DCT
2:18-cv-09534
Boehringer Ingelheim Vetmedica Inc v. Intervet
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Boehringer Ingelheim Vetmedica, Inc. (Delaware)
- Defendant: Merck & Co., Inc. and Intervet Inc. a/k/a Merck Animal Health (New Jersey, Delaware)
- Plaintiff’s Counsel: Walsh Pizzi O'Reilly Falanga LLP
- Case Identification: 2:18-cv-09534, D.N.J., 05/21/2018
- Venue Allegations: Plaintiff alleges venue is proper because Defendant Merck & Co. is incorporated in New Jersey, and Defendant Merck Animal Health has committed acts of infringement and has regular and established places of business in the district.
- Core Dispute: Plaintiff alleges that Defendant’s Circumvent line of porcine vaccines infringes three patents related to compositions and methods for vaccinating pigs against Porcine Circovirus Type 2 (PCV2).
- Technical Context: PCV2 is a highly pathogenic virus that causes significant economic losses in the global swine industry through diseases like post-weaning multi-systemic wasting syndrome (PMWS).
- Key Procedural History: The complaint alleges that Defendant Merck was aware of the Asserted Patents, citing direct and indirect communications, including unsuccessful negotiations for a license from Plaintiff. It also alleges that Defendant’s marketing materials compare the accused products to Plaintiff’s own products, which are marked with the Asserted Patent numbers.
Case Timeline
| Date | Event |
|---|---|
| 2004-12-30 | U.S. Patent No. 9,011,872 Priority Date |
| 2005-12-29 | U.S. Patent Nos. 9,610,345 & 9,669,087 Priority Date |
| 2013-01-01 | Accused Products (Circumvent PCV G2, PCV-M G2) Launch |
| 2015-04-21 | U.S. Patent No. 9011872 Issues |
| 2017-04-04 | U.S. Patent No. 9610345 Issues |
| 2017-06-06 | U.S. Patent No. 9669087 Issues |
| 2018-05-21 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 9,011,872 - "PCV2 Immunogenic Compositions and Methods of Producing Such Compositions," issued April 21, 2015
The Invention Explained
- Problem Addressed: The patent’s background section describes that Porcine Circovirus Type-2 (PCV2) is responsible for economically devastating diseases in swine (Compl. ¶21; ’872 Patent, col. 1:50-2:15). It further notes that prior methods for producing the key vaccine antigen, ORF2 protein, required costly and inefficient extraction from host cells, which limited vaccine production scalability (’872 Patent, col. 2:25-40).
- The Patented Solution: The invention provides an improved method where host cells, infected with a recombinant virus (e.g., a baculovirus), express the ORF2 protein and secrete it into the surrounding liquid growth medium (the supernate). The protein is then recovered directly from this supernate, which avoids the costly and time-consuming cell-lysis extraction step and results in unexpectedly high yields of the protein (’872 Patent, Abstract; col. 3:1-10).
- Technical Importance: This method of recovering the antigenic protein from the supernate rather than the host cells was a significant process innovation that could make large-scale PCV2 vaccine production more efficient and economical.
Key Claims at a Glance
- The complaint asserts independent claim 1 and dependent claims 3-5, 11-14, and 20 (Compl. ¶54).
- Independent Claim 1 requires:
- An immunogenic composition comprising: an effective amount of recombinant PCV2 ORF2 protein
- and, an additional component selected from the group consisting of viral inactivators, inactivated viral vector, viral inactivator neutralizers, and combinations thereof
- wherein the composition provides a protective effect against clinical symptoms associated with a PCV2 infection after administration of a single dose.
- The complaint does not explicitly reserve the right to assert other dependent claims but the list is non-exclusive ("at least claims...").
U.S. Patent No. 9,610,345 - "Use of a PCV2 Immunogenic Composition for Lessening Clinical Symptoms in Pigs," issued April 4, 2017
The Invention Explained
- Problem Addressed: The patent background explains that PCV2 infection is associated with a wide array of clinical manifestations beyond PMWS, such as pneumonia, lymphoid depletion, and reproductive failures, and that prior vaccines had not been confirmed to be effective for treating this broader set of symptoms (’345 Patent, col. 1:53-2:14).
- The Patented Solution: The invention is a method of using an immunogenic composition containing the PCV2 ORF2 protein for the therapeutic purpose of preventing or reducing a specific list of clinical symptoms in pigs. A key aspect is the administration of a single efficacious dose to young piglets, particularly between 2 and 6 weeks of age (’345 Patent, Abstract; col. 2:48-51).
- Technical Importance: The patent claims a therapeutic method of use for a PCV2 vaccine, extending its application beyond simple prevention of infection to the reduction of a broad range of specific, economically significant clinical diseases in swine herds.
Key Claims at a Glance
- The complaint asserts independent claims 1 and 10, as well as numerous dependent claims (Compl. ¶61).
- Independent Claim 1 requires:
- A method for preventing and/or reducing one or more symptoms of PCV2 infection
- comprising administering to a piglet or a group of piglets 2-6 weeks of age a single efficacious dose of an immunogenic composition
- which comprises PCV2 ORF2 protein and at least one additional component (e.g., carrier, adjuvant).
- Independent Claim 10 is similar but specifies that the targeted symptoms are selected from a particular group, including PCV2 virus shedding and lymphoid infection.
U.S. Patent No. 9,669,087 - "Use of a PCV2 Immunogenic Composition for Lessening Clinical Symptoms in Pigs," issued June 6, 2017
- Technology Synopsis: This patent, related to the ’345 Patent, claims a method for preventing one or more clinical symptoms associated with PCV2 infection. The method involves administering a single dose of a composition containing porcine circovirus type 2 ORF2 protein to a pig to prevent symptoms like viral shedding, increased mortality rate, and decreased weight gain (’087 Patent, Abstract).
- Asserted Claims: The complaint asserts independent claim 1 and various dependent claims (Compl. ¶73).
- Accused Features: The complaint alleges that Defendant's method of administering the Circumvent Products to prevent PCV2 symptoms such as virus shedding infringes the ’087 Patent (Compl. ¶73, claim chart).
III. The Accused Instrumentality
Product Identification
- The accused products are Merck’s Circumvent PCV G2 and Circumvent PCV-M G2 vaccines (collectively, "Circumvent Products") (Compl. ¶32).
Functionality and Market Context
- The Circumvent Products are described as live vector vaccines that use a "killed baculovirus vector"—a genetically engineered insect virus—to produce the PCV2 ORF2 antigen and stimulate an immune response in pigs (Compl. ¶33-34). Both products are administered intramuscularly, with marketing materials highlighting a "single dose" option for piglets three weeks of age or older (Compl. ¶36, 45). The complaint includes an image of the Circumvent PCV G2 product label, which identifies the product as a "Porcine Circovirus Vaccine, Type 2, Killed Baculovirus Vector" (Compl. ¶37). The vaccines use an oil-in-water emulsion adjuvant and are intended to prevent viremia, reduce virus shedding, and aid in the reduction of lymphoid infection (Compl. ¶36, 41). The complaint alleges these products directly compete with Plaintiff's own PCV2 vaccines (Compl. ¶47-48).
IV. Analysis of Infringement Allegations
’872 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| An immunogenic composition comprising: a. an effective amount of recombinant PCV2 ORF2 protein | The Circumvent Products are immunogenic compositions that contain a recombinant PCV2 ORF2 protein antigen. | ¶54 | col. 16:21-25 |
| b. an additional component selected from the group consisting of viral inactivators, inactivated viral vector, viral inactivator neutralizers, and combinations thereof | The Circumvent Products contain PCV2 ORF2 proteins expressed in a killed baculovirus vector, which is alleged to be an "inactivated viral vector." | ¶34, ¶54 | col. 10:11-13 |
| c. said immunogenic composition provides a protective effect against clinical symptoms associated with a PCV2 infection after administration of a single dose. | The Circumvent Products are advertised and marketed as providing protection against PCV2 infection and are administered as a single dose. | ¶36, ¶45, ¶54 | col. 2:50-54 |
’345 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A method for preventing and/or reducing one or more symptoms of PCV2 infection comprising a. administering to a piglet or a group of piglets 2-6 weeks of age a single efficacious dose of immunogenic composition | The Circumvent Products are administered to piglets "three weeks or older as a single dose" for preventing/reducing symptoms of PCV2 infection. | ¶61 | col. 2:48-51 |
| b. comprising PCV2 ORF2 protein | The administered Circumvent Products contain PCV2 ORF2 proteins. | ¶61 | col. 6:21-26 |
| c. and at least one additional component selected from the group consisting of a veterinary-acceptable carrier, a pharmaceutical-acceptable carrier, an adjuvant... | The Circumvent Products contain adjuvants and are expressed in a killed baculovirus vector. | ¶16, ¶41 | col. 12:1-14 |
Identified Points of Contention
- Scope Questions: A central dispute for the ’345 Patent may concern the age limitation in Claim 1, which recites administration to piglets “2-6 weeks of age.” The complaint alleges the accused products are administered to piglets “three weeks or older” (Compl. ¶61), and the product label specifies a single dose for pigs "at 3 weeks of age or older" (Compl. ¶37). This raises the question of whether administration to a piglet older than six weeks, as permitted by the product's instructions, falls outside the literal scope of the claim. The complaint includes a marketing chart comparing Merck's product to Plaintiff's, which highlights Merck's product as usable in pigs "as early as 3 days of age" (Compl. ¶48). This further complicates the age-of-use analysis.
- Technical Questions: For the ’872 Patent, a potential issue is whether a composition containing a "killed baculovirus vector" that expresses the ORF2 protein meets the claim limitations of "comprising: a. an effective amount of recombinant PCV2 ORF2 protein" and "b. an additional component selected from the group consisting of... inactivated viral vector." The analysis may focus on whether the protein and the vector are distinct components within the composition in the manner required by the claim language.
V. Key Claim Terms for Construction
The Term: "a single dose" (’872 Patent, claim 1)
Context and Importance
- This term's construction is important because the accused products are primarily marketed for single-dose efficacy, but the product labeling also provides for a two-dose booster regimen for very young piglets (Compl. ¶36). Practitioners may focus on this term because Defendant could argue that a product with a labeled two-dose option does not infringe a claim functionally limited to efficacy after a "single dose," potentially creating a non-infringement defense for at least some uses.
Intrinsic Evidence for Interpretation
- Evidence for a Broader Interpretation: The plain meaning of the phrase refers to the act of administration. The patent specification repeatedly highlights the advantages of achieving protection after a single dose as a key benefit of the invention, suggesting the claim is directed at the functional outcome of one administration, regardless of other possible administration schedules (’872 Patent, col. 2:50-54).
- Evidence for a Narrower Interpretation: The claim requires that the composition "provides a protective effect... after administration of a single dose" (’872 Patent, col. 72:36-39). This could be interpreted as a functional requirement defining the specific capability of the claimed composition, potentially distinguishing it from a composition that is also designed for, and effective in, a multi-dose regimen.
The Term: "administering to a piglet or a group of piglets 2-6 weeks of age" (’345 Patent, claim 1)
Context and Importance
- The construction of this age range is central to the infringement analysis for the ’345 patent. The accused product label instructs administration "at 3 weeks of age or older" (Compl. ¶37), which does not have the 6-week upper limit of the claim. Practitioners may focus on this term because it creates a clear factual dispute over the scope of infringing activity.
Intrinsic Evidence for Interpretation
- Evidence for a Broader Interpretation: The patent specification discloses administration to pigs "of 3 weeks of age or older," and "preferably not older than 15 weeks of age," which is broader than the language used in claim 1 (’345 Patent, col. 2:48-51). Plaintiff may argue that the claim is a picture claim covering a preferred embodiment, and that infringement occurs whenever the product is used on any piglet within the 2-6 week range, a commercially significant application.
- Evidence for a Narrower Interpretation: The claim language "2-6 weeks of age" is precise and unambiguous. Defendant may argue that this language was a deliberate choice to capture a specific, narrow method and that any use on a piglet older than 6 weeks is a substantial, non-infringing use explicitly taught by the product label, defeating allegations of direct and induced infringement.
VI. Other Allegations
- Indirect Infringement: The complaint alleges Merck induces infringement by providing marketing materials and product labels that instruct veterinarians and farmers to administer the Circumvent Products to piglets in a manner that directly infringes, such as using a single dose on a three-week-old piglet (Compl. ¶45, 63, 75).
- Willful Infringement: Willfulness is alleged based on Merck’s purported pre-suit knowledge of the Asserted Patents. The complaint claims this knowledge arose from direct communications, including license negotiations with Plaintiff, and from Merck’s own marketing materials that compare the accused products to Plaintiff's products, which are marked with the patent numbers (Compl. ¶47, 49).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of definitional scope: does the method of use for the accused products, labeled for administration to pigs "at 3 weeks of age or older," infringe the ’345 patent’s claim limitation of administration to piglets "2-6 weeks of age"? The resolution will depend on whether infringement can be found for the overlapping uses and how the existence of substantial non-infringing uses (i.e., on pigs older than 6 weeks) impacts the inducement claims.
- A key question of claim construction for the ’872 patent will be whether a vaccine formulated with a "killed baculovirus vector" that expresses the ORF2 antigen meets the conjunctive requirement of a composition "comprising" both "recombinant PCV2 ORF2 protein" and an "inactivated viral vector" as separate components. The case may turn on whether the court views the protein as an integral part of the vector or as a distinct component within the final composition.