API and IP Newsletter
Contents
505 (b) (2) approvals in February 2025
General information
US judge bars copies of Lilly weight-loss drug
AG Rayfield Secures $9,250,000 Dollar Settlement Against Pharmaceutical Giants AbbVie and Besins
Intellectual Property
Gilead Sciences, Inc. v. Lupin Ltd. et al
505 (b) (2) approvals in February 2025
We track 505 (b) (2) approvals each month. Eight 505 (b) (2) NDA approvals were in February. The details and our comments are below.
General information
US judge bars copies of Lilly weight-loss drug
Small compounding pharmacies must halt selling copies immediately, larger facilities by March 19
Compounders argue FDA relied on Lilly for shortage figures
Separate lawsuit by compounders over Novo Nordisk's Ozempic and Wegovy remains pending
News here
AG Rayfield Secures $9,250,000 Dollar Settlement Against Pharmaceutical Giants AbbVie and Besins
In a groundbreaking case, Oregon Attorney General Dan Rayfield reached a settlement involving a monopoly on testosterone replacement gels. The $9.25 million settlement includes $6,197,500 in disgorged profits and penalties along with attorney fees and costs.
The drug companies, AbbVie and Besins, were gaming the system – preventing competitors from manufacturing generic versions of the gels, by filing lawsuits to extend the amount of time they could charge customers high prices.
News here
Intellectual Property
Gilead Sciences, Inc. v. Lupin Ltd. et al
This case is regarding the claim construction. The matter was before the District of Delaware.
Below is the list of patents that Gilead has listed in the Orange Book for Bictegravir Sodium.
Lupin and Cipla have filed P-IV certificates and are seeking to clarify the definitions of terms used in the claims of several patents in the Orange Book.
On December 18, 2024, the court heard argument about the disputed claim terms of patents US 9,708,342 (“the ’342 Patent”), 10,385,067 (“the ’067 Patent”), and 10,548,846 (“the ’846 Patent”).
The parties briefed the issues and submitted exhibits containing both intrinsic and extrinsic evidence. The Court carefully reviewed all submissions related to the parties’ contentions regarding the disputed claim terms, heard oral arguments, and applied the legal standards in reaching its decision about the meanings of the words in the claims of these patents.
At issue, there are three disputed claim terms in three patents.
The first dispute is over the term “[about [5.5°, 16.1°, 23.3°] 2-θ ±0.2° 2-θ].”
The disagreement concerns whether the claim permits rounding experimental XRPD peak positions to the nearest tenth of a degree to fall within the allowable range.
The plaintiff (Gilead Sciences) contended that the XRPD peak position values should be rounded to the nearest tenth of a degree and proposed interpreting the term as being within 0.2° 2-θ above or below the stated peak, rounded to the nearest tenth of a degree (0.1°) 2-θ. The defendants (Lupin et al.) argued against any rounding, construing the term as being within 0.2° 2-θ above or below [5.5°, 16.1°, 23.3°]. Alternatively, Lupin et al. asserted that the term is indefinite.
The crux of this dispute is whether, as Gilead Sciences argued, the word “about” in the claims permits rounding for the claimed peak position values, or, as Lupin et al. contend, refers to the [±0.2° 2-θ] range, which means no rounding is allowed.
Those skilled in the art understand that the locations of XRPD peaks and/or the intensity measurements for a specific crystalline form of the same compound may differ within an acceptable margin of error.
The values of degree 2 θ allow for appropriate error margins.
Typically, the error margins are represented by “[±].”
For example, the degree 2 θ of about “8.7[±]0.3” denotes a range from about 8.7[+]0.3, which is approximately 9.0, to about 8.7[-]0.3, which is around 8.4.
Depending on the sample preparation techniques, the calibration methods applied to the instruments, and human operational variation, those skilled in the art recognise that the appropriate margins of error for an XRPD can be [±0.5; ±0.4; ±0.3; ±0.2; ±0.1; ±0.05] or less. In certain embodiments of the invention, the XRPD margin of error is [±]0.2.
The Judge did not believe that the reference to “about” in column 6, line 34 of the patent alters the analysis or implies that other parts of the specification do not convey their apparent meaning.
Regarding the Defendants' (Lupin et al.) assertion that if the Judge does not adopt their construction, the term “about” is indefinite, the Judge opines that, in such a case, the defendants (Lupin et al.) bear the burden of proving indefiniteness by clear and convincing evidence.
According to the Honorable Judge, the defendants (Lupin et al.) have not met that burden.
And with that, the Honorable Judge stated that he will adopt Plaintiff's (Gilead) proposal and interpret “about [[5.5°, 16.1°, 23.3°] 2-θ ±0.2° 2-θ]” as “within [0.2° 2-θ above or below the recited peak, rounded to the nearest tenth of a degree (0.1°) 2-θ].
The second term is “A method for treating an HIV infection in a human in need of it” in the preamble.
During the hearing, some parties reached an agreement on the meaning of this term, which the Honorable Judge recorded. On December 19, 2024, the remaining defendant, Lupin Ltd., confirmed its acceptance of the construction agreed upon during the hearing.
Therefore, the term “a method for treating an HIV infection in a human in need thereof” will be interpreted by agreement as “a method for alleviating or eliminating symptoms of an HIV infection and/or reducing HIV viral load in a human in need thereof, which may result in various clinical outcomes, depending on the patient.”
The third and final disputed term is “a multilayer tablet.”
The parties agree that the preamble is limiting. Gilead’s proposed construction is “a tablet with two or more layers, in which at least one of the claimed components is in a separate layer, where a layer is a section or compartment of components.”
Lupin et al. proposed the construction of “at least a bilayer tablet, where at least one of the claimed components resides in one of the separate layers of the bilayer tablet. "
The Hon. Judge agreed with Gilead’s interpretation of this term. Gilead disagreed with Lupin's use of “bilayer” in their proposed interpretation.
This is because the term “bilayer” in the context of the patent refers to a specific embodiment outlined in the specification, denoting a two-layer tablet where the first and second layers are arranged and oriented in a horizontal, striped manner. Since a “bilayer tablet” has a precise meaning within the patent, incorporating this term in the current construction would unnecessarily limit the scope of the claim.
Lupin focused on the meaning of “layer” and offered their expert’s declaration that, within the context of tablet formulation techniques, a layer must be at least a continuous mass, “one thickness course or fold,” lying over another continuous mass and containing at least one of the claimed components.
However, Lupin’s expert understanding is not more instructive than the patent, which defines “layer” as “a section or compartment. "
The specification, however, states: “Unless otherwise specified, the terms ‘first layer,’ ‘second layer,’ ‘third layer,’ and so forth do not indicate a particular order or orientation of the multilayer tablet formulations disclosed herein. “
Instead, these terms serve to differentiate the sections of the composition and to specify the characteristics or components of each section or compartment.
Ultimately, the Honorable Judge believed that Lupin’s proposed construction introduces unnecessary confusion and that Gilead’s construction is more consistent with the specification. Thus, he construed “a multilayer tablet” as “a tablet with two or more layers in which at least one of the claimed components is in a separate layer, wherein a layer is a section or compartment of components.”
It was hereby ordered that the disputed claim terms of the ’342 Patent, ’067 Patent, and ’846 Patent are construed as follows:
1. “about [5.5°, 16.1°, 23.3°] 2-θ ±0.2° 2-θ” means “within 0.2° 2-θ above or below the recited peak, as rounded to the nearest tenth of a degree (0.1°) 2- θ”
2. “A method for treating an HIV infection in a human in need thereof” means “a method for alleviating or eliminating symptoms of an HIV infection and/or reducing HIV viral load in a human in need thereof, which may yield a variety of clinical outcomes, depending on the patient” ; and
3. “a multilayer tablet” means “a tablet with two or more layers in which at least one of the claimed components is in a separate layer, wherein a layer is a section or compartment of components”
Decision here
