Introduction
The litigation between Par Pharmaceutical Inc and Pfizer Inc, specifically involving Hospira (a Pfizer unit), revolves around patent infringement and the approval of generic versions of Par's epinephrine emergency allergy product, Adrenalin. Here is a detailed summary and analysis of the key points in this case.
Background
Par Pharmaceutical Inc developed and marketed Adrenalin, an epinephrine emergency allergy treatment, after obtaining necessary regulatory approvals and patents. The patents in question, U.S. Patent Nos. 9,119,876 and 9,295,657, cover specific improvements related to the stability and shelf life of the product[1].
The Dispute
Hospira, a subsidiary of Pfizer, sought to enter the market with a generic version of Adrenalin. To do this, Hospira filed an Abbreviated New Drug Application (ANDA) with the FDA. Par Pharmaceutical Inc responded by filing a patent infringement lawsuit against Hospira under the Hatch-Waxman Act, alleging that Hospira's generic product infringed on Par's patents[1].
District Court Ruling
The U.S. District Court for the District of Delaware, presided over by Judge Joseph F. Bataillon, ruled in favor of Par Pharmaceutical Inc. The court found that Hospira's generic product infringed on Par's patents and issued an injunction preventing Hospira from manufacturing or selling its generic version until the patents expire in 2035[1].
Appeal to the Federal Circuit
Hospira appealed the district court's decision to the Federal Circuit. On appeal, Hospira argued that the district court erred in finding infringement because the claims in Par's patents required "about" six to eight milligrams of a certain compound, whereas Hospira's generic contained nine milligrams. However, the Federal Circuit affirmed the district court's ruling, stating that Hospira had not provided any authority to support its argument that Par's later statements should control over the evidence relied on by the district court[1].
Patent Validity
A crucial aspect of the case was the validity of Par's patents. Hospira argued that the patents would have been obvious based on prior art, but the district court determined that Hospira failed to show that a skilled artisan would have been motivated to combine the prior art references or that they would have reasonably expected to be successful if they did so[1].
Regulatory Context
The case highlights the complex regulatory history of epinephrine products. Both Par and Hospira had been selling epinephrine products before the current regulatory approval structure was in place and were granted exceptions to continue selling these products. However, in 2006, the FDA increased requirements for these unapproved drugs, leading Par to develop a product that met modern standards and eventually receive the patents at issue[1].
Financial Implications
The ruling has significant financial implications. Adrenalin generated over $179 million in revenue for Par in the year preceding the ruling, a 25% increase from the previous year. The injunction ensures that Par maintains its market exclusivity for the product until the patents expire in 2035[1].
Industry Impact
This case underscores the importance of patent protection in the pharmaceutical industry. It demonstrates how patent litigation can significantly impact the market entry of generic drugs and the revenue streams of both brand-name and generic drug manufacturers.
Key Takeaways
- Patent Infringement: The Federal Circuit affirmed that Hospira's generic version of Adrenalin infringed on Par's valid patents.
- Regulatory Compliance: The case emphasizes the importance of meeting modern regulatory requirements for drug products.
- Financial Consequences: The injunction prevents Hospira from entering the market, ensuring Par's continued market exclusivity and revenue.
- Patent Validity: The court's decision reinforced the validity of Par's patents, rejecting Hospira's arguments of obviousness.
FAQs
Q: What was the main issue in the litigation between Par Pharmaceutical Inc and Pfizer Inc?
A: The main issue was whether Hospira's generic version of Adrenalin infringed on Par's patents covering the drug.
Q: What was the outcome of the district court ruling?
A: The district court ruled in favor of Par, finding infringement and issuing an injunction against Hospira.
Q: What was the Federal Circuit's decision on appeal?
A: The Federal Circuit affirmed the district court's ruling, upholding the finding of infringement and the injunction.
Q: Why was the regulatory context important in this case?
A: The regulatory context was crucial because both companies had been selling epinephrine products under an exception to the current approval structure, and Par eventually obtained patents for meeting modern regulatory standards.
Q: What are the financial implications of this ruling?
A: The ruling ensures Par maintains market exclusivity for Adrenalin until the patents expire in 2035, protecting significant revenue streams.
Cited Sources
- Fed. Circ. Affirms Hospira's Generic Adrenalin Loss To Par - Law360, November 23, 2020.
- Par Pharmaceutical, Inc. v. TWi Pharmaceuticals, Inc. - Casetext, December 3, 2014.
- Pfizer, Inc. v. Food and Drug Admin. - Justia, October 5, 1990.
- Pfizer, Inc. v. Sandoz Inc. - Casetext.
- Puma v. AstraZeneca - District of Delaware, March 18, 2024.
