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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The Headaches in Claiming Antibody-based Inventions Broadly

thumbnail image of DNA strandBy Sandip H. Patel on Posted in Biotechnology, Inter Partes Review, IPR, Sections 102/103
Recent Federal Circuit decisions call into question the value of patents broadly claiming inventions on antibodies and their function in treating debilitating diseases. The decisions in these cases originated in district courts and arguably swept aside the merits of scientific breakthroughs because the inventions claimed were not enabled or were otherwise insufficiently described to justify … Continue Reading

Section 101 Challenges are Out of Bounds in IPR Appeals

thumbnail image of DNA strandBy Lynn L. Janulis, Ph.D. on Posted in Appeals, Biotechnology, Inter Partes Review, IPR, Section 101, Sections 102/103
Neptune Generics v. Eli Lilly & Company, Case No. 2018-1257, 2018-1258 (Fed. Cir. April, 2019), concerns an Eli Lilly & Co. patent protecting method of administering folic acid and a methylmalonic acid (MMA) lowering agent, e.g., vitamin B12. Specifically, the method concerns the administration of these products before administering pemetrexed disodium, an anti-folate chemotherapeutic, to … Continue Reading

Play the Claim

thumbnail image of DNA strandBy Sandip H. Patel on Posted in Biotechnology, Claim Construction, Ex Parte, Reexamination, Sections 102/103
Monsanto Technology LLC v. E.I. DuPont de Nemours & Co. Appeal 2017-1032 (Fed. Cir. Jan. 5, 2018), illustrates “[t]he life of a patent solicitor has always been a hard one.” [1] The case concerns an inter partes reexamination of a Monsanto patent in which the Patent Office concluded the claimed subject matter was inherently described in an … Continue Reading

Rituxan Patent Spared by Failure to Establish Product Label as “Printed Publication”

thumbnail image of DNA strandBy Heather R. Kissling on Posted in Biotechnology, Inter Partes Review, Sections 102/103
A patent relating to a method of treating rheumatoid arthritis using rituximab recently survived its fourth IPR challenge. Celltrion, Inc. v. Biogen, Inc., IPR2016-01614 (PTAB Feb. 21, 2018). The PTAB determined that the Petitioners failed to establish that the challenged claims of the patent were obvious over prior art, in part, because of the Petitioners’ … Continue Reading

Petitioner Failed to Show That Patent Owner’s Drug Product Package Insert Was a Printed Publication

thumbnail image of DNA strandBy Eric M. Brusca, Ph.D. on Posted in Biotechnology, Inter Partes Review, Sections 102/103
On February 9, 2018, the PTAB denied Sandoz Inc.’s petition for inter partes review of U.S. Patent No. 9,512,216, a patent owned by AbbVie Biotechnology Ltd. The patent recites methods for treating moderate-to-severe chronic plaque psoriasis with adalimumab, a human anti-tumor necrosis factor α (TNFα) antibody.  The methods of the claimed invention involve subcutaneously administering … Continue Reading

CAFC Hears IPR Appeal From Parties That Were Time-Barred From Filing Petition

thumbnail image of DNA strandBy Eric M. Brusca, Ph.D. on Posted in Biotechnology, Inter Partes Review, IPR, Joinder
Research Corporation Technologies, Inc. (RCT) sued Mylan Pharmaceuticals, Inc. (Mylan), Breckenridge Pharmaceutical, Inc. (Breckinridge), and Alembic Pharmaceuticals Ltd. (Alembic), in federal district court, accusing them of infringing United States Reissued Patent No. RE38,551. The patent claims pharmaceutical compositions useful in the treatment of epilepsy and other central nervous system disorders. Within one year of being … Continue Reading

PTAB Not Always Bound By Previous Court Decisions Regarding Patent Validity

thumbnail image of DNA strandBy Katherine L. Neville, Ph.D. on Posted in Appeals, Biotechnology, Sections 102/103
In Novartis AG v. Noven Pharm. Inc., Appeal 2016-1678-1679 (April 2017), Novartis appealed two PTAB decisions holding claims of two patents obvious over cited prior art (IPR2014-00549 and IPR2014-00550), arguing that previous judicial holdings of non-obviousness should control the PTAB’s factual findings and that the claims should have been held non-obvious. The two Novartis patents … Continue Reading

Eli Lilly’s Pemetrexed Therapy Claims Survive Challenge At PTAB

thumbnail image of DNA strandBy Heather R. Kissling on Posted in Biotechnology, Inter Partes Review, IPR, Sections 102/103
The Federal Circuit’s decision in Eli Lilly & Co. v. Teva Parenteral Medicines, Inc., 845 F.3d 1357 (Fed. Cir. 2017) attracted much attention for applying the theory of divided infringement in the context of pharmaceutical therapeutic regimen claims.  Before the Federal Circuit decision, a scrum of petitioners successfully petitioned for IPR of the Lilly patent, … Continue Reading

Eli Lilly Successfully Challenges U Penn Erbitux® Claims at PTAB, Derailing Infringement Suit

thumbnail image of DNA strandBy Heather R. Kissling on Posted in Biotechnology, Inter Partes Review, IPR, Sections 102/103
The PTAB recently canceled the University of Pennsylvania’s U.S. Patent No. 7,625,558, a potentially fatal blow to the University’s suit against Eli Lilly and Company alleging its cancer therapeutic Erbitux® (centuximab) infringes the patent.  Eli Lilly and Co. v. Trustees of the Univ. of Penn., Case IPR2016-00458 (July 13, 2017). The PTAB’s decision resolved testimony … Continue Reading

PTAB Exercised Discretion to Terminate Ex Parte Reexaminations in Ariosa v. Illumina; CAFC to Review

thumbnail image of DNA strandBy Heather R. Kissling on Posted in Biotechnology, Inter Partes Review, IPR
Third parties seeking to challenge pre-AIA patents in the USPTO often choose between IPR and ex parte reexamination.  In some cases, petitioners pursue both proceedings, sequentially or in parallel, taking advantage of different timelines to completion, different standards for institution, and using insights gained in one proceeding in the other.  The PTAB recently exercised its … Continue Reading

One-Year Time Bar Does Not Apply to a Request for Joinder of IPR Proceedings

thumbnail image of DNA strandBy Eric M. Brusca, Ph.D. on Posted in Biotechnology, Inter Partes Review, IPR, Joinder
Teva Pharmaceuticals USA, Inc. (“Teva”) filed a Petition, seeking an IPR of claims 1–20 of Allergan’s U.S. Patent No. 8,642,556. [IPR2017-00579, Paper No. 9]  Along with the Petition, Teva filed a Motion for Joinder to join Mylan Pharmaceuticals Inc. v. Allergan, Inc., IPR2016-01129.  This blog has previously reported on the topic of joinder in IPR … Continue Reading

Claim Construction Sends Duke’s Patent Back to PTAB for Reconsideration, In Part

thumbnail image of DNA strandBy Katherine L. Neville, Ph.D. on Posted in Appeals, Biotechnology, Inter Partes Review, Sections 102/103
In a recent appeal from a PTAB final written decision, the Federal Circuit reversed the Board’s determination that all claims of a Duke patent were unpatentable (Duke Univ. v. BioMarin Pharm. Inc., Appeal No. 2016-1106 (Fed. Cir., April 25, 2017). The court concluded that certain of the Board’s claim constructions were incorrect, and that others, while appropriate, … Continue Reading

Presentation Not Qualified as a Printed Publication Because Audience Lacked Expertise

thumbnail image of DNA strandBy Lynn L. Janulis, Ph.D. on Posted in Biotechnology, Inter Partes Review, IPR, Sections 102/103
In a recent final written decision (Trustees of the University of Pennsylvania v. Coalition for Affordable Drugs VIII, LLC, IPR2015-01835, Paper No. 56 (PTAB Mar. 6, 2017)), the Board determined that the Coalition for Affordable Drugs (“Petitioner”) failed to demonstrate that claims 1-10 of U.S. Patent No. 8,618,135 (“the ’135 patent) were obvious. The claims … Continue Reading

PTAB Grants Hospira Petition to Institute IPR of Genentech Antibody Purification Patent

thumbnail image of DNA strandBy Heather R. Kissling on Posted in Biotechnology, Inter Partes Review, IPR, Sections 102/103
IPRs are an attractive option for biosimilar applicants to clear the patent landscape before delving into litigation under the Biologics Price Competition and Innovation Act of 2009 (BPCIA), which is still in its infancy.  Roche’s Herceptin® (trastuzumab) is a prime target for biosimilar makers, accounting for sales of over $6.5 billion in 2015.  Mylan, Celltrion, … Continue Reading

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

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

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

thumbnail image of DNA strandBy Eric M. Brusca, Ph.D. on Posted in Biotechnology, Inter Partes Review, IPR, Trial Procedures
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

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

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

thumbnail image of DNA strandBy Heather R. Kissling on Posted in Biotechnology, Post Grant Review, Section 112
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

thumbnail image of DNA strandBy Joshua T. Elliott on Posted in Biotechnology, Inter Partes Review, IPR, Sections 102/103
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

thumbnail image of DNA strandBy William K. Merkel, Ph.D. on Posted in Appeals, Biotechnology, Claim Construction, Sections 102/103
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

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