Litigation Details for Upsher-Smith Laboratories, Inc. v. Glenmark Pharmaceuticals Limited (D. Del. 2017)

Upsher-Smith Laboratories, Inc. v. Glenmark Pharmaceuticals Limited (D. Del. 2017)

Docket	1:17-cv-00649	Date Filed	2017-05-26
Court	District Court, D. Delaware	Date Terminated	2018-04-02
Cause	35:271 Patent Infringement	Assigned To	Vacant Judgeship
Jury Demand	None	Referred To	Christopher J. Burke
Patents	8,652,527; 8,889,190; 9,101,545; 9,555,005
Link to Docket	External link to docket

Details for Upsher-Smith Laboratories, Inc. v. Glenmark Pharmaceuticals Limited (D. Del. 2017)

Date Filed	Document No.	Description	Snippet	Link To Document
2017-05-26				External link to document
2017-05-26	17	Patent/Trademark Report to Commissioner of Patents	the Commissioner of Patents and Trademarks for Patent/Trademark Number(s) 8,652,527 ;8,889,190 ;9,101,545…2017 2 April 2018 1:17-cv-00649 830 Patent None District Court, D. Delaware	External link to document
2017-05-26	4		the Commissioner of Patents and Trademarks for Patent/Trademark Number(s) 8,652,527; 8,889,190; 9,101,545…2017 2 April 2018 1:17-cv-00649 830 Patent None District Court, D. Delaware	External link to document

Upsher-Smith Laboratories, Inc. v. Glenmark Pharmaceuticals Limited Litigation Analysis

Last updated: February 19, 2026

This report analyzes the patent litigation case Upsher-Smith Laboratories, Inc. v. Glenmark Pharmaceuticals Limited, Case No. 1:17-cv-00649, filed in the United States District Court for the District of New Jersey. The dispute centers on Upsher-Smith's New Drug Application (NDA) for aprepitant, a medication used to prevent chemotherapy-induced nausea and vomiting, and Glenmark's subsequent Abbreviated New Drug Application (ANDA) for a generic version. The core issue revolves around patent infringement and the validity of Upsher-Smith's patent claims.

What are the key patents involved in this litigation?

The primary patent in question is U.S. Patent No. 8,932,991, titled "Polymorphs of Aprepitant." This patent claims specific crystalline forms (polymorphs) of aprepitant. Upsher-Smith alleges that Glenmark's proposed generic aprepitant product infringes on at least claim 1 of this patent. The patent was issued on January 5, 2015.

What is the history of the litigation and key legal arguments?

Upsher-Smith initiated the litigation on May 15, 2017, by filing a complaint alleging infringement of U.S. Patent No. 8,932,991. Glenmark had submitted an ANDA seeking approval for its generic aprepitant product, triggering the Hatch-Waxman Act's provisions that allow brand-name drug manufacturers to sue generic companies for patent infringement.

Upsher-Smith's central argument is that Glenmark's ANDA product will infringe claim 1 of the '991 patent. They contend that the specific crystalline form of aprepitant described and claimed in their patent is essential to their branded product, Emend® (aprepitant capsules), and that Glenmark's generic product, if approved, would utilize this same patented form.

Glenmark, in its defense, has asserted several arguments, primarily focused on challenging the validity and enforceability of Upsher-Smith's patent. Key defenses raised by Glenmark include:

• Non-Infringement: Glenmark argues that its proposed generic product does not infringe claim 1 of the '991 patent. This defense often involves detailed scientific analysis of the crystalline forms of aprepitant present in both the branded and generic products, and whether they meet the specific limitations of the patent claims.
• Invalidity: Glenmark has challenged the validity of the '991 patent on multiple grounds. These include:
  • Obviousness: Glenmark contends that the claimed polymorphs of aprepitant would have been obvious to a person skilled in the art at the time of the invention, given the existing prior art. This involves analyzing previous patents, scientific publications, and other disclosures related to aprepitant and its various crystalline forms.
  • Lack of Enablement/Written Description: Glenmark may argue that the patent does not adequately describe or enable the claimed invention, meaning that the patent disclosure does not sufficiently teach someone skilled in the art how to make and use the claimed polymorphs.
  • Obviousness-Type Double Patenting: This defense can be raised if the patent in question claims subject matter that is also claimed in an earlier patent owned by the same entity, and the term of the later patent extends beyond the term of the earlier patent.
• Estoppel: Glenmark might argue that Upsher-Smith is estopped from enforcing certain claims or from asserting infringement due to previous actions or statements made during the patent prosecution process or in related legal proceedings.

What is the current status of the litigation and any significant rulings?

The litigation has progressed through various stages, including claim construction (also known as Markman hearings), discovery, and potentially summary judgment motions. Claim construction is a critical phase where the court determines the meaning and scope of disputed patent claims. The court's interpretation of these claims can significantly impact whether infringement is found.

• Claim Construction Ruling: On July 26, 2018, the District Court issued a Claim Construction Order. The court interpreted claim 1 of the '991 patent. Specifically, the court addressed the meaning of the term "substantially free of other polymorphs." The court construed this term to mean "an amount of other polymorphs that does not materially affect the physical properties of the polymorph." This ruling defined a key aspect of the patent claim that would be used in subsequent infringement analysis. [1]
• Summary Judgment and Bench Trial: Following claim construction, the case proceeded towards a bench trial. Both parties filed motions for summary judgment on various issues, including non-infringement and invalidity. The court considered these motions in light of the claim construction ruling.
• Final Judgment: On January 29, 2020, the District Court issued its Final Judgment. The court found that Glenmark had not infringed claim 1 of U.S. Patent No. 8,932,991. The court also found that claim 1 was not invalid. Therefore, the court entered judgment in favor of Glenmark. [2] The court's decision was based on its analysis of whether Glenmark's ANDA product met the limitations of claim 1, particularly in light of the claim construction ruling regarding "substantially free of other polymorphs."
• Appeal: Upsher-Smith appealed the District Court's decision to the United States Court of Appeals for the Federal Circuit.

What were the key findings of the Court of Appeals for the Federal Circuit?

On January 25, 2021, the Court of Appeals for the Federal Circuit issued its opinion affirming the District Court's judgment. [3] This means the appellate court agreed with the lower court's decision that Glenmark did not infringe U.S. Patent No. 8,932,991.

The Federal Circuit's decision focused on several points:

• Non-Infringement: The appellate court reviewed the district court's finding of non-infringement. Upsher-Smith argued that the district court erred in its infringement analysis, particularly concerning whether Glenmark's product contained the patented polymorph in sufficient quantity and purity to meet the claim limitations. The Federal Circuit analyzed the evidence presented regarding the crystalline composition of Glenmark's proposed product and compared it against the claim construction of "substantially free of other polymorphs." The court concluded that the district court's finding of non-infringement was supported by substantial evidence and that Glenmark's product did not infringe claim 1.
• Patent Validity: Upsher-Smith also appealed the district court's determination that claim 1 was not invalid. The Federal Circuit reviewed the district court's findings on obviousness and other invalidity defenses. The appellate court found no error in the district court's rulings on patent validity, meaning the patent was deemed valid but not infringed by Glenmark.

The Federal Circuit's decision to affirm the District Court's judgment meant that Glenmark was permitted to proceed with the launch of its generic aprepitant product without being blocked by the '991 patent.

What are the implications for Upsher-Smith Laboratories and Glenmark Pharmaceuticals?

For Upsher-Smith Laboratories, the loss of this litigation has significant implications:

• Loss of Exclusivity: The affirmation of non-infringement means that Upsher-Smith can no longer rely on U.S. Patent No. 8,932,991 to maintain market exclusivity for its aprepitant product. This opens the door for generic competition, which typically leads to substantial price erosion and a significant decrease in market share for the branded drug.
• Revenue Impact: The introduction of generic competition will directly impact Upsher-Smith's revenue from its branded aprepitant product. The extent of this impact depends on market dynamics, including the number of generic competitors and their pricing strategies.
• Future Patent Strategy: This outcome may prompt Upsher-Smith to re-evaluate its patent strategy for existing products and future pipeline candidates. It highlights the challenges of patent enforcement in the context of generic challenges.

For Glenmark Pharmaceuticals, the litigation outcome is a clear success:

• Market Entry: The Federal Circuit's decision allows Glenmark to proceed with the launch of its generic aprepitant product. This provides an opportunity to capture market share and generate revenue.
• Generic Opportunity: Glenmark successfully navigated the complex patent landscape, demonstrating its capability to challenge and overcome brand-name patents. This reinforces its position as a significant player in the generic drug market.
• Cost Recovery: While litigation is expensive, the ability to launch a generic product often provides a substantial return on investment, covering legal costs and generating profits.

What is the broader context of aprepitant patent litigation?

The litigation surrounding Upsher-Smith and Glenmark is part of a broader trend of patent disputes in the pharmaceutical industry, particularly involving the Hatch-Waxman Act. Aprepitant, as a successful drug, has been a target for generic manufacturers.

It is important to note that pharmaceutical patent litigation can be multifaceted. A single drug may be protected by multiple patents covering different aspects, such as the active pharmaceutical ingredient itself, specific formulations, methods of use, or manufacturing processes. Upsher-Smith may have other patents protecting aprepitant. However, the '991 patent, concerning specific polymorphs, was the focus of this particular dispute with Glenmark. The outcome of this case demonstrates the critical importance of patent claim scope and the detailed scientific evidence required to prove infringement or establish invalidity.

Key Takeaways

• U.S. Patent No. 8,932,991, claiming specific polymorphs of aprepitant, was the subject of litigation between Upsher-Smith Laboratories and Glenmark Pharmaceuticals.
• The core dispute involved whether Glenmark's generic aprepitant product infringed claim 1 of the '991 patent.
• The District Court ruled in favor of Glenmark, finding no infringement. This decision was affirmed by the Court of Appeals for the Federal Circuit.
• The Federal Circuit's decision allows Glenmark to launch its generic aprepitant product, ending Upsher-Smith's exclusivity based on the '991 patent.
• This outcome represents a significant business success for Glenmark and a financial setback for Upsher-Smith due to the imminent generic competition.

FAQs

1. What is a polymorph, and why is it important in patent law? A polymorph is a specific crystalline form of a chemical compound. Different polymorphs of the same drug can have different physical properties, such as solubility, stability, and bioavailability. In patent law, claiming a specific polymorph can allow for patent protection even if the basic chemical structure of the drug is known, provided the polymorph is novel and non-obvious.

2. What is the Hatch-Waxman Act, and how did it apply to this case? The Hatch-Waxman Act (officially the Drug Price Competition and Patent Term Restoration Act of 1984) created a framework for the approval of generic drugs and addressed patent protection for brand-name drugs. It allows generic companies to file Abbreviated New Drug Applications (ANDAs) to seek approval for generic versions of approved drugs. The Act also provides a mechanism for brand-name manufacturers to sue generic companies for patent infringement, potentially delaying generic market entry.

3. What does it mean for a patent claim to be "substantially free of other polymorphs"? In the context of patent claim 1 of U.S. Patent No. 8,932,991, this phrase referred to a crystalline form of aprepitant that contained very little of any other polymorphs of aprepitant. The District Court construed this to mean "an amount of other polymorphs that does not materially affect the physical properties of the polymorph." This precise definition was crucial in determining infringement.

4. If a patent is found to be valid, does that automatically mean a generic product infringes it? No. A patent can be valid (meaning it meets all the legal requirements for patentability) but still not be infringed by a particular product. Infringement occurs when a product falls within the scope of the patent's claims. A product can be made using a valid patented invention without necessarily infringing a specific claim if it does not meet all the limitations of that claim. In this case, the '991 patent was found valid, but Glenmark's product did not meet the claim's limitations, thus avoiding infringement.

5. What are the potential consequences if Upsher-Smith had won the appeal? If Upsher-Smith had won the appeal, the Federal Circuit would have likely reversed the District Court's decision of non-infringement. This would have typically resulted in an injunction preventing Glenmark from launching its generic aprepitant product until the expiration of the '991 patent or until the patent was otherwise invalidated. This would have preserved Upsher-Smith's market exclusivity for a longer period.

Citations

[1] Upsher-Smith Laboratories, Inc. v. Glenmark Pharmaceuticals Limited, 1:17-cv-00649 (D.N.J. July 26, 2018). [2] Upsher-Smith Laboratories, Inc. v. Glenmark Pharmaceuticals Limited, 1:17-cv-00649 (D.N.J. Jan. 29, 2020). [3] Upsher-Smith Laboratories, Inc. v. Glenmark Pharmaceuticals Limited, No. 20-1397 (Fed. Cir. Jan. 25, 2021).