Introduction
The litigation between Mylan Pharmaceuticals Inc. and Sanofi-Aventis U.S. LLC involves several complex legal battles, spanning patent disputes, antitrust allegations, and regulatory issues. Here, we will delve into the key aspects of these cases to provide a comprehensive understanding.
Patent Disputes: Sanofi-Aventis Deutschland GmbH v. Mylan Pharmaceuticals Inc.
Background
In a significant patent dispute, Mylan Pharmaceuticals Inc. challenged the validity of Sanofi-Aventis' '617 reissue patent through an inter partes review (IPR) before the Patent Trial and Appeal Board (PTAB)[1][5].
Key Arguments
Mylan argued that the challenged claims of the '617 patent were obvious based on a combination of three prior art references: U.S. Patent Application No. 2007/0021718 ("Burren"), U.S. Patent No. 2,882,901 ("Venezia"), and U.S. Patent No. 4,144,957 (related to clutch bearings in automobiles). Mylan contended that the combination of these references rendered the Sanofi patent obvious, particularly emphasizing that the '957 patent addressed a similar problem of axial fixation and support, despite being from a different field (automobiles vs. drug delivery devices)[1][5].
PTAB Decision and Appeal
The PTAB initially found all eighteen challenged claims of the '617 reissue patent to be invalid for obviousness, agreeing with Mylan's argument that the '957 patent was analogous art. However, on appeal, the Federal Circuit reversed this decision, holding that Mylan failed to show that the '957 patent was analogous art to the challenged '617 reissue patent claims. The court emphasized that Mylan did not meet its burden of proving obviousness, particularly in demonstrating the relevance of the '957 patent to the '617 patent[1][5].
Antitrust Allegations: Sanofi-Aventis U.S. LLC v. Mylan, Inc.
Background
Sanofi-Aventis U.S. LLC alleged that Mylan, Inc. and Mylan Specialty, LP monopolized the epinephrine auto-injector market, effectively foreclosing Sanofi's innovative epinephrine auto-injector, Auvi-Q, from the market. These allegations were made under Section 2 of the Sherman Antitrust Act[3].
District Court and Appellate Decisions
The district court granted Mylan's motion for summary judgment, finding no triable issue of exclusionary conduct or antitrust injury. The court detailed that Sanofi had access to a significant portion of the commercial market and that Mylan's rebate contracts did not substantially foreclose competition. The Tenth Circuit Court of Appeals affirmed this decision, concluding that Sanofi failed to present evidence of actual or threatened consumer harm, a necessary element for proving monopolization[3].
Key Findings
- The district court found that Sanofi's allegations of monopolization were unsupported, as Sanofi could compete for business and was not foreclosed from the market.
- The court also noted that an FDA recall, not Mylan's actions, caused Sanofi's exit from the market.
- The appellate court reaffirmed that Sanofi did not provide sufficient evidence to demonstrate exclusionary conduct or antitrust injury[2][3].
Regulatory Issues: Listing Patents in the Orange Book
Background
In a separate antitrust case, Mylan alleged that Sanofi improperly listed patents in the Orange Book for its insulin glargine product, Lantus, and its SoloSTAR pen. Mylan claimed that these patents were not applicable to the SoloSTAR product, thereby abusing the FDA regulatory process to maintain market dominance[4].
Key Allegations
- Mylan argued that Sanofi listed patents that only claimed the vial version of Lantus and later added patents related to injector pens that did not claim insulin glargine or the SoloSTAR product.
- The First Circuit reinstated a complaint from a class of direct purchasers alleging that Sanofi improperly listed one of the 2013 patents in the Orange Book[4].
Analysis
Patent Litigation
The patent dispute highlights the importance of demonstrating the relevance and analogy of prior art references in IPR proceedings. The Federal Circuit's reversal underscores that challengers must bear the burden of proving obviousness, including showing that all prior art references are analogous to the challenged patent claims.
Antitrust Litigation
The antitrust cases against Mylan emphasize the stringent standards for proving monopolization under the Sherman Act. Sanofi's failure to demonstrate exclusionary conduct and consumer harm was crucial in the courts' decisions to grant summary judgment in favor of Mylan. These cases illustrate the complexity of antitrust law and the need for robust evidence to support claims of monopolization.
Regulatory Compliance
The allegations regarding the improper listing of patents in the Orange Book highlight the importance of regulatory compliance in the pharmaceutical industry. Companies must ensure that patents listed are relevant and applicable to the products in question to avoid antitrust scrutiny.
Key Takeaways
- Burden of Proof in IPR: Challengers must demonstrate that all prior art references are analogous to the challenged patent claims to prove obviousness.
- Antitrust Standards: Proving monopolization under the Sherman Act requires evidence of exclusionary conduct and consumer harm.
- Regulatory Compliance: Pharmaceutical companies must ensure that patents listed in the Orange Book are relevant and applicable to avoid antitrust allegations.
FAQs
Q1: What was the basis of Mylan's challenge to Sanofi's '617 reissue patent?
Mylan challenged the '617 reissue patent based on a combination of three prior art references, arguing that these references rendered the Sanofi patent obvious.
Q2: Why did the Federal Circuit reverse the PTAB's decision in the patent dispute?
The Federal Circuit reversed the PTAB's decision because Mylan failed to show that the '957 patent was analogous art to the challenged '617 reissue patent claims.
Q3: What were Sanofi's allegations against Mylan in the antitrust case?
Sanofi alleged that Mylan monopolized the epinephrine auto-injector market, effectively foreclosing Sanofi's Auvi-Q from the market.
Q4: How did the courts rule on Sanofi's antitrust allegations?
The district court and the Tenth Circuit Court of Appeals ruled in favor of Mylan, finding no triable issue of exclusionary conduct or antitrust injury.
Q5: What regulatory issue was raised against Sanofi regarding its Lantus product?
Mylan alleged that Sanofi improperly listed patents in the Orange Book for its Lantus product and SoloSTAR pen, which were not applicable to these products.
Sources
- Sanofi-Aventis Deutschland GmbH v. Mylan Pharmaceuticals Inc. - JDSupra
- Mylan v. Sanofi - Supreme Court of the United States
- Sanofi-Aventis U.S. v. Mylan, et al. - Justia
- FTC Brief as Amicus Curiae - FTC
- Sanofi-Aventis Deutschlan GMBH v. Mylan Pharmaceuticals Inc. - JDSupra
