Gilead in 2013: AbbVie sought to eliminate competition and dominate market for HCV drugs

I had not seen this lawsuit filed by Gilead against AbbVie and Abbott before. It is an interesting read. According to Gilead:

Abbott executives and “inventors” conspired and carried out the initial steps of the company’s scheme by filing serial fraudulent patent applications asserting that Abbott had invented methods of treating HCV using PSI-7977 as well as the Gilead Combination (as well as thousands of combinations of Abbott’s other competitors’ HCV compounds). The first of these applications is dated October 21, 2011.

Among other things, Gilead asks for "an injunction against any further attempts by AbbVie to claim methods of treating HCV using Sofosbuvir, or combinations of Sofosbuvir and Ledipasvir, as AbbVie 'inventions.'"

A PDF of the suit is available here. I have also cut an pasted the non-redacted sections from paragraphs 1 though 21.


GILEAD SCIENCES, INC., GILEAD PHARMASSET LLC, and GILEAD SCIENCES LIMITED,
Plaintiffs,

v.

ABBOTT LABORATORIES, INC.,
and ABBVIE, INC.,

Case 1:13-cv-02034-UNA Document 6 Filed 12/18/13 Page 1 of 75 PageID #: 465

C.A. No. ________ JURY TRIAL DEMANDED

1. This case involves a scheme by two large pharmaceutical companies, Defendants Abbott Laboratories, Inc. (“Abbott”) and AbbVie, Inc. (“AbbVie”), to attempt to eliminate competition and dominate the market of drugs to treat the hepatitis C virus, known as “HCV.” To execute their scheme, the defendants falsely and knowingly represented to the United States Patent and Trademark Office (“PTO”) that they invented highly valuable methods of treating HCV that were, in fact, invented by plaintiffs Gilead Sciences, Inc. Gilead Pharmasset LLC, Gilead Sciences Limited, and their predecessor Pharmasset, Inc. (collectively “Gilead”) and others. Defendants made these representations despite the knowledge that the inventions for which they claimed ownership had, in fact, been developed by their competitors

Redacted

2. In the past few years, many leading pharmaceutical companies, including Gilead and Defendants, have sought to develop new methods of treating chronic HCV, a debilitating virus that attacks the liver and can cause death. Until recently, the standard of care treatment for HCV included the administration of an injectable medication called pegylated interferon for up to 12 months. Treatments employing interferon have a variable cure rate, and the drug can cause serious and sometimes permanent side effects, including severe flu-like symptoms, hemolytic anemia, worsening of cardiac disease, weight loss, skin rashes, hair loss, muscle or bone pain, diarrhea, and vomiting.

3. Based on recent scientific advancements, it is now believed that millions of HCV sufferers worldwide can be cured by the use of a combination of drugs called Direct Acting Antivirals (“DAAs”), administered in pill form without interferon. These therapies promise high cure rates—90% and higher—much shorter treatment durations—as little as 8 weeks—and dramatically reduced side effects.

4. Given these benefits, there has been intense competition in the pharmaceutical industry to bring the first such innovative combination therapy to market, including between Gilead and Defendants. As of the date of this complaint, Gilead and Defendant AbbVie are widely recognized as being the two companies most likely to first bring an all-oral, interferon free combination therapy to market.

5. Gilead’s combination therapy is the two drugs, Sofosbuvir, also known as PSI- 7977 or GS-7977, and Ledipasvir, also known as GS-5885 (together, “the Gilead Combination”). Sofosbuvir is what is known as a NS5B inhibitor, while Ledipasvir is what is known as an NS5A inhibitor. Gilead acquired Sofosbuvir in 2011 when it acquired Pharmasset. Gilead developed Ledipasvir independently.

6. The Gilead Combination promises to revolutionize the treatment of HCV, offering the ability to cure HCV within as short as 8 weeks with all-oral interferon-free therapy. No longer will patients be required to endure nearly a year of therapy with inferior drugs like interferon that may not work at all. Notably, the promise of Sofosbuvir has already been partially realized. On December 6, 2013, just 8 months after Gilead filed a new drug application for Sofosbuvir, the FDA approved Sofosbuvir as a treatment for HCV in combination with certain other drugs for durations as short as 12 weeks. This approval was hailed throughout the scientific and popular press, including in the New York Times and the Wall Street Journal. Gilead is marketing Sofosbuvir as SOVALDI TM , in 400 mg tablets.

7. The opportunity to combine Sofosbuvir with Ledipasvir or other Gilead NS5A or third-party compounds deemed appropriate for patients was the primary reason Gilead acquired Pharmasset, for which it paid $11 billion.

Redacted.

9. . . . Gilead ultimately announced its acquisition of Pharmasset on November 21, 2011, and completed the transaction on January 17, 2012.

10. While discussions in support of the Gilead-Pharmasset acquisition were ongoing, on September 16, 2011, Gilead filed a provisional patent application covering the Gilead Combination that disclosed that it could be used for as little as 12 weeks. In late 2011 and early 2012, after the transaction with Pharmasset had closed, Gilead publicly disclosed its intention to conduct clinical studies of the Gilead Combination, including studies of the combination for a12- week treatment duration.

11. During this same time frame, Abbott (now AbbVie) published results from clinical trials of its proposed combination, which is far less patient-friendly than Gilead’s. AbbVie’s proposed combination therapy is a combination of four drugs. In addition to the potential patient inconvenience of possibly taking more pills, more drugs mean more potential drug-drug interactions and side effects for patients.

12. On information and belief,

REDACTED

Abbott embarked on an unlawful scheme designed to attempt to block the Gilead Combination (as well as other companies’ potential combinations) from reaching patients. This way, Abbott could dominate the HCV all-oral treatment market, even if its combination was inferior to those of its competitors.

13. On information and belief, Abbott executives and “inventors” conspired and carried out the initial steps of the company’s scheme by filing serial fraudulent patent applications asserting that Abbott had invented methods of treating HCV using PSI-7977 as well as the Gilead Combination (as well as thousands of combinations of Abbott’s other competitors’ HCV compounds). The first of these applications is dated October 21, 2011.

14. Gilead first learned of the defendants’ fraud in the days after Abbott’s patent applications first published on April 25, 2013. At that time, Gilead learned not only of the applications’ existence for the first time but also the speed with which AbbVie (Abbott’s successor-in-interest) had sought to receive patents based on those applications. At the time Gilead learned of the applications, the applications were already in condition for allowance.

15. On May 1, 2013, the same date that the PTO issued notices of allowances for the first two of AbbVie’s patents, Gilead notified AbbVie of its legal obligation to inform the PTO of Gilead’s prior pending patent application covering the Gilead Combination. AbbVie failed to do so. The PTO then issued Patent Nos. 8,466,159 (the ’159 patent) [attached hereto as Exhibit A] and 8,492,386 (the ’386 patent) [attached hereto as Exhibit B] to AbbVie on June 18 and July 23, 2013, respectively, to the following AbbVie “inventors”:

Redacted

16. These two patents purport to claim, as AbbVie’s invention, methods of treating HCV genotype 1 that comprise administering PSI-7977 and GS-5885 to HCV patients for 12 weeks, with and without ribavirin. But AbbVie invented no such thing. That combination therapy is the invention of Gilead and Pharmasset, not AbbVie.

17. Indeed, AbbVie cannot make, use or sell the Gilead Combination without violating the United States patent laws. Both PSI-7977 and GS-5885 are protected by United States Patents Nos.7,964,580, 8,334,270, and 8,580,765 (PSI-7977) and 8,088,368, 8,273,341, and 8,575,118 (GS-5885), respectively, owned by Gilead Pharmasset LLC. Any attempt by AbbVie to make, use or sell the Gilead Combination in the United States would infringe those patents, willfully so.

18. Despite this, and despite its knowledge of Gilead’s prior application for the Gilead Combination, AbbVie continues to this day to assert that it invented the Gilead Combination, both in the United States and abroad. For example, since securing the fraudulent allowance of the ’159 and ’386 patents, AbbVie has pursued additional claims regarding other potential combination therapies that employ Sofosbuvir. On December 16, 2013, the PTO allowed Application Number 13/656,012, which claims, as AbbVie’s invention, 12-week methods of treatment for HCV using PSI-7977 and any NS5A inhibitor; AbbVie paid the issue fee the very next day. Again, AbbVie invented no such thing.

19. Similarly in Europe, AbbVie has pursued a patent application covering the use of Sofosbuvir and GS-5885 for 12-week treatment of HCV genotype 1. In so doing, it presented Gilead’s clinical trial data on the Gilead Combination to the European Patent Office and asserted that Gilead “adopted” AbbVie’s “invention.” There is no truth to such claims.

20. Because AbbVie cannot lawfully manufacture the Sofosbuvir-containing therapies claimed in the ’159 and ’386 patents and the allowed ’012 application, its patenting activity for those therapies has only one potential purpose—to enforce them against the Gilead Combination or future Gilead combinations, either to attempt to block them from the market or to extract royalties from Gilead.

21. As detailed further herein, AbbVie’s conduct in pursuing this conspiracy is fraudulent, intentional and in willful violation of the Patent Laws of the United States, the Delaware Deceptive Trade Practices Act and common law of Slander of Title and Tortious Interference with Prospective Business Relations,

Redacted

. As detailed herein, Gilead seeks restitution and damages for this unlawful conduct forthwith, as well as the invalidation of the currently issued AbbVie patents that claim therapies using Sofosbuvir and an injunction against any further attempts by AbbVie to claim methods of treating HCV using Sofosbuvir, or combinations of Sofosbuvir and Ledipasvir, as AbbVie “inventions.”

[snip]

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