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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IPR Institution Denied Because Petitioner Used Hindsight Bias to Formulate Arguments

thumbnail image of DNA strandBy Eric M. Brusca, Ph.D. on Posted in Biotechnology, Inter Partes Review, Sections 102/103
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

thumbnail image of DNA strandBy Lynn L. Janulis, Ph.D. on Posted in Appeals, Biotechnology, Inter Partes Review, Sections 102/103
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

thumbnail image of DNA strandBy William K. Merkel, Ph.D. on Posted in Biotechnology, Inter Partes Review, Post Grant Review, Sections 102/103
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 Cir. Aug. 16, 2016) affirmed in a non-precedential decision the PTAB’s final written decision in IPR2014-00115 that the challenged claims were not unpatentably obvious over three references.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

thumbnail image of DNA strandBy William K. Merkel, Ph.D. on Posted in Biotechnology, Inter Partes Review, Post Grant Review
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

thumbnail image of DNA strandBy Eric M. Brusca, Ph.D. on Posted in Biotechnology, Inter Partes Review, Sections 102/103
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

thumbnail image of DNA strandBy Sharon M. Sintich, Ph.D. on Posted in Biotechnology, Inter Partes Review, Post Grant Review
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

thumbnail image of DNA strandBy Marshall Gerstein on Posted in Biotechnology, Inter Partes Review, Section 112
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

thumbnail image of DNA strandBy Sharon M. Sintich, Ph.D. on Posted in Biotechnology, Institution / Denial, Inter Partes Review, Sections 102/103
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

thumbnail image of DNA strandBy Katherine L. Neville, Ph.D. on Posted in Appeals, Biotechnology, Institution / Denial, Inter Partes Review, Sections 102/103
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

thumbnail image of DNA strandBy Eric M. Brusca, Ph.D. on Posted in Biotechnology, Inter Partes Review, Real Party-in-Interest, Sections 102/103
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

thumbnail image of DNA strandBy Lynn L. Janulis, Ph.D. on Posted in Appeals, Biotechnology, Inter Partes Review, Sections 102/103
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

thumbnail image of DNA strandBy William K. Merkel, Ph.D. on Posted in Biotechnology, Inter Partes Review, Post Grant Review, Sections 102/103
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

thumbnail image of DNA strandBy David A. Gass on Posted in Appeals, Biotechnology, Inter Partes Review, Post Grant Review, Section 101
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

thumbnail image of DNA strandBy Katherine L. Neville, Ph.D. on Posted in Appeals, Biotechnology, Section 101
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

thumbnail image of DNA strandBy Eric M. Brusca, Ph.D. on Posted in Biotechnology, Inter Partes Review, Sections 102/103
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

PTAB Revises Claim Construction in Final Written Decision, But Still Finds Claims Invalid

thumbnail image of DNA strandBy Heather R. Kissling on Posted in Biotechnology, Sections 102/103
On January 11, 2016, the PTAB issued a final written decision in ABS Global, Inc. et al. v. XY, LLC, IPR2014-01161, holding claims 1 and 3 of U.S Patent No. 7,195,920 invalid for obviousness.  The IPR is part of a long-running dispute between the parties involving multiple issues and multiple patents, as reported previously. … Continue Reading

Cross-Pollination of Information From Litigation to IPR Can Lead to Trouble for Parties

thumbnail image of DNA strandBy Katherine L. Neville, Ph.D. on Posted in Biotechnology, Discovery, Inter Partes Review
In a recent order by the magistrate judge in Jazz Pharmaceuticals, Inc. v. Amneal Pharmaceuticals, LLC (NJD, Jan. 22, 2016), defendants Amneal Pharmaceuticals and Par Pharmaceuticals were reprimanded and threatened with sanctions and monetary fines for trying to use confidential information from the litigation to move for additional discovery in a related IPR proceedings.  The judge … Continue Reading

PTAB Reminds Petitioners That Conclusions in Expert Declarations Must be Supported by Explanations

thumbnail image of DNA strandBy Eric M. Brusca, Ph.D. on Posted in Biotechnology, Inter Partes Review, Sections 102/103
On January 19, 2016, the PTAB denied Coalition for Affordable Drugs V LLC’s (CFAD) request for rehearing following the Board’s decision denying institution of IPR.  In IPR2015-01086, CFAD filed a petition requesting an IPR of claims 1–13 in Biogen International GmbH’s (Biogen) U.S. Patent No. 8,759,393.  The Board denied the petition and CFAD filed a … Continue Reading

PTAB Warns Again That Prosecution Declarations Without Depositions May Be Given Little or No Weight

thumbnail image of DNA strandBy Marshall Gerstein on Posted in Biotechnology, Discovery, Inter Partes Review
If you rely in an IPR on a declaration submitted during prosecution, the PTAB may give it little or no weight if your opponent cannot cross-examine the declarant. In Praxair Distribution, Inc. v. INO Therapeutics LLC, the PTAB instituted inter partes review of U.S. Patent No. 8,846,112, directed to methods of providing nitric oxide gas … Continue Reading

Broader is Better for the Petitioner, but Inherency is Intrinsically Difficult

thumbnail image of DNA strandBy Marshall Gerstein on Posted in Biotechnology, Inter Partes Review, Sections 102/103
Two recent PTAB final written decisions highlight the benefits that the “broadest reasonable interpretation” standard for claim construction provides to Petitioners, as well as the difficulty Petitioners face in proving inherent anticipation.  The PTAB instituted two IPRs on the same patent: one on an anticipation ground, and another on an obviousness ground.  The Petitioner failed … Continue Reading

PTAB Dismisses Biosimilar Company’s IPR Petition Without Prejudice, When Petitioner Loses its Expert

thumbnail image of DNA strandBy Marshall Gerstein on Posted in Biotechnology, Estoppel
The PTAB recently granted Celltrion’s motion to dismiss its IPRs without prejudice, after Celltrion suddenly lost its ability to rely on a key expert declaration.  Celltrion had filed IPR petitions against two patents covering use of Rituxan®, and had sought joinder with pending IPRs filed by Boehringer Ingelheim (BI) against the same patents.  Although Celltrion … Continue Reading

Pharma industry continues efforts to exempt patents from IPR

thumbnail image of DNA strandBy John R. Labbé on Posted in Biotechnology, Inter Partes Review, Legislation
The pharmaceutical industry continues its efforts to exempt pharmaceutical and biotechnology patents from inter partes review (IPR). Neither the House’s Innovation Act nor the Senate’s PATENT Act currently contain any provisions that would exempt particular patents from these proceedings. But as we reported in June, some members of the Senate judiciary committee appear sympathetic to … Continue Reading
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