DCT
2:19-cv-03893
American Infertility Of New York v. Braverman Reproductive Immunology
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: American Infertility of New York, P.C. (New York)
- Defendant: Braverman Reproductive Immunology, P.C. and Reproductive Immunology Supplements, Inc. (New York)
- Plaintiff’s Counsel: La Reddola, Lester & Associates, LLP
- Case Identification: 2:19-cv-03893, E.D.N.Y., 07/05/2019
- Venue Allegations: Venue is alleged to be proper as Defendants are New York corporations that reside and conduct business within the judicial district, where the complained-of acts of infringement allegedly occurred.
- Core Dispute: Plaintiff alleges that Defendants’ sale and marketing of a DHEA supplement infringes patents related to methods of using androgens to improve female fertility outcomes.
- Technical Context: The technology involves the administration of androgens, such as dehydroepiandrosterone (DHEA), to treat female infertility, particularly in women with diminished ovarian reserve.
- Key Procedural History: The complaint alleges that on May 30, 2019, approximately five weeks prior to filing suit, Plaintiff’s counsel sent a letter to Defendants providing detailed information about the patents-in-suit and requesting information about Defendants’ sales and marketing of DHEA. This event may be central to the allegations of willful infringement.
Case Timeline
| Date | Event |
|---|---|
| 2004-10-26 | Earliest Priority Date for ’400 and ’436 Patents |
| 2011-11-29 | U.S. Patent No. 8,067,400 Issued |
| 2016-06-28 | U.S. Patent No. 9,375,436 Issued |
| 2019-05-30 | Plaintiff allegedly sent notice letter to Defendants |
| 2019-07-05 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 8,067,400 - "Androgen Treatment in Females"
The Invention Explained
- Problem Addressed: The patent’s background section describes the problem that women with diminished ovarian function were largely considered "untreatable," suffering from decreased egg production, poor quality eggs, and high rates of miscarriage, often due to chromosomal abnormalities (aneuploidy) in embryos (Compl. ¶13; ’400 Patent, col. 1:56-col. 2:4).
- The Patented Solution: The invention is a method of improving fertility outcomes by administering an androgen, such as dehydroepiandrosterone (DHEA), for at least two months. This pre-treatment is described as improving the number and quality of eggs and embryos, increasing pregnancy rates, and reducing miscarriage rates by decreasing aneuploidy (’400 Patent, Abstract; col. 2:7-30).
- Technical Importance: The invention provided a method-based therapeutic approach for a patient population that previously had very limited treatment options (’400 Patent, col. 2:4-5).
Key Claims at a Glance
- The complaint asserts independent claims 1 and 6 (Compl. ¶¶23, 26).
- Claim 1:
- A method of decreasing aneuploidy rates in human embryos
- comprising administering androgen to a female
- for at least two months
- Claim 6:
- A method of decreasing time to pregnancy and increasing pregnancy rates in females
- comprising administering an androgen
- for at least two months
- The complaint asserts dependent claims 3 and 4 (Compl. ¶¶24-25).
U.S. Patent No. 9,375,436 - "Androgen Treatment in Females"
The Invention Explained
- Problem Addressed: The patent addresses the same technical problem as the ’400 Patent: infertile women with diminished ovarian function who respond poorly to conventional treatments and have a high probability of miscarriage and aneuploid embryos (’436 Patent, col. 1:40-57).
- The Patented Solution: The invention is directed to a method of using DHEA to treat a human female with diminished ovarian reserve. A key aspect of the method claimed is the administration of the androgen for at least four weeks without the concurrent administration of gonadotropin, a hormone commonly used in other fertility treatments (’436 Patent, Abstract; col. 7:6-9).
- Technical Importance: This patent claims a specific treatment protocol that isolates the therapeutic effect of DHEA from other hormonal interventions commonly used in fertility cycles (’436 Patent, col. 7:6-9).
Key Claims at a Glance
- The complaint asserts independent claim 1 (Compl. ¶27).
- Claim 1:
- A method of reducing aneuploidy rates in human embryos
- comprising: administering an androgen selected from the group consisting of DHEA and testosterone to a human female
- for at least four weeks
- without concurrent administration of gonadotropin
- The complaint asserts dependent claims 3 and 4 (Compl. ¶¶28-29).
III. The Accused Instrumentality
Product Identification
The accused instrumentality is a supplement product containing dehydroepiandrosterone ("DHEA") (Compl. ¶5).
Functionality and Market Context
- The complaint alleges that Defendants sell the DHEA product in bottles of 25 mg capsules with directions for 12-week supplementation at dosages of 50 to 75 mg per day (Compl. ¶¶8, 30).
- It is alleged that the product is marketed and sold through an interactive website for the purpose of improving fertility, including in conjunction with in vitro fertilization (IVF) treatments (Compl. ¶¶7-9). The marketing materials allegedly state that the DHEA supplement "will ‘improve your fertility’," "increases pregnancy rates and live birth rates," and "improves ovarian health and egg and embryo quality" (Compl. ¶¶9, 31).
- No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
U.S. Patent No. 8,067,400 Infringement Allegations
| Claim Element (from Independent Claim 6) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A method of decreasing time to pregnancy and increasing pregnancy rates in females | Defendants allegedly market their DHEA product with claims that it "will improve your fertility" and "increases pregnancy rates and live birth rates." | ¶31 | col. 2:51-56 |
| comprising administering an androgen | The accused product is a supplement containing DHEA, which is an androgen and the specific compound recited in asserted dependent claim 3. | ¶5, ¶24 | col. 1:11-13 |
| for at least two months. | The product is allegedly sold with instructions for "12-week supplementation," which is longer than the claimed two-month period. | ¶8, ¶33 | col. 1:13-15 |
U.S. Patent No. 9,375,436 Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A method of reducing aneuploidy rates in human embryos... | Defendants allegedly market the DHEA product on a website named "preventmiscarriage.com" and claim it improves embryo quality, which the patent links to reducing aneuploidy rates. | ¶8, ¶9 | col. 2:59-64 |
| ...administering an androgen selected from the group consisting of DHEA and testosterone to a human female | The accused product is a supplement containing DHEA, which is sold for administration to women seeking to conceive. | ¶5, ¶9 | col. 3:56-61 |
| for at least four weeks | The product is allegedly sold with instructions for "12-week supplementation," which is longer than the claimed four-week period. | ¶8 | col. 2:59-64 |
| without concurrent administration of gonadotropin. | The complaint alleges infringement of this claim, implying the product is administered, or intended to be administered, without concurrent gonadotropin. | ¶33 | col. 7:6-9 |
Identified Points of Contention
- Scope Questions: A central point of contention for the ’436 Patent will likely be the negative limitation "without concurrent administration of gonadotropin." The complaint alleges the product "can or should be used in conjunction with fertility treatments" (Compl. ¶9), which often include gonadotropin. This raises the question of whether marketing a supplement for a general fertility regimen, which may later include gonadotropin, can infringe a claim that requires its absence.
- Technical Questions: The infringement theory relies on the marketing claims and instructions provided by Defendants (Compl. ¶¶31, 33, 37). An evidentiary question will be whether the content on the website and accompanying the product provides sufficiently specific instructions to users to perform all the steps of the patented methods, thereby supporting a claim for indirect infringement.
V. Key Claim Terms for Construction
- The Term: "without concurrent administration of gonadotropin" (from ’436 Patent, Claim 1)
- Context and Importance: This negative limitation is the primary feature distinguishing this claim from other method claims in the patent family. Its construction will be critical to determining infringement, as the accused DHEA supplement is allegedly marketed for use with fertility treatments that may include gonadotropin. Practitioners may focus on this term because its interpretation could either broadly cover pre-treatment with DHEA before an IVF cycle or narrowly restrict the claim to situations completely divorced from such treatments.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification states that "DHEA works not only in conjunction with gonadotropin stimulation of ovaries, but also without gonadotropin stimulation of ovaries" (’436 Patent, col. 7:6-9). This language could suggest that the "without" administration is a distinct, patentable method, even if DHEA is later used with gonadotropins.
- Evidence for a Narrower Interpretation: The specification repeatedly discusses DHEA as a preparatory treatment for an IVF cycle, which is a process that centrally involves gonadotropin administration (’436 Patent, col. 3:35-41). This context could be used to argue that the "without" limitation creates ambiguity or should be interpreted narrowly to avoid ensnaring the very uses contemplated by the patent.
VI. Other Allegations
- Indirect Infringement: The complaint alleges both induced and contributory infringement (Compl. ¶¶46-53). The inducement claim is based on allegations that Defendants’ website, promotional literature, and product instructions direct and encourage consumers to use the DHEA supplement in a manner that practices the patented methods (Compl. ¶37).
- Willful Infringement: The complaint alleges willful and intentional infringement (Compl. ¶39). This allegation is based on alleged pre-suit knowledge of the patents, purportedly established by a detailed letter sent by Plaintiff’s counsel to Defendants on May 30, 2019, to which Defendants allegedly did not respond (Compl. ¶¶34-35).
VII. Analyst’s Conclusion: Key Questions for the Case
- A central issue will be one of claim scope: can the negative limitation “without concurrent administration of gonadotropin” in the ’436 Patent be met when a DHEA supplement is marketed for a general course of fertility improvement that may, at a later stage, involve fertility treatments that use gonadotropin?
- A key evidentiary question will concern indirect infringement: does the marketing on Defendants' website and the instructions sold with their DHEA product provide sufficiently specific direction to constitute active inducement for end-users to perform every step of the claimed methods?
- A third question will relate to willfulness: did the pre-suit letter provide actual, unambiguous notice of infringement sufficient to establish the requisite knowledge and intent for enhanced damages, and what is the significance of Defendants’ alleged failure to respond?