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Lessons Learned from AIA Invalidity Proceedings in the Bio/Pharma Space

September 16, 2016, marked the fourth anniversary of the effective date for the invalidity proceedings before the Patent Trial and Appeal Board (PTAB or Board) created by the America Invents Act (AIA). These new AIA proceedings, particularly covered business method reviews (CBM) and inter partes reviews (IPR), had an almost immediate impact on litigation defense strategies in the financial services and technology fields.

The impact in the bio/pharma field was slower at the beginning, but the number of AIA petitions for review of bio/pharma patents has steadily increased over the past four years. In fiscal year (FY) 2016, bio/pharma patents have accounted for 14% of the 1,529 AIA petitions filed at the U.S. Patent and Trademark Office (PTO).[1] This is an increase from 9% in FY 15 and 6% in FY 14.[2] The increased and more routine use of these AIA invalidity proceedings in the bio/pharma field is having an impact on even the highly regulated areas of Hatch-Waxman drug (ANDA) and biosimilar patent litigation.

Who Is Using PTAB Proceedings to Challenge Bio/Pharma Patents?

A review of the bio/pharma AIA petitions[3] filed in 2013 and 2016 provides insight into how AIA petitions have influenced litigation strategies. As shown in the Figure below, there has been a dramatic shift in the way AIA petitions are being used to challenge bio/pharma patents. In 2013, the majority of the petitions were filed on litigated patents (approximately 75%), but many more of those petitions challenged patents involved in non-ANDA litigations (approximately 55%) than ANDA litigations (approximately 19%). In 2016, while petitions have again primarily been filed to challenge patents that are in litigation (approximately 80%), there has been a significant shift in the type of related litigation. Indeed, the percentage of petitions challenging patents that are involved in (or have been involved in) ANDA litigations versus non-ANDA litigations flipped in 2016 as compared to 2013.

The decrease in the percentage of petitions filed on bio/pharma patents that are involved in non-ANDA litigations was not due to a decline in the filings of such petitions. Indeed, the number of petitions filed for such patents remained the same in 2013 to 2016 (26 petitions in each year). Rather, the overall percentage decrease for challenges to patents involved in non-ANDA litigations was primarily due to a significant increase in the number of petitions challenging patents involved in ANDA litigations – up from 9 in 2013 to 82 so far in 2016.

Although more challenges in the ANDA context in 2016 were filed by petitioners that do not appear to be the first ANDA filers (approximately 43%), the apparent first ANDA filers have also filed a significant number of petitions (approximately 27%). Interestingly, the remaining 30% of the petitions filed in 2016 challenging patents involved in ANDA litigations have been filed by petitioners that are not involved in the related ANDA litigations. Many of these petitioners have been parties in other ANDA litigations, so those petitioners could be pursuing FDA approval for the drugs at issue in those ANDA litigations under a certification that they will not launch until the Orange Book patents covering the product expire (a Paragraph III certification).

There also has been an increase in challenges to patents related to biologics – up from 1 in 2013 (2%) to 12 already in 2016 (9%) – but, at present, few of those patents have been challenged in biosimilar litigation. Time will tell if petitions will continue to be filed at the current pace, and if there will be a further redistribution of the types of patents challenged as biosimilar litigation ramps up.

Lessons Learned

The influence of AIA proceedings on bio/pharma litigation was addressed in an MBHB webinar,[4] but there are certainly a number of takeaways that can be gleaned from the AIA petitions that have been filed over the past four years involving bio/pharma patents.

For the Petitioner

The Petition

The petition is the petitioner’s first chance to impress upon the Board that the challenged claims should have never issued. As a practical matter, petitioners that have been served with a complaint for patent infringement need to be sure to have their petition on file within one year of being served with the complaint,[5] as the Board strictly enforces that deadline.[6] In addition, care should be taken to ensure that the petition includes all required information, as petitions have frequently been rejected on procedural grounds for failure to provide necessary information.[7] With respect to the grounds in the petition, there is a higher likelihood of institution (and ultimately, cancellation) based on obviousness challenges than on anticipation challenges. And if the petition relies on the same reference for both anticipation and obviousness grounds, there is a better chance of institution on the obviousness challenge than for anticipation. Finally, given the word count limits,[8] it may be better to file multiple petitions to fully address multiple grounds for challenging the patent rather than shortchanging some of the grounds in order to fit within the limits of a single petition. This option is more costly since multiple request fees would be due,[9] but pre-paid post-institution fees can be recovered via a request for refund if the Board does not institute review of one (or more) of the petitions, or if the Board institutes review for fewer claims than requested.[10]

Request for Rehearing

A petitioner can seek rehearing following a decision denying institution,[11] but to date, such requests have rarely been successful. Indeed, it is not uncommon for the Board to use the request as a means to amend or revise the Institution Decision based on the petitioner’s comments in the request. A request for rehearing can also be filed following an unfavorable Final Written Decision, but again, such requests are rarely successful. Thus, a petitioner should weigh the potential benefits (and the likelihood of achieving those benefits) against the costs associated with making such requests.

Motion for Joinder

A motion for joinder allows would-be petitioners who missed the “one-year from being served with an infringement complaint” window to join an instituted IPR, provided that such a motion is filed within one month of the institution decision in the IPR for which joinder is requested.[12] To expedite the decision on the motion for joinder and to increase the likelihood that the motion will be granted, the movant’s own IPR petition (which is filed with the motion) should track the instituted grounds and omit any uninstituted grounds or any additional grounds. In addition, the movant should reach out to the original petitioner as early as possible to discuss coordination of efforts, and attempt to reach agreement on how the parties will coordinate efforts before filing the motion, if possible.[13]

Opposition to Amendment

Following institution, the patent owner can seek permission from the Board to file a motion to amend.[14] However, a recent study from the PTO indicates that few patent owners have successfully amended claims in AIA proceedings, due at least in part to the high burden on the patent owner to show, by a preponderance of the evidence, the patentability of the proposed substitute claims.[15] If faced with a motion to amend, a petitioner should consider all avenues of attack, including whether the patent owner has met its burden of demonstrating that the proposed claims overcome all the prior art at issue, meet all the other requirements for patentability, and do not enlarge the scope of the claims of the patent or introduce new subject matter.[16]

For the Patent Owner

Experts

Technical expert witnesses play a critical role in patent litigation in district court. These experts provide testimony to assist the court in understanding the invention, including how it works and its real-world implications. Most importantly, these technical expert witnesses assist the Court in placing itself in the shoes of the hypothetical person of ordinary skill in the art to understand the teachings of the prior art at the time of the invention.

While technical expert witnesses play a similar role in AIA proceedings, the strategies for presenting an expert witness’s testimony are different in such a setting, where the testimony is presented almost entirely through written declarations and deposition testimony and not through the presentation of a live witness. For a patent owner, one critical strategy decision is when to utilize expert testimony in the AIA proceedings. As of May 2016, patent owners may submit expert testimonial evidence with the patent owner’s preliminary response.[17] While it may be too soon to reach any significant conclusions, we did not observe any noticeable impact on the likelihood of denial of institution based on the use of an expert declaration in the patent owner’s preliminary response. This may be due to the fact that, at the institution stage, deference is given to the petitioner in the event of a disagreement between the opinions of the two competing experts (which will almost always be the case). Since it is unlikely that a patent owner’s expert will win the battle of the expert testimonials at the institution stage of the proceedings, serious consideration should be given to foregoing expert testimony at the preliminary response stage. If there is a compelling reason to use expert testimony in that preliminary response, it is advised to limit the expert’s testimony according to the specific need, as using an expert could lock the expert into a position unnecessarily early in the proceedings.

Secondary Considerations

Objective indicia of non-obviousness (aka secondary considerations) play an important role in the obviousness analysis in district court. This is not surprising, particularly in ANDA litigation, because the patented product is often a drug product or method of treatment that has achieved commercial success because it fills a previously unmet treatment need for a population of patients. But do these secondary considerations carry any weight in the Board’s decision to institute? The answer is no. Because deference is given to the petitioner in the Board’s institution decision, at best, the Board will acknowledge the patent owner’s preliminary evidence of secondary considerations and note that they will wait to determine the weight of that evidence once the record is complete.[18]

If secondary considerations carry so little weight in the institution decision, will they carry more weight in the Board’s ultimate obviousness analysis at final written decision? The answer to that question is also no, but for a very different reason. Often the evidence of secondary considerations is based upon the clinical studies and success of the commercial product. At the district court level, this is effective because the claims at issue have often been narrowed to those that specifically encompass the labeled drug product and the infringing generic version of that product. In contrast, the claims under review in the IPR proceeding often include the broadest claims. Therefore, the PTAB often holds that the secondary consideration evidence presented does not overcome the petitioner’s prima facie case of obviousness because the evidence either lacks the requisite nexus with the claims and/or is not commensurate in scope with the broadest claims under review. [19]

One strategy to increase the weight and effectiveness of secondary consideration evidence is to cancel the broadest claims under review in favor of narrower claims (already in the patent or added by amendment) that specifically encompass the commercial embodiment of the claimed product. While, as a rule, amendment practice has been met with almost no success, this is a situation where amendment might pay off (if all of the other amendment requirements can be met), as it would create a situation more akin to how secondary considerations evidence is traditionally presented to and considered by a district court. A second strategy is to present the secondary consideration evidence on a claim-by-claim basis, in recognition that the secondary consideration evidence may not be equally applicable to all of the challenged claims. Presenting the secondary consideration evidence in a claim-by-claim manner instead of generally should help ensure that the evidence corresponds to the scope of the challenged claim.



[1] Data from the PTO website, available at https://www.uspto.gov/sites/default/files/documents/2016-08-31%20PTAB.pdf. The data is current as of August 31, 2016, but is not reflective of the entire FY 16, which ended September 30, 2016. The PTO classifies Bio/Pharma patents as those in Technology Center 1600.

[2] Id.

[3] We reviewed petitions for IPR and post-grant review (PGR) filed for patents within Classes 424 and 514 (Drug, Bio-Affecting and Body Treating Compositions) of the U.S. Patent Classification System. For 2016, we reviewed the petitions filed through October 14.

[4] See Alison Baldwin and Paula Fritsch, Ph.D., The Shifting Landscape of Bio/Pharma Litigation: The Influence of PTAB Proceedings, MBHB Webinar (September 20, 2016), available at http://www.mbhb.com/events/xpqEventDetail.aspx?xpST=EventDetail&event=203.

[5] 35 U.S.C. § 315(b); 37 C.F.R. § 42.101(b).

[6] See, e.g., IPR2014-00361, Paper 14, and IPR2016-00282, Paper 19.

[7] See, e.g., IPR2014-01422, Paper 14, denying institution for failure to name all real parties in interest, where allowing the petitioner to cure the defect would be futile because the corrected petition would be untimely.

[8] 37 C.F.R. § 42.24.

[9] 37 C.F.R. § 42.15.

[10] See https://www.uspto.gov/patents-application-process/appealing-patent-decisions/trials/patent-review-processing-system-prps-0 at E7.

[11] 37 C.F.R. § 42.71(c).

[12] 37 C.F.R. § 42.122(b).

[13] See, e.g., IPR2016-01122, Papers 10, 12-14, where the second petitioner’s petition copied the instituted grounds from the IPR for which joinder was requested, but the second petitioner and the original petitioner had not reached agreement on coordination amongst the parties at the time the second petition and the motion for joinder were filed, which led the patent owner to initially oppose the motion for joinder. That opposition was withdrawn once the petitioners reached a coordination agreement.

[14] 37 C.F.R. § 42.121.

[15] Patent Trial and Appeal Board Motion to Amend Study, available at https://www.uspto.gov/sites/default/files/documents/2016-04-30%20PTAB%20MTA%20study.pdf.

[16] See 37 C.F.R. § 42.121; Nike, Inc. v. Adidas AG, 812 F.3d 1326, 1334 (Fed. Cir. 2016) (“[T]he Board did not err by placing the burden on [Patent Owner] to establish patentability over the prior art of [Patent Owner]’s proposed substitute claims.”).

[17] Amendments to the Rules of Practice for Trials Before the Patent Trial and Appeal Board, Federal Register, Vol.81, No. 63, Friday, April 1, 2016.

[18] See, e.g., IPR2013-00371, Paper 11.

[19] See, e.g., IPR2014-00784/IPR2015-00518, Paper 112.

 

© 2016 McDonnell Boehnen Hulbert & Berghoff LLP

 

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