DCT
2:10-cv-02734
Bayer Healthcare Pharma Inc v. Biogen Idec Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Bayer HealthCare Pharmaceuticals Inc. (Delaware)
- Defendant: Biogen Idec MA Inc. (Delaware)
- Plaintiff’s Counsel: Greenbaum, Rowe, Smith & Davis LLP
- Case Identification: 2:10-cv-02734, D.N.J., 04/04/2011
- Venue Allegations: Plaintiff asserts that venue is proper based on Defendant’s persistent and continuous business contacts within the District of New Jersey, including the development, sale, and distribution of pharmaceutical products.
- Core Dispute: Plaintiff seeks a declaratory judgment that its multiple sclerosis drug Betaseron® does not infringe Defendant’s U.S. Patent No. 7,588,755, and that the patent is invalid and unenforceable.
- Technical Context: The lawsuit concerns foundational recombinant DNA technology for producing human fibroblast interferon (interferon-beta), a protein used as a therapeutic agent for immunomodulatory conditions like multiple sclerosis.
- Key Procedural History: The complaint details a nearly 30-year prosecution history for the patent-in-suit, which originated from a 1981 application. A central allegation is that the patent is unenforceable due to inequitable conduct. Plaintiff alleges that Defendant made contradictory arguments regarding the obviousness of expressing the interferon gene to the U.S. Patent and Trademark Office (USPTO) and the Canadian Patent Office. Specifically, to overcome a rejection in the U.S., Defendant allegedly argued there was "no reasonable expectation of success," while simultaneously arguing in a sworn Canadian affidavit that such expression was expected and routine. The complaint alleges these contradictory Canadian filings were not properly disclosed to the USPTO.
Case Timeline
| Date | Event |
|---|---|
| 1980-04-30 | '755 Patent Priority Date (GB App. No. 8011306) |
| 1981-04-03 | Initial U.S. patent application filed on behalf of Dr. Fiers |
| 1993-01-01 | Betaseron® approved by the Food and Drug Administration (approx. date) |
| 1997-03-24 | Biogen's response to USPTO arguing no reasonable expectation of success |
| 1997-10-10 | Biogen's further response to USPTO arguing no reasonable expectation of success |
| 2001-11-19 | Dr. Fiers's sworn affidavit filed in Canadian prosecution |
| 2009-04-27 | USPTO issues Notice of Allowance for the '755 patent |
| 2009-06-05 | Alleged "document dump" of 1900+ pages to USPTO |
| 2009-09-15 | U.S. Patent No. 7,588,755 issues |
| 2009-09-22 | Biogen sends letter to Bayer initiating licensing discussions |
| 2011-04-04 | Complaint for Declaratory Judgment filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 7,588,755 - DNA Sequences, Recombinant DNA Molecules and Processes for Producing Human Fibroblast Interferon-like Polypeptides
Issued September 15, 2009.
The Invention Explained
- Problem Addressed: The patent's background section describes that while human fibroblast interferon (IFN-β) showed promise as a therapeutic agent, it was exceedingly difficult to isolate in sufficient quantities from natural sources like human diploid cells to be clinically useful (’755 Patent, col. 2:38-53; Compl. ¶32).
- The Patented Solution: The invention provides a method to overcome this scarcity by using recombinant DNA technology. The process involves identifying and isolating the DNA sequence that codes for IFN-β, inserting that DNA into a cloning vehicle (such as a plasmid), and introducing that recombinant molecule into a non-human host organism (e.g., E. coli bacteria). This transformed host then acts as a biological factory, producing large, clinically viable quantities of the desired interferon polypeptide (’755 Patent, Abstract; col. 5:4-29; Fig. 1).
- Technical Importance: This recombinant approach was a cornerstone of the modern biotechnology industry, enabling the mass production of therapeutic proteins that were previously rare and expensive, thereby making new treatments possible (Compl. ¶30-31).
Key Claims at a Glance
- The complaint identifies Claim 1 as being at issue (Compl. ¶45).
- The essential elements of independent claim 1 are:
- A method for immunomodulation or treating a viral condition, a viral disease, cancers or tumors;
- comprising the step of administering to a patient a therapeutically effective amount of a composition;
- wherein the composition comprises a recombinant polypeptide produced by a non-human host;
- the host having been transformed by a recombinant DNA molecule that includes a DNA sequence coding for a polypeptide with antiviral activity;
- and said DNA sequence is operatively linked to an expression control sequence.
- The complaint seeks a declaration that all claims of the patent are invalid and unenforceable, thereby implicating the dependent claims as well (Compl. ¶26, ¶71).
III. The Accused Instrumentality
Product Identification
- The accused instrumentality is the importation, manufacture, use, or sale of Betaseron® (Compl. ¶1).
Functionality and Market Context
- Betaseron® is a protein pharmaceutical based on interferon beta-1b and is approved by the FDA for treating relapsing forms of multiple sclerosis (Compl. ¶1, ¶7). Its administration to patients for this purpose is alleged by Defendant to constitute the "method for immunomodulation" recited in the patent's claims.
- The complaint highlights the product's commercial significance, noting its global sales exceed one billion dollars (Compl. ¶8).
IV. Analysis of Infringement Allegations
As this is a declaratory judgment action filed by the accused infringer, the complaint frames the dispute as one of non-infringement. The infringement theory described is that which Plaintiff Bayer attributes to Defendant Biogen. The complaint does not contain a detailed claim chart but outlines the general basis of the dispute.
Claim Chart Summary
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality (Inferred from Complaint) | Complaint Citation | Patent Citation |
|---|---|---|---|
| A method for immunomodulation...comprising the step of administering to a patient in need of such treatment a therapeutically effective amount of a composition... | The FDA-approved use of Betaseron® is for treating multiple sclerosis, which involves administering a therapeutically effective dose of the drug to patients. | ¶1, ¶7 | col. 49:60-63 |
| ...a composition comprising: / a recombinant polypeptide produced by a non-human host... | Betaseron® is a protein pharmaceutical based on interferon beta-1b (Compl. ¶7), which is produced using the recombinant DNA techniques described as the basis of the invention (Compl. ¶30-32). | ¶7, ¶45 | col. 1:15-24 |
| ...transformed by a recombinant DNA molecule comprising a DNA sequence...which code [sic] for a polypeptide displaying antiviral activity... | Betaseron® is a form of interferon-beta, which is known to have antiviral activity. Its production relies on a host transformed with a recombinant DNA molecule containing the gene sequence for interferon-beta. | ¶7, ¶32 | col. 1:44-46 |
Identified Points of Contention
- Scope Questions: A likely point of contention, though not detailed in the complaint, is whether Betaseron®, which is interferon beta-1b, falls within the scope of the "recombinant polypeptide" defined in the patent. This may involve comparing the specific amino acid sequence of Betaseron® to the sequence disclosed in the patent (’755 Patent, Fig. 4) and arguing about the significance of any differences.
- Validity/Enforceability Questions: The complaint's primary focus is on invalidity and unenforceability. A central question for the court will be whether the claimed method was obvious, given prior knowledge of interferon's therapeutic potential and established methods for gene expression (Compl. ¶46). The most significant issue raised is inequitable conduct. The complaint presents a side-by-side table contrasting statements made to the U.S. Patent Office with sworn statements made to the Canadian Patent Office regarding the "reasonable expectation of success" for expressing the interferon protein (Compl. ¶54). This evidence directly frames the question of whether Defendant intentionally misled the USPTO to secure the patent.
V. Key Claim Terms for Construction
- The Term: "recombinant polypeptide"
- Context and Importance: The definition of this term is critical to the infringement analysis. The central question is whether Plaintiff's product, Betaseron®, which is a specific form of interferon known as interferon beta-1b, is encompassed by the term "recombinant polypeptide" as used and defined in the patent. Practitioners may focus on this term because subtle differences between the accused product and the specific embodiments disclosed in the patent can be a basis for a non-infringement defense.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent abstract describes the invention as relating to polypeptides "displaying a biological or immunological activity of human fibroblast interferon" (’755 Patent, Abstract). This language could support an interpretation that covers any recombinantly produced polypeptide that functions like fibroblast interferon, regardless of minor structural variations.
- Evidence for a Narrower Interpretation: The specification discloses a specific 166-amino acid sequence for the "mature" interferon polypeptide (’755 Patent, Fig. 4). A party could argue that "recombinant polypeptide" is limited to this specific sequence or only minor, inconsequential variations thereof, potentially excluding variants like interferon beta-1b if the differences are deemed significant.
VI. Other Allegations
- Indirect Infringement: Plaintiff seeks a declaration of non-infringement for both direct and indirect infringement (Compl. ¶1, ¶75). The basis for an indirect infringement allegation would be that Plaintiff, by selling Betaseron® with instructions for treating multiple sclerosis, knowingly encourages and induces physicians and patients to perform the patented method.
- Willful Infringement: As a declaratory judgment plaintiff, Bayer does not face a willfulness claim. However, Bayer requests that the court find the case "exceptional" and award attorneys' fees pursuant to 35 U.S.C. § 285 (Compl., Prayer for Relief D). The factual basis for this request is the extensive allegation of inequitable conduct during the patent's prosecution, which Plaintiff argues constitutes litigation misconduct or raises the case to an exceptional level (Compl. ¶54-62).
VII. Analyst’s Conclusion: Key Questions for the Case
- A dispositive issue will be one of inequitable conduct: Did the patentee and its attorneys, with an intent to deceive the USPTO, make material arguments regarding the "reasonable expectation of success" that were directly contradicted by sworn statements made in a parallel Canadian prosecution, and did they fail in their duty to disclose those contradictory statements?
- A central validity question will be one of obviousness: At the time of the invention, was the claimed method of treating diseases with recombinantly produced interferon-beta obvious, considering the prior art knowledge of the protein's therapeutic uses, the public availability of its DNA sequence from other researchers, and established techniques for gene expression?
- Should the patent survive the invalidity and unenforceability challenges, a key evidentiary question on infringement will be one of technical scope: Does Plaintiff's Betaseron® product (interferon beta-1b) possess the specific structural and functional characteristics required to meet the definition of the "recombinant polypeptide" as that term is construed in light of the '755 patent's specification?