Does AbbVie Have 'Unclean Hands' From Building Humira Patent Thicket? Judge Allows Discovery

Magistrate judge says Boehringer's theory 'may or may not be viable' as an infringement defense; permits third party subpoenas for information on clinical trials.

Boehringer Ingelheim GMBH is trying to cut down AbbVie Inc.'s thicket of Humira (adalimumab) patents by claiming they were obtained to improperly delay biosimilar competition.

As a defense to AbbVie's infringement suit, BI contends that AbbVie has "unclean hands" from amassing so many patents. Under the "unclean hands" doctrine, a plaintiff is precluded from relief if it engaged in wrongdoing. The claim is unusual in a patent dispute but the magistrate judge in the case has allowed BI to pursue discovery and ordered AbbVie to turn over documents requested by BI.

"Boehringer's theory may or may not be viable as a patent defense or as a basis for relief by way of counterclaim," Magistrate Judge Richard Lloret of the US District Court for the District of Delaware stated in a June 4 memorandum and order. "The viability of the claim as a matter of law may be tested through summary judgement."

If BI were to succeed, the court could potentially find a swath of patents invalid, clearing the path for biosimilars to enter the market.

The more than 100 patents covering Humira have deterred BI and Amgen Inc. from launching their biosimilars, the only two to be approved by FDA. Pfizer Inc. executives commented at a media briefing in April that the high number of Humira patents makes it difficult to try to invalidate them. Pfizer has an adalimumab biosimilar in Phase III. (Also see "Humira's 'Unique' Number Of Patents Makes Biosimilar Entry Risky, Pfizer Says " - Pink Sheet, 10 Apr, 2018.)

Line Between Licit, Illicit Conduct Is 'Unclear'

AbbVie filed suit against BI in August 2017 saying it had identified 74 patents as being infringed by BI. It opted to cap the number in the initial round of litigation to eight. The complaint was filed after FDA approved BI's biosimilar to Humira, Cyltezo (adalimumab-adbm). (Also see "Humira Biosimilar: Boehringer Faces Same Launch Hurdles As Amgen" - Pink Sheet, 28 Aug, 2017.)

"The simple act of applying for and receiving a patent, standing alone, can hardly be the basis for patent invalidation" – Magistrate Judge Richard Lloret

Amgen, which obtained FDA approval of its biosimilar Amjevita (adalimumab-atto) in September 2016, settled an infringement suit with AbbVie. The agreement allows it to launch in Europe on Oct. 16, 2018 and in the US on Jan. 31, 2023. Samsung Bioepis Co. Ltd., which has a pending adalimumab biosimilar application, reached a similar agreement with AbbVie, which allows it to launch 150 days after Amjevita. (Also see "The New 180 Days? Humira Biosimilar Deals Give Amgen 150-Day Jump On Samsung" - Pink Sheet, 5 Apr, 2018.)

Humira has been the top-selling drug in the world for six years, generating nearly $18.4bn in global sales in 2017. The biologic was approved in December 2002.

In its answer to AbbVie's complaint, BI asserted that AbbVie "engaged in a pattern of pursing numerous overlapping and non-inventive patents for the purpose of developing a 'patent thicket,' using the patenting process itself as a means to seek to delay competition against its expensive and lucrative adalimumab product."

While Judge Lloret is allowing BI to pursue discovery, he suggested that showing unclean hands could be difficult.

In a footnote to his order, he noted that the anti-competitive effect of a so-called "patent thicket" has been the subject of scholarly and judicial debate.

"Whether the creation of a 'patent thicket' can amount to a cognizable defense to a claim of patent infringement, such as unclean hands, and where the boundary line between licit and illicit conduct might be, is not clear. The simple act of applying for and receiving a patent, standing alone, can hardly be the basis for patent invalidation," he stated.

The "unclean hands" defense was successfully raised by Gilead Sciences Inc. in its patent battle with Merck & Co. Inc. A jury found that Gilead's Sovaldi (sofosbuvir) and Harvoni (ledipasvir/sofobuvir) hepatitis C drugs infringed Merck patents and awarded Merck $200m. A judge subsequently revoked the award, finding Merck had "unclean hands" because of misconduct by its former patent attorney who was responsible for prosecuting the patents. (Also see "HCV Patent Case: With "Unclean Hands," Merck Can't Collect Jury Award From Gilead" - Pink Sheet, 7 Jun, 2016.)

Humira IP Strategy Slide Show

One of the documents BI sought to back up its claim is a January 2011 AbbVie slide presentation titled "Humira IP Discussion." In a June 14 order, Lloret noted that AbbVie had asked to claw back the unredacted version of the presentation after BI quoted from the document in its interrogatory responses. AbbVie said the unredacted version had been produced inadvertently.

Lloret said the presentation discussed intellectual property strategies for Humira in the face of business threats posed by biosimilars. He ordered AbbVie to produce six slides unredacted and permitted two slides to remain fully redacted and three others to be partially redacted, finding they are subject to attorney-client privilege. The redacted slides include communications about the quality of patent claims and the timeline for execution of AbbVie's patent strategy.

Subpoenas For Humira Clinical Trial Information

BI also won a dispute over its ability to subpoena third parties for information related to three Humira clinical trials, the ARMADA study concerning rheumatoid arthritis, a continuation of the ARMADA study, and the ATLAS study pertaining to ankylosing spondylitis.

BI is seeking the data to support a public use defense, whereby a party is immune from infringement claims if the invention was disclosed to the public at least one year before the patent application was filed.

"Details of the clinical testing process and protocols, and communications with patients, are reasonably calculated to produce relevant evidence concerning a public use defense," the judge stated in a May 23 order.

He denied AbbVie's motion for a protective order to stay responses to eight third-party subpoenas. Those receiving subpoenas included Regents of the University of California, University of Alabama at Birmingham, and Brigham and Women's Hospital.

AbbVie argued that the discovery would require disclosure of patient records protected under the Health Insurance Portability and Accountability Act and that researchers may grow wary of participating in clinical trials with AbbVie if they must respond to discovery in lawsuits.

The judge rejected these arguments, saying the burden of HIPPA redaction is a routine concern in any cases involving health care records, and that the risk of having to respond to discovery "is or should be factored into the cost of doing clinical trials, either up front or by way of indemnification."

The case is one of the most high profile biosimilar disputes, which is reflected in the line up of attorneys on both sides. AbbVie is represented by Latham & Watkins, Wilmer Cutler Pickering Hale and Dorr, and Finnegan, Henderson, Farabow, Garrett & Dunner and BI is represented by Paul Hastings, along with local counsel.