Litigation Details for MITSUBISHI TANABE PHARMA CORPORATION v. SANDOZ INC. (D.N.J. 2017)

MITSUBISHI TANABE PHARMA CORPORATION v. SANDOZ INC. (D.N.J. 2017)

Docket		Date Filed	2017-07-20
Court	District Court, D. New Jersey	Date Terminated
Cause	15:1126 Patent Infringement	Assigned To	Freda L. Wolfson
Jury Demand	None	Referred To
Patents	7,943,788; 8,222,219; 8,785,403
Link to Docket	External link to docket

Details for MITSUBISHI TANABE PHARMA CORPORATION v. SANDOZ INC. (D.N.J. 2017)

Date Filed	Document No.	Description	Snippet	Link To Document
2017-07-20	173	Opinion	infringement of U.S. Patent Nos. 7,943,788 (“the ’788 patent), 8,222,219 (“the ’219 patent), and 8,785,403… (“the ’403 patent”) (collectively, “the patents-in-suit”). Compl. at ¶ 10. The patents-in-suit are… B. Local Patent Rules Pursuant to the Local Patent Rules for the District of…Local Patent Rules. Zydus contends that the “priority date” disclosure required by Local Patent Rule….D. Cal. July 17, 2015) (“Patent L.R. 3-1(f) particularly requires a patent holder to assert a specific	External link to document

MITSUBISHI TANABE PHARMA CORPORATION v. SANDOZ INC.: A Landmark Patent Infringement Case

The pharmaceutical industry is no stranger to complex patent litigation, and the case of MITSUBISHI TANABE PHARMA CORPORATION v. SANDOZ INC. (3:17-cv-05319-FLW-DEA) stands out as a significant example. This high-stakes legal battle, which unfolded in the United States District Court for the District of New Jersey, offers valuable insights into patent infringement claims, the intricacies of drug development, and the challenges faced by both innovator and generic pharmaceutical companies.

Background of the Case

The lawsuit was initiated by Mitsubishi Tanabe Pharma Corporation (MTPC) and several Janssen entities (collectively referred to as "Plaintiffs") against Zydus Pharmaceuticals (USA) Inc. ("Zydus" or "Defendant"). The core of the dispute revolved around patents related to the drugs Invokana and Invokamet, which are used to treat type 2 diabetes.

The Patents at Stake

The litigation centered on three key patents:

1. United States Patent Number 7,943,788 ("the '788 Patent")
2. United States Patent Number 8,222,219 ("the '219 Patent")
3. United States Patent Number 8,785,403 ("the '403 Patent")

These patents collectively protect the pharmaceutical composition and treatment methods associated with the Invokana Products.

The Alleged Infringement

The crux of the Plaintiffs' infringement claims stemmed from Zydus's filing of Abbreviated New Drug Applications (ANDAs) with the Food and Drug Administration (FDA). These ANDAs sought approval for the commercial manufacture and marketing of generic versions of Invokana and Invokamet before the expiration of the patents-in-suit.

Legal Proceedings and Key Issues

The case, presided over by Chief Judge Freda L. Wolfson, involved a six-day bench trial conducted remotely due to the COVID-19 pandemic. The trial focused on two primary issues:

1. Whether the patents-in-suit were invalid as obvious
2. Whether claims 12 and 20 of the '788 Patent were invalid under the doctrine of obviousness-type double patenting

Zydus's Defense Strategy

Interestingly, Zydus did not contest the infringement itself. Instead, the company stipulated that its submission of the ANDAs and any commercial activities related to the ANDA products before the expiration of the patents-in-suit would indeed infringe on the asserted claims. This strategic move shifted the focus of the trial to the validity of the patents themselves.

The Obviousness Challenge

Zydus's primary defense rested on the claim that the asserted patents were invalid due to obviousness. In patent law, an invention is considered obvious if a person with ordinary skill in the relevant field could have easily created it using existing knowledge at the time of invention. This defense strategy aimed to undermine the novelty and non-obviousness requirements for patent validity.

Obviousness-Type Double Patenting

Additionally, Zydus challenged claims 12 and 20 of the '788 Patent under the doctrine of obviousness-type double patenting. This legal concept prevents patent owners from extending their monopoly by obtaining multiple patents on obvious variations of the same invention.

Expert Testimony and Evidence

The trial featured extensive expert testimony from both sides. Numerous experts in fields such as chemistry, pharmacology, and economics provided their insights on the issues of obviousness and obviousness-type double patenting.

Plaintiffs' Expert Witnesses

The Plaintiffs presented expert testimony to support the non-obviousness of their patents and to defend against the double patenting allegations. These experts likely focused on the innovative aspects of the Invokana Products and the unexpected benefits they provided in treating type 2 diabetes.

Defendant's Expert Witnesses

Zydus, on the other hand, brought forward four expert witnesses:

1. Thomas T. Bannister, Ph.D.
2. DeForest McDuff, Ph.D.
3. Jonathan S. Velasco, M.D.
4. Bernhardt L. Trout, Ph.D.

These experts presumably provided testimony supporting Zydus's claims of patent invalidity due to obviousness and double patenting.

The Court's Findings

After careful consideration of all the evidence presented, Chief Judge Wolfson reached a decision that favored the Plaintiffs:

1. The patents-in-suit were found not to be invalid as obvious.
2. Claims 12 and 20 of the '788 Patent were determined not to be invalid under the doctrine of obviousness-type double patenting.

"After consideration of all the evidence, the Court finds that the patents-in-suit are not invalid as obvious and that claims 12 and 20 of the '788 Patent are not invalid under the doctrine of obviousness-type double patenting."[1]

This ruling effectively upheld the validity of the Plaintiffs' patents and, combined with Zydus's earlier stipulation, confirmed the infringement.

Implications of the Ruling

The court's decision in this case has several significant implications for the pharmaceutical industry and patent law:

1. Strength of Innovator Patents

The ruling reinforces the strength of patents held by innovator pharmaceutical companies. By rejecting the obviousness and double patenting challenges, the court has set a precedent that may make it more difficult for generic manufacturers to invalidate similar patents in the future.

2. Generic Entry Barriers

For generic drug manufacturers, this decision potentially raises the bar for entering the market with competing products. The unsuccessful challenge by Zydus may discourage other companies from pursuing similar strategies, potentially delaying the introduction of generic alternatives.

3. Importance of Expert Testimony

The case highlights the crucial role of expert testimony in patent litigation. The court's reliance on expert opinions underscores the need for companies to secure highly qualified and credible experts to support their positions in such cases.

4. Impact on Drug Pricing

By upholding the patents, the decision may indirectly affect drug pricing. The extended exclusivity period for Invokana and Invokamet could delay the entry of lower-cost generic alternatives, potentially impacting patients and healthcare systems.

Lessons for Pharmaceutical Companies

This case offers several valuable lessons for both innovator and generic pharmaceutical companies:

1. Robust Patent Strategies

Innovator companies should focus on developing robust patent portfolios that can withstand scrutiny on multiple fronts, including obviousness and double patenting challenges.

2. Thorough Prior Art Searches

Generic manufacturers must conduct exhaustive prior art searches and carefully evaluate the strength of their invalidity arguments before pursuing ANDA filings and subsequent litigation.

3. Strategic Use of Stipulations

Zydus's decision to stipulate to infringement and focus on invalidity arguments demonstrates the importance of strategic decision-making in patent litigation. Companies should carefully weigh the pros and cons of such approaches.

4. Preparation for Remote Trials

The successful conduct of this trial in a remote setting due to the COVID-19 pandemic illustrates the need for companies and their legal teams to be prepared for virtual litigation environments.

The Appeal Process

Following the district court's decision, Zydus filed an appeal with the United States Court of Appeals for the Federal Circuit. This move indicates that the legal battle is far from over and highlights the high stakes involved in pharmaceutical patent litigation.

Potential Outcomes of the Appeal

The appeal process opens up several possibilities:

1. The Federal Circuit could affirm the district court's decision, solidifying the victory for MTPC and Janssen.
2. The appellate court might reverse the ruling, potentially invalidating the patents and opening the door for Zydus's generic products.
3. A partial reversal or remand could lead to further proceedings at the district court level.

Broader Impact on the Pharmaceutical Industry

The MITSUBISHI TANABE PHARMA CORPORATION v. SANDOZ INC. case serves as a microcosm of the ongoing tensions between innovator and generic pharmaceutical companies. It highlights several industry-wide issues:

1. Innovation vs. Accessibility

The case underscores the delicate balance between protecting innovation through strong patent rights and ensuring access to affordable medications through generic competition.

2. Litigation Costs

The extensive nature of this litigation, involving multiple experts and a six-day trial, emphasizes the significant costs associated with pharmaceutical patent disputes. These costs can impact both innovator and generic companies, potentially influencing their strategic decisions.

3. Regulatory Landscape

The case draws attention to the complex regulatory environment surrounding drug approvals and patent challenges, highlighting the need for companies to navigate these waters carefully.

4. Future of Generic Challenges

The outcome of this case and its appeal may influence how generic manufacturers approach future patent challenges, potentially shaping the landscape of pharmaceutical competition.

Key Takeaways

1. The court upheld the validity of patents related to Invokana and Invokamet, rejecting claims of obviousness and obviousness-type double patenting.

2. Expert testimony played a crucial role in the court's decision, emphasizing the importance of securing qualified experts in patent litigation.

3. The case highlights the complex interplay between patent protection, generic competition, and drug accessibility in the pharmaceutical industry.

4. Strategic decisions, such as Zydus's stipulation to infringement, can significantly shape the course of patent litigation.

5. The ongoing appeal process underscores the high stakes and prolonged nature of pharmaceutical patent disputes.

6. The outcome of this case may influence future strategies for both innovator and generic pharmaceutical companies in patent litigation and drug development.

7. The successful conduct of a remote trial demonstrates the adaptability of the legal system to challenging circumstances like the COVID-19 pandemic.

FAQs

1. Q: What were the main patents involved in this case? A: The case involved three key patents: United States Patent Numbers 7,943,788, 8,222,219, and 8,785,403, which relate to the drugs Invokana and Invokamet used for treating type 2 diabetes.

2. Q: Why did Zydus stipulate to infringement? A: Zydus likely stipulated to infringement to focus its defense on challenging the validity of the patents through obviousness and obviousness-type double patenting arguments. This strategy allowed them to concentrate their resources on these specific legal challenges.

3. Q: How might this case affect future generic drug approvals? A: The case may raise the bar for generic manufacturers seeking to invalidate patents held by innovator companies. This could potentially delay the entry of some generic drugs into the market, affecting competition and pricing in the pharmaceutical industry.

4. Q: What is obviousness-type double patenting? A: Obviousness-type double patenting is a legal doctrine that prevents patent owners from extending their monopoly by obtaining multiple patents on obvious variations of the same invention. It ensures that patent protection doesn't extend beyond the statutory period through related patents.

5. Q: How might the ongoing appeal impact the pharmaceutical industry? A: The outcome of the appeal could have far-reaching consequences for both innovator and generic pharmaceutical companies. It may influence strategies for patent protection, challenge approaches, and ultimately affect the balance between innovation incentives and access to affordable medications.

Sources cited: [1] https://caselaw.findlaw.com/court/us-dis-crt-d-new-jer/2126788.html