Background
The litigation between Shire Development LLC and Teva Pharmaceuticals USA, Inc. revolves around patent infringement claims related to several pharmaceutical compositions developed by Shire. The case, filed in the United States District Court for the District of Delaware (Civil Action No. 1:17-cv-01696-RGA), involves disputes over the interpretation and validity of Shire's patents.
Patents in Dispute
The patents at the center of this litigation are primarily related to pharmaceutical compositions capable of sustained release of amphetamines or amphetamine salts, particularly those used for treating Attention Deficit Hyperactivity Disorder (ADHD)[4].
Claims and Disputes
The litigation focuses on several claims within the '768 Patent, which pertains to "compositions for providing an orally administrable sustained release (SR) form of one or more amphetamines and/or amphetamine salts." The disputed terms appear in multiple claims, including claims 1, 7, 9, 11, 12, 13, 14, and 35 of the '768 Patent[4].
Claim Construction
A crucial aspect of the litigation is the construction of the patent claims. The court relies on both intrinsic and extrinsic evidence to determine the meaning of the disputed terms. Intrinsic evidence includes the patent claims, specification, and prosecution history, while extrinsic evidence encompasses external sources such as expert testimony, dictionaries, and learned treatises. The court's construction based solely on intrinsic evidence is considered a determination of law[4].
Intrinsic vs. Extrinsic Evidence
The court emphasized that intrinsic evidence is more reliable and useful in claim construction compared to extrinsic evidence. The prosecution history, in particular, was scrutinized to understand the intent of the applicant and the examiner. For instance, the court analyzed the exchanges between the applicant and the examiner to determine whether the sustained release components were the sole source of the claimed plasma profile. The court concluded that the prosecution history did not support the defendants' position that the sustained release components were the sole source[4].
Restriction Requirement
Teva argued that a restriction requirement during the patent application process eliminated claims to compositions containing immediate release components. However, Shire countered that this interpretation was factually and legally incorrect, as a restriction requirement is a non-substantive administrative procedure. The court agreed with Shire, noting that the Group II claims, which were pursued by the applicant, allowed the composition to contain other unclaimed components[4].
Settlement and Licensing Agreements
Prior to the final judgment in this case, Shire had settled similar litigation with Teva concerning another product, INTUNIV (guanfacine) Extended Release Tablets. The settlement allowed Teva to market generic versions of INTUNIV after the expiration of the 180-day exclusivity period granted to Actavis, the first ANDA filer[2][5].
Court's Decision
In the case at hand, the court's decision was based on the detailed analysis of the patent claims, specification, and prosecution history. The court found that the prosecution history did not support Teva's interpretation of the claims and instead aligned with Shire's understanding that the entire composition, not just the sustained release components, contributed to the claimed plasma profile[4].
Key Takeaways
- Patent Claim Construction: The court's construction of patent claims is critical and relies heavily on intrinsic evidence.
- Intrinsic vs. Extrinsic Evidence: Intrinsic evidence is more reliable in claim construction.
- Prosecution History: The prosecution history is essential in understanding the intent of the applicant and the examiner.
- Restriction Requirements: These are non-substantive administrative procedures and do not limit the scope of claims as argued by defendants.
- Settlements and Licensing: Settlements can provide licenses for generic versions of patented products after certain exclusivity periods.
FAQs
Q: What were the main patents in dispute in the Shire Development LLC v. Teva Pharmaceuticals USA, Inc. case?
A: The main patents in dispute were related to pharmaceutical compositions for sustained release of amphetamines or amphetamine salts, particularly the '768 Patent.
Q: How does the court determine the meaning of disputed terms in patent claims?
A: The court determines the meaning using both intrinsic evidence (patent claims, specification, and prosecution history) and extrinsic evidence (external sources like expert testimony).
Q: What is the significance of the prosecution history in patent litigation?
A: The prosecution history is crucial in understanding the intent of the applicant and the examiner, helping to clarify the meaning of disputed terms.
Q: What was the outcome of the settlement between Shire and Teva regarding INTUNIV?
A: The settlement allowed Teva to market generic versions of INTUNIV after the expiration of the 180-day exclusivity period granted to Actavis.
Q: Why is intrinsic evidence considered more reliable than extrinsic evidence in claim construction?
A: Intrinsic evidence is considered more reliable because it directly reflects the intent of the applicant and the examiner as recorded in the patent and its prosecution history.
Cited Sources
- Shire Development, LLC v. Watson Pharmaceuticals, Inc. - Casetext
- Shire Settles Patent Infringement Lawsuit Against Teva Concerning INTUNIV - PR Newswire
- Shire Development LLC, Shire LLC, and Shire US Inc., v. Teva Pharmaceuticals USA, Inc., et al. - District of Delaware
- Shire Dev. LLC v. Teva Pharms. United States, Inc. - Casetext
- Shire Settles Patent Infringement Lawsuit Against Teva Concerning INTUNIV - Takeda Newsroom
