Biotechnology

Eye on Biotech, biotechnology, post-grant, IPREye on Biotech: Through the rise of biosimilars, the evolution of patent eligibility (Section 101), and the advent of hedge-fund challenges to pharma patents, Marshall Gerstein keeps a watchful eye on PTAB developments in the world of biotechnology and life sciences. Follow this industry-focused section of our blog to stay informed on post-grant proceedings and the related issues that matter most to your business.

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CFAD Fails to Knock Out 4 Acorda Patents to Multiple Sclerosis Drug

A recent set of final written decisions in four IPRs against Acorda Therapeutics puts more marks in the loss column for Kyle Bass and the Coalition for Affordable Drugs.  In IPRs 2015-01850, -01853, -01857 and -01858 (Coalition for Affordable Drugs v. Acorda Therepuatics Inc.), the Coalition for Affordable Drugs (CFAD) requested review of Acorda Therapeutics … Continue Reading

Don’t Switch Horses Midstream

In IPR2015-01157, 10X Genomics, Inc. challenged claims 1-31 of USPN 8,889,083 owned by the University of Chicago.  PTAB instituted trial on grounds of obviousness over two references.  Each party relied on the testimony of one or more experts, and the Patent Owner challenged expert testimony as exceeding the proper scope of Petitioner’s Reply. The technology … Continue Reading

Your Supplemental Evidence is Timely, but is it Relevant to a Claim at Issue? PTAB Will Decide.

Once a trial has been instituted at the PTAB, a party seeking consideration of supplemental evidence may file a motion in accordance with the following requirements: (1) the request for the authorization to file a motion to submit supplemental information must be made within one month of the date the trial was instituted; and (2) … Continue Reading

Purdue Not Estopped From Raising Invalidity Contentions at Trial That Were Submitted But Not Instituted During IPR

Recently, the Federal District Court for the District of New Jersey allowed Purdue Pharma to assert invalidity arguments in the litigation that were previously submitted in an IPR petition, but upon which IPR review was not instituted. See Depomed Inc. v Purdue Pharma LP, Civil Action 13-571, Order (D.N.J. Nov. 4, 2016). The Court rejected … Continue Reading

Federal Circuit to PTAB (Again) – Explain Yourself!!

The Federal Circuit has once again vacated and remanded a PTAB final written decision on the basis that the PTAB did not adequately explain its reasons for finding a claimed invention obvious.  In In re Nuvasive, Appeal No. 15-1670 (Fed. Cir. Dec. 7, 2016), the Federal Circuit reviewed the PTAB’s final written decision in IPR2013-00506 … Continue Reading

PTAB Institutes Third Biotech/Pharma Post-Grant Review

To date, only 43 petitions for Post-Grant Review have been filed with the PTAB.  Nine PGR petitions (21% of total petitions) have been filed to challenge patents arising from Art Unit 1600, which examines applications directed to biotechnology and organic chemistry subject matter.  The PTAB recently instituted the third ever PGR for a biotech-related patent … Continue Reading

PTAB Cancels Gattax® Patent Claims in Coalition for Affordable Drugs IPRs

In two final written decisions (IPR2015-01093 and IPR2015-00990), the PTAB found that challenged claims in Shire’s U.S. Patent No. 7,056,886 (the ’886 patent) were invalid as obvious.  The decisions highlight potential issues related to patents directed to pharmaceutical formulations that petitioners and patent owners alike may want to consider if confronted with an IPR related … Continue Reading

Ignore Occam’s Razor at your Peril

In IPR 2015-01127, PAR Pharmaceuticals, challenged claims 1-11 of USPN 8,404,215 owned by Horizon Therapeutics, LLC on grounds of obviousness over various combinations of six references.  Lupin Ltd. and Lupin Pharmaceuticals, Inc. filed another challenge to the claims of the ‘215 patent on the same grounds using the same arguments and evidence as used by … Continue Reading

3 Is a Magic Number for Mylan: 3 Teva Copaxone Patents Struck Down in IPRs

In a series of unfortunate events for Teva Pharmaceuticals, three patents covering methods for administering the blockbuster multiple sclerosis (MS) drug Copaxone® (glatiramer acetate) (owned by Yeda Research and Development Co.) were struck down by the PTAB in recent IPR decisions (IPR2015-00830, IPR2015-00643, and IPR2015-00644).  These patents are directed to methods for administering Copaxone in … Continue Reading

IPR Institution Denied Because Petitioner Used Hindsight Bias to Formulate Arguments

On August 23, 2016, the PTAB denied Mylan Laboratories Limited’s (Mylan) petition for IPR (IPR2016-00627) against a patent owned by Aventis Pharma S.A. (Aventis). In doing so, the PTAB offered guidance regarding what is required to successfully make out a claim of obviousness regarding a new chemical compound. In particular, the PTAB’s decision offers insight … Continue Reading

PTAB Accords Little Weight to Evidence without Analysis or Explanation

The PTAB recently issued a final written decision in an inter partes review (IPR), refusing to cancel claims in Verinata Health, Inc.’s U.S. Patent No. 8,318,430.  Ariosa Diagnostics v. Verinata Health, Inc., Cases IPR2013-00276 and -00277 (P.T.A.B. Aug. 15, 2016). The claims are directed to methods for determining the presence or absence of fetal aneuploidy … Continue Reading

Federal Circuit Affirms PTAB Upholding Patent Claims

In what has been a rare outcome to date, the Federal Circuit in Apotex v. Wyeth, dkt. no. 2015-1871 (Fed. Cir. Aug. 16, 2016) affirmed in a non-precedential decision the PTAB’s final written decision in IPR2014-00115 that the challenged claims were not unpatentably obvious over three references.  At trial, the PTAB found that Apotex did … Continue Reading

Priority Claims Unchallenged In Prosecution Can Be Weak Links

IPR2015-00291 decided a petition filed by Daiichi Sankyo Co. Ltd. against USPN 8,168,181 owned by Alethia Biotherapeutics, Inc.  The ‘181 patent issued from a continuation-in-part of the U.S. national phase of a PCT application and contains claims drawn to methods of impairing osteoclast differentiation, useful in treating various bone diseases.  The Board denied the Patent … Continue Reading

Been There, Done That: Petitioners Should Find Art and Arguments Not Previously Considered During Prosecution

This blog has previously explained on July 23, 2015, December 10, 2015, and December 16, 2015 why it is important for parties to AIA trials to carefully consider the patent prosecution history.  Under 35 U.S.C. § 325(d), the Board has discretion to deny an AIA trial if “the same or substantially the same prior art or … Continue Reading

Status Report on IPR Statistics for the Biotech/Pharma Technology Center

On June 30, 2016, lead APJ Jacqueline Wright Bonilla provided a status report on Inter Partes Review/Post Grant Review in the Biotechnology and Chemical Technology Center 1600 during the Biotechnology/Chemical/Pharmaceutical Customer Partnership (BCP) Conference.  The statistics discussed during this BCP Conference are current as of May 31, 2016. … Continue Reading

Squeezing the ‘Antibody Exception’ to Written Description into a Corner

The PTAB has continued the trend of pushing the -“antibody exception” to written description into an ever-smaller corner. Claims to methods of using antibodies that bind Siglec-15 to impair osteoclast differentiation and inhibit bone resorption were deprived of priority because the parent application failed to disclose the “antigenic regions useful for generating antibodies having the … Continue Reading

Rare Grant of Rehearing of Denial of Petition for Inter Partes Review

The Board initially denied institution of Mylan Pharmaceuticals’ petition for inter partes review of U.S. Patent No. RE44,186, owned by AstraZeneca.  After a rare grant of Mylan’s request for rehearing, the Board reconsidered the record and decided to institute the IPR.  The decision to institute focused on the content of Mylan’s expert testimony; and although … Continue Reading

Federal Circuit Confirms PTAB Can Cite Prior Art in IPR Final Decision That Was Not In Grounds Of Institution

In a recent appeal from a PTAB final written decision, the Federal Circuit determined that a patentee was not denied notice or an opportunity to respond to references cited in the final written decision as representing the state of the art,  but that were not the basis for a grounds for institution.  (Genzyme Therapeutic Prods. … Continue Reading

The Personal Touch: PTAB Grants Bass and Spangenberg IPR Petition

On May 20, 2016, the PTAB granted Kyle Bass and Erich Spangenberg’s petition for IPR (IPR2016-00245) against a patent owned by Alpex Pharma SA (Alpex).  The petition sought cancellation of claims 1-9 of U.S. Patent No. 8,440,170, asserting that the claims were obvious in view of numerous references.  The claims of the ‘170 patent are generally … Continue Reading

Federal Circuit Upholds Rule that New Petitioner Arguments Cannot Be Raised in IPR Reply Briefs

The Federal Circuit recently affirmed the Board’s IPR decision that IBS failed to satisfy its burden of demonstrating obviousness of the challenged claims of Illumina’s U.S. Patent No. 7,566,537 (“the ‘537 patent), and determined that the Board did not abuse its discretion in refusing to consider IBS’s reply brief.  Intelligent Bio-Systems, Inc. v. Illumina Cambridge … Continue Reading

Supporting Evidence, Not Counter-Punching, May Be Needed In An IPR

In IPR2015-01537, Momenta petitioned for IPR of claims 1-15 of U.S. Patent No. 8,476,239 owned by Bristol-Myers Squibb (BMS) on grounds of obviousness over three references: Cohen, Shire, and Carpenter.  Petitioner also relied on expert testimony.  The claims recite formulations containing CTLA4Ig, which is a stabilized form of a negative regulator (checkpoint inhibitor) of the … Continue Reading

Patent Applicants Who Appeal Must Wait Their Turn with the PTAB

Biotechnology patent applicants dissatisfied with the examination of their patent applications can look to the PTAB for relief by filing an appeal – but they will need to be very, very patient. The procedures created by the America Invents Act (AIA) for challenging U.S. patents – inter partes review, post grant review, and covered business … Continue Reading

Patent Ineligibility Under §101 Continues Slow Ooze Over More Territory

Biotech companies have increasingly found themselves the target of IPRs, and we have discussed this in some of our past posts.  Meanwhile, in the District Courts, biotech companies are defending against a new wave of challenges to the patent-eligibility of their inventions under 35 U.S.C. § 101.  While challenges under § 101 cannot be raised as grounds … Continue Reading

It’s Complicated: PTAB Reinforces Notion That Petitioners Should Consider Expert Testimony in Complex Technology Areas

This Blog previously highlighted the risks involved when a petitioner does not submit an expert declaration with their petition.  This risk may be lessened where the “the invention and prior art references are directed to relatively straightforward and easily understandable technology.” [Paper No. 41 at 17 n.6 of IPR2014-00169] (ruling in favor of petitioner despite … Continue Reading
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