter, a glimpse of the analysis is provided in below table.
General information
Purdue Pharma can appeal rejection of bankruptcy plan
A U.S. judge on Friday allowed Purdue Pharma to immediately challenge her rejection of legal protections for Sackler family members who own the OxyContin maker, and which were a major component of its bankruptcy reorganization plan.
News here.
What Sci-Hub’s latest court battle means for research
Sci-Hub, the popular website that offers access to millions of pirated research papers and books, is no stranger to legal action. But, for the first time, the site is defending its operations in court, in a copyright case filed in India by a group of major publishers.
In a lawsuit presented in Delhi’s high court, the American Chemical Society, Elsevier and Wiley say that the site infringes their copyright, and ask the court to instruct Internet service providers in India to block access to it.
News here.
Intellectual Property
Formoterol and Budesonide (Symbicort) Federal Circuit affirmed validity and remanded infringement determination of district court
OB listed patents
All listed patents in the Orange Book covering AstraZeneca’s Symbicort which is used for treating asthma and chronic obstructive pulmonary disease were asserted.
In appeal, Mylan challenged the district court’s construction of 0.001%, the claimed concentration of PVP. Mylan also challenges several of the factual findings underlying the district court’s non-obviousness determination, including its finding that the prior art taught away from the claimed invention
This write-up would be confined only to construction of 0.001%, the claimed concentration of PVP. The question before the court was whether the concentration of PVP being 0.001% means 0.001% within one significant figure encompassing a concentration of PVP in the range of 0.0005% to 0.0014%, as AstraZeneca contends and as the district court construed this term or it has a narrower meaning in view of the specification and the prosecution history precisely 0.001% w/w PVP with only minor variations, as Mylan contends.
The inventors discovered that certain HFA formulations comprising formoterol and budesonide together with PVP and PEG. Specifically, the written description explains that the concentration of PVP (0.001% w/w) used in this formulation has been found to give consistently stable formulations over the required dose range.
And the written description repeatedly touts the superior stability of formulations with 0.001% w/w PVP.
As part of experiments, the inventors tested formulations including PVP at concentrations of 0.0001%, 0.0005%, 0.001%, 0.01%, 0.03%, and 0.05% w/w and characterized each formulation for stability.
The original version of claim 2 that was filed PVP concentration was from about 0.0005 to about 0.05 %w/w. The Examiner rejected the claims as obvious over two prior art references. The inventors then amended the claims, deleting the PVP range limitation from claim 2 in its entirety and amending claim 1 to recite that the “PVP is present in an amount of 0.001%
The Examiner once again rejected the claims, stating that it was imperative for the inventors to show criticality of the invention comprising 0.001% w/w PVP by testing the invention comprising slightly more and less than 0.001% w/w PVP.
In response, the inventors asserted that the criticality of 0.001% w/w PVP in a formulation containing 2 mg/ml budesonide, it was illustrated by the data provided in the written description
In short, over the course of the prosecution history, the inventors narrowed the claimed concentration of PVP to 0.001% w/w from a broader range without using the qualifier “about.”
AstraZeneca first argued that the written description and prosecution history only ever express the PVP concentration with one significant figure, whereas the concentration of some of the other ingredients, e.g., budesonide, are expressed using additional significant figures. Thus, according to AstraZeneca, adopting Mylan’s proposed construction would effectively make the concentration of PVP more precise than the inventors intended, because the inventors could have used additional significant figures to reflect the need for greater precision with the concentration of PVP.
In the Court’s view the written description repeatedly differentiates between formulations comprising 0.001% w/w PVP and, e.g., those comprising 0.0005% w/w PVP,
AstraZeneca also argued that Mylan’s proposed construction is an impermissible attempt to limit the scope of the claims to the preferred embodiment.
The Court was not persuaded. The Court was mindful not to limit claims to the preferred embodiments.
But AstraZeneca’s proposed construction would read on two distinct formulations described in the written description namely, a formulation comprising 0.0005% w/w PVP and one comprising 0.001% w/w PVP. Yet, the inventors had chosen to claim only one of these formulations, which according to the Court supported construing the claims as limited to that formulation.
Hence, the construction the Court adopted, which allowed for only minor variations in the PVP concentration at the fourth decimal place (0.00095% to 0.00104%), reflected the level of exactness the inventors used in the written description in concluding that 0.001% w/w PVP is the most stable formulation compared to formulations with slightly more or less PVP.
Although the term “0.001%” without any broader context might indicate a range from 0.0005% to 0.0014%, here, in the context of the concentration of PVP, in light of the testing data in the specification and the amendments and arguments in the prosecution history, the Court finally concluded that the construction of this term most consistent with the intrinsic evidence is not so broad. Accordingly, the Court construed 0.001%” as that precise number, with only minor variations, i.e., 0.00095% to 0.00104%.
So, the Court therefore vacated the stipulated judgment of infringement and remand for the district court to find in the first instance whether Mylan’s ANDA Product would infringe the asserted claims under the proper claim construction.
Decision here
