Case Overview
The case of Bayer Healthcare LLC v. Mylan Pharmaceuticals Inc., filed as 1:15-cv-01162 in the Delaware District Court, is a significant patent infringement lawsuit involving the pharmaceutical industry. Here is a detailed summary and analysis of the key aspects of this litigation.
Nature of the Action
This lawsuit is an action for patent infringement under the patent laws of the United States, specifically Title 35, U.S. Code. Bayer Healthcare LLC, Bayer Healthcare Pharmaceuticals Inc., and Onyx Pharmaceuticals, Inc. (collectively referred to as "Bayer" or "Plaintiffs") filed the complaint against Mylan Pharmaceuticals Inc. and Mylan Inc. (collectively referred to as "Mylan" or "Defendants")[4].
Patents-in-Suit
The lawsuit centers around several patents held by Bayer, including U.S. Patent No. 8,841,330 (the ’330 patent) and U.S. Patent No. 8,822,933 (the ’933 patent). These patents relate to the drug Xarelto (rivaroxaban), a factor Xa inhibitor used to prevent and treat blood clots[4].
Mylan’s ANDA Filing
Mylan filed an Abbreviated New Drug Application (ANDA) with the FDA seeking approval to market a generic version of Xarelto. This filing included a Paragraph IV certification, which asserts that Mylan’s proposed generic drug does not infringe the valid patents held by Bayer or that the patents are invalid[4].
Jurisdiction and Venue
The Delaware District Court has subject matter jurisdiction over this case pursuant to 28 U.S.C. §§ 1331, 1338(a), 2201, and 2202. Personal jurisdiction over Mylan is established because Mylan has registered to do business in Delaware and has appointed a registered agent in the state to accept service of process[4].
Infringement Allegations
Bayer alleges that Mylan’s ANDA product will infringe the ’933 patent upon FDA approval. Bayer claims that Mylan knows and intends to market, use, distribute, offer for sale, and sell its generic product in the United States, including in Delaware, which would constitute infringement of the ’933 patent[4].
Defenses and Counterclaims
Mylan’s defense includes challenging the validity of Bayer’s patents and arguing that their generic product does not infringe the patents in question. Mylan also seeks a declaration of non-infringement and invalidity of the patents, which is a common strategy in ANDA litigation to clear the path for FDA approval of their generic drug[4].
Legal Expenses and Tax Implications
Although not directly part of this specific case, it is worth noting that Mylan has incurred significant legal expenses in defending against patent infringement suits related to their ANDA filings. In a separate case, Mylan Inc. v. Commissioner of Internal Revenue, the Third Circuit held that legal expenses incurred to defend patent infringement suits are deductible as ordinary and necessary business expenses, while expenses for preparing notice letters must be capitalized as part of the FDA approval process[2].
Hatch-Waxman Act Considerations
The Hatch-Waxman Act plays a crucial role in this litigation. Mylan’s Paragraph IV certification triggers a 45-day period during which Bayer can file a patent infringement lawsuit, which can stay the FDA’s approval of Mylan’s ANDA for up to 30 months. In a related case, Mylan Pharms. Inc. v. Bayer Intellectual Property GmbH, Mylan sought a declaratory judgment of non-infringement to address potential delays in FDA approval due to patent issues, highlighting the complex interplay between patent litigation and FDA approval processes under the Hatch-Waxman Act[1].
Court Decisions and Rulings
The court has to consider several key issues, including the validity of Bayer’s patents, whether Mylan’s ANDA product infringes these patents, and the impact of any potential infringement on Mylan’s market entry. In similar cases, courts have often grappled with the best mode requirement under 35 U.S.C. § 112 and the entitlement to earlier filing dates for patent applications, as seen in Bayer AG v. Schein Pharm., Inc.[5].
Impact on Market Entry
The outcome of this litigation has significant implications for Mylan’s ability to enter the market with a generic version of Xarelto. If Mylan prevails, it could gain earlier market entry, potentially disrupting Bayer’s exclusivity period and impacting the pharmaceutical market dynamics.
Key Takeaways
- Patent Infringement Claims: Bayer alleges that Mylan’s generic version of Xarelto will infringe their patents.
- ANDA Filings: Mylan’s ANDA filing includes a Paragraph IV certification challenging the validity or non-infringement of Bayer’s patents.
- Jurisdiction and Venue: The Delaware District Court has jurisdiction over the case due to Mylan’s business activities in the state.
- Hatch-Waxman Act: The Act’s provisions govern the interplay between patent litigation and FDA approval processes.
- Legal Expenses: Significant legal expenses are incurred by generic drug manufacturers in defending against patent infringement suits.
FAQs
Q: What is the main issue in the Bayer Healthcare LLC v. Mylan Pharmaceuticals Inc. lawsuit?
A: The main issue is whether Mylan’s generic version of Xarelto infringes Bayer’s patents and whether Mylan can obtain FDA approval despite these patent claims.
Q: What is a Paragraph IV certification in the context of ANDA filings?
A: A Paragraph IV certification is a statement by the ANDA applicant that the proposed generic drug does not infringe the valid patents held by the brand-name drug manufacturer or that the patents are invalid.
Q: How does the Hatch-Waxman Act affect this litigation?
A: The Hatch-Waxman Act allows for a 45-day period for the brand-name manufacturer to file a patent infringement lawsuit, which can delay FDA approval of the generic drug.
Q: What are the implications of this litigation for Mylan’s market entry?
A: If Mylan prevails, it could gain earlier market entry with its generic version of Xarelto, potentially disrupting Bayer’s exclusivity period.
Q: How are legal expenses treated in ANDA-related patent litigation?
A: Legal expenses incurred to defend patent infringement suits are generally deductible as ordinary and necessary business expenses, while expenses for preparing notice letters must be capitalized.
Cited Sources
- Mylan Pharms. Inc. v. Bayer Intellectual Property GmbH, C.A. No. 23-556-RGA, 2024 WL 359468 (D. Del. Jan. 31, 2024)
- Mylan Inc v. Commissioner of Internal Revenue, No. 22-1193 (3d Cir. 2023)
- Bayer Healthcare LLC et al. v. Mylan Inc et al., Case docket and documents for 1:15-cv-01162
- Bayer Healthcare LLC, et al. v. Mylan Pharmaceuticals Inc., et al., Complaint, Case 1:15-cv-01162-UNA
- Bayer AG v. Schein Pharm., Inc., 129 F.Supp.2d 705 (D.N.J.2001)
