Biotechnology

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Funny vintage detective looking through a magnifier

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 arguments previously were presented to the Office.”  The Board recently exercised that discretion in denying an inter partes review petition and, in doing so, provided yet another warning to petitioners: do not waste the Board’s time presenting in a petition prior art and arguments that were already considered during prosecution, and be sure to address deficiencies in prior art combinations the patentee overcame during prosecution.  Drug Prices for Consumers,  LLC v. Forest Labs. Holdings Ltd., Case IPR2016-00379, Paper 14 (PTAB July 1, 2016).
Continue Reading Been There, Done That: Petitioners Should Find Art and Arguments Not Previously Considered During Prosecution

US Patent and Trademark Office in Alexandria, VA.

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

A businessman panics after realizing he's painted himself 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 desired functional properties.” Consequently, the claims were anticipated by the cited reference under 35 U.S.C. §102(a), and Patentee’s other evidence of prior conception, diligence and reduction to practice was insufficient to antedate the reference. Daiichi Sankyo Co., Ltd. v. Alethia Biotherapeutics, Inc., IPR2015-00291 (Paper No. 75, June 14, 2016) (final written decision).
Continue Reading Squeezing the ‘Antibody Exception’ to Written Description into a Corner

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 not mentioned in the decision, the replacement of one APJ in the PTAB panel for the decision on rehearing might have played a role in the grant of the request for rehearing and the decision to institute the IPR on rehearing even though both decisions were unanimous.
Continue Reading Rare Grant of Rehearing of Denial of Petition for Inter Partes Review

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. Ltd. v BioMarin Pharm. Inc., Appeal Nos. 2015-1720, -1721 (Fed. Circ., June 14, 2016)).  The court concluded that there is no requirement, either in the PTAB’s regulations, in the Administrative Procedure Act (APA), or as a matter of due process, for the institution decision to anticipate and set forth every legal or factual issue that might arise during the trial, and that the PTAB acted properly in citing the additional references. 
Continue Reading Federal Circuit Confirms PTAB Can Cite Prior Art in IPR Final Decision That Was Not In Grounds Of Institution

Gavel and PillOn 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 directed to orally disintegrating tablets with a speckled appearance.  According to the ‘170 patent, the speckled appearance can be achieved by using colored granules of a water-soluble sugar, and provides easy identification by doctors and patients.  Bass and Spangenberg argue in the petition that the patent is invalid as obvious because speckles comprising colored granules of a water-soluble sugar were well-known in the art at the time of the invention.
Continue Reading The Personal Touch: PTAB Grants Bass and Spangenberg IPR Petition

DNAThe 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 Ltd., Case No. 2015-1693 (Fed. Cir. May 9, 2016). Illumina contended that its challenged claims, directed to a method of labeling nucleotides to determine their identity in a sequencing by synthesis (SBS) method, were nonobvious based on its use of a particular azidomethyl group as a 3′ OH blocking (or protecting) group.
Continue Reading Federal Circuit Upholds Rule that New Petitioner Arguments Cannot Be Raised in IPR Reply Briefs

BoxerIn 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 immune system useful in treating autoimmune disease and rheumatoid arthritis, for example.  The Patent Owner opposed institution by attacking the Petitioner’s position as failing to provide a reason to combine the cited references and as relying on impermissible hindsight in arriving at a formulation that satisfied all features recited in the claims (i.e., tonicity, pH, excipient concentration, excipient:therapeutic mass ratio, volume, and stability). 
Continue Reading Supporting Evidence, Not Counter-Punching, May Be Needed In An IPR

Line of business people in profileBiotechnology 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 methods – have transformed strategies for contesting the validity of patents.  In just a few years, the Patent Trial and Appeal Board (PTAB) has become one of the busiest forums for contesting patent validity, due in part because the PTAB must complete its review within 18 months of receiving a petition. Patent applicants dissatisfied with a patent examiner’s rejection of their patent application may appeal the rejections to  the same PTAB that administers AIA trials. But, these applicants cannot expect the PTAB to decide their appeal with the same timeliness with which the PTAB completes AIA trials.
Continue Reading Patent Applicants Who Appeal Must Wait Their Turn with the PTAB

Bottle of Ooze

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 in an IPR, the PTAB has required proof of eligibility where patent owners have sought to amend their claims during IPRs.  In at least two final written decisions in IPRs, the PTAB denied motions to amend claims because the PTAB concluded the amended claims recited subject matter ineligible for a patent under § 101 and in view of previous rulings in related district court proceedings that claims of similar scope were ineligible subject matter. 
Continue Reading Patent Ineligibility Under §101 Continues Slow Ooze Over More Territory

Resources & Info

Arthrex and the Supreme Court Resource Center

In United States v. Arthrex, Inc., the Supreme Court has heard whether 125+ PTAB decisions rendered through October 2019 must be remanded for new decisions. Read about how that issue developed through our post.

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Our Team

PTABWatch, provided by Marshall, Gerstein & Borun LLP, analyzes and reports recent developments concerning Post-Grant Proceedings at the Patent Trial and Appeal Board (PTAB) of the U.S. Patent and Trademark Office (USPTO), including Inter Partes Review (IPR), Post Grant Review (PGR), and Covered Business Method (CBM) proceedings.